- FDA Submission Planned in First Half of 2008 -
SAN DIEGO and INDIANAPOLIS, Dec. 6 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY)
today announced study results from a 24-week study of monotherapy, or
stand-alone, BYETTA (exenatide) injection taken twice daily in drug-naive
patients with type 2 diabetes. Study participants taking 5 mcg or 10 mcg of
monotherapy BYETTA twice daily showed significant reductions in A1C (a
measure of average blood sugar over 3 months) by 0.7 percentage points and
0.9 percentage points, respectively, from an average baseline A1C ranging
from 7.8 to 7.9 percent. In addition, approximately 60 percent of study
participants on either 5 mcg or 10 mcg of monotherapy BYETTA at the
conclusion of the study had an A1C of 7 percent or less, a common target
for good glucose control. The companies plan a regulatory submission to the
U.S. Food and Drug Administration (FDA) in the first half of 2008.
In this 24-week, randomized, placebo-controlled study, 232 drug-naive
people with type 2 diabetes were treated with monotherapy BYETTA or
placebo. More than 85 percent of study participants in the 5 mcg and 10 mcg
arms completed the study. Weight loss from baseline was significant and
similar to that observed in previous BYETTA studies.
"The American Diabetes Association's (ADA) clinical guidelines for the
treatment of patients with type 2 diabetes are to achieve target glucose
control, as well as weight loss in overweight or obese patients," said
James Malone, M.D., Global Medical Director, Eli Lilly and Company. "These
data are robust and are consistent with data from other trials that support
the use of BYETTA before starter insulin. If approved for monotherapy,
BYETTA may provide an additional treatment option for physicians to
consider earlier in the continuum of care."
There was a low incidence of nausea reported in both treatment arms of
the study of approximately 3 and 13 percent in the 5 mcg and 10 mcg arms,
respectively. There were no instances of severe hypoglycemia in this study.
Overall hypoglycemia observed was similar to that seen in studies where
BYETTA was used in conjunction with metformin only.
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 as an add-on therapy 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. This study was conducted following receipt of an approvable
letter for a monotherapy indication from the FDA in 2005.
Study Design
The 24-week, randomized study included 232 people with type 2 diabetes
who were not achieving adequate glucose control using diet and exercise
without previous use of antidiabetes agents. Study participants were
randomized to receive subcutaneous injections of placebo, 5 mcg exenatide,
or 10 mcg exenatide twice daily without taking any oral antidiabetes
agents. Patients randomized to 10 mcg exenatide received 5 mcg injections
for the first 4 weeks, and increased to 10 mcg injections for the final 20
weeks.
Full study results will be included in future scientific publications.
About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of drugs called incretin mimetics 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 thiazoladinedione, and progressive weight loss.
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).
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 and Lilly
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. 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.
This press release contains forward-looking statements about Amylin and
Lilly. 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, label expansion requests, including the FDA submission
referred to in this press release, 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 Amylin and Lilly's most
recently filed SEC documents such as their Quarterly Reports on Form 10-Q.
Amylin and Lilly 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 November 27, 2007.
(2) "All About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed November 27,
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 November 27, 2007.
(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.
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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Related links:
http://www.amylin.com
http://www.lilly.com http://www.lillydiabetes.com
http://www.BYETTA.com
CONTACT:
Kindra Strupp of Lilly, +1-317-277-5170,
cell, +1-317-554-9577; or Alice Izzo of Amylin, +1-858-642-7272,
cell, +1-858-232-9072
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