Amgen's bone drug denosumab is one of the most closely tracked development programs in biotech. But with an FDA deadline for its final decision looming on Monday, analysts are making the case that a delay is likely.
According to a Dow Jones report, a lineup of analysts believe that there's a good chance they'll be left waiting on the sidelines for a few more months as regulators ponder Amgen's application and the panel vote in its favor. Denosumab has proven very effective in a variety of clinical trials, but it relies on an entirely new mechanism of action--inhibiting a protein involved in the destruction of bone. Aside from vaccines, denosumab will be the first biologic that will be marketed primarily to primary care docs rather than specialists. With the FDA regularly missing its deadlines already, and regulators puzzling out a new mechanism, analysts like Credit Suisse's Michael Aberman wouldn't be surprised "if the timeline slipped."
Amgen isn't likely to be sweating too much over the final decision. It has positive data from six late-stage trials. But if the regulators wait much longer a significant delay could force the company to cut its projections for 2010, when denosumab is expected to begin delivering blockbuster revenue.
- here's the piece from Dow Jones