Nov 9, 1999 New antihypertensive medication survey reveals that nearly 19 million hypertensive patients may have significant drug-tolerability problems
Oct 19, 1999 Solvay pharmaceuticals exercises option to purchase DURAMED Pharmaceuticals common stock
Oct 18, 1999 Antihypertensive TEVETEN® (eprosartan mesylate) tablets is now available in the U.S.
Oct 7, 1999 Solvay pharmaceuticals, Inc. introduces ACEON® (perindopril erbumine) tablets to U.S. market
Oct 6, 1999 DURAMED Pharmaceuticals and SOLVAY Pharmaceuticals announce alliance in the USA
Sep 29, 1999 Prestigious SOLVAY Pharmaceuticals menopause prize goes to research on HRT and Stroke
Sep 21, 1999 Fluvoxamine: helping patients recover after trauma
Jul 20, 1999 SOLVAY Pharmaceuticals, Inc. acquisition of UNIMED Pharmaceuticals,Inc
Jun 14, 1999 SOLVAY Group announces agreement to acquire UNIMED Pharmaceuticals, Inc to strengthen its marketing presence among U.S. primary care physicians
May 11, 1999 SOLVAY acquires TEVETEN®, an innovative cardiovascular drug, for world-wide marketing
May 5, 1999 SOLVAY Pharmaceuticals, Inc. enters cardiovascular market acquires U.S. rights to ACEON® (perindopril erbumine) for hypertension
Apr 16, 1999 BERNA and SOLVAY Pharmaceuticals collaborate in influenza vaccines
Apr 16, 1999 Novel vaccine approaches for the control of infectious diseases such as AIDS, hepatitis B and influenza
Apr 7, 1999 Solvay group: LUVOX® and DEPROMEL®, first innovative mental health drug(SSRI), approved for Japanese market
Mar 30, 1999 Microsurgical developments pvc-rat reduces use of live rats drastically
Dec 21, 1998 U.S. Food and drug administration (FDA) approves PROMETRIUM® capsules for hormone replacement therapy
Oct 30, 1998 Social Phobia: an under-recognized and undertreated disorder
Oct 29, 1998 Can antidepressants help the prevention of suicide? Proper treatment of depression key in suicide prevention
Apr 14, 1998 SOLVAY Pharmaceuticals, Inc. (USA) launches marketing of ESTRATAB® tablets for the prevention of osteoporosis
March 13, 1998 Sex, depression and quality of life
Jan 22, 1998 SOLVAY Pharmaceuticals: new organizations in Scandinavia and Greece reflect determination to strengthen healthcare activities
Jan 5, 1998 SOLVAY Pharmaceuticals, inc. acquires U.S. marketing rights to PROMETRIUM® natural micronized progestorone
Nov 17, 1997 Biotech alliance signed between SOLVAY and INNOGENETICS in genomic research. SOLVAY takes an equity stake into Innogenetics
Oct 16, 1997 Solvay Pharmaceuticals acquires marketing rights for innovative combination hormone replacement patch from MERCK
May 26, 1997 SOLVAY Group grants FUJISAWA the distribution rights of LUVOX® to Japan
Mar 25, 1997 LUVOX® (fluvoxamine maleate) tablets offers hope for Obsessive Compulsive Disorder (OCD) in children and adolescents–First SSRI To Gain Indication–

 



November 9, 1999

NEW ANTIHYPERTENSIVE MEDICATION SURVEY REVEALS THAT NEARLY 19 MILLION HYPERTENSIVE PATIENTS MAY HAVE SIGNIFICANT DRUG-TOLERABILITY PROBLEMS

Study Also Shows That One-Third of Hypertensives Have Uncontrolled, Elevated Systolic Blood Pressure

ATLANTA, Nov. 9, 1999 – Today, a national antihypertensive medication survey released in a symposium sponsored by the Association of Black Cardiologists, Inc. (ABC), revealed that nearly four out of every 10 patients (38 percent) being treated for high blood pressure may stop taking their medication due to drug tolerability problems. The survey also found that 95 percent of patients believe that their blood pressure is under control, yet 35 percent of these patients reported elevated or uncontrolled systolic blood pressure above 140 mm Hg, suggesting that elevated systolic blood pressure — the leading cause of cardiovascular morbidity and mortality — is misunderstood among patients.

“This survey highlights the extent of the tolerability problem in hypertension, which is widespread among all patient populations, and underscores the need for the medical community to continue searching for pharmacological alternatives,” says Dr. Frank James, President of the Association of Black Cardiologists, Inc. “Surprisingly, the survey also presents some new challenges in treating high blood pressure, because the findings show that elevated systolic blood pressure is not being controlled to the recommended levels.”

The survey, released by ABC, demonstrates that among patients being treated for hypertension, 36 percent have changed medications at least once because of the severity of side effects. Also, 13 percent of respondents stated that their current medication dosage had to be adjusted, at least once, because of adverse events. The most commonly reported side effects were fatigue (22%), and dizziness (21%). African American respondents were significantly more likely to experience the side effects of headache, potassium loss and weakness compared to Caucasian respondents.

The survey also finds that younger patients (ages 25-54) are significantly more likely than their older counterparts (age 55 and up) to characterize side effects as having a significant impact on their life.

The ABC survey confirms recent trends from the Third National Health and Nutrition Examination Survey (NHANES-III) that demonstrate a downward trend in hypertension awareness, treatment, and control among patients. Phase 2 of the NHANES (1991-1994) revealed that among high blood pressure patients, there is a decrease in awareness of hypertension (68 percent in 1994 vs. 73 percent in 1991). Similarly, treatment rates have declined from 65 percent in 1991 to 54 percent in 1994 and high blood pressure control (achieving target measurements within the normal range) has declined from 29 percent in 1991 to 27 percent in 1994.

Isolated Systolic Hypertension on The Rise
The survey reports that on average, 30 percent of patients have been diagnosed with isolated systolic hypertension (ISH), per physician practice. ISH — a condition that exists when the systolic pressure is higher than 140 mm Hg with a diastolic pressure that is less than 90 mm Hg — is the most common form of high blood pressure in older Americans. ISH affects more than three million people over the age of 60.

More than half of physicians surveyed (52.5 percent) believe that controlling systolic pressure is the most important goal in treating elderly hypertensives. Conversely, nearly 20 percent believe that diastolic control is the most important goal of therapy.
The ABC survey also found that 44 percent of African Americans vs. 31 percent of Caucasians reported systolic readings > 140 mm Hg. Similarly nearly 40 percent of the diabetic patient population reported a reading above 140 mm Hg.

“Systolic blood pressure is a major predictor of cardiovascular diseases and this survey underscores the need to do a better job at controlling systolic blood pressure in key patient groups,” says Dr. Domenic Sica, chairman of Clinical Pharmacology and Hypertension at the Medical College of Virginia of Virginia Commonwealth University. “Clearly, these new results also indicate a greater need to educate patients on what constitutes elevated hypertension, including systolic blood pressure.”

A study conducted in 1991, called the Systolic Hypertension in the Elderly Program (SHEP), reported a significant reduction in stroke and coronary events with successful lowering of systolic blood pressure to below 140 mm Hg through drug therapy. SHEP proved that ISH is not a normal part of the aging process, but a strong indicator of increased cardiovascular risk.

Tolerability Problems Include Drug-Drug Interactions
The physician component of the survey also confirmed that the tolerability problem extends beyond side effects. Seventy-five percent of treating physicians reported that drug-drug interactions are a common problem with their patients. Conversely, 88 percent of respondents in the patient arm of the study stated that they had little drug-drug interaction problems.

“Physicians are very concerned about drug-drug interactions, while patients are generally not aware of the significant problems that concomitant drug regimens can create,” added Dr. James. “The ABC survey reinforces that the tolerability problem extends beyond common side effects or adverse reactions in the hypertensive patient.”

In addition to their hypertension treatments, the research revealed that most hypertensive patients take 2 or more additional medications. Forty-six percent take 2-3 other medications while 36 percent take 3-5 other medications. Because of this drug-drug prevalence, 95 percent of physicians reported that the method of elimination is an important consideration in their selection of anti-hypertensive medication. Most drugs are either eliminated through the liver or
the kidney. Those that have a dual elimination process are often preferred because they lower the likelihood of toxicity if one or the other organ is functionally impaired.

Rating Antihypertensive Medications
Combination therapy is the most common treatment regimen. Physicians who were surveyed indicated that, on average, 39 percent of their patients receive combination therapy. The most commonly prescribed class of medication is the ACE inhibitors (prescribed to 31 percent of patients). ARBs are the least commonly prescribed treatment class (prescribed to 11 percent of patients). However, cardiologists are more likely to prescribe ARBs than general practitioners (14% vs. 9% respectively).

Most physicians surveyed reported having to switch a patient’s medication at least once to address efficacy. According to the survey, diuretics (46.5 percent) are the most likely to be changed because of efficacy problems, followed by beta blockers (21.8 percent), calcium channel blockers (15.8 percent), ACE inhibitors (9.9 percent) and ARBs (5.9 percent).

Interestingly, almost one quarter of the physicians believe that ARBs are the most likely medication to be stopped because of adverse events or side effects. However, these same physicians reported the fewest efficacy problems and lowest level of drug interactions with ARBs.

According to Dr. Sica this is not necessarily a contradiction. “ARBs are a relatively new classification of hypertensive drugs,” says Sica. “Many physicians have not used them long enough to understand them. If an adverse event occurs when patients are being treated with a new drug, physicians will likely assume it is caused by the new treatment even if the reaction is unrelated. However, numerous clinical studies have showed us that ARBs have a tolerability profile similar to or better than placebo; therefore, it is necessary to translate this knowledge into clinical practice.”
Physicians also indicated the percentage of patients in their practice that experience the most common and specific side effect in conjunction in each drug class :
– Of patients treated with beta-blockers, the average percentage of patients having fatigue as a side effect is 34 percent.
– Of patients treated with diuretics, the average percentage of patients experiencing electrolyte imbalance as a side effect is 30 percent.
– Of patients treated with calcium channel blockers, the average percentage of patients having edema as a side effect is 26 percent.
– Of patients treated with ACE inhibitors, the average percentage of patients having cough as a side effect is 21 percent.
– Of patients treated with ARBs, the average percentage of patients having cramping as a side effect is 7 percent.

The Study
The study was comprised of two audiences, patients and physicians, and utilized two key research methods, qualitative and quantitative, with each audience. The patient research consisted of a small-scale, telephone-based, qualitative study with 20 clinically diagnosed, hypertensive patients. Findings from the qualitative research were used to design a more in-depth telephone questionnaire. Three hundred fourteen (314) patients completed the telephone questionnaire. The survey gathered information from 314 patients for a margin of error on the overall findings of +/- 5.5 percent at the 95 percent confidence interval.

The physician audience primarily consisted of primary care physicians and cardiologists. Again, a two-phase research approach was utilized. The qualitative research consisted of 12 telephone interviews with physicians. Following the completion of the qualitative research, a structured questionnaire was conducted among 101 physicians representing five physician groups (cardiology, internal medicine, family/general practice, nephrology and geriatrics).

The study was funded by a grant from Unimed Pharmaceuticals, a Solvay Pharmaceuticals, Inc. company. The study was conducted by the independent research firm, Berrier & Associates, in October, 1999.

The Association of Black Cardiologists is a not-for-profit 501(c) 3 volunteer organization of more than 600 African-American cardiologists and medical professionals that is fully accredited by the Accreditation Council for Continuing Medical Education (ACCME). ABC was founded by Dr. Richard Allen Williams and sixteen other cardiologists in 1974. ABC emerged out of a need for health providers, particularly those who provide cardiovascular care to African-Americans, to coalesce as a group to promote primary prevention, quality of life and culturally sensitive clinical management of cardiovascular diseases. According to Dr. Williams, “The Association of Black Cardiologists was created because children deserve to know their grandparents.”

For information, contact:

Jennifer Saltz
Principal PR
(404) 898-1729

Lynda Woodworth
Principal PR
(212) 537-8078

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October 19, 1999

SOLVAY PHARMACEUTICALS EXERCISES OPTION TO PURCHASE DURAMED PHARMACEUTICALS COMMON STOCK

CINCINNATI, October 19, 1999 — Duramed Pharmaceuticals, Inc. (Nasdaq:DRMD) today announced that it has been notified that Solvay Pharmaceuticals, Inc. is exercising the option granted October 6, 1999, and intends to purchase the maximum number of 3,000000 shares of Duramed common stock at $9.00 per share made available under the option, subject to certain conditions. On or before October 22, 1999, Solvay Pharmaceuticals will purchase 1,666,666 shares of Duramed common stock. Duramed expects to satisfy the conditions of that purchase.

Purchase of the remaining 1,333,334 shares available under the option is subject to additional conditions, including: satisfactory completion of all applicable regulatory requirements, including Hart-Scott-Rodino antitrust review; the future creation of an additional director position on Duramed’s board of directors to be designated by Solvay Pharmaceuticals; and, final approval by the Solvay America, Inc. board of directors.

The sale of 1,666,666 shares of newly issued stock will increase Duramed’s total fully diluted shares outstanding to approximately 29 million. The closing market price of Duramed common stock on October 18, 1999 was $8 11/16 per share.

Duramed Pharmaceuticals and Solvay Pharmaceuticals In Product Promotion Alliance

On October 6, 1999, the companies announced an alliance to jointly promote three of the companies’ hormone products in the United States: Duramed Pharmaceuticals’ CENESTIN® (synthetic conjugated estrogens, A) Tablets and Solvay Pharmaceuticals’ ESTRATEST®/ESTRATEST® H.S. Tablets (esterified estrogens and methyltestosterone) and PROMETRIUM® (progesterone) Capsules.

