TEL AVIV - Collgard Biopharmaceuticals Ltd., an Israel-based company targeting treatments for tissue trauma, has established a U.S. subsidiary, Collgard Biopharmaceuticals Inc., in Boston.

Neal Farber has been appointed president and CEO of operations in both the U.S. and Israel.

Collgard's frontline product, Halofuginone, was marketed for 20 years as an oral veterinary drug in domestic animals before Collgard scientists found it to be a specific and extremely potent inhibitor of collagen type I synthesis in soft tissues at the transcriptional level. (See BioWorld International, June 26, 1996, p. 5.)

This breakthrough discovery was followed by multifaceted test applications that quickly birthed hopes of curing collagen-related diseases. Collgard-sponsored human studies in Israel were conducted with a topical application of Halofuginone for treating scleroderma, a disfiguring skin disease, and graft-vs.-host disease.

Prior to joining Collgard, Farber was vice president of corporate development at Cubist Pharmaceuticals Inc., in Cambridge, Mass., and director of business development at T Cell Sciences Inc., in Needham, Mass. He also held several positions in the business and research groups at Biogen Inc., in Cambridge, “seeing them through successful business and product development to become healthy public companies,“ said Farber.

Science Foundation, 'Business Acumen'

“Farber brings high-level veteran executive ability on a strong scientific foundation, coming from Harvard University, where he was a Helen Hay Whitney Research Fellow in the department of molecular and cellular biology, and as a Hammett Chemistry Awardee from Columbia University,“ Ehud Geller, Collgard chairman and founding partner of Medica LP, told BioWorld International. “His business acumen and scientific background helped him understand immediately that Halofuginone is a real winner, not just another step in the development chain.“

Collgard Biopharmaceuticals is a wholly owned subsidiary of Medica, the U.S.-Israel health care investment firm formed in 1995 with a “unique strategy focused only on the health care and life sciences sectors,“ said Geller, who also was president of Interpharm Laboratories Ltd., in Rehovot, and executive vice president of Teva Pharmaceuticals Inc., Israel's largest biopharmaceutical company.

“Collgard has made enormous progress with Halofuginone during the past two years, with major achievements routinely requiring 10 to 50 times the initial investment of $10 million. Because the company is virtual, it could invest directly on experiments, rather than on building laboratories and infrastructure. Our results in each system tested have been dramatic, prompting a new conceptualization of disease treatment based on a specific conversion of inhibitory mechanisms that we termed 'panstasis,'“ said Eli Hazum, vice president of R&D for Collgard.

“No further discovery is needed,“ Farber said. “Positive, reproducible results in animal models in four disease areas have been demonstrated. Clinical trials have begun, and a risk-attenuated clinical strategy has been firmly incorporated. And the commercial opportunities in specifically inhibiting collagen production have been established.

“Assuming successful completion of clinical trials, the company expects regulatory filings to take place at the beginning of 2000,“ Farber added. “We plan to submit Halofuginone for orphan drug status approval for scleroderma treatment, which would expedite the FDA review process significantly.“

Faster FDA Approvals

An increase in overall cancer research has been fueled by the FDA's accelerated approval process, which has reduced the average approval time to 12.4 months from the industry average of 29 months for products to treat life-threatening cancer.

Collgard plans to commence cancer clinical trials in the beginning of 1999, and the company is seeking $5 million in equity financing both to advance Halofuginone development and to conduct clinical trials in two market opportunities.

“We estimate that this infusion of financing will enable the achievement of at least three significant milestones confirming the human therapeutic value of Halofuginone as a drug,“ Farber said.

The first milestone, he observed, will be advancing Phase II scleroderma trials to establish an easy-to-apply topical formulation. The second will involve commencing Phase Ib trials in certain solid tumors to test the safety and panstatic effects of orally administered Halofuginone. The third will be conducting a restenosis study in a pig model as the basis for an investigational new drug application to demonstrate Halofuginone's potential effectiveness in the prevention of blood-vessel blockage following balloon angioplasty.

“Collgard has attained significant progress, rapidly moving from concept through founding and beyond basic research,“ Farber said. “The main focus of the company is now at the preclinical product development and clinical trial stage. This is a very attractive feature, both for investors seeking rapid value creation and for pharmaceutical partners looking for clinical-stage licensing opportunities.“

Discussions are ongoing with major pharmaceutical companies regarding each of the company's top three therapeutic indications.

Several patents have been applied for the use of Halofuginone in humans, giving exclusive license to the company. Two already have been issued in the U.S. *