Healthcare Industry News:  Bristol-Myers Squibb 

Biopharmaceuticals Cardiology Endocrinology

 News Release - March 9, 2010

Bristol-Myers Squibb and AstraZeneca Announce the Commencement of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus Trial (SAVOR-TIMI 53)

PRINCETON, N.J. & WILMINGTON, Del.--(HSMN NewsFeed)--Bristol-Myers Squibb Company (NYSE: BMY ) and AstraZeneca (NYSE: AZN ) today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors. The five-year study will follow approximately 12,000 patients with type 2 diabetes, who have either a history of previous cardiovascular events or multiple risk factors for vascular disease, and includes patients with renal impairment.

The objectives of the SAVOR-TIMI 53 trial are to test the hypothesis of whether treatment with ONGLYZA compared with placebo when added to a patients’ current standard of care will result in a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke and to exclude an unacceptable cardiovascular toxicity. The SAVOR-TIMI 53 trial was in part designed to fulfill a post-marketing requirement for the U.S. Food and Drug Administration (FDA), as well as to help answer the important question of potential benefit beyond glucose lowering. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.

Eugene Braunwald, M.D., Chairman, and Deepak L. Bhatt M.D., MPH, Senior Investigator of the TIMI Study Group, in conjunction with Itamar Raz, M.D., Head of the Diabetes Unit at the Hadassah University Medical Center, Jerusalem, will serve as principal investigators and conduct the trial for Bristol-Myers Squibb and AstraZeneca.

"One of the objectives of the SAVOR-TIMI 53 study is to test superiority of treatment with ONGLYZA versus placebo when added to current therapy, as well as exclude unacceptable cardiovascular risk," said Eugene Braunwald, M.D., Chairman of the TIMI Study Group.

ONGLYZA has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the United States and European Union. ONGLYZA was approved by the U.S. FDA in July 2009. ONGLYZA (saxagliptin) is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. ONGLYZA once daily can be used in combination with commonly prescribed oral anti-diabetic medications – metformin, sulfonylureas or thiazolidinediones (TZD) – or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). ONGLYZA has not been studied in combination with insulin.

IMPORTANT INFORMATION ABOUT ONGLYZA

Indication and Important Limitations of Use

ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

ONGLYZA has not been studied in combination with insulin.

Important Safety Information
  • Use With Medications Known to Cause Hypoglycemia: Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with ONGLYZA.
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.
Most common adverse reactions (regardless of investigator assessment of causality) reported in =5 percent of patients treated with ONGLYZA (saxagliptin) and more commonly than in patients treated with control were upper respiratory tract infection (7.7 percent, 7.6 percent), headache (7.5 percent, 5.2 percent), nasopharyngitis (6.9 percent, 4.0 percent) and urinary tract infection (6.8 percent, 6.1 percent). When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo was 3.1 percent, 8.1 percent and 4.3 percent, respectively.

Drug Interactions: Because ketoconazole, a strong CYP 3A4/5 inhibitor, increased saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg when coadministered with a strong CYP 3A4/5 inhibitor (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).

Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance =50 mL/min). ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter.

Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. ONGLYZA, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when ONGLYZA is administered to a nursing woman.

Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric patients have not been established.

Please see accompanying US Full Prescribing Information or visit www.bms.com.

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 commercialize select investigational drugs for type 2 diabetes. 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 discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

About TIMI Study Group

Since its inception in 1984 the principal goal of the TIMI Study Group (TIMI) has been to conduct high quality clinical trials that enhance the care of patients with coronary artery disease. TIMI has been involved in a wide array of phase 1 to phase 4 trials as well as registries. These have ranged in size from less than 30 to more than 25,000 subjects. The interventions studied include fibrinolytic, antithrombotic, anti-platelet, anti-ischemic and lipid lowering agents as well as percutaneous coronary intervention.

About Hadassah University Medical Center, Jerusalem, Israel

The Hadassah University Medical Center is a leading provider of medical and health services in Israel, known for its pioneering vision and enduring commitment to patient-centered care and groundbreaking research.

The Diabetes Unit at Hadassah Medical Organization is made up of a multidisciplinary team of physicians and scientists, recognized experts in the field of diabetes both at the basic science and clinical levels. The Diabetes Unit team is currently leading several clinical studies worldwide. For more information please visit: Hadassah Diabetes Center

ONGLYZA is a trademark of the Bristol-Myers Squibb Company.


Source: Bristol-Myers Squibb

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