FEATURE: BioMimetic Pharmaceuticals


Company Profile: BioMimetic Pharmaceuticals

A year and a half ago, Charles Hart, PhD, left his job and 22 years of seniority at ZymoGenetics to take over as chief scientific officer of Franklin-based BioMimetic Pharmaceuticals, a biotech upstart that hopes to develop a new generation of tissue generation treatments.

He hasn't regretted the decision.

"I like living in this area," says the newly minted Tennessean. For much the same reason, company founder Sam Lynch moved from New York back to Tennessee to start up BioMimetic in 2001. And with a third venture round under its belt, one product under consideration by the FDA and others in development, 2005 is turning into a watershed year for the company.

"We've certainly got big aspirations," says Hart. By the end of this year, BioMimetic's payroll is expected to swell from 24 to 35. The company added two new members to its leadership team in mid-July: Steven N. Hirsch joined the company as executive vice president, orthopedics and COO and Earl M. Douglas, Esq. has been appointed general counsel. The biotech is moving into 16,000-sq.-ft. of the Cool Springs Life Sciences Center -- the first major biotech center in middle Tennessee -- as the primary tenant. If everything works out according to plan, the expanding company will add more people and space in coming years.

Says Hart: "We certainly expect to grow."

Researchers at BioMimetic have been developing a therapy for bone loss due to periodontal disease. Working with a synthetic scaffolding material already on the market, they have been adding a platelet-derived growth factor, or PDGF agent, that initiates a wound-healing response in the body. The synthetic material creates a scaffold for the PDGF to stimulate the proliferation and in-growth of osteoblasts, cells responsible for the formation of bone. It also brings new blood vessels into the site. "That's critical to good blood supply."

Because the product -- Gem 21S -- is being developed as a dental device, says Hart, BioMimetic was able to move swiftly into a pivotal trial with 180 subjects to demonstrate efficacy. The biotech has completed human clinical trials on their healing therapy, and last July the FDA's advisory committee for dental products gave the premarket approval application for Gem 21S a unanimous thumbs up. Hart says the company is in the final stages of gaining full approval from the FDA, which they hope will come sometime in the next few months.

If the company is successful in its FDA application, it will manufacture the treatment and Luitpold Pharmaceuticals -- a division of Sankyo -- will sell it. Says Hart: "They are one of the market leaders in distributing bone grafting products."

Tennessee isn't just a friendly place to raise a business and a family. The state is also home to a big orthopaedic community, including companies like Smith & Nephew Orthopaedics and Wright Medical Technology. BioMimetic hopes to soon get their attention for the products it has in development.

BioMimetic's experimental therapies involve adding growth factor to "more putty and paste-type materials," says Hart. "It's moldable, like silly putty." Researchers are working to create substances that can be packed into a fracture site or turned into a fluid that can be injected into a damaged area, such as the spine.

Their work has drawn the attention of some of the leading venture capitalists in the field, including Burrill & Co. One Tennessee firm, Memphis Biotech Ventures, has also come in to back BioMimetic.

BioMimetic recently wrapped a two-part Series C round of venture capital, bringing in $38 million.

"One of the key points in our decision to invest in BioMimetic," commented Evan S. Melrose, MD, managing director at PTV Sciences, "was company management's proven ability to execute on its product development strategy. This has led to the rapid advancement of the company's lead product candidate into and through clinical development, positioning the company to launch its first product later this year.  This clearly places BioMimetic as a leader in the development of true biological-based therapies for the treatment of bone injuries."

In the classic development mode of a biotech company, a public offering would be in the works for the next funding step.

"We believe that if the market becomes attractive, we'll seriously consider an IPO," says Hart. But the recent funding round was substantial enough to leave BioMimetic in control of its own destiny for now. The company has the cash to bring one product to market while developing new ones in the pipeline, and it can wait out the current market blues that have forced some companies to take a deep discount in order to sell shares.

Adds Hart: "We can choose our time when we want to go."

John Carroll is editor of FierceBiotech.

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