BioMimetic's GEM OS1 Study Can Proceed as Planned
BY LAUREN UZDIENSKI, APRIL 22, 2008
In an "unusual and positive" move, the FDA has sent BioMimetic Therapeutics a letter confirming that the company's GEM OS1 IDE study can proceed as planned. This news comes three weeks after an FDA communication to J&J regarding an increase in cancer deaths correlated with its diabetic foot ulcer ointment, Regranex. Regranex utilizes PDGF, the same active ingredient used in GEM OS1 and throughout BMTI's portfolio, and BMTI's stock dove on the news.
The stock since rebounded to some extent, and should continue to recover on the latest word from the FDA; in a review of the differences between GEM OS and Regranex (primarily relating to dosing), the agency found no need for changes in the existing study design, and BMTI does not anticipate that there will be any need for additional data. The company reiterated that Regranex can be applied up to 140 days in a row, whereas GEM OS1 is delivered in a single application at the time of surgery. Though study enrollment slowed since the Regranex communication, with the FDA's letter and BMTI's outreach to its investigators, BMTI estimates that enrollment should be back on track in the next three or four weeks. The enrollment slowdown should not materially impact the company's timeframe for the PMA filing.
"Different product, different company" was the tone on the analyst call this morning, and as BMTI emphasized the FDA's continued approval of the GEM OS1 study as well as the support of study investigators and IRBs, management seemed eager to put the Regranex story behind them. If and how quickly investors will do the same remains to be seen; BMTI was trading at $10.30 intraday today, still off 30% from pre-Regranex levels, but up 60% from the low-point post-Regranex.
