San Diego, and Indianapolis, and Cambridge, Massachusetts
- U.S. New Drug Application Filing Planned by the End of the First
Half of-2009 -
Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and
Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced
positive results from a 30-week Phase 2/3 study of once-weekly
exenatide long-acting release (LAR) injection compared with BYETTA(R)
(exenatide) injection taken twice daily in patients with type 2
Once-weekly exenatide demonstrated a statistically significant
improvement in glycaemic control between the two treatments as
measured by hemoglobin A1c (HbA1c). HbA1c is a measure of glucose
control over the previous 3 months. Once-weekly exenatide lowered
HbA1c by approximately 1.9 percentage points from baseline, compared
to a lowering of approximately 1.5 percentage points for BYETTA.
Nearly half of all patients taking once-weekly exenatide achieved an
HbA1c target of 6.5 percent or less. (The International Diabetes
Federation recommends a target HbA1c of 6.5 percent or less.)
Exenatide LAR is an investigational once-weekly formulation of
exenatide. Exenatide is the active ingredient in BYETTA and is
currently available in many countries worldwide for the treatment of
type 2 diabetes. Exenatide is approved in the US as add-on therapy
for people currently using metformin, a sulfonylurea, or a
The study enrolled patients not achieving adequate glucose control
with either diet and exercise or with use of one or more oral
glucose-lowering agents. Nearly 90 percent of subjects in both
treatment arms completed the study. After 30 weeks of treatment, both
once-weekly exenatide and exenatide treatment resulted in an average
weight loss of approximately 3.6 kilograms (8.0 pounds). Both
exenatide and once-weekly exenatide were generally well tolerated.
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 HbA1c, the key measure of
success in the management of type 2 diabetes, and was associated with
weight loss in some patients," said Orville G. Kolterman, M.D.,
Senior Vice President Clinical and Regulatory Affairs, Amylin
Pharmaceuticals. "These data build on the benefits of exenatide as an
important treatment option and suggest that once-weekly
administration of exenatide has the potential to help patients
further improve their diabetes control."
No cases of major or severe hypoglycaemia were reported in either
treatment arm regardless of background therapy. Minor hypoglycaemia
was reported with once-weekly exenatide use and was limited to
subjects using background sulphonylurea therapy. Once-weekly
exenatide was associated with approximately 30 percent less nausea
than exenatide. 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
decreased with time. The antibody profile of subjects treated in this
study was consistent with the previously reported profiles of
exenatide 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 in the United States. Exenatide is
indicated for use in people with type 2 diabetes who are unsuccessful
at controlling their blood sugar levels using common oral diabetes
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, non-inferiority 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 randomised to receive
subcutaneous injections of either once-weekly exenatide 2.0
milligrams or exenatide taken twice daily [5 mcg twice daily for 4
weeks and 10 mcg twice daily for the remainder of the study]. All
subjects who completed the randomised portion of the study are
continuing in an open-ended study receiving once-weekly exenatide.
Full study results will be included in future scientific
Diabetes affects an estimated 246 million adults worldwide and
more than 48 million in Europe(1,2). Approximately 90 to 95 percent
of those are affected by type 2 diabetes, a condition characterised
by failure of the pancreatic beta-cell to adequately respond to the
increased demands for insulin and obesity-related insulin
resistance(3). In western countries, around 90 percent of type 2
diabetes cases are attributable to weight gain(4). Type 2 diabetes
usually occurs in adults over the age of 40, but is increasingly
common in younger people(2). In virtually every developed society,
diabetes is ranked among the leading causes of blindness, renal
failure and lower limb amputation, as well as death through its
effects on cardiovascular disease (70-80 percent of people with
diabetes die of cardiovascular disease)(5). The calculated estimates
of the costs of diabetes care in Europe amount to 42.8 billion
International Dollars per year(6).
Exenatide is the first approved incretin mimetic, a class of class
of drugs for the treatment of type 2 diabetes. Exenatide 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 regulate blood sugar(7).
About Incretin Mimetics
Incretin mimetics are a distinct class of agents used to treat
type 2 diabetes. An incretin mimetic works to mimic the anti-diabetic
or glucose-lowering actions of the naturally occurring human incretin
hormone GLP-1. 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 promoting satiety.
About BYETTA(R) (exenatide) injection
Exenatide is the first in a class of drugs for the treatment of
type 2 diabetes called incretin mimetics. Exenatide 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. Exenatide is approved in the European Union as
adjunctive therapy to improve blood sugar control in patients with
type 2 diabetes who have not achieved adequate glycaemic control on
maximally tolerated doses of metformin and/or a sulphonylurea, two
common oral diabetes medications.
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.
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.
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
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.
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: the first and only long-acting atypical
antipsychotic medication approved for use in schizophrenia which is
marketed worldwide by Janssen-Cilag (Janssen), a wholly owned
division of Johnson & Johnson; and the first and only once-monthly
injectable medication approved for the treatment of alcohol
dependence which is 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 diabetes, addiction and central nervous system disorders.
Alkermes' headquarters are in Cambridge, Massachusetts, and it
operates research and manufacturing facilities in Massachusetts and
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 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 regarding the timing of the new drug
application 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 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.
The parties undertake no duty to update forward-looking statements.
(1) The International Diabetes Federation Diabetes Atlas.
Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2
FD3-87B73F80BC2268 2A . Accessed June 14, 2007.
(2) The International Diabetes Federation, Prevalence / All
diabetes. Available at
http://www.eatlas.idf.org/Prevalence/All_diabetes/. Accessed October
(3) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with
diet, sulfonylurea, metformin, or insulin in patients with type 2
diabetes mellitus: progressive requirement for multiple therapies
(UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
(4) The International Diabetes Federation Diabetes Atlas.
Available at: http://www.eatlas.idf.org/Obesity_and_type_2_diabetes/
Accessed on October 29, 2007.
(5) The International Diabetes Federation, Complications.
Available at http://www.eatlas.idf.org/Complications/ Accessed
October 29, 2007.
(6) The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003: 186.
(7) 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20071031/CLW032LOGO )
ots Originaltext: Eli Lilly and Company
Im Internet recherchierbar: http://www.presseportal.ch
Media contacts: - Alice Bahner Izzo of Amylin, +1-858-642-7272, or
cell, +1-858-232-9072; Derin Denham of Lilly, +1-317-277-6749, or
cell, +1-317-370-1435; Rebecca Peterson of Alkermes, +1-617-583-6378,
or cell, +1-617-899-2447. Photo:
http://www.newscom.com/cgi-bin/prnh/20071031/CLW032LOGO , PRN Photo