FRANKLIN, Tenn., Jan. 8 /PRNewswire/ -- BioMimetic Pharmaceuticals, Inc. (BMPI) announced today that it has established a worldwide strategic alliance with Luitpold Pharmaceuticals, Inc., a subsidiary of Sankyo Co. Ltd., for research, development, marketing and manufacturing of GEM 21S(R), BMPI's lead periodontal product. GEM 21S(R) combines the tissue growth factor, recombinant human platelet-derived growth factor BB (rhPDGF-BB), with a resorbable synthetic bone matrix, beta-tricalcium phosphate (b-TCP), for the treatment of periodontal and cranio-maxillofacial osseous defects (bone defects of the jaws, head and face).
"BMPI is committed to the efficient development of bio-regenerative products that have the potential to transform patient care," commented Dr. Samuel Lynch, Chairman and Chief Executive Officer of BioMimetic Pharmaceuticals. "GEM 21S(R) is the first totally synthetic product combining a bone-like matrix with a purified recombinant growth factor for the treatment of moderate to advanced periodontal diseases. As such, it has the potential to become the standard of care in this field."
The alliance is expected to generate revenues for BMPI in excess of $150 million. A significant portion of the payments by Luitpold to BMPI are for research and development expenses, marketing assistance, and achievement of regulatory milestones. In addition, BMPI will receive a low double digit royalty on sales. The partnership further calls for BMPI to be the sole manufacturer of the final product under a manufacturing supply agreement. Additional financial details were not disclosed.
BMPI has recently completed a 180 patient pivotal clinical trial with GEM 21S(R) for the treatment of periodontal disease. It has filed for product approval in the European Union and intends to submit regulatory filings to the FDA in the first quarter of 2004.
"We are very pleased to enter into this agreement with Luitpold and Sankyo Pharmaceuticals," said Dr. Lynch. "Through their Osteohealth division they are a leader in the marketing of periodontal and oral surgical bone regeneration products. We believe that the execution of this alliance, which is one of the largest ever completed for a product in the periodontal and oral surgery fields, will usher in a new and exciting era of bio-regenerative medicine in dentistry."
About Periodontal Disease
Currently there are approximately two million periodontal surgeries performed every year in the United States. Periodontal disease results from inflammation of the gum tissue adjacent to the tooth, and commonly leads to loss of bone and ligament structures supporting the tooth. As a result, the patient often requires therapeutic treatment to avoid tooth loss. Current therapies include surgical intervention consisting of root planning, placement of grafts and/or barrier products, and the use of antibiotics. These methods primarily work to eliminate the inflammatory response adjacent to the tooth, but do not routinely stimulate the regeneration of the supporting tissues (bone and ligaments). Thus, there is a need for improved therapeutics to regenerate supporting bone and ligament structures. Studies indicate that rhPDGF-BB, when used in combination with a bone matrix, may stimulate restoration of bone and ligament around teeth affected by periodontal disease.
About BioMimetic Pharmaceuticals, Inc.
BMPI is a private company focused on development and commercialization of protein therapeutics for the healing and restoration of bone and other tissues. In addition to GEM 21S for the treatment of periodontal disease, BMPI is developing and retains all rights to rhPDGF for orthopedic applications.
Investors in the company include Burrill and Company (San Francisco, Calif.), Holden Capital (Denver, Colo.), Novo A/S (Copenhagen, Denmark), and Memphis Biomed Ventures (Memphis, Tenn.). For further information, visit http://www.biomimetics.com/.
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 BioMimetics Pharmaceuticals. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. BioMimetics' 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 our unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, litigation and other risks. Except as required by law, BioMimetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
Question and Answer Conference Call
If you have questions regarding the contents on this release, Dr. Lynch will be conducting a question and answer sessions on January 8, 2004 at 10:45 - 11:15 a.m. Eastern. The call in number is 1-800-347-6311.
BioMimetic Pharmaceuticals, Inc.