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Takeda's ARB Enters Phase III Trials In Japan As Company Moves To Acquire U.S. Biopharmaceutical Firm IDM

This article was originally published in PharmAsia News

Executive Summary

TOKYO - Takeda Pharmaceutical's angiotensin receptor blocker compound TAK-536 has entered Phase III clinical trials in Japan, just as the country's largest drug maker moves to complete its tender offer for the acquisition of U.S. biotech outfit IDM Pharma

TOKYO - Takeda Pharmaceutical's angiotensin receptor blocker compound TAK-536 has entered Phase III clinical trials in Japan, just as the country's largest drug maker moves to complete its tender offer for the acquisition of U.S. biotech outfit IDM Pharma.

Slated to replace Takeda's antihypertensive Blopress (candesarton), TAK-536 has shown "much stronger anti-hypertensive action," compared with Blopress and other currently available ARBs in clinical tests, Takeda spokesperson Hisako Nagata told PharmAsia News.

The compound now is in Phase II clinical trials in the United States and in the European Union, she said.

Blopress was launched as an ethical product in Japan in June 1999. Nagata said Takeda "will release TAK-536 before the Blopress patent expires." She declined to comment on when the patent expires. The Japanese patent law awards the patent right to a drug for 20 years. Blopress was approved in the U.S. and EU in 1997. (Inteleos database)

Japan's antihypertensive drug market in fiscal 2008, including ARBs and calcium channel blockers, was worth ¥1.0185 trillion ($10.5 billion), of which Blopress commanded the largest share totaling ¥137.9 billion ($1.43 billion), according to Nagata and industry data.

Takeda's R&D of new drugs has showed an uneven pattern in recent years. In April, the company announced it was withdrawing its diabetes drug TAK-379 from the United States and Europe because regulatory authorities said it had failed to clear clinical evaluation standards (Also see "Takeda Looks To Counter R&D Setbacks With Ramped Up Sales Efforts" - Scrip, 14 May, 2009.). In February, it discontinued developing TAK-242 for severe sepsis treatment.

Chibagin Asset Management Head of Research Fujio Ando said Takeda is "struggling" to show results and seems to be rushing applications for higher clinical development stages worldwide.

Meanwhile, on the same day that Takeda announced its Phase III trials, the company also disclosed that its tender offer for 86.4 percent of the outstanding common shares of IDM Pharma at $2.64 per share was approved, and the company would soon acquire the remaining shares for the same price. Takeda allocated $58 million for the acquisition.

Nagata said the acquisition is part of Takeda's long-term business policy to expand into biopharmaceutical and oncology products and is consistent with its May 2008 acquisition of Millennium Pharma, also a U.S. biopharmaceutical firm.

PharmAsia News recently interviewed Graeme Martin, president of Takeda's Palo Alto, Calif.-based corporate venture arm Takeda Research Investment, about the changing scope of corporate venture capital's role (Also see "Takeda Research Investment’s Graeme Martin On Corporate Venture Capital’s Role in Developing Next-Generation Biologics: An Interview With PharmAsia News(Part 2 of 2)" - Scrip, 19 Jun, 2009.)

- Toshio Aritake ([email protected])

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