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ActivX Biosciences, Inc./Kyorin Pharmaceutical Co., Ltd. Begins First U.S. Phase I Study For Novel Anti-Diabetic Drug


3/15/2006 10:19:54 AM

LA JOLLA, Calif., March 15 /PRNewswire/ -- ActivX Biosciences, Inc., a wholly-owned subsidiary of Tokyo-based Kyorin Pharmaceutical Co., Ltd., announced the filing of an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) for KRP-104, a compound for the treatment of type 2 diabetes. This is Kyorin's first independently filed IND with the FDA. The U.S. Phase I clinical trial of KRP-104 commenced on March 3, 2006.

In May 2002, ActivX and Kyorin entered into a collaboration for the discovery and development of new drugs for the treatment of type 2 diabetes. The companies' joint research quickly led to the identification of KRP-104 for clinical development. In December 2004, Kyorin acquired ActivX, and the La Jolla-based company now acts as Kyorin's U.S. center for drug discovery and clinical development. KRP-104 is an orally active, dipeptidyl peptidase-IV (DPPIV) inhibitor which lowers blood glucose levels by blocking the degradation of the hormone GLP-1 thereby stimulating glucose-dependent insulin secretion and lowering blood glucose levels without hypoglycemic effects.

"The first U.S. IND by Kyorin and ActivX marks the culmination of Kyorin's strategy to become a global R&D presence," said Dr. John W. Kozarich, Chairman & President of ActivX and Chief Scientific Advisor for Kyorin. "KRP-104 is entering a highly competitive area of clinical development with a number of compounds in advanced clinical stages. We believe, however, that KRP-104 has a unique pharmacological profile that will more than compensate for its later market entry."

Dr. Diane Plotkin, Director of Clinical Operations in the new Clinical Development Department at ActivX commented, "KRP-104 is the first product of the highly effective collaboration between Kyorin and ActivX scientists from early discovery through development. I am enthusiastic about my leadership role in helping Kyorin establish a reputation for clinical development excellence in the U.S."

About ActivX Biosciences, Inc.

ActivX Biosciences, Inc. (www.activx.com), a wholly-owned subsidiary of Tokyo-based Kyorin Pharmaceutical Co., Ltd., in La Jolla, California, has drug discovery, proteomics technology and clinical development capabilities. The company applies proprietary chemical technologies and high-throughput protein analysis to the drug discovery and development process. By focusing on functional proteins, ActivX addresses disease mechanisms directly, in contrast to approaches such as expression profiling, in which the measured analyte is several steps removed from the site of drug action. ActivX and its partners are using ActivX's proprietary technology to address critical challenges in drug discovery, including selectivity profiling of candidate drug molecules across whole protein families in biological samples to guide their medicinal chemistry optimization; identifying novel drug targets and biomarkers; and characterizing off-target activities of candidate and established drugs to understand the basis for their efficacy and toxicity.

About Kyorin Pharmaceutical

Kyorin Pharmaceutical Co. Ltd. (www.kyorin-pharm.co.jp) is a fully integrated, research-oriented pharmaceutical company headquartered in Tokyo, Japan, with a focus in the areas of infectious diseases, immunology and allergic diseases and metabolic diseases. Some of its key products and development compounds include Norfloxacin (first new quinolone antibiotic licensed to Merck and Co.) and Gatifloxacin (new quinolone antibiotic licensed to Bristol-Myers Squibb). In addition to ActivX, Kyorin has extended its research capabilities through the establishment of Kyorin-Scotland Research Laboratories in conjunction with Scottish Biomedical Foundation Limited and with the formation of an affiliate company, Nisshin Kyorin Pharmaceutical Co., Ltd.

ActivX Biosciences, Inc.

CONTACT: John W. Kozarich, Ph.D., Chairman and President of ActivXBiosciences, Inc., +1-858-526-2502



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