Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly

Companies Committed to Investing in New Product Presentations for Patients

SAN DIEGO and INDIANAPOLIS, April 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today announced that the companies have agreed in principle to the terms of a joint supply agreement for an exenatide once weekly pen device. Separately, the companies announced that they have initiated a phase 1/2 clinical study to examine a new exenatide once weekly suspension formulation.

Exenatide once weekly is an investigational diabetes therapy that is injected subcutaneously once a week and is currently in phase 3 development. Exenatide is also the active ingredient in twice daily BYETTA(R) (exenatide) injection, currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies.

Exenatide Once Weekly Pen Supply Agreement

Amylin and Lilly have agreed in principle to cooperate in the development, manufacturing and marketing of exenatide once weekly in a dual chamber cartridge pen configuration. This design will enable patients to mix and administer exenatide once weekly from a pre-filled pen device, instead of the syringe and vial currently used in clinical trials. The companies will share the capital and development costs of the pen, including the initial capital investment of approximately $216 million over the next few years. Amylin and Lilly have agreed that the cost of the initial capital investment will be allocated 60 percent to Lilly and 40 percent to Amylin.

Amylin will be responsible for developing and manufacturing the final pen product for the U.S., and for manufacturing unlabeled and unpackaged pens for the markets outside the U.S. Lilly will be responsible for labeling and final packaging of the pen product to support sales outside of the U.S. Amylin and Lilly will share sales and marketing rights in the U.S., while Lilly will be responsible for sales and marketing outside of the U.S.

"The agreement for an exenatide once weekly pen device underscores our commitment to enhance the user experience for patients with type 2 diabetes," said Vince Mihalik, senior vice president, sales and marketing, and chief commercial officer at Amylin Pharmaceuticals. "While our DURATION-1 patient questionnaire results showed that the delivery system used in clinical trials was well accepted by patients, we continue to look for ways to enhance delivery and offer patients a range of choices through alternative delivery possibilities."

Clinical Trial Initiated for New Exenatide Once Weekly Suspension Formulation

Exenatide once weekly suspension is an investigational formulation that eliminates the need to reconstitute the product prior to use. The companies have initiated a phase 1/2 clinical trial designed to evaluate the pharmacokinetics, tolerability and safety of this new exenatide once weekly formulation in both healthy volunteers and people with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. The trial began this month and initial findings are expected by the end of 2009.

Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.

About Diabetes

Diabetes affects more than 23 million people in the U.S. and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and costs approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control and low incidence of hypoglycemia when used with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight loss product. BYETTA was approved in April 2005 and has been used by more than one million patients since its introduction. For full prescribing information, visit www.BYETTA.com.

Important Safety Information for BYETTA

BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.

When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is the most common side effect when first starting BYETTA, but decreases over time in most patients.

If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all of the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away. For full prescribing information, visit www.BYETTA.com.

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information about Amylin Pharmaceuticals is available at www.amylin.com.

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products visit, www.lillydiabetes.com.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and exenatide once weekly and the revenues generated from BYETTA may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; New Drug Applications and label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for BYETTA and exenatide once weekly may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin's and Lilly's most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.

P-LLY

(i) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed March 28, 2009.

(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed March 28, 2009.

(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed March 28, 2009.

(iv) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes." JAMA: 291(3), January 21, 2004.

(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.

(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008;31 Suppl 1:S61-78.

(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.

Source: Amylin Pharmaceuticals, Inc.

CONTACT: Anne Erickson of Amylin, +1-858-754-4443, cell, +1-858-349-3195, anne.erickson@amylin.com; or Kindra Strupp of Lilly, +1-317-277-5170, cell, +1-317-554-9577, kstrupp@lilly.com

Web Site: http://www.amylin.com/ http://www.lilly.com/

 

Posted: April 2009


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