- Both Groups Experienced Significant Weight Loss - - New Drug Application Filing Planned by the End of the First Half of 2009 -SAN DIEGO & INDIANAPOLIS & CAMBRIDGE, Mass., Oct 31, 2007 (BUSINESS WIRE) -- 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
"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.
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
Full study results will be included in future scientific
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 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.
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 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
For complete safety profile and other important prescribing
considerations, visit 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 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
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.
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.
1 The International Diabetes Federation Diabetes Atlas. Available
2682A. Accessed October 30, 2007. (Due to its length, this URL may
need to be copied/pasted into your Internet browser's address field.
Remove the extra space if one exists.)
2 "All About Diabetes." American Diabetes Association. Available
at: http://www.diabetes.org/about-diabetes.jsp. Accessed October 30,
3 "Direct and Indirect Costs of Diabetes in the United States."
American Diabetes Association. Available at:
. Accessed October 30, 2007. (Due to its length, this URL may need to
be copied/pasted into your Internet browser's address field. Remove
the extra space if one exists.)
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,
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. and Eli Lilly and Company and Alkermes, Inc.
Amylin Pharmaceuticals, Inc.
Alice Bahner Izzo, 858-642-7272
Eli Lilly and Company
Kindra Strupp, 317-277-5170
Rebecca Peterson, 617-583-6378 office