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AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Report Positive New Phase 3 Dapagliflozin Data


9/24/2013 6:56:50 AM

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New Phase III Data Showed Dapagliflozin Significantly Reduced HbA1c Compared to Placebo at 24 Weeks in Patients With Type 2 Diabetes Inadequately Controlled With the Combination of Metformin Plus Sulfonylurea

WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)-- AstraZeneca (AZN) and Bristol-Myers Squibb Company (BMY) today announced results from a Phase III study evaluating dapagliflozin in adult patients with type 2 diabetes who were inadequately controlled on combination treatment with metformin plus sulfonylurea. Patients treated with dapagliflozin 10 mg as an add-on therapy to metformin plus sulfonylurea demonstrated significant improvements in glycosylated hemoglobin levels (HbA1c) and, among key secondary endpoints, significant reductions in fasting plasma glucose (FPG) and in body weight compared to placebo at 24 weeks. Significant improvements were also observed in seated systolic blood pressure (SBP) at eight weeks in patients treated with dapagliflozin compared to placebo. The results were presented today at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

In this study, overall rates of adverse events were similar between the two treatment groups, and most were reported as mild or moderate in intensity. More patients in the dapagliflozin group reported hypoglycemia, genital infection and renal adverse events compared to the placebo group. Rates of urinary tract infection were the same for both groups.

“The improvements in glycemic control combined with the significant reduction in body weight observed in this study add to the clinical profile of dapagliflozin, specifically when used as part of a triple oral therapy regimen with metformin and sulfonylurea,” said Stephan Matthaei, M.D., primary study investigator and director of the Diabetes and Metabolism Center, Quakenbrück Hospital, Quakenbrück, Germany.

Dapagliflozin is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. It is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand. A resubmission of the New Drug Application (NDA) for dapagliflozin was accepted for review by the U.S. Food and Drug Administration (FDA) in July 2013 with a new Prescription Drug User Fee Act (PDUFA) goal date of January 11, 2014.

Study Results

At the end of 24 weeks, patients treated with dapagliflozin 10 mg added to metformin plus sulfonylurea demonstrated significantly greater improvements in glycemic control compared to those who received placebo, with a mean change from baseline in HbA1c of -0.86% (95% Confidence Interval [CI]: -1.00, -0.72) in the dapagliflozin group versus -0.17% (95% CI: -0.31, -0.02) in the placebo group (p-value

More patients treated with dapagliflozin (31.8%) achieved an HbA1c

At week 24, patients treated with dapagliflozin showed significant improvements in adjusted mean FPG (-34.23 mg/dL; 95% CI: -40.98, -27.48) compared to patients who received placebo (-0.78 mg/dL; 95% CI: -7.56, 6.01; p-value

Patients treated with dapagliflozin experienced significant reductions in mean body weight (-2.65 kg; 95% CI: -3.16, -2.14) at week 24 compared to patients who received placebo (-0.58 kg; 95% CI: -1.09, -0.07; p-value

At week eight, patients treated with dapagliflozin had significant reductions in mean SBP (-4.04 mmHg) compared to patients who received placebo (-0.27 mmHg; p-value = 0.025).

Overall, 48.6% of patients in the dapagliflozin group and 51.4% of patients in the placebo group experienced = 1 adverse events, most of which were reported as mild or moderate in intensity. Adverse events of special interest occurring during the 24 weeks included hypoglycemia (12.8% for dapagliflozin vs. 3.7% for placebo; no major episodes observed), urinary tract infection (6.4% for dapagliflozin vs. 6.4% for placebo), genital infection (5.5% for dapagliflozin vs. 0% for placebo) and renal adverse events (1.8% for dapagliflozin vs. 0% for placebo). One event of pyelonephritis was observed in the dapagliflozin group. One or more serious adverse events occurred in 0.9% of patients in the dapagliflozin group and 5.5% of patients in the placebo group. The overall profile of dapagliflozin in this trial is consistent with those seen in Phase II and III clinical trials for dapagliflozin.

Study Design

This 24-week Phase III, randomized, double-blind, placebo-controlled study with an ongoing 28-week extension is designed to evaluate the efficacy and safety of dapagliflozin in patients with type 2 diabetes with inadequate glycemic control on combination therapy with metformin plus sulfonylurea. The primary endpoint is mean change in HbA1c from baseline to week 24. Secondary endpoints include mean change from baseline to week 24 in FPG and total body weight, proportion of patients achieving HbA1c levels of

The study includes 216 adult patients with type 2 diabetes (aged = 18 years) with inadequate glycemic control (HbA1c = 7.0% and = 10.5%) receiving metformin (= 1500 mg QD) and a maximum tolerated dose of sulfonylurea (at least half the maximum label dose for = 8 weeks). Patients were randomized to receive dapagliflozin 10 mg (n = 108) or placebo (n = 108) for 24 weeks.

About SGLT2 Inhibition

The kidney plays an important role in maintaining normal glucose balance by filtering and reabsorbing glucose from circulation. SGLT2, a sodium-glucose cotransporter found predominantly in the kidney, is responsible for the majority of glucose reabsorption. In patients with type 2 diabetes, the capacity of the kidney to reabsorb glucose is increased by approximately 20%, further exacerbating the hyperglycemia associated with the disease. Selective inhibition of SGLT2 reduces the reabsorption of excess glucose and enables its removal via the urine.

About Diabetes

In 2012, diabetes was estimated to affect more than 370 million people worldwide. The prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterized by insulin resistance and dysfunction of beta cells in the pancreas, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.

About the AstraZeneca/Bristol-Myers Squibb Diabetes Alliance

Dedicated to addressing the global burden of diabetes by advancing individualized patient care, AstraZeneca and Bristol-Myers Squibb are working in collaboration to research, develop and commercialize a versatile portfolio of innovative treatment options for diabetes and related metabolic disorders that aim to provide treatment effects beyond glucose control. Find out more about the Alliance and our commitment to meeting the needs of health care professionals and people with diabetes at www.astrazeneca.com or www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

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 about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

AstraZeneca Cautionary Statement Regarding Forward-Looking Statement

In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This press release contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward looking statements reflect knowledge and information available at the date of preparation of this press release and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trade marks, or the risk of failure to obtain patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation. Nothing in this press release should be construed as a profit forecast.

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 product development. 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. Forward-looking statements in this 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, 2012, in our Quarterly Reports on Form 10-Q and our 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.

Contact:

Media:

AstraZeneca

Kirsten Evraire, 302-885-0435

kirsten.evraire@astrazeneca.com

or

Bristol-Myers Squibb

Shelly Mittendorf, 609-480-2951

shelly.mittendorf@bms.com

or

Investors:

AstraZeneca

Karl Hard, 44-20-7604-8123

karl.j.hard@astrazeneca.com

or

Bristol-Myers Squibb

Ranya Dajani, 609-252-5330

ranya.dajani@bms.com

or

Ryan Asay, 609-252-5020

ryan.asay@bms.com

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