18 July 2001
SOLVAY PHARMACEUTICALS moves ahead in Irritable Bowel Syndrome with cilansetron – A clinical services agreement is signed WITH QUINTILES TRANSNATIONAL
SOLVAY PHARMACEUTICALS has decided to move ahead with its phase III program with cilansetron, a 5HT3 antagonist for the treatment of irritable bowel syndrome (IBS). Revisions to the former program were necessitated by recent events concerning competitors. Constructive discussions with the US Food and Drug Administration resulted in a revised clinical phase III program. The final data set will determine the chances of marketing authorizations and completion of the program will be pursued with top priority. Registration submissions during 2003 are likely. In the mean time, Solvay Pharmaceuticals continues to negotiate with potential alliance and marketing partners for cilansetron.
Cilansetron was created by SOLVAY PHARMACEUTICALS’ own drug discovery activities. Phase II placebo controlled clinical studies in the US and EU have demonstrated cilansetron’s ability to treat both male and female patients suffering from diarrhea predominant Irritable Bowel Syndrome (IBS). IBS is an unpleasant condition, characterized by abdominal pain, flatulence and altered bowel habits and is a significant quality-of-life lowering factor for the large populations of men and women suffering from it.
In order to expedite the execution of this large clinical program SOLVAY PHARMACEUTICALS has signed a “preferred-provider” clinical services agreement with the major contract research organisation QUINTILES TRANSNATIONAL. Under the agreement SOLVAY PHARMACEUTICALS gets access to state-of-the-art clinical trial execution at competitive, volume-dependant prices, as well as a certain priority claim on QUINTILES resources. In return QUINTILES gets a structured relationship with a significant customer and an insight into planned and possible future work that allows it to orient its activities more efficiently and effectively. This will not only benefit the cilansetron program but also other promising opportunities from Solvay Pharmaceuticals R&D portfolio.
This non-exclusive agreement is for a period of 5 years in the first place and services provided include clinical monitoring, data management, biostatistics, quality assurance and patient recruitment as well as clinical trial supply services and central laboratory services.
Dr Werner Cautreels, SOLVAY PHARMACEUTICALS head of global R&D, said; “Cilansetron is an exciting, although challenging, product opportunity. We are pleased to sign this preferred provider agreement with QUINTILES today, which will allow us to conduct the clinical program within the proposed aggressive timelines. Working with Quintiles raises our ability to progress our portfolio optimally and shorten development times. Their experience, skills, dedicated cutting-edge information technology capabilities and global network makes them a preferred provider of clinical trial services to us. Accessing their strong skills base complements and accelerates our ability to add value to our portfolio faster.”
SOLVAY PHARMACEUTICALS has carefully selected the therapeutic indications in which it is active and more than 6000 people work in-house. These are principally active in the areas of gastroenterology, cardiology, psychiatry and hormone replacements for both males and females. Within SOLVAY PHARMACEUTICALS R&D in-house work continues on activities that add highest value, which includes discovery efforts, early clinical work and the design stages of larger clinical trials and programs. External purchasing of clinical trial execution buys access to information technologies and trained and experienced people that could not be justified exclusively for captive use.
Solvay is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs about 32,000 in 50 countries. In 2000 its consolidated sales amounted to EUR 8.9 billion, generated by its four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals. Solvay is listed in the Euronext 100 index of top European companies. For further information please consult: www.solvay.com and solvaypharmaceuticals.com.
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