Washington Editor

Two-year-old Therapeutic Human Polyclonals Inc. stands to gain $45 million through an arrangement with SangStat Medical Corp. in which the companies intend to develop the world's first humanized polyclonal antibodies.

The deal is the first for Therapeutic Human Polyclonals (THP), a Sunnyvale, Calif.-based company with an office in Munich, Germany. The collaboration combines THP's novel approach to produce humanized polyclonal antibodies in rabbits with SangStat's polyclonal-based therapeutics from animals.

For THP, this deal means the company can look to expanding its one-person U.S. office to a staff of 20 or so by the end of next year, Wim van Schooten, THP's co-founder and CEO, told BioWorld Today. He explained that research necessary to form the company was conducted in Germany, but future clinical and business operations will take place in the U.S.

While SangStat, of Fremont, Calif., could not be reached for comment, Richard Murdock, the company's interim chairman, president and CEO, released a prepared statement saying, "The collaboration between SangStat and THP represents an historic and logical step in the development and use of antibodies to fight disease. Just as the development of humanized monoclonal antibodies represented a significant medical advance, we believe the development of humanized polyclonal antibodies, if successful, will prove to be a watershed event in medical science."

Of the deal with SangStat, van Schooten said the twofold collaboration validates THP's technology and will enable the company to take the next step in researching and developing complete products.

The first part of the collaboration deals with a humanized version of SangStat's Thymoglobulin polyclonal antibody product (anti-Thymocyte-globulin, rabbit), which is currently used in immunosuppressed patients. SangStat said a humanized version might provide the opportunity for repeat dosing in solid organ and bone marrow transplantation, and might be useful in the treatment of immunocompetent patients with autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, diabetes and lupus.

Meanwhile, the second part of the deal focuses on the development of humanized polyclonal antibodies for the treatment of hematologic diseases such as B-cell lymphomas, leukemia and other B-cell-related disorders.

Simply put, van Schooten said THP will use its technology to improve SangStat's product.

THP has developed the PolyTarg platform that expands the use of antibody therapeutics from single-specificity monoclonal antibodies to polyclonal drugs with greater use. Humanized polyclonals, according to THP, are highly specific, but more versatile, and capable of targeting complex multiantigenic targets that are not sufficiently addressed by monoclonal therapies.

While THP valued the deal at $45 million, SangStat described itself as a co-investor in a two-stage financing in THP worth $10 million. In the first stage, SangStat contributed $3.2 million and Research Corporation Technology contributed $1.8 million.

The second stage will occur if certain milestones are met, at which time SangStat and RCT, of Tucson, Ariz., would make additional investments of the same amount. Following the second round, SangStat will have the option to invest $15 million.

Furthermore, for each product developed in the collaboration, SangStat would pay license fees, royalties and clinical milestones, according to THP.

In another part of the deal, Roland Beulow, senior vice president of discovery research at SangStat, will become chief scientific officer at THP.

SangStat's stock (NASDAQ:SANG) closed Monday at $17.63, up 4 cents.

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