On October 11, 1999, a combined national sales force of more than 300 Duramed Pharmaceuticals and Solvay Pharmaceuticals sales representatives began promoting the alliance products to obstetricians and gynecologists across the United States. Solvay Pharmaceuticals’ resources also include teams of regional marketing managers, field trainers, medical liaison teams and a medical advisory committee comprised of leading women’s health physicians.

CENESTIN is designated as the primary product in the Duramed/Solvay Pharmaceuticals alliance while the Solvay Pharmaceuticals products will address additional important therapeutic requirements in women’s health. All three products are expected to benefit from the broadened exposure in the marketplace. Under the terms of the alliance, Duramed Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc. will retain all revenue from their respective products.

CENESTIN® was approved by the U.S. Food and Drug Administration (FDA) in March 1999. CENESTIN offers millions of women and their physicians a new, appealing plant-derived synthetic conjugated estrogens product with a slow-release formulation. Solvay Pharmaceuticals is a leader in the women’s health market. Its products, ESTRATEST®/ESTRATEST® H.S. Brand Tablets and PROMETRIUM® Capsules will complement CENESTIN in the pharmaceutical sales effort.

About Solvay Pharmaceuticals, Inc. Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. The Group’s members employ some 33,000 people in 46 countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Additional information about the Group can be found on the World Wide Web at http://www.solvay.com

About Duramed Pharmaceuticals, Inc. Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. The company’s business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women’s health and the hormone replacement therapy market.

On March 24, 1999, the U.S. Food and Drug Administration (FDA) approved the company’s first branded product, CenestinÒ (synthetic conjugated estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms. The company is undertaking a clinical program to evaluate Cenestin in additional tablet strengths and for the prevention of osteoporosis. One important element of these clinical trials – the bone marker study — is complete. Preliminary results are favorable and clearly show a reduction in bone markers, which indicates a bone preservation effect. In addition, in the cardiovascular evaluation, a positive lipid profile was found. The company anticipates beginning the full osteoporosis clinical study in 2000 to confirm the beneficial results indicated by the bone marker study. Further, Duramed anticipates receiving approval for the 1.25 mg tablet strength of Cenestin by December 1999 and approval for the 0.3 mg tablet strength in mid-2000.

The company’s stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at www.duramed.com.

###

Like all estrogen drug products, CENESTIN®, and ESTRATEST®/ESTRATEST® H.S. Brand Tablets should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with CENESTIN included headache, insomnia, asthenia, nervousness, paresthesia, and depression. The most common adverse events reported with ESTRATEST®/ESTRATEST® H.S. Brand Tablets include those typical of estrogen therapy (such as breast tenderness, headache, nausea, edema and abdominal pain) and of androgen treatment (including hair loss, acne and hirsutism). Common side effects of PROMETRIUM® Capsules are breast tenderness, dizziness, abdominal bloating, and vaginal discharge. For additional information on CENESTIN®, ESTRATEST® Brand Tablets or PROMETRIUM® Capsules, please see full prescribing information.

The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward-looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed’s SEC filings, including its annual report on Form 1O-K/A. Back to top


October 18, 1999

ANTIHYPERTENSIVE TEVETEN® (EPROSARTAN MESYLATE) TABLETS IS NOW AVAILABLE IN THE U.S.

(October 18, 1999, Chicago, IL) Unimed Pharmaceuticals Inc., a Solvay Pharmaceuticals, Inc. company, announced today that TEVETEN® Tablets is now available in U.S. pharmacies for the treatment of hypertension in all levels of severity. TEVETEN® is the latest member of the newest class of antihypertensive drugs – angiotensin II receptor blockers (ARBs). TEVETEN® is an efficacious and well-tolerated antihypertensive medication providing effective 24-hour control of high blood pressure with once-daily dosing, regardless of patient age or gender.1 TEVETEN® has been available in Germany, Ireland, Denmark, Finland, Sweden, The Netherlands and Portugal and was evaluated in more than 3,300 patients and healthy volunteers in worldwide clinical trials.2

“TEVETEN® promises to be an effective treatment for all levels of severity for a wide range of patients, including the elderly, patients with diabetes, patients with renal impairment, and African American patients,” says Dr. Domenic Sica, Medical College of Virginia of Virginia Commonwealth University.

In May of 1999, Solvay S.A. acquired the worldwide rights to market, manufacture and further develop TEVETEN® from SmithKline Beecham. Chicago-based, Unimed Pharmaceuticals, Inc., a wholly-owned subsidiary of Solvay Pharmaceuticals Inc., will market and further develop TEVETEN® in the United States. Unimed Pharmaceuticals will provide competitive resources and the appropriate detailing capacity to successfully compete in the antihypertensive market and fully leverage the excellent profile of TEVETEN®.

“TEVETEN® is an important addition to Unimed’s portfolio. We expect TEVETEN® to become one of the leading ARBs and antihypertensive medications in the U.S.,” says Robert Dudley, CEO, Unimed Pharmaceuticals. “Our resources have been allocated to make this a successful market roll-out for both the patients and prescribing physicians.”

Clinical Efficacy and Tolerability of TEVETEN®

Extensive studies have demonstrated TEVETEN®’s efficacy and tolerability profile. In summary:

•TEVETEN® produced favorable decreases in, both, sitting diastolic blood pressure and systolic blood pressure, with greater response than enalapril, the leading angiotensin-converting enzyme inhibitor, in patients with mild to moderate hypertension.3 •TEVETEN® clinical trials have demonstrated a side effect profile similar to placebo and is not generally associated with the dry cough commonly associated with ACE inhibitors.4 •TEVETEN® may be used in combination with selected antihypertensive drugs.5,6 •TEVETEN® is not metabolized by the cytochrome P450 isoenzyme system; therefore, the potential for drug-drug interactions with agents metabolized via this enzyme system is significantly reduced. 8 •TEVETEN® is effective and well-tolerated in elderly patients.9 •TEVETEN® requires no initial dosing adjustment for elderly or hepatic-impaired patients or those with renal impairment. 10

The recommended starting dose of TEVETEN® is 600 mg daily, which may be increased up to 800 mg daily depending upon the patient’s blood pressure response.11

TEVETEN® related adverse events were of mild or moderate severity. The overall incidence of adverse experiences and the incidences of specific adverse events reported with TEVETEN® were similar to placebo and were similar in patients regardless of age, gender, or race.

TEVETEN®, like other drugs that act directly on the renin-angiotensin system, can cause injury and even death to the developing fetus when it is used during the second and third trimesters of pregnancy. When pregnancy is detected, TEVETEN® should be discontinued as soon as possible.12

In May 1999, the FDA approved TEVETEN® for once-daily dosing. TEVETEN® was developed using state-of-the-art methodology and is currently indicated for the treatment of hypertension in all levels of severity. A fixed combination of TEVETEN® with a diuretic is also in late stage development.

Unimed Pharmaceuticals, a wholly-owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV and other infectious diseases. Unimed Pharmaceuticals is home to more than 70 employees with expertise in ethical drug development, marketing and sales.

Solvay Pharmaceuticals, Inc. of Marietta, GA, is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.

Lynda Woodworth

Principal PR

+1 212-537-8181

————————————————————————
1. Weber M. Clinical efficacy of eprosartan. Pharmacotherapy 1999;19(4 Pt 2):95S-101S

2. Unimed data on-file

3. Gavras I, Gavras H. “Effects of eprosartan versus enalapril in hypertensive patients on the renin-angiotensin-aldosterone system and safety parameters: results from a 26-week, double-blind, multicentre study. Eprosartan Multinational Study Group. Curr Med Res Opin 1999; 15(1):15-24.

4. Hedner T, Himmelmann A, for the Eprosartan Multinational Study Group. The efficacy and tolerance of one and two daily doses of eprosartan in essential hypertension. J Hypertens 1999;17(1):129-136.

5. Study RSD-100WH3/1 (050). A long-term (two-year), open-label, multicenter study of once daily oral SK&F 108566-J (Eprosartan Mesylate) in patients with essential hypertension.

6. Study RSD-100VP/1 (052). A long-term, open-label, multicenter, multi-country extension study of once daily oral SK&F 108566 (Eprosartan) in patients with essential hypertension who have completed a clinical trial with eprosartan.

7. Ilson B, Kazierad DJ, Freed M. Overview of the clinical pharmacology of eprosartan, a novel angiotensin II receptor antagonist. Poster presented at American Society of Hypertension Thirteenth Scientific Meeting, New York, New York. May 13-16, 1998. Am J Hypertension 1998; 11(4pt 2): 108A, E050 abstract.

8. Ilson B. Drug interaction studies with eprosartan, a novel angiotensin II receptor antagonist. Poster presented at American Society of Hypertension Thirteenth Scientific Meeting, New York, New York. May 13-16, 1998. American Journal of Hypertension 1998; 11(4pt 2):108A, E051 abstract.

9. Argenziano L, Fratta L, et al. Effect of eprosartan and enalapril in the treatment of elderly hypertensive patients: Subgroup analysis of a 26-week, double-blind, multicentre study. Curr Med Res Opin 1999; 15(1):9-14.

10. TEVETEN Product Insert on File

11. Gradman AH, Gray J, et al. Assessment of once-daily eprosartan an angiotensin II antagonist, in patients with systemic hypertension. Eprosartan Study Group. Clin Ther 1999 Mar; 21(3):442-53.

12. TEVETEN Product Insert on File
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October 7, 1999

SOLVAY PHARMACEUTICALS, INC. INTRODUCES
ACEON® (perindopril erbumine) TABLETS TO U.S. MARKET

One Tablet, 24-Hour Control of Hypertension
Marietta, GA, Oct. 6, 1999 – ACEON® (pronounced ace-e-on) Tablets, a once-daily medication for the treatment of essential hypertension, is now available in the United States, Solvay Pharmaceuticals, Inc., announced today.

An important addition to the antihypertensive armamentarium in the United States, perindopril already is a leading antihypertensive therapy in Europe.1 It was first marketed in France ten years ago as Coversyl®, and will be launched in the United States as ACEON® Tablets. Based on extensive clinical experience, ACEON® Tablets has been shown to be effective and well-tolerated.

In clinical studies in more than 3400 hypertensive patients, perindopril was proven to provide continuous 24-hour blood pressure control throughout the entire dosing interval with a single daily dose. In a pivotal clinical study, perindopril demonstrated approximately equivalent blood pressure reduction at 6 and 24 hours after administration. (2)

According to the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNCVI), therapies that provide continuous 24-hour efficacy with a single daily dose are the optimal treatment choice. Twenty-four hour coverage offers protection against sudden increases of blood pressure after waking from overnight sleep.(3)
“We all experience normal increases and decreases in blood pressure throughout the day,” says Michael Weber, MD, chairman, department of medicine, The Brookdale University Hospital and Medical Center, and investigator for perindopril. “For example, when we wake from sleep each morning, most people experience a sudden rise in blood pressure. For the hypertensive patient, this could be a concern if their medication doesn’t provide full 24-hour coverage.

“Now with perindopril (ACEON® Tablets), we have another well-tolerated treatment option that provides the continuous 24-hour blood pressure effect needed to protect patients during those early morning hours, ” continues Dr. Weber.

Hypertension in the United States
As many as 50 million Americans have hypertension, according to the American Heart Association. Blood pressure is the result of two forces. One is created by the heart as it pushes blood into the arteries and through the circulatory system; the other is the force of the arteries as they resist blood flow. Elevated blood pressure indicates that the heart is working harder than normal, putting it and the arteries under a greater strain.(4)

Healthy arteries have an elastic quality that allows them to expand and contract in response to the pressure of the blood as it is pushed from the heart through the arteries. The risk of hypertension increases as elasticity decreases due to age and other risk factors. (5)

ACEON® Tablets is the first antihypertensive therapy in its class with product labeling describing an increase in compliance (elasticity) of large arteries in patients, consistent with the results of animal studies. This suggests a direct effect on the arterial smooth (elastic) muscle, which plays a major role in regulating blood pressure. (2) This is a new and evolving area of research that is attracting a great deal of interest from researchers and clinicians.
“Even with the many effective antihypertensive therapies available in the U.S., we have not reduced the incidence of cardiovascular disease as much as we should have,” explains Joel Neutel, M.D., chief of the division of clinical pharmacology and hypertension at the Veterans Affairs Medical Center, Long Beach, CA. “Since no two patients with high blood pressure are alike, the more safe and efficacious therapies that we have to treat this disease, the more effective we can be in controlling hypertension in the individual patient.”

ACEON® (perindopril erbumine) Tablets is a member of the class of drugs called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors act to reduce blood pressure by interfering with the conversion of angiotensin I to the artery-constricting angiotension II. Blocking the production of angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure.6 As a therapeutic category, ACE inhibitors account for 37.5 percent of the total antihypertension prescriptions in the U.S.(7)

Marketing and Availability
Recognizing the U.S. potential for such a widely used and established antihypertensive, Solvay Pharmaceuticals has now licensed ACEON® Tablets and will market it nationwide. The introduction of ACEON® Tablets marks Solvay Pharmaceuticals’ entry into the U.S. cardiovascular market. Perindopril was approved by the U.S. Food and Drug Administration in December 1993, and is currently available in 113 countries. (1)

“We are pleased to enter the U.S. cardiovascular market with such a promising hypertension therapy that has been used so successfully in other countries,” said David A. Dodd, President and CEO of Solvay Pharmaceuticals, Inc. “This new antihypertensive therapy is the first of several cardiovascular products that Solvay Pharmaceuticals will bring to the U.S. market.”

