TOKYO - In its quest to expand into the antibody therapy area, Kyowa Hakko Kogyo signed a license contract for marketing Alnylam's respiratory syncytial virus injection drug in Japan and East Asian countries, a Kyowa Hakko spokesman confirmed June 23.

The Cambridge, Mass. company's RSV01, an RNAi therapeutic is currently in Phase II clinical trials in the U.S. for treatment of RSV infection. In Japan, there are roughly 100,000 RSV infection patients, many of them infants, but no vaccines are available, Kyowa Hakko Spokesman Kenshiro Honda told PharmAsia News.

RNAi therapeutics target the cause of diseases by potently silencing specific messenger RNAs to prevent disease-causing proteins from being made.

In recent years, Honda said the company has been reinforcing research and development of antibodies with the hope of developing antibody-based innovative drugs. It is participating in the Japanese government's national project for pharmaceuticals using biotech and antibodies.

Development of Kyowa Hakko's RSV marks the first time the company will engage in antibody therapies, he said.

Asked why the company decided to distribute Alnylam's RSV01, Honda said, "we can learn know-how and acquire other valuable information from Alnylam" for the development of proprietary pharmaceuticals and other products.

Kyowa Hakko is preparing to apply in 2014 for Ministry of Health, Labor and Welfare approval of RSV01. That process is expected to take up to two years for clearance, Honda said. The company plans to sell the drug in Japan, Korea, China, Taiwan, as well as in Southeast Asian countries.

The spokesman confirmed that Kyowa Hakko will pay Alnylam $15 million upfront and an additional $78 million in development and sales milestone payments. It will pay "double-digit" royalties to the U.S. firm contingent on sales of the drug in Japan and other Asian countries, he said.

The contract includes additional RSV-specific RNAi therapeutic compounds that comprise the ALN-RSV program.

Kyowa Hakko's licensing agreement came weeks after Takeda signed a "strategic worldwide platform alliance" in RNAi therapeutics with Alnylam. The Takeda-Alnylam contract excludes the RSV01 (Also see "Join The Club: Alnylam Signs On Takeda In RNAi Platform Deal" - Scrip, 28 May, 2008.).

The Kyowa Hakko deal with Alnylam is specifically for RSV01, Honda said.

Kyowa Hakko also signed a co-development deal with Australian biotech firm Arana to develop anticancer drug ART104 for colorectal cancer (Also see "Arana Therapeutics VP Cliff Holloway On Building A U.S.-Style Biotech In Australia: An Interview With PharmAsia News" - Scrip, 30 April, 2008.).

- Toshio Aritake (pharmasia@elsevier.com)

Kyowa Hakko Enters Antibody Space With Alnylam RNAi RSV Therapy

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