By Mary Welch
In an agreement that Genzyme Transgenics Corp. (GTC) called "very significant," the company will develop and produce monoclonal antibodies in the milk of transgenic goats for Centocor Inc., with payment of up to $3.4 million in the first phase of the deal.
After about a year and a half, Centocor will decide whether or not to commercialize products. If the company opts to move in that direction, then GTC, of Framingham, Mass., will supply the antibodies at a transfer price.
"We are not disclosing further financial details," said Patricia Dimond, spokeswoman for Framingham, Mass.-based Genzyme Transgenics. "However, it is very significant for us."
Centocor, of Malvern, Pa., would not disclose its intentions for the monoclonal antibodies to be provided in the GTC deal. In August, the company won FDA approval for Remicade (infliximab), a monoclonal antibody for the treatment of Crohn's disease. Centocor also developed the anti-platelet agent ReoPro, a monoclonal-antibody-based product co-marketed in the U.S. by Centocor and Eli Lilly & Co., of Indianapolis.
This is GTC's thirteenth development deal for transgenically produced therapeutic monoclonal antibodies and the company's second this quarter. In October, the company signed a collaboration with an unnamed West Coast pharmaceutical company and will receive up to $3 million in development and milestone fees. The antibody that is the focus of that deal is projected to enter Phase III trials next year, and GTC could receive manufacturing and royalty fees in the neighborhood of $35 million.
"Another reason why we're excited about this collaboration is that there is renewed interest in the clinical promise of monoclonal antibodies, especially in oncology and autoimmune diseases," Dimond said. "We believe that transgenic technology is uniquely suited for the production of therapeutics requiring large doses and chronic administration."
GTC has deals with Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., to make an HIV drug in goats' milk; Bristol-Myers Squibb Co., of New York, for treatments of psoriasis, organ transplant rejection and autoimmune disorders; B. Braun Melsungen AG, of Melsungen, Germany, for recombinant human protein drugs; and Advanced Cell Technologies Inc., of Worcester, Mass., for cloning cows capable of producing human serum albumin in their milk.
In collaboration with BASF AG, of Ludwigshafen, Germany, GTC expects its first transgenically produced version of a therapeutic antibody to enter bridging human trials next year for treatment of rheumatoid arthritis.
"We think this represents a unique opportunity for Genzyme Transgenics to show that transgenically produced monoclonal antibodies could be produced in larger numbers and more cost-effectively than those produced [by current standard methods]," Dimond said.
Also in October, Genzyme Transgenics received a patent granting it exclusive rights to the transgenic production of immunoglobulins at commercially useful levels in mammal milk.
GTC's stock (GZTC) closed Wednesday at $5.625, up $0.375. Centocor's stock (CNTO) ended the day at $37.562, up $2.437. *