BioWa, Licenses Anti-FGF8 Antibody From Kyowa Hakko Kogyo Co., Ltd.

PRINCETON, N.J., Oct. 21 /PRNewswire/ -- BioWa announced today that it has successfully licensed from Kyowa Hakko Kogyo Co., Ltd. , its parent company, the exclusive worldwide rights except Asia to develop and commercialize Anti-Fibroblast Growth Factor 8 (FGF8) monoclonal antibody, a potential new treatment for breast, ovarian and prostate cancers.

Under the terms of the agreement, BioWa expects to develop and commercialize anti-FGF8 antibody, which is currently in pre-clinical development. In return, Kyowa Hakko Kogyo Co. has an option to develop and commercialize the product in Asia and will be responsible for all development activities and costs. Under the terms of the agreement, BioWa retains all rights to anti-FGF8 antibody in non-Asia countries. Each party has the right to use pre-clinical and clinical data generated by the other party for developing anti-FGF8 antibody in their respective territories.

"We are pleased to announce the second antibody addition to BioWa's pipeline of products," said Dr. Nobuo Hanai, CEO & President of BioWa. "BioWa is committed to building a strong antibody pipeline of large market value products through our own internal clinical development programs. Anti-FGF8 antibody is an important addition to BioWa's portfolio, which now consists of two pre-clinical stage products being investigated across a broad range of indications."

About anti-FGF8 antibody

FGF8 has been implicated as a negative player for cancer. Originally discovered as an autocrine growth factor, FGF8 is over-expressed in prostate, breast and ovarian cancers and also correlates with Gleason scores in prostate cancer. Various cell and animal models support its role in oncogenesis and tumor cell survival. In addition, FGF8 has been shown experimentally to be a viable target for amelioration of symptoms in both rheumatoid arthritis (RA) models (collagen-induced) and osteoarthritis (OA) models (monosodium iodoacetate (MIA)-induced).

The worldwide market potential of this product in cancer is large. Prostate cancer, especially hormone-refractory disease (HRPC) is in great need of novel therapeutics. Although many of the cancer vaccines are targeting HRPC, improvements seen to date have been marginal. In advanced breast cancer, there still remains the need for additional survival benefits and for responses in more patients.

In RA, while disease-modifying anti-rheumatic drugs (DMARDs) and anti-TNF agents have provided clinical improvements in moderate and especially advanced patients, the disease still requires new drugs in the armamentarium. In OA, the need for new drugs is clear. Most of the drugs used to treat OA have been palliative therapies to decrease pain and inflammation.

The worldwide market potential for this anti-FGF8 antibody is expected to gross over $400M worldwide peak sales.

About BioWa

BioWa is a wholly owned subsidiary of Kyowa Hakko Kogyo Co., Ltd., Japan's leading pharmaceutical and largest biotech company. BioWa is the exclusive worldwide licensor of POTELLIGENT(TM) technology, which creates high antibody- dependent cellular cytotoxicity (ADCC) monoclonal antibodies. ADCC is a critical function of the immune system that enhances the ability of antibodies to kill tumor cells, and POTELLIGENT(TM) technology significantly enhances ADCC activity of an antibody in vitro, thereby increasing the potency and efficacy of such antibody in vivo. BioWa is currently developing ADCC enhanced monoclonal antibody-based therapeutics to fight cancer, asthma and other life- threatening and debilitating diseases and both BioWa and Kyowa have POTELLIGENT(TM) antibody products in various clinical stages. BioWa creates and develops enhanced ADCC antibodies for itself and others, offering a full range of antibody discovery and development capabilities. For more information about BioWa visit its web site at http://www.biowa.com.

POTELLIGENT(TM) is the registered trademark of Kyowa Hakko Kogyo Co., Ltd. All rights are reserved.

CONTACT: BioWa, Inc.: Nobuo Hanai, Ph.D., President and CEO,+1-609-580-7500, x7501, or Martina Molsbergen, Senior Director, BusinessDevelopment, +1-609-580-7500, x7506

Web site: http://www.biowa.com/