Dosage and Administration
In patients with essential hypertension including the elderly, the recommended initial dose of ACEON® (perindopril erbumine) Tablets is 4 mg once a day. The usual maintenance dose range is 4 to 8 mg, administered as a single daily dose. In hypertensive patients with minimally impaired kidney function, the initial dose should be 2mg per day and increased up to 8 mg per day until blood pressure control is achieved. ACEON® Tablets may also be administered in two divided doses.(2)

In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitors may cause excessive hypotension, and may be associated with ologuria or azotemia, and rarely with acute renal failure and death. In patients with ischemic heart disease or cerebrovascular disease, such an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident. (2)

Common Side Effects and Other Important Information
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected ACEON® Tablets should be discontinued as soon as possible. See the package insert for WARNINGS: Fetal/Neonatal Morbidity and Mortality. (2)

ACEON® Tablets is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitor, as well as those with a history of angioedema related to previous treatment with an ACE inhibitor. (2)

In clinical trials, cough was the most frequent adverse event possibly or probably related to treatment occurring in 6% of patients treated with ACEON® (perindopril erbumine) Tablets compared to 1.8% in patients receiving placebo. Other commonly reported side effects included: proteinuria, palpitation, sinusitis, viral infections, dyspepsia, fever, upper extremity pain, and hypertonia. (2)
Like other ACE inhibitors, ACEON® Tablets can cause symptomatic hypotension. ACEON® Tablets has been associated with hypotension in 0.3 % of uncomplicated hypertensive patients in the U.S. placebo-controlled trials. Symptomatic hypotension associated with the use of ACE inhibitors is more likely to occur in patients who have been volume and/or salt-depleted, therefore, these conditions should be corrected before initiating therapy with ACEON® Tablets. (2)

Adjusted doses of ACEON® Tablets may be used safely in hypertensive patients with minimal renal impairment, type 1 diabetes mellitus, and congestive heart failure. In controlled trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. Also, black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to nonblacks. (2)

Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment, especially patients with a collagen vascular disease such as lupus erythematosus or scleroderma. Available data are insufficient to show whether ACEON® Tablets cause agranulocytosis at similar rates. (2)
Solvay Pharmaceuticals, Inc., of Marietta, Ga., is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, women’s health, gastroenterology and mental health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.

Please see accompanying package insert for other important safety and prescribing information.

References
1. Data on file, Solvay Pharmaceuticals, Inc.
2. Solvay Pharmaceuticals, Inc. ACEON® Tablets. Product labeling information. Rev. April 1999.
3. National Institutes of Health. The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication No. 98-4080. November 1997; 23.
4. American Heart Association. Blood Pressure.
(http://www/americanheart.org/Heart_and_Stroke_A_Z_Guide/bp.html).
(http://www/americanheart.org/Heart_and_Stroke_A_Z_Guide/hbps.html). (http://www/americanheart.org/Heart_and_Stroke_A_Z_Guide/hbp.html).
5. Van Bortel LM, et al. Disparate Effects of Antihypertensive Drugs on Large Artery Distensibility and Compliance in Hypertension. The American Journal of Cardiology 1995; 46E.
6. The Bantam Medical Dictionary (second revised edition). Bantam Books. New York. 1994; 3.
7. Scott Levin data, 1999.

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October 6, 1999,

DURAMED PHARMACEUTICALS AND SOLVAY PHARMACEUTICALS ANNOUNCE ALLIANCE IN THE USA

CINCINNATI, OH and MARIETTA, GA (October 6, 1999) — Duramed Pharmaceuticals, Inc. (Nasdaq:DRMD) and Solvay Pharmaceuticals, Inc. today announced an alliance to jointly promote in the US three of the companies’ hormone products: Duramed Pharmaceuticals’ CENESTIN(tm) (synthetic conjugated estrogens, A) Tablets and Solvay Pharmaceuticals’ ESTRATEST®/ESTRATEST® H.S. Tablets (esterified estrogens and methyltestosterone) and PROMETRIUM® (progesterone) Capsules.

Promotion Efforts Planned for October
A combined national sales force of more than 300 Duramed Pharmaceuticals and Solvay Pharmaceuticals sales representatives will begin Oct. 11, 1999 to promote the alliance products to obstetricians and gynecologists across the United States. Solvay Pharmaceuticals’ resources also include teams of regional marketing managers, field trainers, medical liaison teams and a medical advisory committee comprised of leading women’s health physicians.

“This alliance means more expansive, more visible market coverage for both Duramed and Solvay Pharmaceuticals women’s health products, starting with Duramed Pharmaceuticals’ CENESTIN(tm),” said Duramed Pharmaceuticals Chairman and Chief Executive Officer E. Thomas Arington. He added, “We have been extremely pleased with the physician/patient response to CENESTIN(tm) since our marketing efforts began in mid-summer. We believe, however, that Solvay Pharmaceuticals’ demonstrated strength in this marketplace makes it a perfect ally for Duramed Pharmaceuticals.”

CENESTIN(tm) is designated as the primary product in the Duramed/Solvay Pharmaceuticals alliance while the Solvay Pharmaceuticals products will address additional important therapeutic requirements in women’s health. All three products are expected to benefit from the broadened exposure in the marketplace. Under the terms of the co-promotion alliance, Duramed Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc. will retain all revenue from their respective products.

David A. Dodd, President and Chief Executive Officer, Solvay Pharmaceuticals, said, “We see this alliance enhancing our franchise in women’s health, increasing the value of our efforts in the obstetric and gynecological offices and further demonstrating our strong commitment to the U.S. women’s healthcare market. Duramed Pharmaceuticals is an excellent strategic partner due to its demonstrated success in bringing new products to the market and its shared commitment to women’s health care, as evidenced by its investment in developing hormone products and technology.”

CENESTIN(tm) was approved by the U.S. Food and Drug Administration (FDA) in March 1999. CENESTIN offers millions of women and their physicians a new, appealing plant-derived synthetic conjugated estrogens product with a slow-release formulation. Solvay Pharmaceuticals is a leader in the women’s health market. Its products, ESTRATEST® Brand Tablets and PROMETRIUM® Capsules will complement CENESTIN(tm) in the pharmaceutical sales effort.

Solvay Pharmaceuticals Granted Equity Option in Duram ed
Duramed has given Solvay Pharmaceuticals an option to purchase a minimum of 1,666,666 shares and a maximum of 3,000000 shares of common stock of Duramed at a price of $9.00 per share. The closing price of Duramed common stock on October 5, 1999 was $7 1/16 per share. If completed, the sale of the minimum number of 1,666,666 shares will be closed by the end of October. The sale of any additional shares is expected to be closed by the end of the year.

About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. The Group’s members employ some 33,000 people in 46 countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals.

About Duramed Pharmaceuticals, Inc.
Duramed Pharmaceuticals, Inc. develops, manufactures and markets prescription drug products. The company’s business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women’s health and the hormone replacement therapy market.

The company’s stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at http://www.duramed.com.

SOLVAY S.A. Headquarters
Mrs Dominique Clerbois
Head of Corporate Communications and Investor Relations
Tel : 32/2/509.60.16
Fax : 32/2/509.72.40
E-mail : dominique.clerbois@solvay.com

SOLVAY PHARMACEUTICALS, INC.
Karen Carlisle
Tel: (770) 578-5581
E.mail: karen.carlisle@solvay.com

DURAMED PHARMACEUTICALS, INC.
Investor relations:
(513) 731-9900

DURAMED PHARMACEUTICALS, INC.
MEDIA INQUIRIES
Ellen Knight or Ursula Miller
Dan Pinger Public Relations Inc.
(513) 564-0700

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September 29, 1999

PRESTIGIOUS SOLVAY PHARMACEUTICALS MENOPAUSE PRIZE GOES TO RESEARCH ON HRT AND STROKE

A leading European Union researcher into the menopause has been awarded the prestigious Solvay Pharmaceuticals Menopause Prize, jointly awarded by the European Association of Gynaecologists and Obstetricians (EAGO) and Solvay Pharmaceuticals, one of the world’s leading companies in women’s health. The event took place at the XIV EAGO Congress in Granada, Spain.

The 1999 winner of the Solvay Pharmaceuticals Menopauze Prize is Anette Tønnes Pedersen, MD, Ph.D of the Department of Obstetrics and Gynaecology, Hvidovre Hospital, University of Copenhagen, Denmark.

The Prize of Dfl. 25,000 is awarded every two years to the researcher, scientist or physician from any EU country for original research which, in the opinion of the judges, makes an outstanding contribution toward scientific understanding of the menopause or related issues.

Dr. Pedersen’s prize-winning Abstract entitled “Hormone Replacement Therapy and Risk of Stroke” found that HRT had no impact on the risk of non-fatal haemorrhagic or thromboembolic stroke. While evidence of a protective effect of postmenopausal hormone replacement therapy (HRT) on the primary prevention of cardiovascular disease has been compelling, the effect of HRT on the risk of cerebrovascular diseases has sofar remained controversial.

Dr. Pedersen said: “The question of whether or not to start HRT is of key importance among many peri- and postmenopausal women.

Any uncertainty in the form of unresolved issues about HRT will inevitably influence their decisions and may affect compliance.

We needed conclusive evidence on the impact of oestrogen and combined oestrogen-progestogen replacement therapy on haemorrhagic as well as thromboembolic strokes.

We found – most importantly – that the current use of sex steroids in the form of postmenopausal HRT had no negative effect on risks in this key area of women’s health.”

Stroke is a major contributor to long-term disability, and the third leading cause of death among postmenopausal women in developed countries, after coronary heart disease and cancer.

“Dr. Pedersen’s research has made an important contribution to our understanding of this key field and was outstanding in its trial design and execution. Its scientific excellence must give us considerable confidence in the validity of its findings.

Women considering HRT or currently receiving combined therapy will be reassured by Dr Pedersen’s conclusions”, said Professor Ulmsten, the Chairman of the International Scientific Committee of the Solvay Pharmaceuticals Menopause Prize.

Dr. Pedersen’s study is the largest ever conducted on HRT and the risk of stroke. The study included 1,422 stroke cases. The population-based study design allowed the accurate estimate of absolute incidence of non-fatal stroke events. No significant impact was found of either former use, current use of unopposed oestrogens or current use of combined regimens on the risk of subarachnoid haemorrhage, intracerebral haemorrhage or thromboembolic stroke.

However, an approximately twofold, significantly increased risk of transient ischaemic attacks (TIA) was seen among women previously receiving HRT and among current users of unopposed oestrogens. No association between current use of combined hormones and TIA was shown.
Solvay Pharmaceuticals is a sector of the Belgian chemical-pharmaceutical concern Solvay SA, dedicated to optimal patient health management, providing products and undertaking innovative research in the core areas of psychiatry, cardiology (heart and vascular diseases), gastro-enterology (stomach and intestinal complaints) and gynaecology (women’s health).

For more information please contact:
Mrs. Drs. Cilia Linssen, Communications Manager, Pharmaceuticals Communications,
Solvay Pharmaceuticals
Telephone +31-294-477483, mobile +31-6-51247876.

The widespread fear among women1 that all hormone replacement therapy (HRT) use will lead inevitably to weight gain is unfounded, according to a growing body of research evidence, presented at the XIV EAGO Congress in Granada, Spain.

At the onset of the menopause, women who do not take HRT show an increase in total mass. Additional fat deposits appear, especially in the abdominal region, a phenomenon known as central obesity. This localised increase in body fat in post- menopausal women is believed to be an important risk factor for the development of cardiovascular disease.

Fear of weight gain is a major factor affecting women’s compliance with HRT. Yet there is a compelling body of evidence to suggest that this fear is unfounded, at least not for every type of HRT.

THE EVIDENCE
In the Postmenopausal Estrogen/Progestin Intervention Trial (PEPI-trial) of 875 women, the weight increase in the placebo group was higher than in any of the 4 HRT groups. The average weight gain in the treatment groups was less than 1 kg within 3 years.

HRT AND DECREASED WEIGHT – THE USE OF FEMOSTON®
A recent randomised study of 100 postmenopausal women found significant differences in weight, following HRT or placebo treatment. 26 women were given placebo, while the remainder was randomised to one of three treatment groups: those given tibolone 2.5 mg/day (28 women); those given oral estradiol 2mg/day plus sequential dydrogesterone 10 mg/day Femoston® for 14 of 28 days per cycle (26 women), or those given a transdermal estradiol patch releasing 50 microgram/day in addition to oral sequential dydrogesterone 10mg/day for 14 out of 28 days per cycle (20 women).

In the orally treated group given Femoston®, the expected increase in additional body fat mass reverted, which led to a stable – or reduced – body weight. This means that women taking Femoston® actually lose weight.

By contrast, the study found that untreated post-menopausal women in the placebo group showed a mean gain of fat mass of 3.6 kg in a two-year period.

Women taking the HRT treatment Femoston® had a mean fat mass reduction of 1.2 kg in contrast to both transdermal estradiol and tibolone (Livial®, a product with oestrogenic, progestogenic and androgenic effects). The body weight of women using the transdermal patch increased by 2 %. (2)

WEIGHT GAIN AND COMPLIANCE – REDUCING HRT’S BENEFIT
HRT offers its most beneficial effect: relieving climacteric symptoms, prevention of osteoporosis and decreasing cardiovascular risk in the long term over a period of several years. However, only 3 women in every 10 who are prescribed HRT continue treatment for more than 3 years.(3) It has been estimated that as many as 20% of women stop HRT because of weight gain. (3)

WEIGHT GAIN AND THE MENOPAUSE
Women’s concerns about postmenopausal weight gain are justified – but a causal link to HRT is not. However, weight gain is undesirable for a number of reasons. There is an established link between body fat distribution (a waist-to-hip ratio of more than 0.85, for example) as well as being overweight, and the risk of developing cardiovascular disease.(4) These factors may be either directly linked to cardiovascular disease (5), or indirectly linked.

