BioMimetic shares hit new low after FDA request
Nashville Business Journal by Chris Silva, Staff Reporter
Date: Wednesday, January 4, 2012, 2:46pm CST
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Chris Silva
Staff Reporter - Nashville Business Journal
Shares in Nashville-based BioMimetic Therapeutics Inc . slumped today to their lowest point ever, after the company disclosed a setback as it seeks approval from the Food and Drug Administration for Augment, its bone graft device.
BioMimetic had been hoping for FDA approval of the device by the end of 2011. However, the company received a letter from the FDA sometime over the holidays requesting additional clinical information. BioMimetic disclosed the FDA's request late Tuesday.
The biotechnology company said during a conference call yesterday that it intends to answer the agency by mid-2012, and that Augment approval could occur 15 to 24 months from now if the agency is satisfied with its responses.
BioMimetic had stated in its 10-Q report filed Nov. 8, 2011 that its cash balance would be sufficient to meet anticipated requirements “at least through early 2013.”
BioMimetic (Nasdaq: BMTI) said a $10 million milestone payment due to the company from Luitpold Pharmaceuticals will help it sustain operations as it continues to work on gaining FDA approval. The $10 million milestone payment has been added to the company’s year-end cash guidance of $55 million to $62 million.
“With careful cash management, this amount should be sufficient to see us through to the final FDA response relating to Augment in the U.S.,” said Sam Lynch, president and CEO of BioMimetic.
The $10 million was the result of GEM 21S – a nearly identical product to Augment – gaining the CE mark of approval in the European Union for the treatment of defects resulting from tooth extraction or trauma. The approval was attained on behalf of Luitpold, which purchased GEM 21S from BioMimetic in 2008.
The announcement “bodes well for the approval of Augment in the EU, which is also currently under review,” said Lynch, adding a decision on that front is expected by mid-2012.
