FDA Oct Calendar and Biotech Scheduled $Events

Several here which could create movements in pricing and value, and receive recognition from conference scheduled

Four scheduled to report earnings: (10/13-JNJ, GILD)  (10/14-ABT)  (10/15-CBST)

Clinical trials with potential data readouts or other biotech events expected sometime in October:

Protalix BioTherapeutics - PLX
Drug/indication: prGCD (Uplyso) in Gaucher’s disease.

Allos Therapeutics - ALTH 
Commercial launch of Folotyn in peripheral T-cell lymphoma

PFE - Pfizer

WYE Wyeth  announced on 5/7/09 that the FDA Granted a priority (six month) review for the company’s pending BLA for Prevnar (Pneumococcal 13-valent Conjugate Vaccine) which was filed at the end of March. The proposted indication in the U.S. for the Prevnar 13 is for the prevention of invasive pneumococcal disease (IPD) and the otitis media (ear infections) caused by the 13 seotypes included in the investigation vaccine in children aged two months through five years. Prevnar 13 is also being studied in gloval phase 3 clinical trials in adults, with regulatory submissions expected in 2010

Oct. 5-6   JMP Securities Healthcare Focus conference - Oct. 7-8 Cowen & Co. 12 th Annual Therapeutics Conference

Oct. 8th - SPPI

The FDA accepted Spectrum Pharma’s supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8 2009. The FDA Approved Fusilev on March 7, 2008 for rescue after high dose methotrexate therapy in osteosarcoma. Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvetent overdosage of folic acid antagonists. In December 2008, the FUSILEV was listed in the National Comprehensive Cancer Network (NCCN) Drugs and Biologic Compendium to be used in combination with high dose methotrexate for the treatment of bone cancer (osteosarcoma and dedifferentiated chrondrosarcoma), and the NCCN Clinical Practice Guidelines in Oncology in Colon Cancer and Rectal Cancel were updated to reflect the Fusilev is available in the United States

Oct. 13  AVNR
Presentation at the American Neurological Association meeting of detailed data from the phase III study of Avanir Pharmaceuticals’ Zenvia, an experimental drug for the treatment of uncontrollable laughing and crying episodes — a condition known medically as pseudobulbar affect. Avanir announced positive top-line resultsfrom this study in August.

Oct. 14
The FDA’s Peripheral and Central Nervous System Drug Advisory Committee will convene to review Acorda Therapeutics’ fampridine (brand name Amaya). The proposed indication for Amaya is to improve the walking ability of patients with multiple sclerosis. Biogen Idec BIIB  is Acorda’s marketing partner for Amaya.
(The FDA briefing documents for Amaya should be posted to the agency’s web site on Oct. 12 or 13)

Oct. 16-21
The American College of Rheumatology annual meeting in Philadelphia. Noteworthy clinical data expected for presentation includes Pfizer’s CP-690550 in rheumatoid arthritis and Rigel Pharmaceuticals’ RIGL R788 in rheumatoid arthritis

Oct. 19 AMGN
FDA approval decision date for Amgen’s osteoporosis drug denosumab. If approved, Amgen will market the drug under the brand name Prolia.

Oct 22nd - BIIB + ACOR

Biogen Idec (NASDAQ:BIIB) and Acorda Therapeutics, Inc. (NASDAQ:ACOR)  announced that they have entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR

The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application (NDA) for Fampridine-SR. The NDA was assigned Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR for MS/ME.

Biogen Idec has outstanding capabilities in commercializing neurology and oncology products and is known globally for its reputation as an innovative leader in the field of multiple sclerosis. We are delighted to be working with them to make Fampridine-SR, if approved, available to people living with MS in Europe, Canada, Australia and other areas of the world,” said Ron Cohen, M.D., President and CEO of Acorda. “We believe that Biogen Idec’s international expertise in MS and neurology also will help us optimize future development of Fampridine-SR and maximize its value in markets outside the U.S.”

Oct. 24-28
The Obesity Society annual meeting convenes in Washington, D.C. Detailed data from phase III studies of three closely watched weight-loss drugs will be presented at the meeting: Arena Pharmaceuticals’ ARNA lorcaserin, Vivus’ VVUS , Qnexa and Orexigen Therapeutics’ OREX. Contrave

Oct. 30 GTXI-TSPT
FDA approval decision date for GTX’s GTXI, Acapodene for the reduction of bone fractures in prostate cancer patients undergoing androgen deprivation therapy.
FDA approval decision date for Transcept Pharmaceuticals’ TSPT, Intermezzo for insomnia.

Oct. 30-Nov. 4
The American Association for the Study of Liver Disease convenes in Boston. The most important meeting for hepatitis C drug research held on the U.S. every year. Several for consideration here are:  Vertex Pharmaceuticals VRTX, InterMune ITMN, Pharmasset VRUS, Idenix Pharmaceuticals IDIX, Anadys Pharmaceuticals ANDS