BYDUREON(TM) (exenatide for extended-release injectable suspension) Proposed NameSAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Mar 15, 2010 (BUSINESS WIRE) -- 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(TM) (exenatide
for extended-release injectable suspension).
In the complete response letter there are no requests for new
pre-clinical or clinical trials. Requests raised in the letter primarily
relate to the finalization of the product labeling with accompanying
Risk Evaluation and Mitigation Strategy (REMS) and clarification of
existing manufacturing processes.
The complete response letter does not contain requests related to the
December 2009 observations from the FDA's pre-approval inspection at the
Ohio manufacturing facility. All of those observations have been
"This is a significant step forward in our ability to bring this
important therapy to patients," said Orville G. Kolterman, M.D., senior
vice president of research and development, Amylin Pharmaceuticals. "We
have a clear path forward and are working diligently to submit our
response to the FDA in the next few weeks."
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(R)
(exenatide) injection, which has been available in the U.S. since June
2005 and is used in approximately 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
The NDA for BYDUREON was submitted in May 2009 and accepted by the FDA
in July 2009. It is based on data from the DURATION clinical trial
program, as well as more than seven years of clinical experience with
Amylin to Host Investor Conference Call
Amylin will hosta conference call to discuss the complete
response letter for BYDUREON on Monday, March 15 at 8:30 a.m. ET/5:30
a.m. PT. Daniel M. Bradbury, president and chief executive officer,
Amylin Pharmaceuticals, will lead the call.
The call will be webcast live through Amylin's corporate Web site 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)
291-9234 (U.S./Canada) or (617) 614-3923 (international), conference
access code 12781062. 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 (888) 286-8010 (U.S./Canada) or (617) 801-6888
(international), conference access code 34108583.
Diabetes affects more than 24 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 is the
fifth leading cause of death by disease in the U.S. and costs
approximately $174 billion per year in direct and indirect medical
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
About BYETTA(R) (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 one million
patients since its introduction. See important safety information below.
Additional information about BYETTA is at www.BYETTA.com.
Important Safety Information for BYETTA(R)
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
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 (http://pi.lilly.com/us/byetta-pi.pdf)
and Medication Guide (http://pi.lilly.com/us/byetta-ppi.pdf).
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(R) technology for
long-acting medications. BYDUREON is not currently approved by any
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, California.
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, Indiana, 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, Massachusetts, 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 in a timely manner 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 a 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, such as the NDA filing for BYDUREON
mentioned in this press release, 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(TM) and BYETTA(R) are trademarks
of Amylin Pharmaceuticals, Inc., and Medisorb(R)
is a registered trademark of Alkermes, Inc.
i The International Diabetes Federation Diabetes Atlas.
Available at: http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed March 12, 2010.
ii Diabetes Statistics. American Diabetes Association.
Available at http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed March 12, 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 March 12, 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.
Amylin - Anne Erickson
Phone: (858) 754-4443
Cell: (858) 349-3195
Lilly - Kindra Strupp
Phone: (317) 277-5170
Cell: (317) 554-9577
Alkermes - Rebecca Peterson
Phone: (781) 609-6378
Cell: (617) 899-2447