Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study
October 31 2007 - 6:00AM
PR Newswire (US)
- Both Groups Experienced Significant Weight Loss - 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.
DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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 Web site:
http://www.amylin.com/
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