Bristol-Myers Squibb

Further to Bristol-Myers Squibb acquisition of Amylin Pharmaceuticals in August 2012, our existing collaboration with Bristol-Myers Squibb was expanded to include the development and commercialisation of Amylin’s portfolio of diabetes products. These products complement the alliance’s existing diabetes portfolio and include GLP-1 receptor agonists, BYETTA® (exenatide) and BYDUREON® (exenatide extended-release formulations), as well as metreleptin, an investigational drug leptin analogue and SYMLIN® (pramlintide acetate), an amylin analogue. The addition of Amylin’s products strengthens our worldwide diabetes alliance, creating a broader disease management platform for patients, physicians and payers.

Unmet Medical Need

According to the World Health Organisation, 346 million people have diabetes, and related deaths are projected to double between 2005 and 2030. Approximately one in every 11 adults (9%) in the US has been diagnosed with diabetes, of which Type 2 diabetes, a chronic progressive disease, accounts for c.90-95% of cases. Many Type 2 diabetes patients have additional co-morbidities such as obesity and cardiovascular complications (Source: CDC, 2012 and Decision Resources).

In patients with Type 1 diabetes and often with Type 2 diabetes, beta cells have been damaged or destroyed, resulting in insulin and amylin deficiencies and elevated levels of glucose. Amylin is now recognized to play a role in assisting insulin in regulating glucose control by delaying gastric emptying (thereby decreasing rapid absorption of glucose and other fuels during digestion of meals) and decreasing meal caloric intake. In addition to synthetic insulin and amylin hormones or analogues, a number of approaches that act independently of these hormones may provide a novel option for adults with diabetes in helping manage their glucose levels.

Products

BYETTA® (exenatide) was the first glucagon-like peptide -1 (GLP-1) receptor agonist to be approved by the US Food and Drug Administration (FDA) for the treatment of Type 2 diabetes. Also approved in Europe, it is an injectable prescription medicine that may improves blood sugar control in adults with Type 2 diabetes, when used with a diet and exercise program. It can also be used with other classes of anti-diabetic drugs.

BYDUREON® (exenatide extended-release for injectable suspension) was approved by the FDA as the first and only once-weekly medicine for the treatment of Type 2 diabetes, it is also approved in Europe. As a long-acting formulation of BYETTA, BYDUREON® provides more continuous levels of this GLP-1 receptor agonist to improve glucose control. Each dose of BYDUREON® is made up of biodegradable microspheres that provide a controlled release of exenatide throughout the week.
Exenatide also forms an integral part of our life-cycle management pipeline, including delivery devices and formulation improvements.

SYMLIN® (pramlintide acetate) injection is approved by the FDA for the treatment of Type 1 and Type 2 diabetes patients with inadequate glycemic control on meal-time insulin. It is the first and only analogue of the human hormone amylin and a first-in-class diabetes therapy offering improved glucose control with potential for weight loss.

Metreleptin, an analogue of the hormone leptin, is currently under review at the FDA for the treatment of diabetes and/or hypertriglyceridema (high levels of triglycerides in the bloodstream) in patients with rare forms of inherited or acquired lipodystrophy.

About the Original 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 certain investigational drugs for Type 2 diabetes. The collaboration is focused around ONGLYZA® (saxagliptin), part of the innovative class of DPP-4 inhibitors, KOMBOGLYZE™ combines ONGLYZA (saxagliptin and metformin immediate release (metformin IR)) in a twice-daily tablet and FORXIGA® (dapagliflozin), an investigational SGLT2 inhibitor. The companies have also developed an extended release formulation, KOMBIGLYZE XR™, which combines ONGLYZA and metformin XR in one tablet taken once per day. As of October 2012, ONGLYZA® has been submitted for regulatory approval in 93 countries and is approved in 77 countries including the US, Canada, Mexico, EU, India, Brazil and China.
FORXIGA® received positive opinion from the CHMP (Committee of Medicinal Products for Human Use) in Europe in April 2012.

Strategic Fit

The expansion of our alliance with Bristol Myers Squibb to include the Amylin Pharmaceutical product portfolio is an innovative way to strengthen our successful five-year partnership and extends our reach across the diabetes treatment portfolio. As the incidence of diabetes continues to grow worldwide towards epidemic proportions, there is a growing need for new treatment approaches. Amylin’s portfolio gives us access to GLP-1s which are becoming an increasingly important class of medicines for treating Type 2 diabetes, as well as creating a more comprehensive disease management platform. We believe that our combined commercial experience and global reach will help to maximise the value of Amylin’s products, while Amylin’s US endocrinology capability has the potential to enhance the promotion of our ONGLYZA® franchise.

Deal Structure

Based on the framework of our existing alliance with Bristol-Myers Squibb, AstraZeneca made a substantial upfront payment in cash to Amylin, a wholly owned subsidiary of Bristol-Myers Squibb.

• Profits and losses arising from the collaboration will be shared equally
• AstraZeneca has exercised an option to gain equal governance rights over key strategic and financial decisions regarding the collaboration for an additional payment of $135 million, subject to approval of certain anti-trust regulatory authorities.

Why Bristol-Myers Squibb and AstraZeneca Extended Their Deal:

• Strengthens alliance leadership position in diabetes
• Adds approved and marketed products for Type 1 and 2 diabetes
• Combined development, regulatory and commercial strengths of partners is expected to unlock the potential of Amylin’s therapies for the benefit of patients worldwide

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AstraZeneca is a leader in the treatment of Cardiovascular and Metabolic Disease and is committed to delivering new innovative medicines that make a difference to patients and society. Our research focuses on small molecule and biologics for disease areas including diabetes and diabetic complications, including diabetic nephropathy, cardiovascular diseases, including cardiac regeneration, atherosclerosis (cerebral, carotid, aortic, coronary, and peripheral), heart failure (systolic and diastolic), cardiorenal syndrome, renal injury (acute and chronic), metabolic syndrome, dyslipidemia, systemic inflammatory states (cellular and humoral affecting metabolism and the cardiovascular/renal systems).

Partnering leadership team