Amylin, Alkermes and Lilly's Bydureon was supposed to show superiority to Novo's Victoza for the treatment of Type 2 diabetes in a head to head trial with 900 patients followed for 26 weeks. Instead the challenger GLP-1 receptor agonist, with its once-weekly dosing regime, tripped up. Novo's drug proved to be superior in lowering AC1 in comparison (1.5 percent vs 1.3 percent). Thus, Bydureon failed to meets its primary end pont for this study.
Will this signal Bydureon's death knell with regard to FDA approval? No. Will if make it harder to get third party payers on board? Probably. Could physician's reasonably conclude Bydureon is less effective than Victoza? Yes. Could this result in a less effective commercial case for a drug that is already 2 years behind its competitor reaching the market? Hell yes.
Results to date - Almyulin stock drops 25%, Alkermes stock drops 12%. Lilly stock flat to slightly down (dependng when you took its pulse). Big toe needs a band aid.
Posted by Bruce Lehr March 3rd 2011.