- Both Groups Experienced Significant Weight Loss -
- New Drug Application Filing Planned by the End of the First Half of 2009
-
SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Oct. 31
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli
Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today
announced positive results from a 30-week comparator study of once-weekly
exenatide long-acting release (LAR) injection and BYETTA(R) (exenatide)
injection taken twice daily in patients with type 2 diabetes. Once-weekly
exenatide, an investigational drug, showed a statistically significant
improvement in A1C of approximately 1.9 percentage points from baseline,
compared to an improvement of approximately 1.5 percentage points for
BYETTA. Approximately three out of four subjects treated with once-weekly
exenatide achieved an A1C of 7 percent or less. A1C of less than 7 percent
is the target for good glucose control as recommended by the American
Diabetes Association.
After 30 weeks of treatment, both once-weekly exenatide and BYETTA
treatment resulted in an average weight loss of approximately eight pounds.
Nearly 90 percent of subjects in both groups completed the study, which
enrolled patients not achieving adequate glucose control with either diet
and exercise or with use of oral glucose-lowering agents. The companies
anticipate a regulatory submission to the U.S. Food and Drug Administration
(FDA) by the end of the first half of 2009.
"Together with our collaboration partners Lilly and Alkermes, we are
pleased that use of once-weekly exenatide met the primary endpoint with a
greater reduction in A1C than BYETTA and with significant weight loss, both
key measures of success in the management of type 2 diabetes," stated
Orville G. Kolterman, M.D., Senior Vice President Clinical and Regulatory
Affairs, Amylin Pharmaceuticals. "These data confirm the benefits of BYETTA
as an important treatment option and suggest that, if approved, once-weekly
exenatide has the potential to help patients improve their diabetes
management. With these safety and efficacy data in hand, we are working
diligently to complete the remaining steps required for our once-weekly
exenatide regulatory submission by the end of the first half of 2009, and
will make every effort to bring this therapy to patients as quickly as
possible."
There was no major or severe hypoglycemia regardless of background
therapy. As expected based on prior BYETTA studies, minor hypoglycemia with
once-weekly exenatide use was limited to subjects using background
sulfonylurea therapy. Once-weekly exenatide was associated with
approximately 30 percent less nausea than BYETTA. Approximately one out of
five subjects receiving once-weekly exenatide reported treatment-related
nausea during the 30-week study. In both groups nausea was predominantly
mild and transient. The antibody profile of subjects treated in this study
was consistent with the previously reported profiles of BYETTA and
once-weekly exenatide.
BYETTA -- the first and only FDA-approved incretin mimetic -- was
approved in April 2005 and has been used by more than 700,000 patients
since its introduction. BYETTA is indicated for use twice a day in adults
with type 2 diabetes who are unsuccessful at controlling their blood sugar
levels using common oral diabetes medications.
Once-weekly exenatide 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 at a carefully
controlled rate.
Study Design
The 30-week, open-label, noninferiority study included 295 subjects
with type 2 diabetes who were not achieving adequate glucose control using
diet and exercise with or without the use of one or more oral antidiabetic
agents. Subjects were randomized to receive subcutaneous injections of
either once- weekly exenatide 2.0 milligrams or BYETTA taken twice daily as
outlined in the approved label. Subjects in both groups who completed the
randomized portion of the study continued in the open-ended portion of the
study receiving once- weekly exenatide.
Full study results will be included in future scientific publications.
Webcast Investor Conference Call
Amylin Pharmaceuticals will webcast a conference call to discuss these
study results today, Wednesday, October 31 at 8:30 a.m. ET (5:30 a.m. PT).
Daniel M. Bradbury, President and Chief Executive Officer of Amylin
Pharmaceuticals, will lead the call.
The call will be webcast live through Amylin's corporate website and a
recording will be made available following the close of the call. To access
the webcast, please log on to http://www.amylin.com approximately fifteen minutes
prior to the call to register, download and install any necessary audio
software. For those without access to the Internet, the live call may be
accessed by phone by calling (866) 356-3095 (domestic) or (617) 597-5391
(international), passcode 19644079. A replay of the call will also be
available by phone for 24 hours beginning approximately one hour after the
close of the call and can be accessed at (888) 286-8010 (domestic) or (617)
801-6888 (international), passcode 23209035.
About Diabetes
Diabetes affects more than 20 million people in the U.S. 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). Approximately 90
percent of people with diabetes are obese or overweight(4).
