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 MentalIllness Bristol-Myers Squibb Company (NYSE: BMY) and OtsukaPharmaceutical Co., Ltd. announced today a development,commercialization and collaboration agreement for aripiprazole, anovel drug under study in Phase III trials as a treatment forschizophrenia. The new compound has a unique mechanism of actionand has the potential to help expand the options for safely andeffectively treating schizophrenia and, possibly, other forms ofmental illness. Aripiprazole was discovered by Otsuka and represents a newgeneration of anti-psychotics with a unique pharmacologicalprofile. In extensive clinical trials, aripiprazole appears toshow efficacy with an excellent tolerability profile. "We're extremely pleased and excited to have the opportunityto collaborate with Otsuka in the development andcommercialization of aripiprazole," said Donald J. Hayden, Jr.,president, Bristol-Myers Squibb Worldwide Medicines Group."Aripiprazole is a new, potential best-in-class agent for thetreatment of schizophrenia and may provide an important additionto available therapy for millions of people afflicted withschizophrenia. Strategically, aripiprazole will strengthenBristol-Myers Squibb's position in neurosciences and serve as aplatform for further global expansion of our central nervoussystem business." Under terms of the agreement, Bristol-Myers Squibb will marketand promote aripiprazole, in collaboration with Otsuka and underOtsuka's trademark, in the U.S. and the European Union. Outsideof these markets, excluding Japan and some Asian and Middle-Eastern countries, Bristol-Myers Squibb will have the exclusivelicense to develop and market aripiprazole. Otsuka and Bristol-Myers Squibb will collaborate to complete the clinical studiesfor schizophrenia, and Bristol-Myers Squibb will conductadditional studies for new dosage forms and new indications. Aregulatory filing for schizophrenia in the U.S. is planned forlate 2001. Schizophrenia is the most chronic and debilitating of allmental illnesses and occurs in approximately 1 percent of theworld population. The disease tends to manifest itself in earlyadulthood and is characterized by hallucination, delusions andparanoia. It is a lifelong disorder with enormous medical, socialand economic consequences if left untreated. While the emergence of newer pharmaceuticals has improvedtreatment of schizophrenia, significant unmet need remains.Specifically, there is a need for drugs with greater efficacy andfewer side effects than associated with current therapies.Currently, only one in three patients suffering fromschizophrenia 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 PhaseII/III clinical trials," Mr. Hayden said. "We're veryenthusiastic about the opportunity to provide patients with whatwe hope will be an improved therapeutic alternative." Yukio Kobayashi, president of Otsuka Pharmaceutical Co., Ltd.said: "Otsuka discovered aripiprazole in 1988 and has developedit independently. It is a new-generation anti-psychotic agentwith a unique mechanism of action. Now, collaboration withBristol-Myers Squibb will enable us to advance a potentially moreeffective therapy for patients suffering from serious mentaldisorders in an even wider and speedier fashion. I look forwardto the great successes this collaboration will bring to theglobal business development of both Bristol-Myers Squibb andOtsuka." Otsuka Pharmaceutical is a diversified health care companyguided by its philosophy: "Otsuka, people creating new productsfor better health worldwide." Its lines of business includeethical and OTC pharmaceuticals, diagnostic agents, clinicallaboratory tests, and consumer nutraceutical foods and beverages.It develops and commercializes a number of therapeutic agents incirculatory, cardiovascular, gastrointestinal, respiratory,ophthalmologic, and dermatological areas. Otsuka is a leader inthe clinical nutritional fluids, such as caloric solutions, witha 40 percent market share in Japan. It has business operations in15 countries, including Japan, the U.S. and key Asian countries. Bristol-Myers Squibb is a diversified worldwide, health andpersonal care company whose principal businesses arepharmaceuticals, consumer medicines, beauty care, nutritionals,and medical devices. It is a leading maker of innovativetherapies for cardiovascular, metabolic and infectious diseases,central nervous system and dermatological disorders, and cancer.The company is a leader in consumer medicines, orthopaedicdevices, ostomy care, wound management, nutritional supplements,infant formulas, and hair and skin care products. The company'sneuroscience franchise encompasses a variety of establishedproducts, such as Serzone for the treatment of depression andBuSpar for anxiety disorders. Its neuroscience pipeline includesa once-a-day formulation of Serzone, a maxi-K channel openerunder investigation for stroke, and a melatonin agonist understudy for sleep disorders. Visit Bristol-Myers Squibb on the World Wide Web athttp://www.bms.com CONTACT: William Dunnett, 609-252-3369, or Sylvia Sharockman,609-252-3390, both of Bristol-Myers Squibb. ots Original TextService: Bristol-Myers Squibb Company Internet:http://www.newsaktuell.de Contact: William Dunnett, 609-252-3369, or Sylvia Sharockman, 609-252-3390, both of Bristol-MyersSquibb Company News On-Call: Bristol-Myers Squibb press releasesavailable by fax, 800-758-5804, ext. BMYFAX, or 269329, or athttp://www.prnewswire.com/comp/269329.html Web site:http://www.bms.com

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