SAN DIEGO, May 26, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (NASDAQ: AMLN) ("Amylin" or "the Company")
today announced that the United States District Court for the
Southern District of California
issued a temporary restraining order (TRO) against Eli Lilly and
Company (NYSE: LLY) ("Lilly") relating to its litigation with
respect to the Amylin / Lilly diabetes collaboration agreement.
The U.S. District Court restrained Lilly from proceeding with
its plans to use the same sales force to sell both exenatide and
Boehringer Ingelheim GmbH's competitive linagliptin. The
court also enjoined Lilly from disclosing any confidential
information about exenatide to any of its sales representatives or
employees participating in the marketing, promotion or sale of
linagliptin.
The complete order is being filed today on Amylin's Current
Report on Form 8-K with the Securities and Exchange Commission.
In 2002, Amylin entered an alliance with Lilly for the global
development and commercialization of exenatide, a medicine
indicated as a first line treatment for type 2 diabetes that is
currently marketed as BYETTA® (exenatide) injection.
Exenatide is also the active ingredient in BYDUREON™
(exenatide extended-release for injectable suspension), a
once-weekly version currently under review by the FDA.
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 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
http://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 Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide)
injection. 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. Further
information on Amylin Pharmaceuticals is available at
www.amylin.com.
This press release contains forward-looking statements about
Amylin, which involve risks and uncertainties. Our actual results
could differ materially from those discussed herein due to a number
of risks and uncertainties, including risks that BYETTA or, if
approved, BYDUREON, and the revenues generated from these products,
may be affected by competition, unexpected new data, safety and
technical issues, or manufacturing and supply issues; risks that
the litigation mentioned in this press release will not produce the
results we expect, including the risk that we may be unable to
obtain injunctive relief; risks that the litigation mentioned in
this press release could adversely impact our exenatide development
and commercialization collaboration with Lilly; risks that BYDUREON
will not be approved for commercialization by applicable regulatory
agencies; risks that our response to the FDA's BYDUREON complete
response letter may not be submitted in a timely manner and/or the
information we provide in our response may not satisfy the FDA;
risks that the FDA may request additional information prior to
approving BYDUREON; scientific, regulatory and other issues and
risks inherent in the drug development and commercialization
process. Commercial and government reimbursement and pricing
decisions, the pace of market acceptance and risks inherent in the
collaboration with and dependence upon Lilly may also affect the
potential for BYETTA or, if approved, BYDUREON. These and
additional risks and uncertainties are described more fully in the
Company's recently filed Form 10-Q. Amylin disclaims any obligation
to update these forward-looking statements.
Media Contacts:
Anne Erickson
(858) 754-4443
anne.erickson@amylin.com
or
Steve Frankel / Annabelle Rinehart
Joele Frank, Wilkinson Brimmer
Katcher
+1-212-355-4449
SOURCE Amylin Pharmaceuticals