Healthcare Industry News: protein therapeutics
News Release - October 13, 2006
BioMimetic Therapeutics Receives FDA Approval that Expands Manufacturing Capacity for GEM 21S(R)Approval of rhPDGF-BB Manufacturing Facility
FRANKLIN, Tenn.--(HSMN NewsFeed)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI ) today announced that the U.S. Food and Drug Administration (FDA) completed its evaluation and approval of the manufacturing facility that produces rhPDGF-BB, the key active ingredient in the Company's lead product, GEM 21S, Growth-factor Enhanced Matrix. As part of the approval process of GEM 21S, the FDA required the review and approval of a manufacturing site owned and operated by Novartis in Vacaville, California which manufactures bulk supply of rhPDGF-BB. The current approval provides additional, large scale manufacturing capacity to ensure the adequate supply of rhPDGF-BB available for use in GEM 21S, which is marketed for the treatment of periodontal bone defects and gingival recession, and GEM OS1, which is currently being evaluated in three clinical trials for orthopedic indications.
"We are pleased with the quick response from the FDA concerning the post-approval requirements for GEM 21S, and we extend our gratitude to Novartis for their cooperation during the audit of their manufacturing facility," commented Dr. Samuel E. Lynch, president and chief executive officer of BioMimetic. "This approval will expand the availability of rhPDGF-BB inventory insuring the Company's ability to meet the demands for commercial supply of GEM 21S."
In addition to the successful inspection and approval of the Novartis manufacturing site, two other FDA conditions placed upon BioMimetic as part of the post-approval requirements for GEM 21S have also been met. These included the establishment of a new analytical test for the identification of rhPDGF-BB in bulk production lots, and the submission of characterization data to the FDA for lots of rhPDGF-BB manufactured through August 2006.
GEM 21S was approved for sale in the United States by the FDA in November 2005, and in Canada by Health Canada in May 2006. Worldwide marketing, sales and distribution of GEM 21S is the responsibility of Osteohealth Company, a division of Luitpold Pharmaceuticals, Inc. which is a group company of Daiichi-Sankyo, Inc.
About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is developing and commercializing bio-active drug-device combination products for the healing of musculoskeletal injuries and disease, including periodontal, orthopedic, spine and sports injury applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21SŪ, as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. Additionally, the Company has clinical trials ongoing for orthopedic bone healing indications. The Company's product and product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of BioMimetic. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements. BioMimetic's actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with the marketing of BioMimetic's product and product candidates, unproven preclinical and clinical development activities, regulatory oversight, and other risks detailed in the company's filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Prospectus dated May 12, 2006, filed with the Securities and Exchange Commission on May 12, 2006 and in the second quarter 2006 10Q dated August 9, 2006. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for changes made to this document by wire services or Internet services.
For further information, visit www.biomimetics.com or contact Kearstin Patterson, manager corporate communications, at 615-236-4419.
Source: BioMimetic Therapeutics
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