FDA issues PMA response letter to BioMimetic's Augment Bone Graft

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that it received a comprehensive post-panel response letter from the FDA related to the Company's Pre-Market Approval (PMA) application for Augment^® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. The FDA acknowledged that the independent Advisory Panel voted in favor of a reasonable assurance of safety, effectiveness and a positive benefit:risk ratio; however the FDA went on to state that "[n]otwithstanding [the Advisory Panel's] recommendation, the PMA, without additional information, must be considered not approvable [and that]. . . to place [the Company's] PMA in approvable form, [the Company] must amend it to include the following . . ." The FDA then listed the information that BioMimetic would need to submit for the application to be approvable, and outlined a pathway that could potentially lead to approval without additional clinical trials to support the safety and effectiveness of Augment.

In the letter, the FDA requests that the Company submit additional information from the Augment pivotal study as it relates to the product's safety and effectiveness, as well as additional information relating to antibody safety and reproductive issues. The FDA also requests that the Company submit additional information relating to post-approval studies to monitor the cancer safety of the product and further evaluate its pharmacokinetic (PK) profile in humans.

Based on the Company's assessment of the letter, the following are FDA's key requests for additional information regarding the pivotal study:

• A re-reading of all 24-week CT scans by the original musculoskeletal radiologist, and at least one additional radiologist, and additional statistical analyses correlating the radiological outcomes to the clinical outcomes to allow FDA to evaluate the "robustness" of the data, given the differences in the outcome of the intent-to-treat and the modified-intent-to-treat patient population analyses;
• Further analysis of all serious study adverse events and re-categorization of all secondary surgeries as failures; and
• Stratification of results by various subgroup patient populations (e.g., patients with degenerative disease or patients with risk factors such as smokers, diabetes or obesity), and stratification of the subgroup data based on the amount of Augment or autograft used.

The Company currently anticipates that by mid-2012 it will submit an amendment to the Augment PMA that will include all of the requested additional information. If the submission is timely and satisfactorily addresses the FDA's issues, product approval could occur within 15-24 months from now. Although the Company is confident that it can address the issues raised by the FDA, there is no assurance that the FDA will be satisfied with the Company's response. The agency noted throughout the letter that if the Company cannot provide the requested additional information, the additional information does not address FDA's issues, or it raises new concerns, a new clinical trial may be required.

The Company continues to believe in the safety and effectiveness of Augment and remains optimistic about obtaining FDA approval of Augment. The Company is encouraged by its dialogue with the FDA and the Agency has indicated a willingness to work constructively with the Company in a timely manner to resolve the issues outlined in the letter. To that end, the Company and the FDA review team have already scheduled an in-person meeting later this month to begin this process.