FEMOSTON®: NO NEGATIVE IMPACT ON WEIGHT
The undesirability of post menopausal weight gain is well founded – but the fear that all HRT contributes to weight gain is not.

Two clinical studies with Femoston® have shown that the shift to central obesity was prevented during one or two years’ treatment respectively 2,6 Femoston® may even lead to weight loss, while conferring all the benefits of HRT.

The combination of healthy diet, regular exercise and HRT can offer postmenopausal women an opportunity to enhance their all-round health, and with it their future quality of life.

Femoston® was developed and is marketed by Solvay Pharmaceuticals. Solvay Pharmaceuticals is a sector of the Belgian chemical-pharmaceutical concern Solvay SA, dedicated to optimal patient health management, providing products and undertaking innovative research in the core areas of psychiatry, cardiology (heart and vascular diseases), gastro-enterology (stomach and intestinal complaints) and gynaecology (women’s health).

References
1 Poll results by SOFRES (2000 questionnaires – weight gain ranked second in HRT concerns after hormones themselves)
2 Hänggi W. et al. Differential impact of conventional oral or transdermal hormone replacement therapy or tibolone on body composition in postmenopausal women. Clin. Endocrinol. 1998;1840:691-699
3 Van Seumeren I. Weight gain and hormone replacement therapy: are women’s fears justified? Maturitas, in press.
4 Lapidus L. et al. Distribution of adipose tissue and risk of cardiovascular disease and death: a 12-year follow-up of participants in the population study of women in Gothenburg, Sweden. Brit. Med. J. 1984; 289: 1257-1261
5 Donahue R.P. et al. Central obesity and coronary heart disease. Lancet 1987; 821-824
6 Van der Mooren M.J. et al. A two-year study on the beneficial effects of 17ß-oestradiol dygesterone therapy on serum lipoproteins and Lp(a) in post-menopausal women: no additional unfavorable effects of dydrogesterone. Eur. J. Obstet. Gynecol. Reprod. Biol. 1993;52:117-123

For more information please contact:
Mrs. Drs. Cilia Linssen, Communications Manager, Pharmaceuticals Communications,
Solvay Pharmaceuticals
Telephone +31-294-477483, mobile +31-6-51247876

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September 21, 1999

FLUVOXAMINE: HELPING PATIENTS RECOVER AFTER TRAUMA

Post-traumatic stress disorder (PTSD) is a relatively common problem that affects not only the patient, but also their family and friends. There is mounting evidence that drugs such as fluvoxamine, one of the class of drugs known as the selective serotonin reuptake inhibitors (or SSRIs), may help these patients recover.
Fluvoxamine – the background
* The SSRI fluvoxamine has been used world-wide for a number of years for the treatment of depression and a range of anxiety disorders such as obsessive-compulsive disorder, panic disorder and social anxiety disorder. More than 35,000 patients world-wide have been entered in clinical studies.
* It is a safe drug. It has no potential for abuse and has less sexual side-effects than the other SSRIs.

Serotonin and PTSD
* There is mounting evidence that the neurotransmitter known as serotonin is involved in PTSD.
* Fluvoxamine has a selective effect on the reuptake of serotonin in neurones in the brain.
* This suggests that fluvoxamine will be useful in alleviating the disturbing irritability, aggression and arousal symptoms of PTSD.

Fluvoxamine – promising effects in PTSD
* To date, three studies have investigated the effects of fluvoxamine in patients with PTSD (both civilians and war veterans).
* All the evidence shows that fluvoxamine clearly improves symptoms of intrusion, avoidance and arousal.
* Fluvoxamine also improves other psychiatric disorders, such as depression and panic disorder, that are commonly seen in PTSD patients.
* Fluvoxamine is safe in patients with PTSD.

Thus, fluvoxamine may help patients to cope with the devastating symptoms of PTSD.

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July 20, 1999

SOLVAY PHARMACEUTICALS, INC. ACQUISITION OF UNIMED PHARMACEUTICALS, INC.

At midnight Monday, July 19, Solvay Pharmaceuticals acquired more than 95 percent of the shares of Unimed Pharmaceuticals. This is an outstanding result and it means the closing on the acquisition will occur immediately (read press release of June 14). By tomorrow afternoon, Unimed will be a wholly owned subsidiary of Solvay Pharmaceuticals. This acquisition is a key step in the Solvay Group’s strategy to rapidly expand its pharmaceutical business in the U.S.

As I mentioned to you in a recent communication, Unimed will be responsible for marketing its existing products, as well as TEVETEN® Tablets. Unimed also will be responsible for the regulatory, manufacturing, quality, and development aspects of its existing products, TEVETEN® Tablets, and development products. In some situations, both organizations will share services, such as marketing research studies or other initiatives.

This is an exciting time for Solvay Pharmaceuticals and we should all take pride in the fact that we are part of a growing enterprise..

David A. Dodd
President and CEO
Solvay Pharmaceuticals, Inc.

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June 14, 1999

SOLVAY GROUP ANNOUNCES AGREEMENT TO ACQUIRE UNIMED PHARMACEUTICALS, INC. TO STRENGHTEN ITS MARKETING PRESENCE AMONG U.S. PRIMARY CARE PHYSICIANS.

As part of the Solvay Group’s strategy of growing faster in pharmaceuticals, Solvay Pharmaceuticals, Inc, has entered into an agreement with Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) to acquire all outstanding Unimed shares.

Terms of the agreement call for the shareholders of Unimed Pharmaceuticals to receive $12.00 in cash for each share of Unimed’s common stock held by them. The net value of the planned transaction is about $123 million. The offer is subject to certain conditions including a minimum tender.

Commenting on the acquisition, Aloïs Michielsen, CEO of Solvay Group said, “Unimed fits very well with the strategic objective of broadening our presence in the U.S. pharmaceutical business. This acquisition will contribute to our plan to rapidly increase the total number of our U.S. sales representation from 450 at the end of 1998 to over 1,000 people in year 2000, selling existing drugs from Solvay Pharmaceuticals and Unimed Pharmaceuticals as well as products recently acquired by Solvay Pharmaceuticals.”

Jürgen Ernst, President of Solvay’s world-wide Pharmaceuticals activities added, “Indeed, in order to quickly and effectively maximize sales potential for both ACEON® Tablets and TEVETEN® Tablets, the two anti-hypertensive drugs acquired by Solvay in May 1999, Solvay Pharmaceuticals will sell ACEON® through its own primary care sales force. However, TEVETEN® Tablets will be sold by Unimed representatives, whose current number will be increased very significantly. Unimed also will strengthen Solvay’s current portfolio of Hormone Replacement Therapies (HRT) by including male HRT and providing an early entrée into the emerging area of andropause.”
Unimed Pharmaceuticals is an emerging Chicago-area pharmaceutical company. The company focuses on drugs that have multiple indications and fall within the therapeutic areas of endocrinology, urology, HIV and other infectious diseases.

The Solvay Group is an international chemical and pharmaceutical group based in Brussels, Belgium. Its members employ some 33,000 people in 46 countries. Its 1998 turnover worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Solvay Pharmaceuticals, Inc., a member of the Solvay Group, is a research-based pharmaceutical company active in the therapeutic areas of cardiology, women’s health, gastroenterology and mental health.

For further information, please contact :

SOLVAY S.A.
Dominique Clerbois

Head of Corporate Communications and Investor Relations
Tel. : +32-2-509.60.16
E-mail: dominique.clerbois@solvay.com

Solvay Pharmaceuticals, Inc.
Jeff Linton,
Vice President
Law, Government x Public Affairs
Tel: 770-578-5739 E-mail: jeff.linton@solvay.com

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May 11, 1999

SOLVAY ACQUIRES TEVETEN®, AN INNOVATIVE CARDIOVASCULAR DRUG, FOR WORLD-WIDE MARKETING

Solvay announces today that it is acquiring Teveten®, a new oral antihypertensive from SmithKline Beecham for world-wide marketing, manufacturing and further development.

Teveten® has been developed by SmithKline Beecham (SB) up to registration, according to state-of-the-art standards. Teveten® is already on the market in Germany, Ireland, Denmark, Finland, Sweden, The Netherlands and Portugal. It is registered in Europe and the US. A fixed combination of Teveten® with a diuretic is also in a late stage of development.

Solvay will assume current marketing activities of SB and will execute a fully fledged product launch in new territories. Solvay will provide competitive resources and the appropriate detailing capacity to successfully compete in this cardiovascular antihypertensive segment and to fully exploit the excellent profile of Teveten® in the market.

Teveten® (eprosartan mesylate) is an angiotensin-II-receptor antagonist, and belongs to the newest class of drugs available for the treatment of hypertension. Teveten® is indicated for use either alone or in combination with other antihypertensives.

Jürgen Ernst, Solvay Pharmaceuticals president said: »This is an important business opportunity in line with the Solvay group strategy to increase its presence in Pharmaceuticals.» We expect Teveten® to become one of our top pharmaceutical products, and to contribute significantly to our global marketing and sales activities. The world-wide market for hypertension is estimated to be 10 billion US dollar, and therefore it is one of the most interesting areas for pharmaceutical marketing.»

SmithKline Beecham decided to divest Teveten® to concentrate efforts on other strategically important products. J.P. Garnier, C.O.O. of SB said: »We are in a very fortunate position and we have to make choices. Teveten® is an excellent product and we are very pleased that Solvay Pharmaceuticals will be able to give it the attention it deserves.»

Uncontrolled hypertension is a major cardiovascular risk factor. It can cause progressive damage to the heart and the vascular system, leading to stroke, heart failure, myocardial infarction, and kidney disease. Cardiovascular diseases are the leading cause of death in the western world. The hypertension market is one of the largest single pharmaceutical markets world-wide.

Solvay Pharmaceuticals is a research-based innovative group of companies with products and research in the areas of cardiology, psychiatry, gastro-enterology and women’s health. The group has a strong presence in Europe, and is growing rapidly in the US and Asia. Solvay Pharmaceuticals is part of the global chemical and pharmaceutical concern Solvay SA, headquartered in Brussels, Belgium. Solvay S.A. is present in 46 countries with about 33,000 employees. Its consolidated sales in 1998 reached EUR 7,5 billion (USD 8,7 billion), generated by four sectors of activity: chemicals, plastics, processing and pharmaceuticals.

For further information, please contact:
Dominique Clerbois
Head of Corporate Communication and Investor Relations
SOLVAY S.A. Headquarters
Tel : 32 2 509 60 16
dominique.clerbois@solvay.com

Puck Bossert
Solvay Pharmaceuticals B.V.
Tel : 31/653/16.59.42

Cilia Linssen
Solvay Pharmaceuticals B.V.
Tel : 31/651.24.78.76

Karen Carlisle
Solvay Pharmaceuticals, Inc.
Tel : 1 770 578 5581

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May 5, 1999

SOLVAY PHARMACEUTICALS, INC. ENTERS CARDIOVASCULAR MARKET ACQUIRES U.S. RIGHTS TO ACEON® (PERINDOPRIL ERBUMINE) TABLETS FOR HYPERTENSION

Solvay Pharmaceuticals, Inc., today announced its entry into the U.S. cardiovascular market with ACEON® (perindopril erbumine) Tablets. This once-daily angiotensin converting enzyme (ACE) inhibitor therapy, indicated for the treatment of essential hypertension, is a major ACE inhibitor product in many markets throughout the world, and marks Solvay Pharmaceuticals’ entry into the highly competitive U.S. cardiovascular arena.

»We are pleased to have obtained this innovative antihypertensive product to initiate our cardiology portfolio in the U.S.», said Solvay Pharmaceuticals President and CEO David A. Dodd. »We expect ACEON® Tablets to contribute significantly to our aggressive marketing and sales plans for our newly established primary care sales force.» Mr. Dodd added »ACEON® Tablets will be available by prescription in the U.S. later this year.»

In clinical studies with hypertensive patients, ACEON® Tablets was proven to provide true 24-hour blood pressure control accompanied by an improvement in arterial elasticity, leading to improved arterial blood flow. Arterial elasticity reflects the ability of the artery to respond to pressure. The role of arterial elasticity as a marker for a variety of vascular diseases is a subject of increasing study and interest.

»ACEON® Tablets offers a potential clinical advantage available in no other antihypertensive therapy,» said Jay N. Cohn, M.D., Professor of Medicine, University of Minnesota Medical School, Minneapolis, Minn. »Studies with ACEON® Tablets have demonstrated its ability to improve arterial elasticity, which is an indicator doctors should be concerned about in patients with high blood pressure,» he explained. Dr. Cohn is a leading investigator of arterial elasticity and the emerging understanding of its clinical benefits in the treatment of hypertension.

ACE Inhibitors’ Mechanism of Action
As many as 50 million Americans have hypertension, according to the American Heart Association. Hypertension, commonly known as high blood pressure, occurs when the force of blood against the walls of the arteries is greater than normal. Hypertension is often characterized by increased resistance from the vessels that carry blood throughout the body and/or the amount of blood the heart has to pump. Hypertension is a major risk factor for coronary heart disease and stroke.

ACE inhibitors act to reduce elevated blood pressure by interfering with the action of the angiotensin converting enzyme that converts inactive angiotensin I to the artery constrictor angiotensin II. Blocking the production of the angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure. As a therapeutic category, ACE inhibitors account for 28 percent of the antihypertensive market in the U.S.

