SAN DIEGO and INDIANAPOLIS, Nov. 8,
2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:
AMLN) ("Amylin") and Eli Lilly and Company (NYSE: LLY) ("Lilly")
today announced an agreement to terminate their alliance for
exenatide and resolve the outstanding litigation between the
companies. As part of the agreement, the parties will transition
full responsibility for the worldwide development and
commercialization of exenatide to Amylin, starting in the United States (U.S.) on November 30, 2011, and progressing to all markets
by the end of 2013.
After nearly a decade-long partnership that achieved a number of
important milestones on behalf of people living with diabetes, the
companies determined it was in the best interest of all
constituents to amicably terminate the collaboration. Both
companies are committed to ensuring a seamless transition of global
product responsibility to Amylin while maintaining continuity of
patient care.
"As pioneers in the GLP-1 market, we are proud of the truly
innovative diabetes products that our two companies have provided
patients," said Daniel M. Bradbury,
president and chief executive officer of Amylin Pharmaceuticals.
"Amylin is excited to assume full responsibility for developing and
commercializing exenatide. We anticipate working with one or more
partners outside the U.S. in order to maximize the global potential
of this innovative molecule and achieve greater operational
flexibility and efficiency. This clarity of focus will provide us
with an enhanced opportunity to increase shareholder value."
Under the terms of the new global agreement, Amylin will make a
one-time, upfront payment to Lilly of $250
million. Amylin will also agree to make future revenue
sharing payments to Lilly in an amount equal to 15 percent of
global net sales of exenatide products until Amylin has made
aggregate payments to Lilly of $1.2
billion plus accrued interest. Amylin will issue a secured
note in the amount of $1.2 billion to
Lilly under which any revenue sharing payments made to Lilly will
reduce amounts outstanding under the note. If Amylin's
investigational once weekly version of exenatide, BYDUREON™
(exenatide extended-release for injectable suspension), has not
received U.S. Food and Drug Administration (FDA) approval prior to
June 30, 2014, Amylin's revenue
sharing obligations will terminate, and Amylin shall thereafter pay
Lilly 8 percent of global net sales of exenatide products. Amylin
will also pay a $150 million
milestone to Lilly contingent upon FDA approval of a once monthly
suspension version of exenatide that is currently in Phase 2. The
companies have also agreed that the maturity date for the
$165 million line of credit that
Amylin drew from Lilly earlier in the year will be extended from
the second quarter of 2014 to the second quarter of 2016.
"This marks an amicable end to a very productive 10-year
collaboration that will continue to benefit many people worldwide.
Lilly and Amylin are proud of the important accomplishments we
achieved together," said Enrique
Conterno, president of Lilly Diabetes. "Lilly remains
confident that the resubmission package for BYDUREON has addressed
the requirements outlined by the FDA and looks forward to Amylin
achieving the alliance's long-held goal of making BYDUREON
available to patients in the U.S. Looking forward, Lilly Diabetes
remains committed to providing a comprehensive portfolio of
diabetes treatment options for patients through our currently
marketed products and robust clinical pipeline."
The transition of commercial operations to Amylin in the U.S.
will be complete by November 30,
2011. Outside the U.S., Lilly will transfer responsibility
for commercialization of BYETTA® (exenatide) injection and BYDUREON
to Amylin on a market-by-market basis in 2012 and 2013. Amylin will
work with Lilly on all plans for markets outside the U.S. during
the transition period and will guarantee that Lilly does not
experience losses on exenatide-related activities during that
period, up to a total cap of $60
million.
The Amylin and Lilly alliance resulted in several innovations in
the diabetes market. These innovations include the 2005 launch of
the first-in-class GLP-1 receptor agonist, BYETTA, a treatment that
has been used by 1.8 million patients worldwide, and submission of
the first once-weekly GLP-1 receptor agonist, BYDUREON, an
investigational medication for type 2 diabetes designed to deliver
continuous therapeutic levels of exenatide in a single weekly dose.
BYDUREON received marketing authorization in the European Union in
June 2011 and is currently under
review in the U.S., with a Prescription Drug User Fee Action
(PDUFA) date of January 28, 2012.
Amylin will continue to evolve the GLP-1 market with the exenatide
franchise through the development of a pen device for BYDUREON and
the exenatide monthly suspension program.
Amylin to Host Investor Conference Call
Amylin will host a conference call to discuss the transition of
the exenatide franchise today 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. A
slide presentation accompanying the conference call will be
available through the "Investors" section of Amylin's corporate
website at www.amylin.com.
The call will be webcast live through the "Investors" section of
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 7156306. 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) 470-8790
(U.S./Canada) or (203) 369-1490
(international).
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. It can also
be used with metformin, a sulfonylurea, a thiazolidinedione or
Lantus® (insulin glargine), which is a long-acting insulin.
BYETTA is not insulin and should not be taken instead of
insulin. BYETTA should not be taken with short- and/or rapid-acting
insulin. BYETTA is not for people with type 1 diabetes or people
with diabetic ketoacidosis. BYETTA has not been studied in patients
with a history of pancreatitis. Other antidiabetic therapies should
be considered for these patients.
BYETTA provides sustained A1C control with potential weight loss
(BYETTA is not a weight-loss product). BYETTA was approved in the
U.S. in April 2005 and in
Europe in November 2006 and has been used by more than 1.8
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. Patients should be observed for signs and
symptoms of pancreatitis after initiation or dose escalation of
BYETTA. The risk of getting low blood sugar is higher if BYETTA is
taken with another medicine that can cause low blood sugar, such as
a sulfonylurea or insulin. The dose of sulfonylurea or insulin may
need to be lowered while BYETTA is used. 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, feeling jittery, dizziness, headache, acid
stomach, constipation and weakness. 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 and Lilly
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 and has a commercial manufacturing facility in
Ohio.
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. C-LLY
Forward Looking Statement
This press release contains forward-looking statements about
Amylin and Lilly. 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 information
provided in the companies' response to the FDA's complete response
letter may not satisfy the FDA; the FDA may request additional
information prior to approval; BYETTA and/or the approval of
BYDUREON and the revenues or royalties 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 in
the United States, if approved, or
in certain European countries 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. Each company's
results may also be affected by risks inherent in the termination
of their collaboration and the risk that Amylin may not have the
financial resources to meet the obligations mentioned in this press
release. Amylin's results may also be affected by risks associated
with its assumption of full responsibilities for the worldwide
development and commercialization of exenatide, including the risks
that the transition of Lilly's collaboration responsibilities to
Amylin will not proceed according to plan, and risks that Amylin's
future efforts to further develop and commercialize the exenatide
franchise, including any efforts to re-partner the development and
commercialization of exenatide outside the United States, may not produce the results
Amylin expects. Lilly's results may be affected by the risks
inherent in the development of Lilly's pipeline, and there can be
no guarantees that pipeline products will receive the necessary
clinical and manufacturing regulatory approvals or that they will
prove to be commercially successful. These and additional risks and
uncertainties are described more fully in Amylin's and Lilly's most
recent SEC filings including their Quarterly Reports on Form 10-Q
and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty
to update these forward-looking statements.
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company