On 4/28/09, Dendreon (NASDAQ: DNDN) announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. On 9/24/09, DNDN announced plans to file an amendment to its existing BLA seeking FDA approval in mid-November for Provenge with a possible decision by the Agency likely to occur around mid-2010. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011.

On 9/24/09, Chelsea Therapeutics (NASDAQ: CHTP) announced top-line results from Study 302, the first of its two Phase 3 trials of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). While Study 302 demonstrated that Droxidopa showed a strong symptomatic benefit during the open-label dose titration and run-in phase of the trial, a preliminary review of the data indicates it did not demonstrate a statistically significant improvement relative to placebo, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA) during the double-blind phase of trial, the study's primary endpoint. Droxidopa was safe and well tolerated, with no significant related adverse events reported.

Another Phase 3 trial, Study 301, was previously reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA) in February 2008. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH.

On 9/24/09, Cephalon (NASDAQ: CEPH) announced that the FDA granted a priority (six-month) review for its supplemental New Drug Application (sNDA) for NUVIGIL (armodafinil) Tablets (C-IV), which was filed in June of this year.