Sanofi-Aventis (SNY) said it has stopped the development of two drugs in its pipeline. The Paris-based pharmaceutical said it is withdrawing its application to market the insomnia drug eplivanserin in the Untied States and Europe because of “the need for significant further clinical developments and market access constraints". The U.S. Food and Drug Administration in September issued a complete response letter to the company saying it would not approve the drug without additional data. Sanofi also said it is discontinuing development of idrabiotaparinux to prevent the formation of blood clots in patients with atrial fibrillation.The company said considering recent therapeutic advances in this field, this compound does not appear able to bring significant improvement in the care of these patients.
Actelion (OTC:ALIOF) said that a late-stage clinical trial of its insomnia drug almorexant met its primary endpoint, but safety concerns from the trial will require further evaluation and assessment in longer-term phase 3 studies. The Allschwil, Swizterland-based company did not disclose the specific safety concerns to emerge from the trial. The phase 3 studies are currently in preparation - in both adults and elderly patients suffering from primary insomnia - and will evaluate long-term efficacy and safety. Almorexant, which is being developed with GlaxoSmithKline (GSK), is a first-in-class dual orexin receptor antagonist that the company says has the potential to shift the paradigm for treating sleep disorders. It is an oral therapy that penetrates the blood-brain barrier and is capable of inducing a transient and reversible blockade of the orexin receptors, which play an important role in maintaining wakefulness, and therefore regulate the sleep-wake-cycle.
Momenta Pharmaceuticals (MNTA) said in a filing with the U.S. Securities and Exchange Commission that it agreed with the Sandoz unit of Novartis (NVS) to end a collaboration and license agreement on M178, one of two biosimilar products covered under a four-product agreement between the two companies. The companies in December 2008 agreed to end their collaboration on the other biosimilar product known as M249. Momenta said it could still be eligible for certain milestone payments related to M178 if Sandoz uses certain intellectual property rights and data developed by Momenta in a Sandoz product that receives regulatory approval. The two companies continue to collaborate on the blood thinner M-Enoxaparin and a generic version of the multiple sclerosis drug Copaxone.
Cephalon (CEPH) said that the U.S. Food and Drug Administration has delayed acting on its supplemental application to begin marketing Nuvigil for improved wakefulness for patients with excessive sleepiness associated with jet lag. The Frazer, Pennsylvania-based company filed the supplemental application on June 29 and the FDA was expected to act on it by December 29. The company said it submitted additional information within 90 days of the assigned action date and that the FDA subsequently said it required more time for a full review of the submission and, therefore, would extend the action date by three months.
The U.S. Food and Drug Administration notified Fibrocell Science (FCSC) that it would not approve its application to market the biologic azficel-T, an autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults without additional data. The agency told the Exton, Pennsylvania-based company that it wanted data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling. The company said it will provide all of the requested data as quickly as possible.
The U.S. Food and Drug Administration said MedImmune is voluntarily recalling some of its H1N1 swine flu vaccine because of the nasal spray not being potent enough, Reuters reported. The recall involves a total of 4.7 million doses of the vaccine, but only about 3,000 of those had yet to be distributed. The rest of the doses were given out in October and November, when the vaccine was still at full potency, the company said. The FDA said people who had already received the vaccine do not need another dose. MedImmune said the recall was triggered when routine checks found unused doses had slight decrease in potentcy. The company said the doses were well within potency specifications at the time of distribution.