Some likely near-term movers on the FDA's decision date calendar for 70 different items (click to enlarge, left) include Cypress Bioscience ( CYPB ) + partner Forest Labs ( FRX ) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end.
Also, Discovery Labs ( DSCO ) is not listed on the calendar, but expects to file a complete response to a May 1st FDA approvable letter for Surfaxin by the end of September and expects a Class I review by the agency with a potential decision in just two months.
Another company not listed on the calendar is BioDelivery Sciences ( BDSI ), which expects approval for Onsolis [BEMA fentanyl] during the first half of 2009 after making modifications to the risk management program it previously submitted as required by the FDA for approval of the high-potency opioid pain medication.
The current slide in shares of Eli Lilly ( LLY ) could prove to be a good entry point assuming the issues surrounding the delay are minor or just caused by the FDA being understaffed. Analysts are forecasting blockbuster sales for Effient, which could eventually reach $2 billion by some estimates; so approval for the drug is important to fuel the future growth of Eli Lilly in the face of looming generic competition for Zyprexa. Effient would represent new competition for the multi-billion dollar blood thinner Plavix, which is marketed by Bristol-Myers ( BMY ) and Sanofi-Aventis ( SNY ). Given the complexity of the regulatory filing for Effient and the previous three month delay, it appears the FDA probably just needs more time to review the application rather than something more ominous such as requiring additional clinical trials.
Also, many companies have faced similar delays by the agency, such as Cardiome's ( CRME ) wait of over six months for an approvable ruling on Kynapid.Momenta Pharma ( MNTA ) represents a pure-play on the future of complex bio-generic drugs with a major near-term opportunity to steal market share from Sanofi's ( SNY ) Lovenox, which posted blockbuster sales of $3.8 billion worldwide in 2007.
The company's stock price tanked to below $5 per share last November as the FDA rejected the ANDA for Enoxaparin. The generic division of the FDA does not issue decision date deadlines, but the fact that no new clinical trials were required and the complete response has now been filed by the Sandoz generic drug division of Novartis ( NVS ) removes a degree of uncertainty and makes it a waiting game for Momenta investors.
$5.39 (10/10/08)
