The FDA did issue a complete response letter to Lilly, Alkermes and Amylin with regard to its application for Bydureon (new name for 1x per week Byetta). But, there were no requirements for clinicals - and the companies only need to respond to some labelling questions and submit a REMS. They were also asked to clarify their existing manufacturing processes, but even that was unrelated to their most recent 483 - for which the Companies have already responded. See GEN.
Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist. Roche's taspoglutide will be a strong competitor in this class when it receives its expected approval. It already showed superiority for many type II diabetics in a phase 3 trial completed in late 2009, and more data is expected soon in 2010. Roche is already touting this as best in class in its investor conference yesterday (Roche late stage pipeline in Fierce Biotech). Regardless, the Bydureon news was good in particular for Alkermes and Amylin investors.
On the dark side, Novelos Therapeutics NOV-002 failed to meet its primary and secondary endpoints in a pivotal phase 3 trial for the treatment of non-small cell lung cancer (NSCLC) as reported in PBR. Novelos management tried to put best light possible on failure by focusing attention on an ongoing phase 2 trial for NOV-002 in breast cancer. The company will also begin a phase 2 trial with hepatitis C with its other lead candidate NOV-205.
Earlier this week, Pfizer has also reported a failure of its figitumumab in phase 3 in another attempt to treat non-adenocarcinoma, non-small cell lung cancer. They reported two additional failed phase 3 attempts with Sutent with Her-2 negative breast cancer. Read gory details in GEN if you dare.
Posted by Bruce Lehr March 19th 2010