SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., 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 glycemic control in patients
with type 2 diabetes.
(Logo:
https://photos.prnewswire.com/prnh/20101020/LA85062LOGO-a)
(Logo:
https://photos.prnewswire.com/prnh/20101020/LA85062LOGO-b)
(Logo:
https://photos.prnewswire.com/prnh/20101020/LA85062LOGO-c)
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.(i, ii) Approximately
90-95 percent of those affected have type 2 diabetes. Diabetes
costs approximately $174 billion per
year in direct and indirect medical expenses.(iii)
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.(iv) In addition,
85 percent of type 2 diabetes patients are overweight and 55
percent are considered obese.(v) Data indicate that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control.(vi, vii)
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.
P-LLY
(i) Diabetes Statistics. American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed March 10, 2011.
(ii) 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.
(iii) 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.
(iv) 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.
(v) 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.
(vi) Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association.
Diabetes Care. 2007;30 Suppl 1:S48-65.
(vii) 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.
SOURCE Amylin Pharmaceuticals, Inc.