Actualizado 09/09/2008 14:32
- Comunicado -

New Data for Investigational Diabetes Drug Saxagliptin Demonstrates Potential for Type 2 Diabetes Treatment (2)

Similar reductions in weight were seen across all treatment groups. Mean change from baseline in body weight at week 24 was: -1.8 kg for saxagliptin 5 mg + metformin, -1.4 kg for saxagliptin 10 mg + metformin, -1.1 kg for saxagliptin 10 mg + placebo and -1.6 kg for metformin + placebo.

About saxagliptin

Saxagliptin is an investigational DPP-4 inhibitor under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. Saxagliptin is being studied in clinical trials as a once-daily therapy to determine its efficacy and safety profile. Saxagliptin was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance.

Saxagliptin Phase III data have previously been presented as a monotherapy, as well as in combination with metformin, sulphonylureas and thiazolidinediones, commonly prescribed oral anti-diabetic medications. The overall clinical development programme included more than 5,000 individuals, more than 4,000 of whom were given saxagliptin.

About DPP-4 inhibitors

DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body's use of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver's production of glucose.

About type 2 diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role.(2a) Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage.(3a)

There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), or the cells ignore the insulin (insulin resistance).(3b) Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms.(4b)

Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities.(4c) People with type 2 diabetes often are characterized with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C ("good") cholesterol levels and high triglyceride levels and hypertension.(4)

Type 2 diabetes accounts for approximately 90 to 95 percent of all diabetes.(4d) This equates to roughly 221 million people with type 2 diabetes globally,(5,4d) and 21.2 million people in the United States alone.(3a,4d)

The American Diabetes Association recommends a hemoglobin A1C measurement of less than 7 percent(6) for most people with type 2 diabetes. The International Diabetes Federation recommends an A1C of less than or equal to 6.5 percent(7) for most people with type 2 diabetes. Hemoglobin A1C is a measurement of a person's average blood glucose level during a two-to-three month period and is considered an important marker of long-term glucose control.(8) Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person's blood glucose after at least 8 hours of fasting and postprandial glucose, a measure of a person's blood glucose after a meal.

Bristol-Myers Squibb and AstraZeneca collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise two investigational drugs for type 2 diabetes - saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

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 research, development and commercialization of products. 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. There can be no assurance that if approved, the product will be commercially successful. 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, 2007, 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.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

---------------------------------


(1) National Institute of Diabetes and Digestive and Kidney Disorders, Diagnosis of Diabetes, http://diabetes.niddk.nih.gov/dm/pubs/di...; accessed June 2, 9 Sep. (2) - American Diabetes Association. All About Diabetes.

a http://www.diabetes.org/about-diabetes.jsp; accessed Aug. 7, 2008

b http://www.diabetes.org/type-2-diabetes.jsp; accessed Aug. 7, 2008

(3) National Diabetes Information Clearinghouse. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. http://diabetes.niddk.nih.gov; accessed Aug. 7, 2008.

a http://diabetes.niddk.nih.gov/dm/pubs/ov...; accessed Aug. 7, 2008

b http://diabetes.niddk.nih.gov/dm/pubs/ov...; Type 2 Diabetes section; accessed Aug. 7, 2008

c http://diabetes.niddk.nih.gov/dm/pubs/ov...; Type 2 Diabetes section; accessed Aug. 7, 2008

d http://diabetes.niddk.nih.gov/dm/pubs/ov...; Type 2 Diabetes section; accessed Aug. 7, 2008

(4) American Heart Association. Type 2 Diabetes; "Who Is At Risk For Type 2 Diabetes" section. http://www.americanheart.org/presenter.j...; accessed Aug. 7, 2008.

(5) International Diabetes Foundation. Diabetes Atlas. Third Edition. 2006. Page 22.

(6) American Diabetes Association, Accord Trial Questions & Answers, http://www.diabetes.org/for-media/pr-accord-trail-QA-020608....; accessed Aug. 7, 2008

(CONTINUA)

Comunicados

Si quieres mejorar el posicionamiento online de tu marca, ahora puedes publicar tus notas de prensa o comunicados de empresa en la sección de Comunicados de europa press

Si necesitas asesoramiento en comunicación, redacción de tus notas de prensa o ampliar la difusión de tu comunicado más allá de la página web de europa press, ponte en contacto con nosotros en comunicacion@europapress.es o en el teléfono 913592600