Eli Lilly and Company logo. (PRNewsFoto) INDIANAPOLIS, IN UNITED STATES
		Alkermes Logo. (PRNewsFoto/Alkermes) CAMBRIDGE, MA UNITED STATES
		Amylin Pharmaceuticals, Inc. logo. (PRNewsFoto/Amylin Pharmaceuticals, Inc.) SAN DIEGO, CA UNITED STATES

 Phase 3 Once Weekly Investigational Diabetes Therapy Also Improved Glucose
       Control in Patients Switching from Exenatide Taken Twice a Day

    SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc.
(Nasdaq: ALKS) today announced results from a 52-week open-label clinical
study that showed the durable efficacy of exenatide once weekly, a
long-acting release formulation of exenatide. Patients taking exenatide
once weekly over the course of one year sustained a similar improvement in
glucose control [A1C: -2.0%+/-0.08; fasting plasma glucose (FPG) -47+/-3
mg/dL] compared to those receiving treatment for 30 weeks [A1C change from
baseline: -1.9%+/-0.08 (LS mean+/-SE)]. This study also showed that
patients who switched from BYETTA(R) (exenatide) injection after 30 weeks
to exenatide once weekly experienced additional improvements in A1C and
fasting plasma glucose. Seventy-four percent of all patients in the study
achieved an endpoint A1C of 7 percent or less at 52 weeks. Patients in both
treatment groups experienced a statistically significant and sustained
average weight loss of 9.5 pounds over 52 weeks. These findings were
presented at the 68th Annual Scientific Sessions of the American Diabetes
Association (ADA) in San Francisco.

    BYETTA is indicated as adjunctive therapy to improve glycemic control
in patients with type 2 diabetes mellitus who are taking metformin, a
sulfonylurea, a thiazolidinedione, a combination of metformin and a
sulfonylurea, or a combination of metformin and a thiazolidinedione, but
have not achieved adequate glycemic control.

    "Diabetes is a lifelong condition that requires constant management of
blood glucose or blood sugar as well as weight. In DURATION-1 trial,
patients significantly reduced their blood glucose levels and, on average,
lost a total of over nine pounds. These improvements were sustained for a
year," said John B. Buse, M.D., Ph.D., Professor of Medicine, Director of
the Diabetes Care Center, and Chief of the Division of Endocrinology at the
University of North Carolina School of Medicine in Chapel Hill.
"Importantly, the study results also showed that steady-state levels of
exenatide may result in improvements in a variety of glucose parameters. If
approved, exenatide once weekly may provide patients with a treatment
option that is on board 24 hours a day, seven days a week, helping to
manage their blood sugar and, secondarily, their weight."

    Study Design and Findings

    The Diabetes Therapy Utilization: Researching Changes in A1C, Weight
and Other Factors Through Intervention with Exenatide ONce Weekly
(DURATION-1) study was a 30-week, randomized, open-label study of 295
patients with type 2 diabetes (baseline values: A1C 8.3%+/-1.0, FPG
169+/-43 mg/dL, weight 225+/-44lbs., BMI 35+/-5.0 kg/m2, diabetes duration
6.7+/-5.0 years; mean+/-SD) who were treated with exenatide once weekly 2.0
mg or BYETTA twice daily as outlined in the approved label subcutaneously.
Following the first 30 weeks of treatment, 258 patients entered an
open-label treatment with exenatide once weekly. Patients either remained
on exenatide once weekly or switched from BYETTA to exenatide once weekly
for an additional 22 weeks.

    Following the 30-week comparison period, patients (evaluable population
N=241) who continued on exenatide once weekly showed sustained improvements
in A1C and fasting plasma glucose levels at week 52 [A1C: -2.0%+/-0.1; FPG
-47+/-3 mg/dL (LS mean+/-SE)]. Patients who switched from BYETTA to
exenatide once weekly had further improvements in glycemic control [A1C:
-2.0% +/-0.1; FPG - 43+/-3 mg/dL] that were consistent with those of
patients receiving exenatide once weekly for 52 weeks. These data suggested
the additional impact of continuous exenatide levels on glycemic control.

