Once-Weekly Exenatide LAR Clinical Study in Type 2 Diabetes Initiated
March 24 2006 - 7:15AM
PR Newswire (US)
SAN DIEGO, CA, INDIANAPOLIS, IN and CAMBRIDGE, MA, March 24
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc.
(NASDAQ:ALKS) today announced that, following discussions with the
U.S. Food and Drug Administration (FDA), a long-term comparator
clinical study of a long-acting release (LAR) formulation of
BYETTA(R) (exenatide) injection in patients with type 2 diabetes
has been initiated. This study is designed to generate the type of
safety and efficacy data that could form the basis of a New Drug
Application (NDA). The 30-week open-label, noninferiority study
will assess whether once-weekly exenatide LAR is at least as
effective in improving glucose control as twice-daily BYETTA.
Approximately 300 subjects with type 2 diabetes who are not
achieving adequate glucose control using diet and exercise with or
without the use of oral antidiabetic agents will be randomized to
one of two treatment groups. Subjects randomized to the exenatide
LAR group will receive once-weekly subcutaneous injections of a
single strength of exenatide LAR. Subjects randomized to the
comparison group will receive twice-daily injections of 10
micrograms of BYETTA. Endpoints include change in hemoglobin A1C (a
standard measure of glucose control), fasting blood glucose, body
weight, and safety parameters. All participants who complete the
randomized portion of the study will have the opportunity to
continue in an extension study and receive once-weekly exenatide
LAR. In parallel with clinical activities, manufacturing process
development and scale-up activities are underway. The material for
this study is being manufactured at development scale, and the
Companies are working to determine the overall manufacturing
strategy. In December 2005, Amylin announced that it purchased a
facility for the commercial production of exenatide LAR and expects
to finalize the commercial manufacturing process for exenatide LAR
by late 2008. BYETTA was approved by the FDA in April 2005 for the
treatment of type 2 diabetes as add-on therapy in patients who are
not achieving acceptable blood sugar control despite using the
commonly prescribed diabetes medications metformin, a sulfonylurea
or a combination of both. Amylin, Lilly, and Alkermes are working
together to develop a sustained release, subcutaneous injection of
exenatide for the treatment of type 2 diabetes based on Alkermes'
proprietary Medisorb(R) technology. Exenatide LAR has not been
approved by the FDA for marketing in the United States. About
BYETTA BYETTA is the first in a new class of drugs for the
treatment of type 2 diabetes called incretin mimetics and exhibits
many of the same effects as the human incretin hormone
glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to
food intake, has multiple effects on the intestine, liver, pancreas
and brain that work in concert to improve blood sugar.(1) About
Incretin Mimetics Incretin mimetics is a new class of therapeutic
agents in the fight against diabetes. An incretin mimetic works to
mimic the antidiabetic or glucose-lowering actions of naturally
occurring human hormones called incretins. These actions include
stimulating the body's ability to produce insulin in response to
elevated levels of blood sugar, inhibiting the release of a hormone
called glucagon following meals, slowing the rate at which
nutrients are absorbed into the bloodstream and reducing food
intake. BYETTA is the first FDA-approved agent of this new class of
medications. About Diabetes Diabetes affects an estimated 194
million adults worldwide(2) and more than 20 million in the United
States.(3) Approximately 90-95 percent of those affected have type
2 diabetes, a condition where the body does not produce enough
insulin and/or the cells in the body do not respond normally to
insulin.(3) Diabetes is the sixth leading cause of death by disease
in the United States(3) and costs approximately $132 billion per
year in direct and indirect medical expenses. Type 2 diabetes
usually occurs in adults over the age of 40, but is increasingly
common in younger people.(3) 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 A1C levels (less than 7.0 percent according to
American Diabetes Association guidelines(4)) with their current
treatment regimen.(5) Important Safety Information for BYETTA(TM)
(exenatide) injection BYETTA(TM) (exenatide) injection improves
blood sugar control in patients with type 2 diabetes who are taking
metformin, a sulfonylurea, or both. 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. BYETTA has not been studied in children or pregnant women.
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. 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 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(TM)
(exenatide) injection. Amylin is located in San Diego, California
with over 1200 employees nationwide. Further information on Amylin
Pharmaceuticals and its pipeline in metabolism 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, Ind.,
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 pharmaceutical company that develops products
based on sophisticated drug delivery technologies to enhance
therapeutic outcomes in major diseases. Alkermes' lead commercial
product, RISPERDAL(R) CONSTA(R) [(risperidone) long-acting
injection], is the first and only long-acting atypical
antipsychotic medication approved for use in schizophrenia, and is
marketed worldwide by Janssen-Cilag (Janssen), a wholly owned
division of Johnson & Johnson. Alkermes' lead proprietary
product candidate, VIVITROL(TM) (naltrexone for extended-release
injectable suspension), is being developed as a once-monthly
injection for the treatment of alcohol dependence. Alkermes has a
pipeline of extended-release injectable products and pulmonary drug
products based on its proprietary technology and expertise.
Alkermes' product development strategy is twofold: Alkermes
partners its proprietary technology systems and drug delivery
expertise with several of the world's finest pharmaceutical
companies and it also develops novel, proprietary drug candidates
for its own account. 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. 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 that current or future clinical trials will
confirm previous results or that the trial discussed above will be
completed when planned; risks and uncertainties that the results
from the clinical trial discussed in this press release will meet
primary endpoints or the clinical study will generate clinical data
that could form the basis of an 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
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 exenatide LAR
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, including Amylin's recently filed Form 10-K. The
parties disclaim any obligation to update forward-looking
statements. P-LLY REFERENCES (1) Kolterman, O, Buse J, Fineman M,
Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y,
Baron A. Synthetic exendin-4 (exenatide) significantly reduces
postprandial and fasting glucose in subjects with type 2 diabetes.
Journal of Clinical Endocrinology & Metabolism. 2003;
88(7):3082-3089. (2) The International Diabetes Federation Diabetes
Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed April 12, 2005. (3) Centers for Disease Control and
Prevention, National Diabetes Fact Sheet. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. (4) American
Diabetes Association. Standards of medical care in diabetes-2006.
Diabetes Care. 2006;29:S4-42. (5) Harris MI, Eastman RC, Cowie CC,
Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic
control of adults with type 2 diabetes. Diabetes Care.
1999;22:403-408. DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT:
Alice Bahner of Amylin Pharmaceuticals, Inc., +1-858-552-2200; or
Jamaison Schuler of Eli Lilly and Company, +1-317-655-2111; or
Rebecca Peterson of Alkermes, +1-617-583-6378 Web site:
http://www.byetta.com/ Web site: http://www.lillydiabetes.com/ Web
site: http://www.lilly.com/ Web site:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf Web site:
http://www.amylin.com/
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