Marketing x Availability
COVERSYL® (perindopril erbumine), to be marketed as ACEON® Tablets in the U.S., was first brought to market in France in 1989, and is currently available worldwide. Now the mainstay of hypertension therapy in 113 countries, product experience includes well over 73 million patient-months. ACEON® Tablets is approved by the U.S. Food and Drug Administration. Due to the product’s overwhelming success worldwide and increasing demand by U.S. physicians, Solvay Pharmaceuticals has now licensed the drug and will make it available in this country.

»We look forward to bringing ACEON® Tablets to market in the U.S. to help fill the need for an effective antihypertensive therapy that may also improve arterial elasticity,» said Mr. Dodd.

ACEON® Tablets will be marketed and distributed nationwide by Solvay Pharmaceuticals, Inc., of Marietta, Ga., a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, women’s health, gastroenterology and mental health. It is a member of the worldwide Solvay Pharmaceuticals Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. Solvay employs about 33,000 people in 46 countries. In 1998, its turnover was EUR 7.5 billion (USD 8.7 billion) resulting from four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.

For further information, please contact:
Dominique Clerbois
SOLVAY S.A.
Head of Corporate Communication and Investor Relations
Tel: 32/2/509.60.16
dominique.clerbois@solvay.com Karen Carlisle
Solvay Pharmaceuticals, Inc.
Tel : 1 770 578 5581

Karen Reina
Ruder Finn Healthcare
1 212 593 6313

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April 16, 1999

BERNA AND SOLVAY PHARMACEUTICALS COLLABORATE IN INFLUENZA VACCINES

Berna and Solvay Pharmaceuticals collaborate in influenza vaccines SOLVAY Pharmaceuticals and BERNA, the Swiss Serum and Vaccine Institute Berne, have recently signed a license and distribution agreement in the field of human influenza. Both companies are marketing influenza vaccines, are engaged in the development of new influenza vaccines, and have new manufacturing techniques and processes.

BERNA has developed a new adjuvanted influenza vaccine, using the virosome technology, currently sold in Switzerland and Italy under the trademark Inflexal Berna® V. SOLVAY Pharmaceuticals has extensive manufacturing capabilities and is working on a new manufacturing process, in which BERNA is interested. The signed agreement which does not touch the independence of the two companies concerns marketing, manufacturing and research activities in influenza vaccines.

As a licensee of BERNA, SOLVAY Pharmaceuticals will receive the right to manufacture and sell the virosomal influenza vaccine under its own trademark in an agreed territory. BERNA will have rights to sell under its own brand SOLVAY’s subunit vaccine in a defined territory.

SOLVAY Pharmaceuticals is working on a new manufacturing process, making use of cell culture for influenza virus multiplication. SOLVAY Pharmaceuticals and BERNA intend to jointly develop this cell-culture process for influenza. Under the agreement, the two companies will also share expertise in the development of new vaccines for preventing influenza.

Dr Laurenz Grünenfelder, Director of BERNA, says : “We are happy to work together with SOLVAY Pharmaceuticals and its very successful business operations to maximise the global availability of the virosomal influenza vaccine.”

Mr Bart Kwist, SOLVAY Pharmaceuticals’ Manager of Global Business Development, says: “This is a good deal for SOLVAY Pharmaceuticals and BERNA since it allows both companies to develop and launch new influenza vaccines.”

BERNA, the Swiss Serum and Vaccine Institute Berne, was founded in Berne, Switzerland in 1898 and is specialised in the development, manufacturing and marketing of vaccines and serums. In the field of vaccine research and development, BERNA enjoys a leading position world-wide. Its business derives from sales of immunobiologicals and plasma derivatives. BERNA’s sales network is covering the world.

SOLVAY is an international chemical and pharmaceutical group, headquartered in Brussels, and directly present in 46 countries with more than 33,000 employees. Its consolidated sales in 1998 reached EUR 7.5 billion (USD 8.7 billion), generated by four sectors of activity: Chemicals, Plastics, Processing, and Pharmaceuticals. Solvay Pharmaceuticals is active in the discovery and marketing of ethical pharmaceutical products.

For more information please contact:
BERNA, Mr. Peter Wiesli, Chairman and CEO, telephone 0041-31-9806209.
Solvay Pharmaceuticals, Mrs Puck Bossert, +31-294-477469
Solvay Pharmaceuticals, Mr. Klaus Weidner, telephone + 49-511-8573457

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April 16, 1999

NOVEL VACCINE APPROACHES FOR THE CONTROL OF INFECTIOUS DISEASES SUCH AS AIDS, HEPATITIS B AND INFLUENZA

Press Release from Symposium
“European Perspective in the Control of Infectious Diseases”

On 16 April 1999, at an international scientific symposium in Malta hosted by Professor Albert Osterhaus, professor of Virology at the Erasmus University in Rotterdam (The Netherlands), new developments in vaccine research were presented to combat important infectious diseases such as AIDS, hepatitis B and influenza.

Today the European population still faces a high person-to-person transmission of certain human infectious diseases. For influenza and hepatitis B, vaccines are available but their utilisation in Europe varies greatly. With regard to influenza vaccination it is known that at most 50% of “high-risk” patients receive yearly vaccination. “High-risk” patients include subjects aged 65 and over, and persons with underlying conditions like heart disease, lung disease and diabetes. These people have the greatest risk to suffer from complications caused by influenza which can lead to hospitalisation or even death.

For hepatitis B a need for increased vaccine usage has been recognised by public health authorities. Vaccination can prevent chronic hepatitis B infection, chronic liver disease, and hepatocellular carcinoma (HCC). However, the strategy of specifically targeting high-risk subjects has failed to prevent about half of total cases which occur in persons with no identifiable risk. Therefore hepatitis B vaccination has been or will be included in the routine vaccination schedule of many European countries.
Groups with high risk for contracting hepatitis B include healthcare workers, clients and staff of institutions for the mentally retarded, haemodialysis patients, homosexually active men and heterosexually active persons with multiple sexual partners, and users of illicit injectable drugs.

Apart from the need for increased vaccine usage to reduce the spread of infectious diseases, scientists have realised in recent years that novel technologies can improve vaccine efficacy and may enable the production of vaccines against new infectious diseases, e.g. AIDS. At the same time, some of these modern technologies may lead to the development of therapeutic vaccines.

In Malta, key European scientists discussed their projects in progress investigating the potential advantages of new and improved vaccines. The meeting was started by the renowned scientists Professor Maurice Hilleman (USA) and Professor Geoffrey Schild (UK), who gave fascinating overviews on the history of vaccines and on future prospects, respectively.

Various researchers discussed their experiences with the virosome technology, one of the most promising candidate adjuvants for the future. As was presented by Dr. Jan Wilschut (NL) and Dr. Reinhard Glück (CH), vaccines using Immunopotentiating, reconstituted Influenza Virosomes (IRIV) as a delivery vehicle have been found to induce an improved immune response. In humans, licensed IRIV-based vaccines containing hepatitis A and influenza antigens have been shown to possess enhanced immunogenicity compared to other vaccines. Further research on the use of this new adjuvant in other fields of vaccinology was advocated.

Professor Luc Montagnier (France), chairman of the World Foundation of AIDS
Research and Prevention, and discoverer of the Human Immunodeficiency Virus type 1 (HIV-1), and Professor Osterhaus held presentations on HIV vaccine developments. It was explained that the control of the HIV virus would ideally require specific mucosal immunity to protect the genital region through which transmission frequently occurs. Therefore a vaccine that stimulated a disseminated mucosal and systemic protective immune response would be extremely useful.
Professor Montagnier indicated that a nasal spray with a virosome-Nef vaccine has shown promising results. Professor Osterhaus presented data on the reasons why Rev and Tat may also be important candidates to be included in a future HIV vaccine.

Professor Jörg Reimann (Germany) and Professor Yezechel Barenholz (Israel) held presentations on the design of vaccines against chronic hepatitis B virus (HBV) infection in preclinical models. It was indicated that a specific cellular immune response to HBV-encoded proteins rather than viral factors seem to be decisive in determining the outcome of HBV infection. Among other things, they are now studying the therapeutic value of CHO-protein- or DNA-based HBV vaccines, including virosomes, in animal models.

Professor Pietro Crovari (Italy) and Professor John Oxford (UK) concluded the day with presentations on novel trends in influenza vaccination. Prof. Crovari presented exciting results of the use of a virosomal influenza vaccine in humans given via the intranasal route.

Prof. Oxford described the progress that has been made over the last 50 years, stating that there is now clear evidence of vaccine efficacy in preventing hospitalisation and death due to influenza. He expected that in the coming years many new developments in influenza vaccines can be expected. Finally he indicated that, statistically speaking, a future influenza pandemic may not be far away. The global influenza outbreaks in 1918, 1957 and 1968 caused intense social and medical disruption. Influenza vaccines have made a unique contribution to the health and security of the population and the recent scientific developments will undoubtedly enhance this trend. However, Oxford hoped that the expectations of society to be protected against infectious diseases would result in increased investments in quality scientific and medical research into influenza vaccines.

The scientific symposium was sponsored by BERNA, Swiss Serum and Vaccine Institute Bern (Switzerland), specialised in the research, manufacturing and marketing of immunobiologicals, and Solvay Pharmaceuticals, a division of the chemical and pharmaceutical group Solvay SA, with headquarters in Brussels (Belgium), which is active in the research, manufacturing and marketing of pharmaceutical products.

For more information, please contact:

Professor Albert Osterhaus, Institute of Virology, Erasmus University, Rotterdam, The Netherlands, telephone +31-(0)10-4088066, fax +31-(0)10-4089485

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April 7, 1999

SOLVAY GROUP: LUVOX® AND DEPROMEL®, FIRST INNOVATIVE MENTAL HEALTH DRUG (SSRI), APPROVED FOR JAPANESE MARKET

On the 7th April 1999 the Japanese Ministry of Health and Welfare approved Luvox® and Depromel® (both brand names contain the active ingredient: fluvoxamine) for marketing in Japan. Luvox® (Solvay’s international brand) is approved for depression and obsessive-compulsive disorders (OCD) in more than 75 countries. It is an innovative mental health drug developed and manufactured by Solvay. It is the first Selective Serotonin Re-uptake Inhibitor (SSRI) to enter the Japanese market. Luvox® is safe and effective in depression and OCD and has less side effects than traditional anti-depressants. Being an SSRI, it inhibits the re-uptake of serotonin, a substance in the brain that plays an important role in mental health disorders like depression and OCD.

In Japan this innovative mental health drug has been co-developed by Solvay-Meiji and Meiji Seika. Solvay-Meiji is a joint venture of Solvay SA and Meiji Seika. Introduction nationwide is foreseen for June 1999, under the trademark LUVOX® by Fujisawa and Solvay Seiyaku (the Japanese fully owned subsidiary of Solvay Pharmaceuticals) as well as under the trademark DEPROMEL® by Meiji Seika.

Experts believe that depression is underrecognized in Japan. Today this market is around USD 140 million, but it is expected to grow. Like in many other countries mental illness is often considered to be profoundly stigmatizing, not just to patients but also to their families. Depression and obsessive-compulsive disorders are complicated diagnoses to make with many patients going unrecognized.

In the last decade the introduction of SSRI’s as antidepressant drugs has had a major impact on the treatment of depression. The antidepressant market in the USA has grown approximately 10-fold and the European antidepressant market has grown approximately 4-fold during this period. This growth can be explained by improvements in the diagnosis of depression, the ease and efficacy of SSRI treatment, and an increase in the duration of the treatment.

Worldwide Luvox® was also the first SSRI to enter other markets, starting with Switzerland in 1983. Since then worldwide use of LUVOX® exceeds 19 million patients. In addition a detailed database of safety information on more than 38,000 patients participating in clinical trials is available. The drug is marketed in 75 countries.

Solvay Pharmaceuticals is a sector of the Belgian chemical-pharmaceutical concern Solvay SA, dedicated to optimal patient health management, providing products and undertaking innovative research in the core areas of psychiatry, cardiology (heart and vascular diseases), gastro-enterology (stomach and intestinal complaints) and gynaecology (women’s health).

Solvay SA is an international chemical and pharmaceutical group, headquartered in Brussels, present in 46 countries with more than 33,000 employees. Its consolidated sales in 1998 reached EUR 7,5 billion (USD 8.7 billion), generated by four sectors of activity: Chemicals, Plastics, Processing, and Pharmaceuticals.

For further information:
Solvay Pharmaceuticals : R. Bickerstaffe (tel: 31 653 380 122) , P. Bossert (tel: 31 653 165 942)
Solvay Corporate Communications: 32 2 509 60 16

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March 30, 1999

MICROSURGICAL DEVELOPMENTS PVC-RAT REDUCES USE OF LIVE RATS DRASTICALLY

Today the Microsurgical Developments PVC-rat (MD PVC-rat) has been officially launched in The Netherlands with the first one being handed over to Mr. Joop van der Reijden, former Minister of Health and presently Chairman of the Dutch television organization Veronica. This Microsurgical Developments PVC-rat is a true-to-life rat model made from a special Solvay PVC. It is a practical device developed for students, micro-surgeons, biotechnicians and other researchers to train basic microsurgical techniques. By making use of this MD PVC-rat the use of live laboratory animals can now be drastically reduced.
Scientists can practice a total of 25 different operation techniques on this MD PVC-rat, including button and suture techniques to attach blood vessels to each other, and transplantation of organs such as kidney and heart. Training in microsurgical techniques is by tradition live animal-based. The number of animals needed in the initial training phases may be very high due to the complexity of the surgery and anaesthesia used. Many techniques need to be practised and mastered and many live animals may be sacrificed during this learning phase. A great deal of laboratory animals can now be spared thanks to the launch of the MD PVC-rat. This model of a life-sized rat is currently produced for MD at a cost of Dlf. 350,– thanks to the sponsorship of Solvay. It is expected that this year a few hundred examples will be sold by the Microsurgical Developments Foundation to research institutes around the world.