    In both groups, A1C reduction was similar at 52 weeks. Seventy-two
percent of patients treated with exenatide once weekly achieved an endpoint
A1C of 7 percent or less, and 54 percent achieved an A1C of 6.5 percent or
less. In patients who switched from BYETTA to exenatide once weekly, 75
percent of patients achieved an endpoint A1C of 7 percent or less and 53
percent achieved an A1C of 6.5 percent or less. An A1C of below 7 percent
is the target for good glucose control as recommended by the ADA. Unlike
the weight gain that is commonly associated with insulin therapy and many
oral diabetes medications, exenatide once weekly was associated with an
average weight loss of 9.5 pounds over 52 weeks.

    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.

    Safety Profile

    Exenatide once weekly was well tolerated during the first 30 weeks of
treatment and the following 22-week, open-ended treatment period with
overall tolerability improving over the course of the study. No major
hypoglycemia events regardless of background therapy, were observed with
exenatide once weekly. Cases of minor hypoglycemia with exenatide once
weekly and with BYETTA use were limited to patients using background
sulfonylurea therapy. In both groups, nausea was predominantly mild and
transient and occurred less frequently in exenatide once weekly patients.
Patients switching from BYETTA to exenatide once weekly did not experience
a significant increase in nausea following the transition. The antibody
profiles of patients treated in this study were consistent with the
previously reported profiles of BYETTA and exenatide once weekly. These
data further supported the known safety profile of the exenatide molecule.

    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, low incidence of hypoglycemia when used with
metformin or a thiazolidinedione, and progressive weight loss. BYETTA was
approved in April 2005 and has been used by approximately one million
patients since its introduction. For full prescribing information, visit
http://www.BYETTA.com.

    About Diabetes

    Diabetes affects more than 21 million in the United States and an
estimated 246 million adults worldwide.(1)(2) Approximately 90-95 percent
of those affected have type 2 diabetes. Diabetes is the fifth leading cause
of death by disease in the United States and costs approximately $132
billion per year in direct and indirect medical expenses.(3)

    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.(4) In addition, 85 percent of type 2 diabetes
patients are overweight and 55 percent are considered obese.(5) Data
support that weight loss (even a modest amount) supports patients in their
efforts to achieve and sustain glycemic control.(6)(7)

    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 http://www.BYETTA.com.

    About Amylin, Lilly and Alkermes

    Amylin, Lilly, and Alkermes are working together to develop exenatide
once weekly, a subcutaneous injection of exenatide for the treatment of
type 2 diabetes based on Alkermes' proprietary technology for long-acting
medications. Exenatide once weekly is not currently approved by any
regulatory agencies.

    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 with over 2,000 employees
nationwide. Further information about Amylin Pharmaceuticals is available
at http://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, http://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 http://www.lilly.com.

    Alkermes, Inc., a biotechnology company committed to developing
innovative medicines to improve patients' lives, manufactures RISPERDAL(R)
CONSTA(R) for schizophrenia and developed and manufactures VIVITROL(R) for
alcohol dependence. Alkermes' robust pipeline includes extended-release
injectable, pulmonary and oral products for the treatment of prevalent,
chronic diseases, such as central nervous system disorders, addiction and
diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research
and manufacturing facilities in Massachusetts and Ohio.

    This press release contains forward-looking statements about Amylin,
Lilly and Alkermes. 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 the revenues generated
from BYETTA may be affected by competition; unexpected new data; 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 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 the companies' most recently filed SEC documents
including their Quarterly Reports on Form 10-Q and Annual Reports on Form
10-K. The companies undertake no duty to update these forward-looking
statements.

    P-LLY

    (1) The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A
. Accessed June 2, 2008.

    (2) "All About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 2, 2008.

    (3) "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 June 2, 2008.

    (4) 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.

    (5) 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.

    (6) Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association. Diabetes Care.
2007;30 Suppl 1:S48-65.

    (7) 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



    (Logo:  http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
    (Logo:  http://www.newscom.com/cgi-bin/prnh/20071031/CLW032LOGO )
    (Logo:  http://www.newscom.com/cgi-bin/prnh/20060610/AMYLINLOGO )

Link to this page: