Roche announced Friday that its Phase III clinical trials have been halted due to adverse reactions to diabetes drug candidate Taspoglutide. This will likely push back the drug's timeline to filing for a min. of 12-18 months and thus its future competitiveness given an increasing number of similar GLP-1(glucagon-like-peptide-1)-based therapies including Amylin's (AMLN) and Alkermes' (ALKS) Bydureon (PDUFA: Oct 22, 2010) and Novo Nordisk's (NVO) newly-approved Victoza. Adverse reactions experienced by patients in Roche's late trials include hypersensitivity reactions, stomach pain, heart and respiratory symptoms. Roche's shares were down 2.43% during Friday's trading.
Meanwhile, shares of AMLN and ALKS popped 19.93% and 9.43%, respectively, as investors see Roche's Taspoglutide NDA delay as a sign of security for Bydureon's marketability. The PDUFA date for Bydureon, the once-weekly version of the previously approved diabetes drug (Byetta), is scheduled for Oct 22, 2010.
No comments:
Post a Comment