Microsurgical Developments (MD) is a Dutch not-for-profit foundation that was established at the end of the 1980s, with as primary objective to replace, reduce and refine animal experiments in biomedical sciences. Over the years MD has developed various teaching materials such as the “Manual of Microsurgery on the Laboratory Rat”, and a set of videotapes accompanying this manual, and now the PVC-rat.

The MD PVC-rat was initiated with a grant from the Dutch Platform for Alternatives for Animal experiments. This platform was inaugurated in the 1980s with among others the active support of the Dutch government, a few phamaceutical companies in The Netherlands, and various animal protection organizations.

Today the launch and marketing of the rat is supported by the Solvay Group, Solvay Plastics (supplier of the special PVC used) and Solvay Pharmaceuticals.

Solvay Pharmaceuticals is one of the top 50 pharmaceutical companies in the world. It has a strong presence in Europe, and is rapidly expanding in the US, Asia, Central and Eastern Europe. The core activities of Solvay Pharmaceuticals consist of discovering, developing, and producing drugs for humans in the fields of psychiatry (mental illness), gastro-enterology (stomach and intestinal complaints), gynaecology (women’s health), and cardiology (heart and vascular diseases).
Solvay Pharmaceuticals deals carefully and caringly with laboratory animals and animal experiments. The company has high standards for this, and these are laid down in a special Company Policy, that strives to continuously replace, reduce, and refine live animal use. While animal experiments are only considered for research into the prevention or cure of human diseases, the company guarantees good housing, supervision, and care for all laboratory animals. In recent years Solvay Pharmaceuticals has achieved an 80% reduction in total animal use.

Solvay Pharmaceuticals and Solvay Plastics are divisions of the international chemical and pharmaceutical group Solvay SA, headquartered in Brussels, present in 46 countries with more than 33,000 employees. Its consolidated sales in 1998 reached EUR 7,5 billion (USD 8,7 billion) generated by four sectors of activity: Chemicals, Plastics, Processing, and Pharmaceuticals.

For more information please contact:
Mrs. Drs. Puck Bossert, Manager Communications, International Pharmaceuticals Communications, Solvay Pharmaceuticals
Telephone +31-294-477469, mobile +31-6-53-165942.

December 21, 1998

U. S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVES PROMETRIUM® CAPSULES FOR HORMONE REPLACEMENT THERAPY

SOLVAY PHARMACEUTICALS, Inc.(USA) announces that the FDA has granted the approval to market in the USA the first oral micronized progesterone – PROMETRIUM® (progesterone, USP) Capsules – for use in Hormone Replacement Therapy (HRT). Last June, PROMETRIUM® Capsules was already launched by SOLVAY PHARMACEUTICALS Inc. in the United States for treatment of secondary amenorrhea.

PROMETRIUM® Capsules is a natural progesterone synthesized from yams that is structurally identical to endogenous (naturally-occurring) progesterone found in a woman’s body. Micronization makes the progesterone easier for the body to absorb.

The 1994 National Institutes of Health-sponsored PEPI (Postmenopausal Estrogen/Progestin Intervention) study showed that PROMETRIUM® Capsules, when administered with estrogen, demonstrated a decreased risk of endometrial hyperplasia and favorable effects on High-Density Lipoproteins (HDL).

“PROMETRIUM® Capsules is an important new HRT option that complements our portfolio of women’s health products” said David A. Dodd, president and CEO of SOLVAY PHARMACEUTICALS. “It confirms the Group’s strategy of being one of the most important players in this field.”

SOLVAY PHARMACEUTICALS also launched in mid-1998 marketing of ESTRATAB® Tablets for the new indication of osteoporosis prevention. The ESTRATAB â Tablets, esterified estrogens synthesized from soy and yam plants, have been for sale in the USA from 1964 onwards, for the treatment of vasomotor symptoms of menopause. In 1997, SOLVAY PHARMACEUTICALS Inc. acquired U.S. licensing rights for the product ESTROGEL® (estradiol, USP), a topical estrogen undergoing Phase III clinical trials for the systemic treatment of vasomotor symptoms; and the exclusive U.S. and Canadian licensing rights for a technologically advanced combination estrogen/progestin hormone replacement matrix patch undergoing Phase III clinical trials for relief of moderate to severe vasomotor symptoms.

Gynaecology represents 25 % of global sales of SOLVAY’s Pharmaceuticals Sector (which amounted to USD 1.15 billion or BEF 42.3 billion in 1997), the other main therapeutic areas being Gastroenterology (36 %), Psychiatry (28 %) and Cardiology (6 %).

SOLVAY is an international chemical and pharmaceutical group, headquartered in Brussels, present in 46 countries with more than 34,000 employees. Its consolidated sales in 1997 reached BEF 311 billion (USD 8.4 billion), generated by four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.

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October 30, 1998

SOCIAL PHOBIA: AN UNDER-RECOGNIZED AND UNDERTREATED DISORDER

Social phobia is a strong fear or avoidance of social situations in which the individual is exposed to scrutiny by others, resulting in acts that are self-perceived as humiliating or embarrassing, such as trembling, stuttering, blushing or not being able to speak at all. Sufferers are not just a “little shy”, they are badly handicapped either in their private or personal life by their disorder. Although social phobia is a disorder that attracts more and more interest both in the scientific and the general public, it remains under-recognized and undertreated in clinical practice.

A very recent study, carried out by Dr Murray Stein, from the University of California at San Diego, and his colleagues from three other centres in the USA has shown that one of the selective serotonin reuptake inhibitor (SSRI) antidepressants, fluvoxamine, not only improves the symptoms of social phobia, but also improves social, work and family life.

* 92 patients (59 men and 33 women; mean age 39 years) with social phobia were included in the study. The mean age at which the patients first suffered from social phobia was between 12 and 14 years.
* The patients were treated for 12 weeks with either the SSRI fluvoxamine at mean daily dose of 202 mg or a placebo. All doses larger than 100 mg per day were taken on a morning and bedtime regiment. The study was carried out in a double-blind manner (i.e. neither the patient nor the doctor knew which of these treatments the patient was receiving).
* The results from 86 patients were assessed (6 patients had no assessments after starting the study).
* Significantly more patients in the fluvoxamine group than in the placebo group responded to treatment (43% vs. 23%). Response was defined as “much improved” or “very much improved” on the Clinical Global Impression (CGI) Improvement scale. This scale records the overall change in the patient’s condition and rates it from “very much improved” to “very much worse”.
* A number of scales (Brief Social Phobia Scale, Liebowitz Social Anxiety Scale, Social Phobia Inventory) specially designed to assess social phobia also all showed that fluvoxamine was significantly (p
* Fluvoxamine was also more effective than placebo in improving disruption in work, social life and family/home life.
* Fluvoxamine was generally well tolerated.
* In conclusion, the results of this study show that fluvoxamine markedly improves the symptoms of social phobia and the disruption it causes in everyday activities.

Stein MB, Pollack MH, Fyer AJ, Davidson JRT. Fluvoxamine in the treatment of social phobia: a multicenter, double-blind, parallel-group comparison with placebo in outpatients. Awaiting publication.

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October 29, 1998

CAN ANTIDEPRESSANTS HELP THE PREVENTION OF SUICIDE? PROPER TREATMENT OF DEPRESSION KEY IN SUICIDE PREVENTION

Worldwide, at least 830000 people are known to have died from suicide in 1996, it is one of the leading causes of death. More people die by suicide than in car accidents. And yet, many countries still do not have a national strategy for suicide prevention. At the 4th World Conference on Injury Prevention and Control in Amsterdam, May 18-19, experts gathered together to discuss such national strategies, what has been done, and what should be done in the future.

According to Dutch expert, Prof. A. Kerkhof, prevention of depression is key. The Netherlands is one of the countries where suicide rates dropped 20% since 1984. This reduction is attributed to better recognition and treatment of depression and suicide risk by professionals in mental health and primary care. As most suicides occur during depressive episodes, the adequate treatment of depression is therefore key, Prof. Kerkhof states.

And much is left to be desired in the treatment of depression, as is shown in the recently published Pan-European study DEPRES on Depression in the Community. This study by Lépine and others, shows that within a six month period 17% of the population in five countries suffered from a depression (7% from major depression).

Many people suffering from depression never seek help, 43%. Of those who seek help, most consult a primary care physician. More than two-thirds of these were not prescribed any treatment. Only 31% received drug therapy, but only 25% of these received antidepressants, the appropriate treatment for depression. Especially, in the elderly, who are notoriously at risk of suicide, depression is prevalent, greatly underdiagnosed, and not treated seriously enough.

Antidepressant therapy can help in suicidal ideation associated with depression. Studies with the selective serotonin reuptake inhibitor fluvoxamine, show that in severely depressed suicidal patients, suicidal thoughts often respond to therapy already in the first week of treatment (statistically significant comparable to placebo).

An advantage of SSRI’s like fluvoxamine is that they do not have the powerful effects on the heart. What make the (older) tricyclic antidepressants so dangerous in overdose. Even two weeks supply of some tricyclics can be fatal when taken all at once. In contrast, patients normally recover without long-term harm from even very large overdoses of SSRI’s. This is important, as statistics show that availability of means to commit suicide are one of the leading factors contributing to increased suicide risk.

Additional Sources:
Statistics World Health Organisation, Division of Mental Health Geneva.
Lépine JP, Gastpar M, et al. Depression in the community: the first pan-European study DEPRES (Depression Research in European Society). International Clinical Psychopharmacology (1997)). 12. 19-29./
Press release “Many countries struggle to bring down their suicide mortality: the Dutch suicide mortality dropped with 20% since 1984. 4th World Conference on Injury Prevention and Control
Ottevanger EA. Fluvoxamine activity with special emphasis on the effect on suicidal ideation. European Journal of Clinical Research 1991;1:47-54.
Henry JA. A fatal toxicity index for antidepressant poisoning. Acta Psychiatrica Scandinavia 1989;80:37-45.
Garnier R, Azoyan P et al. Acute fluvoxamine poisoning. Journal of International Medical Research 1993;21:197-208.

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March 13, 1998

SEX, DEPRESSION AND QUALITY OF LIFE

Press Release From Symposium:
Sexual Dysfunction and Depression
Bern Switzerland, March 13th, 1998

Most antidepressants have sexual side effects. Some don’t. A placebo-controlled study by psychiatrist and neurosexologist Dr. M.D. Waldinger PhD (the Netherlands), showed that most of the SSRI antidepressants have serious sexual side effects, with the exception of fluvoxamine. Where paroxetine delayed time to male orgasm by 780%, and fluoxetine by 660%, fluvoxamine performed like the placebo. This study, that has been published in the Journal of Clinical Psychopharmacology (August 1998), represents one of the recent insights that have put sex back on the psychiatric map. Because for a long time, sexual behavior has not been predominant in psychiatry.

After the Freudian psycho-dynamic period in psychiatry, in which sexual repression was thought to be the root of all neuroses, a period came in which sex played a very minor role in psychiatric thinking. Biological psychiatry made its entrance, and the focus of attention shifted to pharmacology and the brain. Psychiatry became more medicalised. And as Prof. Demyttenaere from Belgium postulates: “the medical world is more focused on dealing with pain than on dealing with sex, or feelings of pleasure. And if medical doctors do talk about sex or pleasure, it is usually as a risk factor for somatic problems”.

Physicians generally assume that persons in the acute phase of depression do not have a sexual life. This is wrong, according to Prof. Demyttenaere. Although depressed persons are often not very happy about their sex-lives, there is no study that indicates that people suffering from depression necessarily have less sex. They may even have more, as is confirmed by data from the famous epidemiological Zurich studies of Prof. Jules Angst. Sexual hyperactivity, according to Demyttenaere may be present in the prelude to a depression, or even as a marker of depression.

The importance of a normal sex life during the long-term treatment of depression is also underestimated, albeit more accepted than during the acute phase. Dr. Waldinger: “The sex life of many persons on antidepressant drugs is completely dead. Often they know, or suspect, it is related to the medication, and will stop taking it for this reason. This can be dangerous, because they may plunge back into depression with all its devastating effects. For these individuals, it would be good to know that there are alternatives to the antidepressants that gave them unwanted sexual side effects.”

After the depression symptoms subside, a person should keep on taking the antidepressant for at least four to six months to prevent a relapse. Depression is often a recurring disease, and persons suffering from it may benefit from taking preventative antidepressant medication, sometimes indefinitely. A recent study, presented by Prof. Montgomery (UK) shows that fluvoxamine significantly reduced the incidence of recurrence, and increased the mean time to recurrence. Fluvoxamine treatment was well tolerated and the incidence of adverse events was similar in the fluvoxamine and placebo groups. There were no sexual side effects in the fluvoxamine-treated persons.

The symposium on March 13th in Bern was a marker of the growing interest in sexual behavior as a topic of scientific study. International scientific experts in psychiatry and sexology gathered here to discuss what we know about, for instance, the complex roles of neurotransmitters and hormones in sexual behavior.

