BioMimetic Pharmaceuticals, Inc. Signs Agreements with Harvard Medical School and ZymoGenetics

FRANKLIN, TN – June 5, 2001- BMPI has signed patent licensing agreements with Harvard Medical School (Boston, MA) and ZymoGenetics, Inc. (Seattle, WA). These agreements cover intellectual property key to BMPI's business and provide BMPI extensive patent protection for its lead products. Collectively, the licenses include rights to nearly 30 issued US patents. BMPI concurrently executed a manufacturing agreement with Chiron Corporation (Emeryville, CA) for the large-scale manufacture of purified recombinant human platelet-derived growth factor BB (rhPDGF-BB), a key component in its lead therapeutic products under clinical development.

BMPI develops products based on the principals of tissue engineering. Tissue engineering is a new, promising field of reconstructive biology that utilizes recent advances in medicine, molecular and cellular biology and polymer chemistry to promote tissue and organ regeneration. Worldwide, restoration of bone and other tissues represents an annual $5-7 billion market opportunity.

"Harvard was pleased to enter into the license agreement with BMPI because of the substantial progress Dr. Samuel Lynch, a former faculty member of Harvard, and his colleagues have made in advancing BMPI's business in the important therapeutic areas of tissue engineering," commented Dr. Jeffrey Labovitz, of Harvard Medical School.

"Given BMPI's strength in tissue engineering technology, we feel the company is well positioned to develop new applications of PDGF for the treatment of periodontal disease and other bone defects," stated Bruce Carter, Ph.D, President and Chief Executive Officer of ZymoGenetics. "Our licensing agreement allows ZymoGenetics to leverage our existing intellectual property in this area, while helping BMPI to advance PDGF as a promising approach to address these clinical conditions." The manufacturing supply agreement between BMPI and Chiron Corporation, one of the leading biotech companies in the US, provides BMPI access to commercial-scale production capability for rhPDGF-BB. Chiron is also the supplier of rhPDGF to Ortho McNeil Pharmaceuticals, a Johnson & Johnson (J&J) company. Ortho-McNeil markets rhPDGF-BB (becaplermin) in a topical gel under the trade name Regranexâ for the treatment of lower extremity diabetic neuropathic skin ulcers.

"In addition to assuring us a large-scale supply of GMP product, this agreement grants us the right to cross reference Chiron's filings at the FDA related to the manufacture of rhPDGF-BB. In this one agreement, we have both secured a long-term supply of the key component in our lead therapeutic products, as well as greatly shortened our product development timeline by obtaining the right to reference Chiron's existing production records at the FDA" commented Dr. Samuel Lynch, Chairman and CEO of BMPI.

The first therapeutic indication to be targeted by BMPI is the treatment of bone defects resulting from periodontal diseases. Periodontal (gum) diseases represent a substantial emerging market opportunity. It is estimated that 10%-15% of the US population has advanced forms of disease that often require surgery or tooth extraction. Approximately 2 million periodontal surgeries are performed annually in the US. Consequently, periodontal surgery is one of the most common surgical procedures performed today. With the aging and relative affluence of the baby-boomers, the number of periodontal surgical procedures is expected to continue to grow. In addition, there are numerous other potential indications for BMPI's lead PDGF therapeutic product. For example, there are about 10 million surgical extractions annually, many of which could potentially benefit from the Company's technologies.

Forward-looking Statements
Some statements in this announcement constitute forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. There can be no assurance that the forward-looking statements included in this announcement will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of this information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.


Back to Headlines