PRINCETON, N.J. and TOKYO, Dec. 27 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced Otsuka has been granted exclusive rights in Japan to develop and commercialize the investigational compound saxagliptin, being studied for the treatment of Type 2 diabetes. Saxagliptin, discovered by Bristol-Myers Squibb, is a dipeptidyl peptidase-4 (DPP-4) inhibitor currently in Phase III development in the United States and Europe.
Terms of the agreement include an upfront payment by Otsuka to Bristol-Myers Squibb. Bristol-Myers Squibb will receive milestone payments based on certain regulatory events, as well as sales-based payments following regulatory approval of saxagliptin in Japan. Bristol-Myers Squibb also retains rights to co-promote saxagliptin with Otsuka in Japan. Under the licensing agreement, Otsuka will be responsible for all development costs in Japan.
"Bristol-Myers Squibb is focused on the research and development of therapies for serious diseases, and this agreement is part of our ongoing effort to provide new options to diabetes patients," said Lamberto Andreotti, executive vice president and president, Worldwide Pharmaceuticals, Bristol-Myers Squibb. "Our collaboration with Otsuka on the antipsychotic agent ABILIFY(R) (aripiprazole) has been very successful, and we are pleased to expand our relationship to include saxagliptin."
"Otsuka has endeavored to contribute to better health worldwide through innovative pharmaceutical products that address unmet medical needs. Our antipsychotic agent ABILIFY has provided us with an opportunity to work closely with Bristol-Myers Squibb, and we are pleased to enhance this partnership and take on responsibility for the development and commercialization of saxagliptin in Japan," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "I hope this compound will provide a new option to patients suffering from diabetes in Japan."
About Saxagliptin
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a new class of diabetes medicines that work by increasing and prolonging the action of natural hormones in the body called incretins. Incretins decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing insulin production in the pancreas, and by reducing production of sugar by the liver. By enhancing the effect of active incretin hormones in the body, DPP-4 inhibitors improve timely insulin release and ultimately decrease high blood sugar levels in patients with Type 2 diabetes.
About Diabetes
Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone needed to carry glucose (sugar) from the blood into cells, where it is converted to energy the cells need to perform properly. When insulin is not present or does not function correctly, the result is high levels of glucose in the blood. Over time, high blood glucose levels can lead to complications in the eyes, kidneys, central nervous system or heart.
Type 2 diabetes is the most common form of diabetes, accounting for approximately 90-95% of diabetes cases. Having Type 2 diabetes increases risk of many serious complications, including heart disease or stroke, high blood pressure, amputation (particularly legs), blindness, nerve damage, and kidney failure. The risk for stroke and the rate of deaths due to heart disease are two to four times higher among people with diabetes, while about 65% of deaths among people with diabetes are due to heart disease and stroke.
The American Diabetes Association (ADA) estimates that more than 20 million people in the United States, or 7% of the population, have diabetes, and that one in three Americans born in 2000 will develop diabetes sometime during their lifetime. In Japan, the Ministry of Health, Labor and Welfare estimates, based on a survey conducted in 2002, that approximately 7.4 million people are strongly suspected of having diabetes mellitus, and that the number is increasing every year. There are currently more than 230 million people living with diabetes worldwide.
The objective in treating diabetes is to control blood glucose to as normal a level as possible. This can be accomplished by a combination of diet, exercise and medication.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
About Otsuka Pharmaceutical Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka -- people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health.
The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US$6.8 billion in annual revenues in fiscal 2005.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the development and commercialization of an investigational compound. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval, or that if approved, will be commercially successful. Nor is there any assurance that any of the milestones based on regulatory events or sales provided for in the agreement will be achieved. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
