BASINGSTOKE, England,
March 10, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE:
LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive
results from a phase 2 study evaluating the effects of a
once-monthly injectable suspension formulation of exenatide on
glycaemic control in patients with type 2 diabetes.
The 121-patient phase 2 study assessed the efficacy, safety and
tolerability of three different doses of exenatide once monthly. It
also assessed exenatide once weekly (exenatide extended-release for
injectable suspension, proposed brand name Bydureon(R)), another
investigational type 2 diabetes therapy. After 20 weeks of
treatment (five injections), patients randomized to the exenatide
once monthly treatment arms experienced average reductions in A1C
ranging between 1.3 and 1.5 percentage points from baseline. In the
exenatide once-weekly treatment arm, the reduction was 1.5
percentage points. A1C is a measure of average blood sugar over
three months.
More than 90 percent of patients overall completed the study.
The most common adverse events among the exenatide once monthly
treatment groups were headache and nausea. Headache and diarrhoea
were most common among the exenatide once-weekly group. No major or
minor hypoglycaemia was reported in the study.
Based on the encouraging results of this study, the companies
plan to proceed with regulatory interactions to outline the next
steps for this important programme.
Exenatide once monthly is a new, extended-release formulation of
exenatide, the active ingredient in Byetta(R) (exenatide)
injection, which is given twice daily. Exenatide once-monthly is
based on the same Medisorb(R) microsphere technology used in
exenatide once-weekly.
- ENDS -
Study Design
This phase 2, randomized, open-label study included 121 adults
with type 2 diabetes who were not achieving adequate glucose
control using diet and exercise alone or with a stable regimen of
metformin, pioglitazone, or both. Subjects were randomized to
receive either 2 mg weekly subcutaneous injections of exenatide
once-weekly or subcutaneous injections of exenatide once-monthly at
a low, medium or high dose, each administered once every four
weeks, for a total of 20 weeks.
About Amylin, Lilly and Alkermes
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. 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.
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 healthcare
professionals improve the lives of people with diabetes, and
research continues on innovative medicines to address the unmet
needs of patients.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Lilly provides
answers - through medicines and information - for some of the
world's most urgent medical needs.
Alkermes, Inc. is a fully integrated biotechnology company
committed to developing innovative medicines to improve patients'
lives. Alkermes' robust 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. Headquartered in Waltham, Mass., Alkermes has a research
facility in Massachusetts and a
commercial manufacturing facility in Ohio.
BYDUREON(R) and BYETTA(R) are trademarks of Amylin
Pharmaceuticals, Inc., and Medisorb(R) is a registered trademark of
Alkermes, Inc. All other marks are the marks of their respective
owners.
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