Once Weekly Exenatide LAR Well Tolerated and Improved Glucose Control
August 22 2005 - 5:30PM
PR Newswire (US)
- Preliminary Results From Phase 2 Study Announced - SAN DIEGO,
INDIANAPOLIS and CAMBRIDGE, Mass., Aug. 22 /PRNewswire-FirstCall/
-- Amylin Pharmaceuticals, Inc., (NASDAQ:AMLN), Eli Lilly and
Company (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS) today announced
results from the ongoing Phase 2 multi-dose study of a long-acting
release (LAR) formulation of BYETTA(TM) (exenatide) injection in
patients with type 2 diabetes. The study was designed to assess the
safety, tolerability and pharmacokinetics of exenatide LAR given
once a week. After 15 weeks, both doses of exenatide LAR were well
tolerated and expected therapeutic blood levels of exenatide were
achieved. Dose-dependent improvements in hemoglobin A1C (A1C) and
weight were observed. A1C, a measure of glucose control, improved
approximately 2 percent for subjects receiving the high dose of
exenatide LAR, compared to placebo. At the beginning of the study,
the average A1C of study participants was approximately 8.5
percent. The decrease in A1C was progressive with no evidence of a
plateau at week 15. Twelve of the 14 high-dose subjects who entered
the study with an A1C greater than 7 percent achieved an A1C of 7
percent or less at 15 weeks. None of the 14 subjects receiving
placebo achieved that target. The American Diabetes Association
recommends a target A1C of less than 7 percent. Fasting blood
glucose concentrations were reduced by approximately 50 mg/dL for
subjects in the high dose group compared to those receiving
placebo. Subjects in this group experienced an average weight
reduction of approximately 9 pounds compared to those receiving
placebo. The most common adverse event was mild nausea, which
occurred in approximately 20 percent of subjects in the high dose
group compared to approximately 7 percent in the placebo group. No
severe gastrointestinal side effects were reported. No severe
hypoglycemia was reported, and no subjects receiving exenatide LAR
withdrew because of adverse events. This Phase 2, randomized,
placebo-controlled, double-blind study includes 45 subjects with
type 2 diabetes who were not achieving adequate glucose control
using diet and exercise with or without metformin. Subjects were
randomized to receive 15 once-weekly subcutaneous injections of
exenatide LAR at one of two doses or placebo. At this time, study
participants have completed the active dosing period. Subjects will
be observed for an additional 12 weeks with follow-up observations
and data analyses ongoing. The companies anticipate that the full
study results will be presented in a future scientific forum. On
April 28, 2005, the Food and Drug Administration (FDA) approved
twice daily exenatide under the trade name BYETTA(TM) (exenatide)
injection for use by people with type 2 diabetes who are
unsuccessful at controlling their blood sugar levels despite using
commonly prescribed oral medications metformin, a sulfonylurea, or
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) injectable long-acting release drug delivery
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 treatment in the fight against diabetes. An
incretin mimetic works to mimic the anti-diabetic 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 18 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 fifth
leading cause of death by disease in the United States (4) 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 (5)) with their current treatment regimen (6). 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. 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. The Company's lead
commercial product is the first and only long-acting atypical
antipsychotic medication approved for use in schizophrenia. The
Company's lead proprietary product candidate, Vivitrex(R)
(naltrexone long-acting injection), is being developed as a
once-monthly injection for the treatment of alcohol dependence. The
Company 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: the
Company 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. The Company's 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 the results referred to in this
release or that the multi-dose trial will be completed when
planned, 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 the LAR version of BYETTA will receive regulatory
approvals 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-Q. The parties undertake no duty 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_2003.pdf. (4) Kochanek
KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002.
National vital statistics reports; vol 53 no 5. Hyattsville,
Maryland: National Center for Health Statistics. 2004. (5) American
Diabetes Association. Standards of medical care in diabetes.
Diabetes Care 2005;28:S4-36S. (6) 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.; Eli
Lilly and Company; Alkermes, Inc. CONTACT: Mark Foletta of Amylin,
+1-858-552-2200; or Scott MacGregor of Lilly, +1-317-651-1494; or
Jaren Madden of Alkermes, +1-617-583-6402 Web site:
http://www.byetta.com/ Web site: http://www.lillydiabetes.com/ Web
site: http://www.lilly.com/ Web site: http://www.amylin.com/
Copyright
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jul 2023 to Jul 2024