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 glycemic 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™), 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 once-weekly BYDUREON
treatment arm, the reduction was 1.5 percentage points. A1C is a
measure of average blood sugar over three months.
“As innovators in the treatment of type 2
diabetes we brought the first GLP-1 product, BYETTA, to patients.
We are now developing once-weekly and once-monthly formulations of
exenatide to expand patient choices for improving glycemic
control,” said Christian Weyer, M.D., senior vice president,
research and development, Amylin Pharmaceuticals. “Based on the
encouraging results of this study, we plan to proceed with
regulatory interactions to outline the next steps for this
important program.”
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 diarrhea were most common among the once-weekly
BYDUREON group. No major or minor hypoglycemia was reported in the
study.
Exenatide once monthly is a new,
extended-release formulation of exenatide, the active ingredient in
BYETTA® (exenatide) injection, which is given twice daily.
Exenatide once monthly is based on the same Medisorb® microsphere
technology used in BYDUREON.
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, Actos® (pioglitazone), or both.
Subjects were randomized to receive either 2 mg weekly subcutaneous
injections of BYDUREON 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 Diabetes
Diabetes affects nearly 26 million people in
the U.S. and an estimated 285 million adults worldwide.1,2
Approximately 90-95 percent of those affected have type 2 diabetes.
Diabetes costs approximately $174 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 In addition, 85 percent of type 2 diabetes patients are
overweight and 55 percent are considered obese.5 Data indicate that
weight loss (even a modest amount) supports patients in their
efforts to achieve and sustain glycemic control.6,7
About BYETTA® (exenatide)
injection
BYETTA was the first glucagon-like peptide-1
(GLP-1) receptor agonist to be approved by the FDA for the
treatment of type 2 diabetes. BYETTA exhibits many of the same
effects as the human incretin hormone 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 an injectable prescription medicine
that may improve blood sugar (glucose) control in adults with type
2 diabetes mellitus, when used with a diet and exercise program.
BYETTA is not insulin and should not be taken instead of insulin.
BYETTA is not currently recommended to be taken with insulin.
BYETTA is not for people with type 1 diabetes or people with
diabetic ketoacidosis. BYETTA has not been studied in people who
have pancreatitis.
BYETTA provides sustained A1C control and low
incidence of hypoglycemia when used alone or in combination with
metformin or a thiazolidinedione, with potential weight loss
(BYETTA is not a weight-loss product). BYETTA was approved in the
U.S. in April 2005 and has been used by more than 1.5 million
patients since its introduction. See important safety information
below. Additional information about BYETTA is available at
www.BYETTA.com.
Important Safety Information for
BYETTA® (exenatide) injection
Based on postmarketing data BYETTA has been
associated with acute pancreatitis, including fatal and non-fatal
hemorrhagic or necrotizing pancreatitis. Patients should be
observed for signs and symptoms of pancreatitis after initiation or
dose escalation of BYETTA. The risk for getting low blood sugar is
higher if BYETTA is taken with another medicine that can cause low
blood sugar, such as a sulfonylurea. BYETTA should not be used in
people who have severe kidney problems and should be used with
caution in people who have had a kidney transplant. Patients should
talk with their healthcare provider if they have severe problems
with their stomach, such as delayed emptying of the stomach
(gastroparesis) or problems with digesting food. Antibodies may
develop with use of BYETTA. Patients who develop high titers to
exenatide could have worsening or failure to achieve adequate
glycemic control. Consider alternative therapy if this occurs.
Severe allergic reactions can happen with BYETTA. There have been
no clinical studies establishing conclusive evidence of
macrovascular risk reduction with BYETTA or any other antidiabetic
drug.
The most common side effects with BYETTA
include nausea, vomiting, diarrhea, dizziness, headache, feeling
jittery, and acid stomach. Nausea most commonly happens when first
starting BYETTA, but may become less over time.
These are not all the side effects from use of
BYETTA. A healthcare provider should be consulted about any side
effect that is bothersome or does not go away.
For additional important safety information
about BYETTA, please see the full Prescribing Information
(www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).
About Amylin, Lilly and Alkermes
Amylin, Lilly and Alkermes are working together
to develop extended-release formulations of exenatide, including
once-weekly BYDUREON and exenatide once monthly. Both formulations
are subcutaneous injections of exenatide for the treatment of type
2 diabetes based on Alkermes’ proprietary Medisorb® technology.
BYDUREON and exenatide once monthly are not currently approved by
any regulatory agency.
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 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.
This press release contains forward-looking
statements about Amylin, Lilly and Alkermes. 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 BYDUREON may not be approved by the FDA and/or the
European Commission as soon as anticipated or at all; the
companies’ response to the FDA’s complete response letter may not
be submitted in a timely manner and/or the information provided in
such response may not satisfy the FDA; the FDA may request
additional information prior to approval; BYETTA and/or the
approval of BYDUREON and the revenues generated from these products
may be affected by competition; unexpected new data; safety and
technical issues; clinical trials, including the trial mentioned in
this press release, not being completed in a timely manner, not
confirming previous results, not being replicated in future
studies, not being predictive of real world use or not achieving
the intended clinical endpoints; label expansion requests or NDA
filings not receiving regulatory approval; the commercial launch of
BYDUREON being delayed; or manufacturing and supply issues. The
potential for BYETTA and/or BYDUREON 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 development and commercialization
of pharmaceutical products including those inherent in the
collaboration with and dependence upon Amylin, Lilly and/or
Alkermes. These and additional risks and uncertainties are
described more fully in Amylin’s, Lilly's and Alkermes’ most recent
SEC filings including their Quarterly Reports on Form 10-Q and
Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake
no duty to update these forward-looking statements.
BYDUREON™ and BYETTA® are trademarks of
Amylin Pharmaceuticals, Inc., and Medisorb® is a registered
trademark of Alkermes, Inc. All other marks are the marks of
their respective owners.
1 Diabetes Statistics. American Diabetes
Association. Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed March 10, 2011.
2 The International Diabetes Federation
Diabetes Atlas. Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed March 10, 2011.
3 Direct and Indirect Costs of Diabetes in the
United States. American Diabetes Association. Available at:
http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.
Accessed March 10, 2011.
4 Saydah SH, Fradkin J and Cowie CC. Poor
control of risk factors for vascular disease among adults with
previously diagnosed diabetes. JAMA. 2004;291:335-42.
5 Bays HE, Chapman RH, Grandy S. The
relationship of body mass index to diabetes mellitus, hypertension
and dyslipidaemia: comparison of data from two national surveys.
Int J Clin Pract. 2007;61:737-47.
6 Nutrition Recommendations and Interventions
for Diabetes: a position statement of the American Diabetes
Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
7 Anderson JW, Kendall CW, Jenkins DJ.
Importance of weight management in type 2 diabetes: review with
meta-analysis of clinical studies. J Am Coll Nutr.
2003;22:331-9.
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