Still waiting for its initial public offering to price, BioNumerik Pharmaceuticals Inc. agreed to license marketing rights to its Phase III chemoprotective agent, Tavocept, to Takeda Pharmaceutical Company Ltd.

Specifically, the agreement includes the product's U.S. and Canadian marketing rights. Terms of the pact call for Takeda Pharmaceuticals North America Inc., a wholly owned subsidiary of Takeda, to market Tavocept following regulatory approval for sale in those territories.

In exchange, San Antonio-based BioNumerik is receiving a $52 million equity investment by Takeda as an up-front payment, and also could receive development milestone payments, funding for future Tavocept research and development and commercial milestone payments based on the achievement of specified sales targets. The companies will share net profits on an equal basis, and BioNumerik will have the right to co-promote Tavocept in the U.S.

Executives at the company could not comment because of an SEC-imposed quiet period related to the IPO, for which BioNumerik filed early this summer. It registered to list its shares on the Nasdaq National Market as "BNPI." At the time, its filing indicated that that its cash reserves stood at $33.2 million as of March 31. (See BioWorld Today, June 11, 2004.)

Officials at Takeda did not return calls seeking comment.

BioNumerik has developed Tavocept as a chemotherapy supportive care drug to prevent or mitigate the incidence, severity and duration of neuropathy, a side effect of paclitaxel. Tavocept is in Phase III development in the U.S., Japan and Europe, and the FDA has designated it a fast-track product. There currently is no FDA-approved treatment to prevent or reduce neuropathy caused by chemotherapy drugs.

Based on preclinical studies and Phase I trials to date, the company said Tavocept has the potential to prevent or mitigate such a side effect. Findings indicate that it potentially can protect cells against the damage or impairment to the functions of the intracellular protein, tubulin, which might be associated with the neuropathy caused by the taxane and platinum classes of antitumor drugs. Tavocept is intended to prevent or mitigate the numbness, pain and loss of feeling in the hands and feet that can be caused by chemotherapeutic drugs.

Osaka, Japan-based Takeda will work with BioNumerik to further study Tavocept and obtain additional information on the ability of Tavocept to protect against neuropathy.

The deal remains subject to U.S. antitrust regulations and approval from BioNumerik's shareholders.

Outside of the rights assigned to Takeda, Tavocept's rights are sewn up in the rest of the world. Baxter Healthcare SA holds the rights to exclusively develop, market, distribute and sell it in all markets other than the U.S., Canada and Japan. Grelan Pharmaceutical Co. Ltd., of Tokyo, holds exclusive rights to Tavocept in Japan.

BioNumerik is focused on developing drugs for cancer patients. Another late-stage product in its pipeline is BNP1350, for which Grelan also holds Japanese rights. The antitumor drug, which is part of the camptothecin class, appears to have fewer side effects and an improved safety profile. The company has completed one Phase II trial and is conducting another three evaluating the product administered intravenously in patients with advanced non-small-cell lung cancer, brain tumors, metastatic melanoma and advanced ovarian cancer. BNP1350 also is being studied in Phase I trials as an orally administered product.

In BioNumerik's most recent financial transaction, it raised $29 million in a private placement with existing investors late last year. (See BioWorld Today, Dec. 18, 2003.)

In a prior IPO attempt, the company in 2001 filed to raise $50 million but withdrew its plans later that year due to unfavorable market conditions. (See BioWorld Today, March 6, 2001.)

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