New data from sophisticated animal experiments performed by pharmacologist Prof. B. Olivier, in collaboration with Dr. Waldinger, may explain the differences between fluvoxamine and fluoxetine in their propensity to cause sexual side effects. The study shows that fluvoxamine and fluoxetine have a preferential effect on different post-synaptic serotonergic receptors. This finding may well lead the way to more insight in the role of different receptors on human sexual behavior.

The important issue is how physicians should approach this topic in daily practice. People do not like to talk to their doctor about sexual problems, but the physician is often embarrassed to ask as well. In a round-table discussion in Bern it was emphasized that physicians should evaluate the sexual functioning of the depressed person before the start of treatment. This should help assess whether sexual dysfunction during treatment was already existing before treatment, or was caused by the treatment. Dr. Waldinger emphasized that depressed persons should be informed beforehand about possible sexual side effects of the treatment: “This will ensure that a patient will mention his/her sexual problems, before stopping treatment on his own accord”.

A physician who is confronted with sexual side effects of antidepressants has several options. Prof. Demyttenaere: “Continuing treatment will seriously interfere with the patient’s quality of life. The risk of non-compliance, and recurrence of depression are considerable.” The regularly practiced drug holidays are not favored by Demyttenaere either: “This is non-compliance education. You teach your patients that it is OK to skip dosages whenever they feel like it. Also it condemns the patient to ‘sex on command’. But especially: drug holidays work only for 10% of patients on fluoxetine, while 10% of patients on sertraline and paroxetine show increases in HAMD scores, probably as a result of withdrawal”.

“In general, we are against using adjunctive therapies, because they may show interactions, and sometimes a reversal of symptoms. The best option, is therefore, to substitute treatment for a drug that doesn’t have these problems”.

Symposium Presenters:
Prof. Jules Angst, Psychiatric University Hospital Zurich, Switzerland Prof. Ian Hindmarch, University of Surrey, UK Prof. Berend Olivier, Utrecht University, The Netherlands Dr. Alessandra Graziottin MD, Board of the Italian Menopause Society, Milan, Italy Prof. Stuart A. Montgomery, St. Mary’s Hospital Medical School, London, UK Dr. Marcel D. Waldinger, Leyenburg Hospital, The Hague, The Netherlands Prof. Koen Demyttenaere, University Hospital Gasthuis Berg, Catholic University of Leuven, Belgium

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April 14, 1998

SOLVAY PHARMACEUTICALS, INC. (USA) LAUNCHES MARKETING OF ESTRATAB® TABLETS FOR THE PREVENTION OF OSTEOPOROSIS.

One month after the American Food and Drug Administration gave its approval to market 0.3 mg ESTRATAB® (Esterified Estrogens Tablets, USP) for the prevention of osteoporosis, Solvay Pharmaceuticals, Inc. (Marietta, Ga., USA) now effectively launches the marketing in the United States of the low oral estrogen dose of ESTRATAB® Tablets for this new indication.

The ESTRATAB® Tablets, esterified estrogens synthesized from soy and yam plants, have been for sale in the USA from 1964 onwards, for the treatment of vasomotor symptoms of menopause, such as hot flushes and night sweats. It is now accepted that a daily oral dose of 0.3 mg ESTRATAB® Tablets not only provides relief from these menopausal symptoms, but is also effective in the prevention of osteoporosis, a debilitating bone-depleting disease: it increases bone mass in the hip and spine, a predictive measure of reduction in the number of fractures that may occur as a woman ages.
Last month, the FDA approved both the 0.3 mg and the 0.625 mg doses of this plant-based estrogen for these purposes. Women taking the lower dose of ESTRATAB® Tablets experience fewer side effects.

The marketing of the 0.3 mg ESTRATAB® Tablets in the USA for osteoporosis is one more step towards the expansion of Solvay’s portfolio of women’s health products and confirms the Group’s claim of being one of the important players in this field. Solvay Pharmaceuticals, Inc., also markets ESTRATEST® (Esterified Estrogens and Methyltestosterone) tablets, for the treatment of moderate to severe vasomotor symptoms associated with menopause in patients not improved by estrogen alone.
Furthermore, Solvay Pharmaceuticals recently acquired U.S. marketing rights to PROMETRIUM® (Progesterone, USP) Capsules, a natural micronized progesterone which is currently under review by the Food and Drug Administration.
U.S. licensing rights were also acquired for ESTROGEL® (17-beta estradiol), a topical estrogen gel, and for a combination estrogen/progestin transdermal patch. Both the gel and the patch are currently undergoing Phase III clinical trials. Women’s Health products in Solvay Pharmaceuticals’ European portfolio include DUPHASTON®, an oral progestogen, FEMOSTON® and PRESOMEN®, two oral HRT combination preparations.

Gynaecology represents 25 % of global sales of Solvay’s Pharmaceuticals Sector (which amounted to USD1.14 billion or BEF 42.3 billion in 1997), the other main therapeutic areas being Gastroenterology (36 %), Psychiatry (28 %) and Cardiology (6 %).

SOLVAY Pharmaceuticals, Inc. of Marietta (Georgia, USA) is a subsidiary to the international chemical and pharmaceutical Solvay Group, based in Brussels (Belgium) and employing over 34,000 in 46 countries.
In 1997 total sales of the Solvay Group amounted to USD 8.4 billion (BEF 311 billion), generated in four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.

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January 22, 1998

SOLVAY PHARMACEUTICALS:
NEW ORGANIZATIONS IN SCANDINAVIA AND GREECE REFLECT DETERMINATION TO STRENGTHEN HEALTHCARE ACTIVITIES

As from January 1st, SOLVAY PHARMACEUTICALS has set up a wholly owned subsidiary in Greece, named SOLVAY PHARMA M.E.P.E. The newly formed company will deal with imports, local manufacturing, marketing and distribution of the Group’s pharmaceutical products and has taken over the activities of SOLVAY PHARMA Hellas, which was mostly a marketing unit.

Earlier, in November 1997, SOLVAY’s pharmaceutical activities in the Nordic countries have changed course as well, with the creation of SOLVAY PHARMA AB (Göteborg, Sweden). Together with its daughter companies: SOLVAY PHARMA AS (Oslo, Norway) and SOLVAY PHARMA ApS (Copenhagen, Denmark), SOLVAY PHARMA AB took over all marketing and sales activities for SOLVAY’s pharmaceutical products in Scandinavia from the MEDA group of companies, SOLVAY PHARMA’s partner for more than 40 years.

By doing so, SOLVAY PHARMACEUTICALS is now present with its own organizations in all major countries of Western and Central Europe.
The aim is to strengthen SOLVAY PHARMA’s position in these markets by improving its identity, by increasing its marketing efforts and consequently to increase sales.

The creation of the new legal entities in Greece and the Nordic countries marks the completion of an era of long-lasting partnerships with local pharmaceutical companies. In Greece , FAMAR A.B.E. -which cooperated excellently with SOLVAY PHARMA Hellas over many years- continues to be the contract manufacturer for the locally made products of SOLVAY PHARMA M.E.P.E. and remains the distributor of its products.
In Scandinavia, the MEDA group will continue to support the three Scandinavian SOLVAY PHARMA companies with medical, regulatory, logistical and administrative functions.

In Scandinavia, SOLVAY PHARMA sales amount to BEF 400 million (USD 11 million) . Most important products are Creon ® (for treatment of pancreatic exocrine insufficiency) and Fevarin ® (SSRI anti-depressant). The three companies will employ some 30 people.

In Greece, sales amount to BEF 230 million (USD 6.5 million). Most successful brands on the Greek market are Duphalac ® (a laxative) and Physiotens ® (for treatment of hypertension). SOLVAY PHARMA M.E.P.E. has currently a payroll of 39.

Worldwide, SOLVAY PHARMACEUTICALS has annual sales of BEF 37 billion (USD 1.2 billion). It concentrates on 4 therapeutic areas: Gastroenterology, Psychiatry, Gynaecology and Cardiology.

SOLVAY is an international chemical and pharmaceutical group, employing some 34,000 , based in Brussels (Belgium) and active in 41 countries. Its 1996 sales amounted to BEF 282 billion (USD 8.8 billion), generated by 4 sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.

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January 5, 1998

SOLVAY PHARMACEUTICALS, INC. ACQUIRES U.S. MARKETING RIGHTS TO PROMETRIUM® NATURAL MICRONIZED PROGESTERONE

Marietta, GA, (January 5th, 1998) — Solvay Pharmaceuticals, Inc. announced today that it will add the natural progesterone, PROMETRIUM® (progesterone, USP) Capsules 100 mg to its expanding portfolio of women’s health products. The acquisition from Schering-Plough Corp. marks the third women’s health product licensed or acquired by Solvay Pharmaceuticals since June 1997.

PROMETRIUM® Capsules is a natural micronized progesterone synthesized from wild Mexican yams. It is identical in chemical structure to endogenous (naturally occurring) progesterone, so it mimics the hormone women produce naturally. It is currently under review by the Food and Drug Administration (FDA), and has received an approvable letter from the agency for the treatment of secondary amenorrhea. Unlike progestins, synthetic forms of progesterone, PROMETRIUM® Capsules, when approved, will be the only oral progesterone available in the U.S.

The 1994 National Institutes of Health-sponsored PEPI (Postmenopausal Estrogen/Progestin Intervention) study showed that PROMETRIUM® Capsules, when administered with estrogen, demonstrated a decreased risk of endometrial hyperplasia and favorable effects on High-Density Lipoproteins (HDL).

“PROMETRIUM Capsules will broaden our growing business franchise in the women’s healthcare arena,” said David A. Dodd, president and CEO of Solvay Pharmaceuticals. “This micronized progesterone will extend the breadth of our portfolio of women’s health products, which includes the flagship products ESTRATAB” (Esterified Estrogens, USP) Tablets and ESTRATEST” (Esterified Estrogens and Methyltestosterone) Tablets.”

Another product recently acquired by Solvay Pharmaceuticals is ESTROGEL”, a topical estrogen gel undergoing clinical trials for the systemic treatment of vasomotor symptoms such as hot flashes and night sweats. This clear, non-staining gel delivers the active ingredient 17 beta-estradiol, the primary human estrogen, into the bloodstream.

In October 1997, Solvay Pharmaceuticals acquired exclusive U.S. and Canadian licensing rights for a technologically advanced combination estrogen/progestin hormone replacement patch currently undergoing Phase III clinical trials for relief of moderate to severe vasomotor symptoms.

Solvay Pharmaceuticals of Marietta (Georgia, USA), a subsidiary to the Solvay Group, is a research-based pharmaceutical company active in the therapeutic areas of psychiatry, gastroenterology, cardiology and gynaecology.

Solvay, an international chemical and pharmaceutical group, headquartered in Brussels (Belgium), employs over 34,000 in 41 countries. Its overall 1996 sales reached BEF 282 billion (USD 8.8 billion), generated in four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.

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November 17, 1997

BIOTECH ALLIANCE SIGNED BETWEEN SOLVAY AND INNOGENETICS IN GENOMIC RESEARCH. SOLVAY TAKES AN EQUITY STAKE INTO INNOGENETICS.

Solvay (Brussels, Belgium) and INNOGENETICS (Ghent, Belgium) jointly announced today that they have entered into an agreement in molecular biology focusing on the discovery of novel genes encoding potential drug targets expected to be involved in human disease processes.

The agreement signed today comprises a research contract between Solvay Pharmaceuticals Research and INNOGENETICS for an initial period of 5 years. It involves a down payment to INNOGENETICS of USD 4 million and an annual research funding of USD 1.5 million up to USD 2 million during the period of the research collaboration. Also included are clinical trial related to milestone payments by Solvay and royalties on products sales. Moreover, Solvay is taking a stake of 8.3% in INNOGENETICS’ capital for an amount of about USD 35.5 million (through a capital increase of 2 million shares at USD 17.75 / share). It is expected that, in the course of next year, SOLVAY will obtain a seat on the Board of Directors of INNOGENETICS.

INNOGENETICS’ experience with gene discovery and cloning is helpful to generate the continuous inflow of new targets for Solvay’s drug discovery pipeline. This is particularly important as, in a few years from now, the human genome will be completely discovered which will allow in depth investigation on the role of genes in pathology.

“Biomedical research is entering a new era: instead of treating the symptoms of diseases, the new drugs will tackle the causes”, declared together Daniel JANSSEN, CEO of the Solvay Group and his designated successor, Aloïs MICHIELSEN. “This collaboration with INNOGENETICS will ensure access for SOLVAY to the newest technologies in that field. After a worldwide search among top biotech companies, our preference was clearly for INNOGENETICS in Ghent. We have a very high regard for the quality of INNOGENETICS’ people and technologies. Moreover, their location will allow close contacts with the Solvay Pharmaceuticals Research teams in Amsterdam (The Netherlands) and in Hannover (Germany). The Solvay Group’s strategy is to expand its Pharmaceuticals business, both in existing markets as well as through long term research”.

“We are extremely pleased with the alliance with Solvay, as it brings INNOGENETICS new fields of therapeutic applications covering areas of very large, unmet clinical needs such as cardiovascular diseases and diseases affecting the central nervous system,” said Hugo VAN HEUVERSWYN, INNOGENETICS’ CEO. “The deal not only illustrates our competitive advantages in the field of research and technology but also our ability to turn them into shareholder value. All INNOGENETICS know how and technology, assembled during the last 12 years can now, in addition to our own areas of focus, also be applied in Solvay’s fields of interest. The beauty of the alliance is that there is no conflict of interest as the areas of disease interest of both companies are not overlapping at all. In addition to research funds and other fees, this alliance shall also provide INNOGENETICS with the benefits of the contributions of Solvay’s other biotech partners and the solid strategic group of scientists they constitute, well prepared to conquer diseases in order to improve quality of life of the elderly in the next century.”

