Significant Reductions in Weight and Fewer Reports of Hypoglycemia Compared to Lantus Also Observed SAN DIEGO & INDIANAPOLIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 20, 2009--
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company
(NYSE: LLY) and Alkermes,
Inc. (Nasdaq: ALKS) today announced positive results from a study
comparing subjects randomized to either exenatide once weekly or Lantus®
(insulin glargine). Patients randomized to exenatide once weekly
experienced a statistically superior reduction in A1C, a measure of
average blood sugar over three months, of 1.5 percentage points from
baseline, compared to a reduction of 1.3 percentage points for Lantus
after completing 26 weeks of treatment. At the end of the study,
patients treated with exenatide once weekly achieved a mean A1C of 6.8
percent compared with a mean A1C of 7.0 percent in those treated with
Lantus. Treatment with exenatide once weekly also produced a
statistically significant difference in weight, with a mean weight loss
of 5.8 pounds at 26 weeks, compared with a mean weight gain of 3.1
pounds for Lantus, a difference of 8.9 pounds between the treatments.
In addition, although patients treated with exenatide once weekly
experienced a greater reduction in blood glucose than those treated with
Lantus, they also reported significantly fewer episodes of confirmed
hypoglycemia.
These intent-to-treat results were from DURATION-3, the third in a
series of studies designed to test the superiority of exenatide once
weekly, an investigational diabetes therapy, as compared to other
diabetes medications. This 26-week open-label, clinical study compared
exenatide once weekly to once-daily doses of Lantus in 467 patients with
type 2 diabetes taking stable doses of metformin alone or in combination
with a sulfonylurea. Exenatide once weekly was administered once a week
in a fixed dose while Lantus was administered daily in a variable dose
determined by patient blood sugar levels.
“Exenatide once weekly outperformed Lantus in this superiority study by
meeting its primary endpoint,” stated Orville G. Kolterman, M.D., senior
vice president of research and development, Amylin Pharmaceuticals.
“Both treatment arms started with a baseline A1C of 8.3 percent and
exenatide once weekly provided statistically significantly greater A1C
reduction, weight loss versus weight gain and fewer episodes of
hypoglycemia.”
More than 90 percent of patients completed the study. During the 26-week
treatment period, the most frequently reported adverse events were upper
respiratory infection, including nasopharyngitis, in both treatment
arms, as well as gastrointestinal events, including nausea, in the
exenatide once weekly treatment group. Patients treated with exenatide
once weekly experienced less confirmed hypoglycemia; the incidence of
hypoglycemia was 4 percent with exenatide once weekly versus 19 percent
with Lantus for patients on metformin background therapy, and 20 percent
with exenatide once weekly versus 44 percent with Lantus for patients on
metformin and a sulfonylurea background therapy, differences that are
statistically significant in both treatment groups.
Study Design
The 26-week open-label, superiority study included 467 subjects with
type 2 diabetes who were not achieving adequate glucose control using
metformin therapy alone or in combination with a sulfonylurea. Subjects
were randomized to receive exenatide once weekly 2 milligrams by
subcutaneous injection weekly or insulin glargine injections
administered daily in a variable dose determined by patient blood sugar
levels. There was no lead-in or wash-out period. The primary endpoint
was reduction in A1C; secondary endpoints included change in body weight
along with other parameters of glucose control, cardiovascular health,
hypoglycemia and patient-reported outcomes. Subjects in both treatment
groups are continuing in an open-ended extension study.
The companies plan to present the full data set at a major medical
meeting and submit the data for publication.
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 results in
approximately $174 billion per year in direct and indirect medical
expenses.(iii)
According to the Centers for Disease Control and Prevention'sNational
Healthand 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 indicate that weight loss (even a modest amount) supports patients
in their efforts to achieve and sustain glycemic control.(vi,vii)
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'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.
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.
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of 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.
Alkermes,
Inc. is a fully integrated biotechnology company committed to
developing innovative medicines to improve patients' lives. 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 facilities in
Massachusetts and a commercial manufacturing facility in Ohio.
This press release contains forward-looking statements about Amylin,
Lilly and Alkermes and the investigational drug, exenatide once weekly.
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 exenatide once weekly may be affected by
unexpected new data; safety and technical issues; clinical trials,
including the clinical trial mentioned in this press release, not being
completed in a timely manner, not confirming previous results, or not
achieving the intended clinical endpoints; the DURATION-3 superiority
study results potentially not being predictive of real world use
including results relative to other diabetes medications; pre-clinical
trials not predicting future results; label expansion requests or New
Drug Application (NDA) filings, not being submitted in a timely manner;
regulatory approval, including approval for exenatide once weekly, being
delayed or not received; or manufacturing and supply issues. The
potential for 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 development and commercialization of pharmaceutical
products including those inherent in the collaboration with and
dependence upon Amylin, Lilly and/or Alkermes. These and additional
risks and uncertainties are described more fully in Amylin’s, Lilly's
and Alkermes’ most recent SEC filings including their Quarterly Reports
on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes
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 July 13, 2009.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed July 13, 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 July 13, 2009.
(iv) Saydah SH, Fradkin J, 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: Alkermes, Inc.
Amylin
Anne Erickson, 858-754-4443
Cell:
858-349-3195
anne.erickson@amylin.com
or
Lilly
Tim
Coulom, 317-655-2998
Cell: 317-544-9757
coulom_timothy_d@lilly.com
or
Alkermes
Rebecca
Peterson, 617-583-6378
Cell: 617-899-2447
rebecca.peterson@alkermes.com