Washington Editor

BioMimetic Pharmaceuticals Inc. signed a second licensing agreement with ZymoGenetics Inc. surrounding development and commercialization of ZymoGenetics' recombinant human platelet-derived growth factor (rhPDGF) for bone diseases and defects.

This second agreement allows BioMimetic (BMPI) to study the PDGF for regeneration and repair of hard tissues for defects and diseases of the entire skeletal system, such as fractures, joint replacement and osteoporosis. In the first licensing deal, signed in May, BMPI bought rights to develop and commercialize the growth factor in periodontal disease. (See BioWorld Today, May 30, 2003.)

Founded in March 2001 and funded with an $8.5 million Series A round, BMPI, a Franklin, Tenn.-based private company, is focused on tissue engineering and developing and commercializing protein therapeutics for healing and restoration of bone and other tissues. Harvey Kellman, company executive vice president, co-founder and director, told BioWorld Today that BMPI is working on a Series B financing.

He said the company believes it will enter the market in the periodontal bone loss indication in early 2004.

"We chose the periodontal product first because it is the fastest route to the market for us," Kellman said. "We always knew we would enter a second agreement for the entire skeletal system."

BMPI has completed enrollment of a pivotal study of PDGF (referred to as GEM21S by the company) in periodontal disease. The product is regulated as a medical device. "We are happy to say that so far everything is looking good and there have been no significant adverse events that we can identify. We are on target to complete the trial sometime late this spring or this summer."

Meanwhile, the orthopedic products are expected to require a more extended development period. "We are starting our preclinical work right now to develop the product and information needed for an IDE [investigational device exemption]," he said.

Kellman wouldn't discuss financial terms of the agreement with ZymoGenetics.

However, Susan Specht, press relations associate at Seattle-based ZymoGenetics, told BioWorld Today the agreement included an up-front payment to ZymoGenetics, plus milestones and royalties. BMPI is responsible for all costs associated with development activities.

She added that ZymoGenetics has no plans to develop PDGF.

"Having demonstrated its ability to rapidly advance rhPDGF into clinical studies for the treatment of periodontal diseases, we feel BMPI is well positioned to continue development of PDGF for other hard tissue defects and therapies," Bruce Carter, president and CEO of ZymoGenetics, said in a prepared statement.

ZymoGenetics' stock (NASDAQ:ZGEN) closed Thursday at $9.82, down 16 cents.