Cool Springs company starts Augment Injectable bone graft trial

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BioMimetic Therapeutics, Inc. (NASDAQ: BMTI), a biotechnology company specializing in the development and commercialization of innovative bioactive products to promote the healing of musculoskeletal injuries and diseases, reported its first-quarter financial results.

For the three months ending March 31, the Cool Springs-based company reported a net loss of $8 million, or $0.28 per diluted share, compared to a net loss of $8.5 million, or $0.39 per diluted share, for the same period in 2010. The Company ended the quarter with $83.7 million of cash and cash equivalents and investments.

During early 2011, BioMimetic Therapeutics made significant advancements in its product development programs and other critical business areas:

•In March, the U.S. Food and Drug Administration (FDA) officially announced that it will hold an orthopedic advisory panel on Thursday, May 12, to review the company’s Premarket Approval (PMA) application for Augment™ Bone Graft for the treatment of foot and ankle fusions in the U.S.

The FDA published details of the meeting in the Federal Register on March 29, 2011. If the panel determines that Augment’s benefits outweigh any potential risks, then the company anticipates approval of Augment by the FDA within six months of the panel meeting.

• In the notification regarding the orthopedic advisory panel, the FDA announced it will make background panel meeting material available to the public approximately two business days prior to the meeting. The documents will be accessible at: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. The Company will not make any comment regarding the panel documents prior to the panel meeting on May 12.

• In early 2011, the company initiated patient enrollment in its North American pivotal trial evaluating Augment Injectable in hind-foot fusion indications. The study is expected to enroll approximately 200 patients at approximately 25 institutions and be fully enrolled around the end of 2011. The PMA filing will be submitted with the final 12 month data. The product will follow a medical device approval pathway and has been assigned to the FDA’s Center for Devices and Radiological Health (CDRH).

• The company recently submitted a device application for approval of Augment Bone Graft to a European regulatory agency and expects a regulatory decision in 2012. BioMimetic will seek a CE Mark in Europe, which is designed to provide a single marketing approval for all countries that make up the European Union (EU).

•In April 2011, in preparation for U. S. launch, the company made and released an additional Augment Bone Graft product kit size and immediately made it available in the Canadian market. This new 1.5cc kit will be complemented with a 6cc size kit, as well as the standard 3cc kit, and all three sizes will be available at launch in the U.S. These kit sizes will provide surgeons with the flexibility to utilize the amount of material they feel is most appropriate for the procedure and as a result will help hospitals eliminate excess waste.

“As anticipated, much of the first quarter of 2011 has been focused on preparing for the May 12 orthopedic advisory panel for our lead product candidate, Augment Bone Graft. We remain optimistic that Augment will receive a positive review at the FDA advisory panel meeting, and that it will be approved for sale in the U.S. later this year,” said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics.

“Additionally, we continue to advance our other product candidates in the pipeline and recently enrolled the first patients in our Augment Injectable North American pivotal trial. Augment Injectable will provide surgeons with enhanced delivery options in open or minimally invasive surgical sites. Further, the submission of our device application for approval of Augment in the EU keeps us on track in international markets.”

As of March 31, 2011, the Company had approximately $25 million of cash and cash equivalents and $58.7 million of short-term and long-term investments in U.S. government sponsored enterprise (“GSE”) securities, corporate bonds and commercial paper. These investments have maturity dates ranging from April 2011 through May 2012 and have S&P ratings ranging from “A1+” to “AAA.”

For the three months ended March 31, 2011, the Company reported total revenues of $0.4 million consisting of product sales, royalty income and sublicense fee income. This compares to total revenues of $0.4 million for the same period in 2010.

Research and development expenses totaled $4.1 million for the three months ended March 31, compared to $4.2 million for the same period in 2010.

General and administrative expenses totaled $4.0 million for the three months ended March 31, 2011, compared to $3.8 million for the same period in 2010. The increase in general and administrative expenses for the three months ended March 31resulted from increased expenditures in G&A activities while preparing for potential product commercialization.

Based on current operating plans, sales and marketing costs associated with the launch of Augment Bone Graft, forecasted timing and costs of clinical trials and other product development programs, the Company anticipates its 2011 year-end balance of cash, cash equivalents and investments to range from $43.0 to $50.0 million, and anticipates its net cash use will be between $42.0 and $49.0 million. Net loss for the year ending December 31, 2011 is forecasted to be in the range of $38.0 to $45.0 million.

All products developed by BioMimetic are based upon recombinant human platelet-derived growth factor (rhPDGF-BB) platform technology, which is a synthetic form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration.

Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments, thus helping patients recover faster from their orthopedic injuries.

In 2005, BioMimetic received marketing approval from the FDA for its first product, GEM 21S®, as a grafting material for bone and periodontal regeneration. GEM 21S is a trademark of Luitpold Pharmaceuticals, Inc., who now owns this dental related product and markets it through its Osteohealth Company in the United States and Canada.

Additionally, BioMimetic Therapeutics has completed and continues to sponsor clinical trials with its three lead product candidates Augment™ Bone Graft, Augment™ Injectable Bone Graft, and Augment™ Rotator Cuff Graft in multiple orthopedic and sports medicine indications including the treatment of foot and ankle fusions, the stimulation of healing of fractures of the wrist, and the surgical treatment of rotator cuff tears.