Bristol-Myers Squibb and Otsuka Announce Commercialization Agreement For Aripiprazole

PRINCETON, N.J., and TOKYO (PROTEXT) - -- Aripiprazole a Promising New Agent for Schizophrenia -- New Therapies Greatly Needed for Debilitating Mental Illness Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today a development, commercialization and collaboration agreement for aripiprazole, a novel drug under study in Phase III trials as a treatment for schizophrenia. The new compound has a unique mechanism of action and has the potential to help expand the options for safely and effectively treating schizophrenia and, possibly, other forms of mental illness. Aripiprazole was discovered by Otsuka and represents a new generation of anti-psychotics with a unique pharmacological profile. In extensive clinical trials, aripiprazole appears to show efficacy with an excellent tolerability profile. "We're extremely pleased and excited to have the opportunity to collaborate with Otsuka in the development and commercialization of aripiprazole," said Donald J. Hayden, Jr., president, Bristol-Myers Squibb Worldwide Medicines Group. "Aripiprazole is a new, potential best-in-class agent for the treatment of schizophrenia and may provide an important addition to available therapy for millions of people afflicted with schizophrenia. Strategically, aripiprazole will strengthen Bristol-Myers Squibb's position in neurosciences and serve as a platform for further global expansion of our central nervous system business." Under terms of the agreement, Bristol-Myers Squibb will market and promote aripiprazole, in collaboration with Otsuka and under Otsuka's trademark, in the U.S. and the European Union. Outside of these markets, excluding Japan and some Asian and Middle- Eastern countries, Bristol-Myers Squibb will have the exclusive license to develop and market aripiprazole. Otsuka and Bristol- Myers Squibb will collaborate to complete the clinical studies for schizophrenia, and Bristol-Myers Squibb will conduct additional studies for new dosage forms and new indications. A regulatory filing for schizophrenia in the U.S. is planned for late 2001. Schizophrenia is the most chronic and debilitating of all mental illnesses and occurs in approximately 1 percent of the world population. The disease tends to manifest itself in early adulthood and is characterized by hallucination, delusions and paranoia. It is a lifelong disorder with enormous medical, social and economic consequences if left untreated. While the emergence of newer pharmaceuticals has improved treatment of schizophrenia, significant unmet need remains. Specifically, there is a need for drugs with greater efficacy and fewer side effects than associated with current therapies. Currently, only one in three patients suffering from schizophrenia remains on initial therapy after one year. "Aripiprazole will be among the most extensively studied anti- psychotic agents with about 5,000 patients in controlled Phase II/III clinical trials," Mr. Hayden said. "We're very enthusiastic about the opportunity to provide patients with what we hope will be an improved therapeutic alternative." Yukio Kobayashi, president of Otsuka Pharmaceutical Co., Ltd. said: "Otsuka discovered aripiprazole in 1988 and has developed it independently. It is a new-generation anti-psychotic agent with a unique mechanism of action. Now, collaboration with Bristol-Myers Squibb will enable us to advance a potentially more effective therapy for patients suffering from serious mental disorders in an even wider and speedier fashion. I look forward to the great successes this collaboration will bring to the global business development of both Bristol-Myers Squibb and Otsuka." Otsuka Pharmaceutical is a diversified health care company guided by its philosophy: "Otsuka, people creating new products for better health worldwide." Its lines of business include ethical and OTC pharmaceuticals, diagnostic agents, clinical laboratory tests, and consumer nutraceutical foods and beverages. It develops and commercializes a number of therapeutic agents in circulatory, cardiovascular, gastrointestinal, respiratory, ophthalmologic, and dermatological areas. Otsuka is a leader in the clinical nutritional fluids, such as caloric solutions, with a 40 percent market share in Japan. It has business operations in 15 countries, including Japan, the U.S. and key Asian countries. Bristol-Myers Squibb is a diversified worldwide, health and personal care company whose principal businesses are pharmaceuticals, consumer medicines, beauty care, nutritionals, and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. The company's neuroscience franchise encompasses a variety of established products, such as Serzone for the treatment of depression and BuSpar for anxiety disorders. Its neuroscience pipeline includes a once-a-day formulation of Serzone, a maxi-K channel opener under investigation for stroke, and a melatonin agonist under study for sleep disorders. 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