# Solvay Pharmaceuticals moves ahead with Cilansetron



## Jeffrey Roberts (Apr 15, 1987)

(Thanks to Trbell for this posting) http://www.solvay.com/news/press/pr2001/pr010718.htm --------------------------------------------------------------------------------Embargo :July 18, 2001 at 8:30 AM (Brussels time) --------------------------------------------------------------------------------SOLVAY PHARMACEUTICALS moves ahead in Irritable Bowel Syndrome with cilansetron A clinical services agreement is signed WITH QUINTILES TRANSNATIONALSOLVAY 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 ourportfolio 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 www.solvaypharmaceuticals.com. For further information please contact : SOLVAY S.A. Headquarters Martial Tardy Corporate Press Officer Telephone : 32/2/509.72.30 Fax : 32/2/509.72.40 E-mail : martial.tardy###solvay.comInternet : www.solvay.com SOLVAY PHARMACEUTICALSRoger BickerstaffeHead of Pharmaceutical CommunicationsTel: +31 (0) 294 477 242Fax: + 31 (0)294 477 112E-mail: roger.bickerstaffe###solvay.com Internet: www.solvaypharmaceuticals.com


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## Kerri (Oct 1, 1999)

Jeff, Any suggestions as to how to find out about where the clinical trials will be in order to participate? The clinical trials sites on line are so old that they haven't changed in months. Thanks for any suggestions you may have.Kerri


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## Kathleen M. (Nov 16, 1999)

You could try contacting Solvay. Also www.centerwatch.com tends to be pretty up to date.Searched on cilansetron and got 2 hits. One listed 7/25/01 and one listed 5/9/01These were the centers listed7/25/01Marilyn ZuckermanOffice ManagerNorth Carolina Pharmaceutical Research, Inc.1310 SE Maynard Rd., Suite 204Cary, NC 27511 USAPhone: 919-467-5771Fax: 919-467-5744E-mail: mzuckerman###aol.comDated 5/9/01Jana Mills, RN, CRCNorth Carolina Pharmaceutical Research, Inc.620 S. Memorial DriveGreenville, NC 27834Telephone: 252-413-6628Fax: 252-752-1350Both were in NC, but you can go to http://www.centerwatch.com/patient/studies/cat90.html and they list trials by state. This seems to be one of the most up-to-date sites for clinical trial information. And for phaseIII they usually end up using more sites than this to get enough patients enrolled, so there may be more places opening up in the next few months. The people running these studies might know what other centers will be part of any multi-center trials so it could be worth giving them a call.K.------------------I have no financial, academic, or any other stake in any commercial product mentioned by me.My story and what worked for me in greatly easing my IBS: http://www.ibsgroup.org/ubb/Forum17/HTML/000015.html [This message has been edited by kmottus (edited 07-27-2001).]


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## Jeffrey Roberts (Apr 15, 1987)

I've contacted my contacts at Solvay indicating our interest in getting involved in the clinical studies asap.I'll keep you posted.Jeff


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## Kerri (Oct 1, 1999)

Jeff, Have you heard back from your contacts at Solvay?Kerri


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## Jeffrey Roberts (Apr 15, 1987)

Still waiting for a reply.Jeff


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## JanEllen (Sep 24, 2001)

I have an appt. for an interview regarding the cilansetron study October 23, here in North Carolina. Has anyone else gotten involved with any of the cilansetron studies?I hope I can get in and don't get the placebo!! I am a former lotronex user--loved the stuff!! I know they are running similar studies in Southern California. I heard the same radio ad in both states as I was traveling. If anyone is interested in the phone number I will be happy to post it, if that is O.K.?


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