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

* Reuters is not responsible for the content in this press release.

Wed Apr 29, 2009 4:43pm EDT

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.

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
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.