On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on 3/30/09, which cited the need to correct formatting issues with the application and requested additional supporting information before the NDA could be accepted for review. On 5/6/09, the FDA accepted the NDA with a priority review designation and PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS.
On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time. HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B).
HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. On 7/1/09, HGSI announced that it expects to have top-line results available on 7/20/09 for BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA in systemic lupus erythematosus (SLE). HGSI will host a conference call to discuss the results on 7/20/09 at 8:15 AM Eastern.
On 7/1/09, Pharming Group (AMS:PHARM) (PINK:PHGUF) announced that it is on track to re-file a request for European Union (EU) marketing approval for its lead product, Rhucin, in September 2009 as the Company confirmed positive results from a final clinical study that included 70 patients in Europe and North America. According to Pharming, none of the Rhucin treated patients experienced a relapse of symptoms in the same attack and there were no clinically relevant safety concerns for the drug. The European Medicines Agency (EMEA) has twice rejected the Company's application to market Rhucin, which treats hereditary angioedema (HAE), which is a condition that causes acute attacks of painful swelling of the skin, intestine, mouth, and throat. Pharming expects to submit its EU marketing authorization application for Rhucin in September 2009 with a FDA filing expected to follow.
Disclosure: No positions.