According to the Centers for Disease Control and Prevention's National
Health and Nutrition Examination Survey, approximately 60 percent of
diabetes patients do not achieve target blood sugar levels with their
current treatment regimen(5). Nearly half of newly treated patients with
diabetes do not adhere to their treatment regimen(6).
About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of drugs for the treatment of type 2
diabetes called incretin mimetics. 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 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. For
full prescribing information, visit http://www.BYETTA.com.
Important Safety Information for BYETTA
BYETTA improves 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, low
blood sugar (hypoglycemia) 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 most common 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 the side effects with BYETTA. A
health care provider should be consulted about any side effect that is
bothersome or does not go away.
For complete safety profile and other important prescribing
considerations, visit http://www.BYETTA.com.
About Amylin, Lilly, and Alkermes
Amylin, Lilly, and Alkermes are working together to develop exenatide
long-acting release injection, a subcutaneous injection of exenatide for
the treatment of type 2 diabetes based on Alkermes' proprietary injectable
long- acting release technology. Once-weekly exenatide has not been
approved by the FDA for marketing in the United States or by regulatory
agencies elsewhere in the world.
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 1,800 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 health care 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. is a biotechnology company that develops innovative
medicines designed to yield better therapeutic outcomes and improve the
lives of patients with serious disease. Alkermes currently has two
commercial products: RISPERDAL(R) CONSTA(R) [(risperidone) long-acting
injection], the first and only long-acting atypical antipsychotic
medication approved for use in schizophrenia, and marketed worldwide by
Janssen-Cilag (Janssen, L.P.), a wholly owned division of Johnson &
Johnson; and VIVITROL(R) (naltrexone for extended-release injectable
suspension) the first and only once-monthly injectable medication approved
for the treatment of alcohol dependence and marketed in the U.S. primarily
by Cephalon, Inc. Alkermes' 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.
Alkermes' headquarters are in Cambridge, Massachusetts, and it operates
research and manufacturing facilities in Massachusetts and Ohio.
This press release contains forward-looking statements, which involve
risks and uncertainties within the meaning of the Private Securities
Litigation Reform Act of 1995. The forward-looking statements are neither
promises nor guarantees, and the businesses of Amylin, Lilly and Alkermes
are subject to significant risks and uncertainties. There can be no
assurance that actual results will not differ materially from the
forward-looking statements discussed in this press release. These
forward-looking statements include risks and uncertainties, including but
not limited to, that current or future clinical trials will confirm
previous results; risks and uncertainties that the results from the
clinical trial discussed in this press release will generate clinical data
that could form the basis of a new drug application (NDA) submission; risks
and uncertainties that Amylin will be able to complete manufacturing
scale-up and construction and validation of its manufacturing facility on a
timely basis, or at all; risks and uncertainties regarding the timing of
the NDA filing referred to in this release; risks and uncertainties
inherent in the collaboration with and dependence upon Lilly, Amylin and/or
Alkermes; risks and uncertainties regarding the drug discovery and
development process, including whether once-weekly exenatide will receive
regulatory approvals, be commercialized or prove to be commercially
successful. These and additional risks and uncertainties are described more
fully in Amylin, Lilly and Alkermes' filings with the United States
Securities and Exchange Commission. The parties undertake no duty to update
forward-looking statements.
P-LLY
REFERENCES
(1) The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A
. Accessed October 30, 2007.
(2) "All About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed October 30, 2007.
(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 October 30, 2007.
(4) James WPT, Jackson-Leach R, Mhurdu CN, et al. Overweight and
Obesity. In Comparative Quantification of Health Risks: Global and Regional
Burden of Disease Attributable to Selected Major Risk Factors, eds. Ezzati
M, Lopez AD, Rodgers A, Murray CJL. WHO, Geneva, 2003.
(5) Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for
vascular disease among adults with previously diagnosed diabetes. JAMA.
2004: 291(3), 335-342.
(6) Hertz RP, Unger AN, Lustik MB. Adherence with pharmacotherapy for
type 2 diabetes: a retrospective cohort study of adults with employer-
sponsored health insurance. Clin Ther. 2005;27:1064-1073.
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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Related links:
http://www.amylin.com
CONTACT:
Alice Bahner Izzo of Amylin, +1-858-642-7272,
+1-858-232-9072, cell; or Kindra Strupp of Lilly,
+1-317-277-5170, +1-317-554-9577, cell; or Rebecca Peterson of
Alkermes, +1-617-583-6378, +1-617-899-2447, cell
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