PERTH, Australia - Japan-based Takeda and San Francisco-based Cell Genesys formed a global development alliance for Cell Genesys' lead product GVAX immunotherapy for prostate cancer, now in Phase III.

In exchange for exclusive worldwide commercial rights to GVAX, Takeda will pay Cell Genesys $50 million up front and up to $270 million in additional payments on regulatory approval and commercialization milestones.

Takeda pays for all external development costs associated with the ongoing Phase III trials, as well as commercialization expenses and manufacturing costs. The two companies would not disclose what they estimated those costs to be.

There are two Phase III clinical studies ongoing: VITAL-1 and VITAL-2. Enrollment for VITAL-1 is complete with 626 patients with advanced prostate cancer. In January an independent data safety monitoring board "gave Cell Genesys the signal to continue the studies," Takeda told "The Pink Sheet" DAILY.

The companies expect VITAL-1 to complete in the latter part of 2009, at which point an interim analysis is expected for VITAL-2. That trial still is enrolling patients, the firm said (¹ Also see "Cell Genesys’ New Data Bolster GVAX Survival Mechanism" - Pink Sheet, 15 February, 2008.).

The trial sites are in the U.S. and Europe; the firms are undecided about whether they will file simultaneously in those regions. Takeda also said the companies have yet to make a decision about when they will file in Japan or other countries in Asia.

"Takeda's strategy is to enhance the pipeline for four basic areas: franchise one is lifestyle or metabolic diseases such as hypertension or diabetes; franchise two is oncology and urology; franchise three is central nervous system diseases; and franchise four is gastroenterological diseases," Takeda said.

"For the oncology field, we don't have an anti-cancer development in Phase II or III, so we need to enhance the pipeline as early as possible," Takeda told the DAILY, "either by in-house research and development, lifecycle management and also, in this case in-licensing alliances."

"Oncology for us is very important and the potential for the field is huge because there are so many unmet needs," the firm added.

Takeda licensed 13 candidates from Amgen for the Japanese market in February; it also bought out Abbott Laboratories' half of TAP Pharmaceuticals. The deals reflect a growing trend among Japanese drug makers looking overseas to expand their pipelines (² Also see "Takeda Makes $1 Billion Move For Amgen Development Rights" - Pink Sheet, 4 February, 2008.).

Cell Genesys boasts Takeda's prostate cancer experience

"In our view this is one of the most important transactions in the history of the company," Cell Genesys CEO Stephen Sherwin said in an April 1 webcast announcing the deal. "Takeda is indeed the best possible partner we could have found for GVAX prostate immunotherapy."

Sherwin stressed Takeda's success as a global company, which leads pharma sales in Japan and ranks 15 in sales globally.

"This is the company that has the most impressive record of achievement in the prostate cancer field," Sherwin said, adding that Takeda pioneered gonadotropin-releasing hormone agonist Lupron (leuprolide acetate), "the global standard of care for patients with prostate cancer who fail chemotherapy."

"Takeda has a global infrastructure and corporate experience that is unparalleled in the prostate cancer field. That, together with a commitment to oncology, makes for a perfect strategic fit," Sherwin said.

He also said the deal with Takeda only pertains to GVAX for prostate cancer, and that Cell Genesys will be looking at other indications for the immunotherapy.

- Tamra Sami (t.sami@elsevier.com)

Takeda, Cell Genesys Ink $270 Million GVAX Deal For Prostate Cancer

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