FDA

BioCryst Pharmaceuticals (Nasdaq: BCRX) today announced results from the completed Phase IIa trial of BCX-4208 in patients with moderate to severe plaque psoriasis. Consistent with interim findings reported in May 2008, this study of BCX-4208, a potent, rationally designed, orally available purine nucleoside phosphorylase (PNP) inhibitor, met its primary objectives of safety and tolerability. In addition, BCX-4208 displayed dose-dependent reductions in peripheral blood lymphocyte counts, including subsets measuring B cells (CD20), total T cells (CD3), T helper cells (CD4) and T suppressor/cytotoxic cells (CD8).

BioCryst is an integrated biopharmaceutical company utilizing crystallography and structure-based drug design to develop a deep pipeline of novel therapeutics targeting major illnesses.

Celgene Corporation (NASDAQ: CELG) announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy.

A drug designated as a Fast Track product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to provide a therapy where none exists or provide a therapy which may offer a significant improvement in safety and/or effectiveness over existing therapy.

GTC Biotherapeutics (Nasdaq: GTCB) has been granted Priority Review from the FDA on its Biologic License Application, or BLA, for ATryn, recombinant form of human antithrombin.

Priority Review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the FDA's target date for action on the BLA is February 7, 2009.

EPIX Pharmaceuticals (NASDAQ: EPIX) announced that Bayer Schering Pharma will transfer the worldwide commercial rights for the novel blood pool magnetic resonance angiography (MRA) agent, Vasovist(R) (gadofosveset trisodium) to EPIX. The collaboration agreement between the two parties will terminate effective March 1, 2009; until that time, Bayer Schering Pharma will continue to provide continued supply of Vasovist in the 19 countries where it is currently marketed.

According to Bayer Schering Pharma, the company is committed to ensuring that patients and physicians in the countries where Vasovist is currently marketed have continued access to Vasovist during this transition period.

EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform.

ImClone Systems (NASDAQ: IMCL) submitted an application to the FDA to broaden the use of ERBITUX to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

The application, submitted on August 29, 2008, was prepared in conjunction with Bristol-Myers Squibb Company (NYSE: BMY), ImClone's partner for ERBITUX in North America. ImClone has requested Priority Review of the application, which, if granted, means that the FDA would make a decision on the application within six months. The FDA will notify ImClone whether it has accepted the submission by the end of October.

NOTE: Bristol-Myers recently offered $60 per share to acquire ImClone, but no deal has been reached yet.