subject: Sanofi-aventis: Cns Franchise Takes A Knock [print this page] Sanofi-Aventis: CNS franchise takes a knock
Sanofi-Aventis has withdrawn its US and EU applications for its insomnia candidate, eplivanserin. Previously posited to emerge as a key player in the insomnia market, the drug's discontinuation represents a blow to Sanofi-Aventis' diminishing late-stage CNS pipeline. The company's decision also casts doubt on the future of the serotonergic drug class in the treatment of insomnia. ( http://www.bharatbook.com/detail.asp?id=70280&rt=Sanofi-Aventis-PharmaVitae-Profile.html )
In a statement updating its R&D pipeline, Sanofi-Aventis has announced the withdrawal of its US and EU applications for the approval of eplivanserin as a treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance. The company's decision follows a Complete Response Letter issued by the FDA in September 2009 which requested additional information regarding the drug's benefit-risk ratio.
The discontinuation of eplivanserin - an oral serotonin type 2 A receptor antagonist - is at odds both with the drug's encouraging Phase III results and Sanofi-Aventis' confidence in the drug, as demonstrated by the company's decision to file for approval under the brand name Ciltyri. As such, it is likely that the discontinuation is based on safety concerns prompted by the FDA's request for additional information.
On the basis of published data, it previously expected eplivanserin to emerge as a key player in the future insomnia market, with sales forecast to reach $808m across the US and five major EU markets (France, Germany, Italy, Spain and the UK) by 2017. According to eplivanserin's Phase III program (which included more than 2,700 patients), the drug significantly reduced wake time after sleep onset and improved quality of sleep. Results also reported eplivanserin to be well-tolerated and devoid of the next-day residual effects associated with available insomnia drugs belonging to the benzodiazepine drug class. Eplivanserin's novel mechanism of action, first-to-market status of the serotonergic drug class and likely non-scheduled status were expected to drive sales upon its launch.
In view of previously favorable revenue forecast for eplivanserin, the drug's discontinuation is disappointing to Sanofi-Aventis, presently the leading player in the insomnia market owing to the commercial success of Ambien (zolpidem). Nevertheless, despite this recent setback, It expects Sanofi-Aventis to retain its leading position in the insomnia market owing to Ambien's follow-on product, Ambien CR, which is forecast to lead the market by 2017 with sales of over $1.5 billion. In the absence of pipeline insomnia products, protection of Ambien CR's patent (which is not due to expire until 2019 in the US) will be of key importance to the company.
Sanofi-Aventis' recent decision over eplivanserin follows the company's February 2009 discontinuation of volinanserin. Like eplivanserin, volinanserin was a 5HT-2A antagonist in Phase III development for chronic insomnia. Therefore, with a diminishing late-stage pipeline consisting solely of one multiple sclerosis candidate (teriflunomide), the future of Sanofi-Aventis' CNS franchise appears bleak. Furthermore, discontinuation of eplivanserin casts doubt on the future of the novel serotonin type 2 A receptor antagonist class in the treatment of insomnia.
