Shirley, NY – November 19, 2004 - The Food and Drug Administration’s (FDA) Dental Products Advisory Panel unanimously recommended approval for GEM 21S™. GEM 21S™ is being developed for the treatment of bone defects of the jaw in patients with advanced periodontal and periodontal-related diseases requiring surgical treatment. GEM 21S™ is a combination of synthetic bone matrix combined with a tissue growth factor.

The FDA Panel met on July 13, 2004 to review the Company’s Premarket Approval Application (PMA), which was submitted to the FDA on March 12, 2004. As a result of the review, the advisory committee recommended that GEM 21S™ be approved with only two conditions associated with product labeling. There were no post-approval requirements recommended by the advisory panel.

"We are extremely pleased that the FDA Advisory Panel has provided a strong vote of support for the approval of GEM 21S™," stated Samuel E. Lynch, D.M.D., D.M.Sc., Chairman and Chief Executive Officer of BioMimetic Pharmaceuticals (BMPI), Franklin, TN. "The results of our clinical studies demonstrate that GEM 21S™ significantly stimulates the growth of bone in the jaw and leads to enhanced healing of both bone and soft tissue lesions associated with periodontal disease. As a result of these findings, we believe that GEM 21S™ has the potential to dramatically improve bone and gingival tissue regeneration following surgical treatment of periodontal disease."

"We have worked hard to establish clear communications with the FDA during the submission and review of our PMA," commented Mark Citron, Vice President of Regulatory Affairs at BioMimetic Pharmaceuticals. "This fact was acknowledged by the panel, and we look forward to continuing our cooperative efforts with the FDA as they complete their review of the PMA submission."

GEM 21S™ is a fully synthetic regeneration system. The product combines recombinant human platelet-derived growth factor BB (rhPDGF-BB) with a resorbable synthetic bone matrix (β-tricalcium phosphate, β-TCP). The rhPDGF-BB provides the biological stimulus for healing by stimulating the proliferation and in-growth of osteoblasts, cells responsible for the formation of bone, while the β-TCP provides the framework of scaffold for the new bone growth.

The PMA filing that was reviewed by the FDA advisory panel contained results from a 180 patient double-blind, randomized controlled trial that was designed to evaluate the safety and efficacy of GEM 21S™ for the regeneration of bone and other periodontal tissues in the treatment of osseous periodontal defects.

In addition to filing for regulatory approval for GEM 21S™ in the United States, BMPI has also filed for regulatory approval in Europe using a CE Mark. The CE Mark is designed to provide marketing approval in all countries that make up the European Union.

BMPI has entered into an exclusive worldwide marketing and distribution partnership with Osteohealth Company, a division of Luitpold Pharmaceuticals, Inc. for GEM 21S™. Under this agreement, Osteohealth is responsible for the worldwide sales, distribution and post-approval development of GEM 21S™ for periodontal disease and future cranio-maxillofacial applications.

"The acquisition of rhPDGF expands our product portfolio and represents a major step in consolidating Osteohealth’s leadership in the worldwide dental tissue regeneration market. With the closure of this transaction, we have made a major commitment to researching and developing clinical applications of growth factor technology," said Mary Jane Helenek, R.Ph., M.S., M.B.A., President and Chief Executive Officer of Luitpold Pharmaceuticals, Inc. a wholly owned subsidiary of Sankyo Co. Ltd.