SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Oct.
19 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes,
Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has issued a complete response letter
regarding the New Drug Application (NDA) for BYDUREON™ (exenatide
extended-release for injectable suspension).
In the complete response letter the FDA requested a thorough QT
(tQT) study with exposures of exenatide higher than typical
therapeutic levels of BYDUREON. The tQT protocol will be agreed to
by the FDA prior to study initiation. Additionally, the FDA has now
requested the results of the DURATION-5 study to evaluate the
efficacy, and the labeling of the safety and effectiveness, of the
commercial formulation of BYDUREON. This letter did not cite any
manufacturing processes referenced in the FDA's March 15 complete response letter. REMS and
product labeling discussions will continue following submission of
the additional data.
The companies' goal is to submit their reply to the complete
response letter by the end of 2011, pending discussions with the
FDA. Based on the requirements for additional data, this will
likely be considered a Class 2 resubmission requiring a six-month
review.
"We are committed to working closely with the FDA to resolve the
issues raised in the complete response letter so that BYDUREON can
be approved, and we can make this important treatment available to
patients with type 2 diabetes as quickly as possible," said
Orville G. Kolterman, M.D., senior
vice president, chief medical officer, Amylin Pharmaceuticals. "We
remain confident in BYDUREON based on the extensive exenatide
database, including more than seven years of clinical experience
with BYETTA, the twice-daily form of exenatide that is available in
more than 60 countries worldwide."
BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name
for exenatide once weekly. It is an investigational,
extended-release medication for type 2 diabetes designed to deliver
continuous therapeutic levels of exenatide in a single weekly dose.
BYDUREON is a once-weekly formulation of exenatide, the active
ingredient in BYETTA® (exenatide) injection. BYETTA has been
available in the U.S. since June 2005
and is used in more than 60 countries worldwide to improve glycemic
control in adults with type 2 diabetes. BYDUREON and BYETTA belong
to the glucagon-like peptide-1 (GLP-1) receptor agonist class of
medications.
The NDA for BYDUREON was submitted in May
2009 and is based on data that include the DURATION-1
head-to-head clinical study, safety data from DURATION-2 and more
than seven years of clinical experience with BYETTA. The agency
issued a complete response letter to the companies in March 2010 and in May
2010 classified the companies' first complete response as a
Class 2 resubmission with a PDUFA action date of October 22, 2010.
Amylin to Host Investor Conference Call
Amylin will host a conference call to discuss the complete
response letter for BYDUREON at 4 p.m.
PT on Oct. 19. Daniel M. Bradbury, president and chief
executive officer, Amylin Pharmaceuticals, will lead the call.
The call will be webcast live through Amylin's corporate website
and a recording will be made available following the close of the
call. To access the webcast, please log on to www.amylin.com
approximately 15 minutes prior to the call to register, download
and install any necessary audio software. For those without access
to the Internet, the live call may be accessed by phone by calling
(800) 857-5738 (U.S./Canada) or
(415) 228-4970 (international), conference access code 7487145. A
replay of the call will also be available by phone beginning
approximately two hours after the close of the call and can be
accessed at (866) 375-1047 (U.S./Canada) or (203) 369-0288 (international).
About Diabetes
Diabetes affects more than 24 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 is the first FDA-approved GLP-1 receptor agonist for the
treatment of type 2 diabetes. BYETTA 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.
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
recommended to be taken with insulin. BYETTA is not for people with
type 1 diabetes or people with diabetic ketoacidosis.
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 April 2005 and has been used by more than 1.3
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 post-marketing data, BYETTA has been associated with
acute pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. 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. Severe allergic
reactions can happen with BYETTA.
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
BYDUREON, a subcutaneous injection of exenatide for the treatment
of type 2 diabetes based on Alkermes' proprietary Medisorb®
technology for long-acting medications. BYDUREON is not currently
approved by any regulatory agencies.
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.
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 as soon as anticipated or at all;
the companies' response to the 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 not being completed in a timely
manner, not confirming previous results, 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.
P-LLY
(i)The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed September 21, 2010.
(ii) Diabetes Statistics. American Diabetes Association.
Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed September 21, 2010.
(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 September 21, 2010.
(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.; Eli Lilly and Company;
Alkermes, Inc.
Copyright . 19 PR Newswire