This alliance with INNOGENETICS is fully complementary to previous agreements already signed by Solvay in the field of biotechnologies like combinatorial chemistry and high throughput drug screening.

Solvay is a Belgium-based international chemical and pharmaceutical group with 1996 sales of USD 8.8 billion including USD 1.2 billion from Pharmaceuticals. 1996 Pharmaceuticals RxD expenditures for Solvay amounted to USD 200 million, i.e about 17% of sales. The Solvay Pharmaceuticals companies operate worldwide and are leading producers of pharmaceuticals in the field of psychiatry, gastroenterology, gynecology and cardiology.

INNOGENETICS, founded in 1985, is an established Belgium-based biotechnology company engaged in research, development and marketing of diagnostic products for the detection of human diseases, and in the discovery and development of new therapeutic products. INNOGENETICS has now more than 325 employees. INNOGENETICS targets five disease areas : infectious diseases, tissue repair and immune, neurodegenerative and genetic disorders. INNOGENETICS’ goal is to build an innovative international biomedical company, characterized by a vertically integrated business in diagnostics, and in partnering strategy in therapeutics. Since November 28, 1996, INNOGENETICS (symbol : INNX) is listed on EASDAQ, the new pan-European stock market for growth companies.

For further information, please contact:

Mr. Wim Ottevaere
Innogenetics N.V.
Industriepark Zwijnaarde 7, Box 4
B – 9052 Gent (Belgium)
Tel : 32/9/241.09.52
Fax : 32/9/241.07.99

Mr. Johnny Kegels
PR Force
Scheldestraat 32
B – 2000 Antwerpen (Belgium)
Tel : 32/3/241.00.30
Fax : 32/3/248.65.15

Mrs Dominique CLERBOIS
Solvay S.A.
33, rue du Prince Albert
B – 1050 Bruxelles (Belgium)
Tel : 32/2/509.60.16
Fax : 32/2/509.72.40

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October 16, 1997

SOLVAY PHARMACEUTICALS ACQUIRES MARKETING RIGHTS FOR INNOVATIVE COMBINATION HORMONE REPLACEMENT PATCH FROM MERCK.

SOLVAY PHARMACEUTICALS Inc, based in Marietta (Georgia, USA) has acquired from MERCK KGaA of Darmstadt (Germany) licensing rights for the USA and Canada for a combination hormone replacement therapy (HRT) matrix patch. This patch, currently undergoing phase II/III clinical trials, will offer a technically advanced option for women seeking relief from menopausal vasomotor symptoms such as hot flashes and night sweats. Merck will retain an option to co-promote the product within the USA and Canada.
The proposed once-a-week estrogen/progestin therapy is expected to be the first combination patch available in the USA to contain levonorgestrel, a progestin known for its tolerability among medical experts. Patch delivery provides physicians and patients a convenient alternative to oral therapy and allows them to match different lifestyle needs of their patients. Currently, there is no transdermal estrogen/progestin combination product on the US or Canadian market.

The combination HRT product, which fits well with SOLVAY PHARMACEUTICALS’ expanding portfolio of women’s health products, will be developed in the USA.
SOLVAY PHARMACEUTICALS will initially seek an indication for the treatment of moderate to severe vasomotor symptoms associated with menopause.
“This combination HRT patch will enhance our franchise in women’s health, increase the value of our efforts in the obstetric and gynecological offices and demonstrate the strength of our clinical development capabilities,” said David A. Dodd, President and CEO of SOLVAY PHARMACEUTICALS. “It also will give physicians and patients a safe and effective new therapeutic option to treat the symptoms of menopause.”
“SOLVAY PHARMACEUTICALS is a growing leader within the U.S women’s healthcare market and a company with a solid record of proven success,” said Professor Bernhard Scheuble, Executive Director of Worldwide Pharmaceuticals, of MERCK. “We are proud to have them as a partner and look forward to working jointly to bring this cutting-edge product to the market.” Hormone Replacement is one of the areas on which SOLVAY PHARMACEUTICALS concentrates is resources. Its wide range of HRT and other specialty products in gynaecology includes FEMOSTON ®, ESTRATEST ®, ESTRATAB ® , the PRESOMEN ® line and DUPHASTON ® . The company has leading positions in the European and U.S.-markets. Only recently SOLVAY PHARMACEUTICALS obtained U.S. marketing rights for ESTROGEL ®, a topical estrogen gel undergoing Phase III clinical trials for the systemic treatment of vasomotor symptoms.

MERCK KGaA (or: ‘Kommandit Gesellschaft auf Aktien’), headquartered in Darmstadt, Germany, heavily invests in Pharma R&D focusing on cardiovascular-, central nervous system diseases, oncology and diabetes.

Some of MERCK’s major products originating from its research are also successfully marketed in the USA.
MERCK KGaA has a leading position in the thyroid hormone product sector, and since 1989 has heavily invested in the development of its women’s health product portfolio. The company employs 29,000 and its 1996 sales amounted to 7 billion DEM (4.5 billion USD), 60 % of which were in pharmaceutical products.
SOLVAY PHARMACEUTICALS Inc. of Marietta (Georgia, USA), as a subsidiary of SOLVAY PHARMACEUTICALS worldwide, is a research-based pharmaceutical company active in the therapeutic areas of women’s health, psychiatry and gastroenterology.

The SOLVAY Group is an international chemical and pharmaceutical company, based in Brussels (Belgium), active in 41 countries, employing over 35,000 persons. Its 1996 sales amounted to 8.8 billion USD (282 billion BEF), which were generated in four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.

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May 26, 1997

SOLVAY GROUP GRANTS FUJISAWA
THE DISTRIBUTION RIGHTS OF LUVOXTM IN JAPAN

The SOLVAY Group and FUJISAWA Pharmaceutical Co. entered into a distribution agreement for LUVOXTM (fluvoxamine) in Japan.

SOLVAY will manufacture and package LUVOXTM tablets and FUJISAWA will distribute and promote LUVOXTM in Japan.

SOLVAY SEIYAKU, SOLVAY’S pharmaceutical company in Japan, will be involved in pre-marketing activities and will copromote LUVOXTM after launch.

Fluvoxamine is a product of the SOLVAY Group’s health research discovered by SOLVAY DUPHAR laboratories in the Netherlands.

Fluvoxamine is already marketed in 52 countries and has been prescribed to more than 15 million patients world-wide.

In Japan, fluvoxamine was jointly developed by SOLVAY MEIJI YAKUHIN K.K. and MEIJI SEIKA K.K. for the indications of depression, depressive state and Obsessive Compulsive Disorder (OCD). Application for registration of LUVOXTM was submitted to the Ministry of Health and Welfare in 1996. Marketing of fluvoxamine by MEIJI SEIKA and FUJISAWA under two different brand names will start after registration has been obtained.

The key symptoms of depression are a depressed mood and a loss of interest or pleasure associated with such symptoms as appetite and sleep disturbances, decreased energy, feelings of worthlessness or guilt, concentration difficulties, and in the more severe cases thoughts of death or suicide.

Obsessive Compulsive Disorder (OCD) is a disease characterized by obsessive thoughts and/or compulsive (uncontrollable) behaviours, like handwashing, checking, counting, etc., causing overwhelming anxiety and distress to the patients.

Both depression and OCD are thought to be caused by the imbalance of a chemical in the brain called serotonin, which sends impulses from one nerve to another.

LUVOX (fluvoxamine maleate) is a selective serotonin reuptake inhibitor (SSRI) which offers a new method of treatment for depression and OCD by reducing effectively the symptoms of the disease without the side effects associated with the traditional treatments.

Fluvoxamine is expected to be the first SSRI in Japan.

FUJISAWA Pharmaceutical Co-Ltd. is one of the leading pharmaceutical companies in Japan with annual consolidated sales of about $ 2.5 billion (BEF 80 billion) in 1996 and is now actively developing its operations on a global scale, particularly in North American, Europe and Asia.

SOLVAY is an international chemical and pharmaceutical group, based in Brussels (Belgium) with operations in 41 countries and employing more than 35, 000 people. In 1996, it’s total sales amounted to USD 8.8 billion (BEF 282 billion) generated by five sectors of activity : Alkalis, Peroxygens, Plastics, Processing and Healthcare.

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March 25, 1997

LUVOX® (Fluvoxamine Maleate) TABLETS OFFERS HOPE FOR OBSESSIVE COMPULSIVE DISORDER (OCD) IN CHILDREN AND ADOLESCENTS

— First SSRI To Gain Indication —

MARIETTA, GA, March 25, 1997 — LUVOX® (fluvoxamine maleate) Tablets is the first SSRI to gain clearance from the U.S. Food and Drug Administration (FDA) to treat Obsessive Compulsive Disorder (OCD) [http://www.ocdresource.com] in children and adolescents. As the first selective serotonin reuptake inhibitor (SSRI) for this indication, LUVOX® Tablets* offers new hope for the estimated one million children and adolescents who have OCD. The product is jointly marketed by Solvay Pharmaceuticals, Inc. and Pharmacia x Upjohn, Inc.

OCD can strike in children as young as three or four, but is often undetected at this early age. Although children and adults experience many of the same obsessions (fear of contamination, need for symmetry, excessive doubt) and compulsions (excessive cleaning/washing, arranging/organizing, checking/questioning), children and adolescents with OCD are more likely to involve family members in their rituals. For example, they may insist their laundry be washed several times, demand that parents check their homework repeatedly, or become upset if siblings “contaminate” their bedroom.

Child and adolescent psychiatrist and OCD specialist, Mark Riddle, M.D., Director, Division of Child and Adolescent Psychiatry, Johns Hopkins Children’s Center, considers the FDA clearance an important step in treating biological brain disorders in juveniles. “Until now, there has been little information about how children and adolescents react to various medications, while the need to medically treat this, and other debilitating mental illnesses, is acute in this age category,” said Dr. Riddle. “The clinical studies required for FDA review of fluvoxamine for children and adolescents have provided important information about the safety and efficacy of this medication in children.”

LUVOX® Tablets has been widely used for adults with OCD and has become the number one prescribed medication for OCD by psychiatrists in the United States.

Benefits of LUVOX® Tablets

A 10-week, randomized, double-blind, placebo-controlled, multi-center study of LUVOX® Tablets involving 120 children ranging in age from 8 to 17 years showed that fluvoxamine is more effective than placebo for the treatment of OCD. LUVOX® Tablets was also well-tolerated; only three children taking fluvoxamine dropped out of the study due to adverse effects, none of which were considered serious. Most commonly observed side effects included agitation, hyperkinesia, depression, dysmenorrhea, flatulence and rash.

Conducting clinical tests and obtaining FDA clearance to market LUVOX® Tablets for use in juveniles with OCD is only part of the process in helping these children. Experts agree that education is the key to helping children and adolescents with OCD gain appropriate medical treatment.

“It is critical we remove the stigma of the disease and its treatment so children and adolescents suffering from OCD can benefit from early diagnosis and treatment, and lead more fulfilling lives,” said Larry Stone, M.D., president, American Academy of Child x Adolescent Psychiatry. “Many children with OCD benefit from a variety of treatments, including medication.”

What Causes OCD?
Research suggests that OCD is caused by an imbalance of the brain chemical called serotonin. This imbalance can be genetic, even though the disorder itself may not be hereditary. People with OCD experience unwanted, recurrent and disturbing thoughts they are powerless to suppress. This causes overwhelming anxiety, prompting them to perform repetitive, ritualized, compulsive behavior to alleviate the anxiety.

Why OCD is Hard to Recognize
According to the National Institutes of Health, childhood OCD is more prevalent than other childhood ailments such as juvenile diabetes (100000 cases in children 19 and under), yet remains largely undiagnosed and untreated. In young children, the disorder is often unrecognized because parents may attribute obsessive-compulsive behavior to a developmental stage and youngsters may not realize their thoughts and actions are unusual. Older children may hide their behavior, fearing that they are going crazy. Keeping this secret is exhausting and typically undermines a child’s ability to function normally in school and at home. Relationships with family and friends deteriorate, and parents agonize over their child’s peculiar behavior and hope “the phase” will pass quickly.

Impact of Untreated OCD
Children with OCD experience physical exhaustion and mental anguish from compulsive rituals such as repeated checking of school assignments, and obsessive fears such as harm coming to a family member as a result of household items being in disarray. Juvenile OCD can be particularly devastating because it coincides with a crucial period of social and emotional development. Schoolwork, home life and friendships are often affected.

LUVOX® Tablets was developed in the U.S. by Solvay Pharmaceuticals, Inc. Solvay Pharmaceuticals and Pharmacia x Upjohn, Inc. formed a strategic alliance in May 1991 to jointly market LUVOX® Tablets in the United States.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is a research-based pharmaceutical company active in the therapeutic areas of mental health, women’s health and gastroenterology. It is a member of the Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.

Pharmacia x Upjohn, Inc., is a research-based pharmaceutically- focused company dedicated to helping people around the world live longer and fuller lives. The company was formed through a merger of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia x Upjohn, Inc. is a provider of human health care and related products, and operates on a global basis. The company has a corporate management center in London and major research and manufacturing centers in the United States, Sweden and Italy.

Editor’s Note:
For more information about Obsessive Compulsive Disorder (OCD),** call 1-800-NEWS-4-OCD (800-639-7462) or visit “The OCD Resource Center” on the Internet at http://www.ocdresource.com.

1 Based on clinical standards, placebo-related side effects are generally found between 4% to 7% of patients. These findings should be interpreted in this context.

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