TOKYO - Kyowa Hakko Kirin signed a licensing agreement with Sanofi-Aventis for worldwide co-development and marketing rights, excluding Japan and Asia, for Kyowa's anti-LIGHT fully humanized monoclonal antibody, the company said May 14.

The anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes) mAB is a "one of-a-kind" human mAB with no known rival, Kyowa Hakko Kirin Spokesman Hiroyuki Yoshimine told PharmAsia News May 15.

First discovered by the La Jolla Institute for Allergy and Immunology, the LIGHT molecule was developed into the anti-LIGHT fully human mAB jointly by the institute and Kyowa Hakko Kirin's fully-owned subsidiary in La Jolla, Yoshimine said. Kyowa Hakko Kirin obtained a global exclusive license for development and marketing of the LIGHT molecule and anti-LIGHT antibodies, he said.

Kyowa Hakko Kirin's anti-LIGHT mAB currently is in preclinical development in Japan and elsewhere, Yoshimine said. While its target applications appear plentiful, the spokesman said, the company is concentrating research and development for treatment of ulcerative colitis and Crohn's disease, rheumatoid arthritis and psoriasis, he said.

Under the terms of the deal, Kyowa Hakko Kirin will receive up to $315 million, which includes an upfront contract fee and development milestones from Sanofi-Aventis, as well as additional sales royalties, Yoshimine said.

Sanofi will have exclusive rights to develop the product worldwide, except in Japan and other Asian countries, where both parties will co-develop the product. Kyowa Hakko Kirin retains the right to market the product in Japan and in Asia, while Sanofi has exclusive rights to market and sell the product in the rest of the world. Also, each party has an option to co-promote the product in the territory of the other party, according to Sanofi.

The LIGHT molecule is a new protein of the tumor necrosis factor super family. It has the property of activating T-cells, natural killer cells, monocytes and dendritic cells via multiple receptors. Anti-LIGHT antibodies are believed to serve as antagonists to block the transmission of information leading to activating those cells, the spokesman said.

"We are very pleased with this new agreement with Kyowa Hakko Kirin that will strengthen Sanofi-Aventis' pipeline in the field of inflammation," Sanofi R&D Senior VP Marc Cluzel said. "There are very important breakthroughs in the field of inflammation like anti-TNFs, but unfortunately not all patients benefit from these new therapies. [The] anti-LIGHT antibody may represent an alternative therapy for those patients."

The Japanese company has become a leading biotech company, particularly for antibody engineering technology for new drugs to treat cancer and kidney and immunology diseases, Fuji Ando, a senior managing director and head of research of Chibagin Asset Management Co., said May 18.

"While Ajinomoto and other companies are stalling in their R&D and pharmaceutical development, Kyowa Hakko Kirin is making steady progress on antibodies," he said. Moving its current antibody development into clinical trials, however, would take a few more years, he said.

Kyowa earlier anounced it intends to go head to head in 2012 with the world's largest biotech companies with antibody-based drugs derived from its Potelligent and Complegent technologies, which also have been licensed to 10 drug makers, including major multinationals. Kyowa Kirin President Yuzuru Matsuda anticipates blockbuster status for drugs based on the antibody technologies (PharmAsia News, Jan. 22, 2009).

In June 2008, RNAi giant Alnylam transferred Asia development and commercialization rights to Kyowa Hakko Kirin for a leading respiratory syncytial virus infection drug ALN-RSV01, which is in Phase II clinical trials in the U.S. The Japanese company paid $15 million in cash upfront, may pay up to $78 million in development and sales milestone payments, and pay the U.S. biotech double-digit royalties from Asia sales (Also see "RNAi Giant Alnylam Says Alliances with Japanese Pharmas Well Underway" - Scrip, 3 March, 2009.).

-Toshio Aritake (pharmasia@elsevier.com)

Kyowa Hakko Kirin Licenses Anti-LIGHT MAB To Sanofi-Aventis

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