FDA approval of Abbott’s SIMCOR® marks start of co-promotion with Solvay
FDA Decision Triggers Milestone Payment of USD 100 million by Solvay to Abbott
Solvay welcomes the recent U.S. Food and Drug Administration (FDA) approval to market SIMCOR® (Niaspan®/simvastatin), a fixed-dose combination lipid therapy developed by Abbott, in the United States, which has resulted in a milestone payment of USD 100 million from Solvay to Abbott. This marks the start of planned co-promotion efforts. Solvay Pharmaceuticals was granted co-promotion rights in the United States for SIMCOR® as a result of an agreement with Abbott announced on October 22, 2007.
Further to the USD 100 million capital investment, Solvay Pharmaceuticals will start contributing to the commercial expenses of SIMCOR® in the first quarter of 2008.
“The treatment of cardiometabolic diseases is one of Solvay Pharmaceuticals’ strategic therapeutic areas,” said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc. “We are excited about the collaboration on SIMCOR®, which extends Solvay’s presence in the United States and builds on a long-standing partnership with Abbott on TriCor®. Further developments include SLV348/ABT 335, the next-generation fenofibrate, for which Abbott submitted a New Drug Application to the FDA in the 4th quarter of 2007.”
SIMCOR® combines two well-established and leading medications, Niaspan and simvastatin, to target multiple lipid parameters – LDL “bad” cholesterol and HDL “good” cholesterol – in a single pill.
SIMCOR is the combination of two cholesterol-lowering medications: niacin extended-release (Niaspan®) and simvastatin. SIMCOR is used along with diet to lower levels of total cholesterol, LDL “bad” cholesterol and triglycerides, and to increase HDL “good” cholesterol. SIMCOR is used when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate, and when diet and other non-drug measures alone have not been successful. Patients should stay on a diet low in saturated fat and cholesterol while taking this medicine. No additional benefit of SIMCOR on heart disease over and above that shown for niacin alone and simvastatin alone has been demonstrated.
Important Safety Information About SIMCOR®
SIMCOR should not be used by people with liver problems, stomach ulcers, or serious bleeding problems; in women who are pregnant, may become pregnant, or nursing; and in people allergic to any product ingredient. Patients should contact their health care provider if symptoms of unexplained muscle pain, tenderness, or weakness occur, as this may be a sign of a serious but rare muscle disorder, from which rare cases of death have occurred. Health care provider should be informed about any other medications, vitamins, or nutritional supplements people are taking to avoid possible serious drug interactions. SIMCOR should not be substituted for equivalent doses of immediate-release niacin. Liver damage has been reported when substituting sustained-release niacin products with immediate-release niacin at equivalent doses. Always check with a health care provider before changing medication. SIMCOR should be used with caution by patients who consume large amounts of alcohol. Health care providers may do simple blood tests before and during treatment with SIMCOR to check for liver problems.
SIMCOR may cause an increase in blood sugar levels. Patients with diabetes should report any changes in blood sugar levels to their health care provider. Women of childbearing age should use an effective method of birth control to prevent pregnancy while using SIMCOR. Flushing (warmth, redness, itching, and/or tingling of the skin) is the most common side effect and may become less frequent over time. Additional symptoms may include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or swelling. Flushing may vary in severity and is more likely to occur when starting therapy or during dose increases. By taking SIMCOR at bedtime, flushing will most likely occur during sleep. If awakened by flushing, patients should take their time getting up, especially if feeling dizzy, faint, or taking blood pressure medications. Other common side effects may include headache, itching, nausea, back pain, and diarrhea.
Available since 1997, Niaspan is the only available FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.
Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone have been inadequate, to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction. In patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Important Safety Information About Niaspan
Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash.
Important Safety Information About Simvastatin
Simvastatin is a prescription tablet and isn’t right for everyone, including women who are nursing or pregnant or who may become pregnant, and anyone with liver problems. Unexplained muscle pain or weakness could be a sign of rhabdomyolysis, a rare but serious side effect and should be reported to a doctor right away. Simvastatin may interact with certain foods or other medicines including lipid-lowering medications called fibrates or niacin, increasing a patient’s risk of getting this serious side effect. Patients should tell their doctor about any other medications they are taking. The most common side effects are headache, abdominal pain, and constipation.
SOLVAY PHARMACEUTICALS is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men’s and women’s health. Its 2007 sales were EUR 2.6 billion, and it employs more than 9,000 people worldwide. For more information, visit solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to EUR 9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE – Bloomberg: SOLB.BB – Reuters: SOLB.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com