CHMP Recommends Approval of BYETTA for Use With Basal Insulin

SAN DIEGO and INDIANAPOLIS, Feb. 17, 2012 /PRNewswire/ — Amylin

Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today
announced that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a positive opinion in the European
Union (EU) for the expanded use of BYETTA® (exenatide twice-daily) as an add-on
therapy to basal insulin, with or without metformin and/or Actos®
(pioglitazone), for the treatment of type 2 diabetes in adults who have not
achieved adequate glycemic control with these agents. The CHMP’s decision is now
referred for final action to the European Commission, which has the authority to
approve medicines for the EU. The Commission usually decides on CHMP
recommendations within two to three months.

“The combination of BYETTA with basal insulin has potential as a complementary
treatment approach for several reasons,” said Christian Weyer, M.D., senior vice
president, research and development, Amylin Pharmaceuticals. “BYETTA is given in
a fixed-dose regimen. Its effects contribute to improved glycemic control after
meals, complementing the control of fasting blood sugar achieved with basal
insulin. And in a clinical study, patients using BYETTA with insulin glargine
achieved better glycemic control, without weight gain or an increased risk of
hypoglycemia, than patients using insulin glargine without BYETTA.”

The double-blind clinical trial evaluating BYETTA as an add-on therapy to
insulin glargine was published in Annals of Internal Medicine.[1] In the 30-week
study, BYETTA 10 micrograms or placebo was added to existing insulin glargine
therapy (with or without metformin, pioglitazone or both), which was titrated to
achieve target fasting glucose levels. At study entry, patients who may have
been at increased risk of hypoglycemia (A1C less than or equal to 8 percent)
reduced their dose of insulin glargine by 20 percent. Five weeks after
randomization, all patients had insulin doses titrated to achieve target fasting
glucose levels. The primary endpoint was reduction in A1C, a measure of average
blood sugar over three months; secondary endpoints included change in body
weight along with other parameters of glucose control, cardiovascular health,
hypoglycemia and patient-reported outcomes.

After 30 weeks of treatment, BYETTA demonstrated a statistically significant
reduction in A1C compared to placebo, lowering A1C by 1.7 percentage points from
a baseline of 8.3 percent. Patients treated with optimized insulin glargine plus
placebo experienced a 1.0 percentage point decrease in A1C from a baseline of
8.5 percent. Patients who added BYETTA to their insulin glargine regimen saw
their weight decrease by an average of 4 pounds, compared with an increase of 2
pounds in patients who were treated with optimized insulin glargine plus
placebo. BYETTA is not indicated for the management of obesity and weight loss
was a secondary endpoint in the trial. Fasting glucose change and hypoglycemia
incidence were similar between treatment groups.

Thirteen BYETTA recipients and one placebo recipient (9 percent vs. 1 percent)
discontinued the study because of adverse events (p less than 0.010); rates of
nausea (41 percent vs. 8 percent), diarrhea (18 percent vs. 8 percent), vomiting
(18 percent vs. 4 percent), headache (14 percent vs. 4 percent) and constipation
(10 percent vs. 2 percent) were higher with BYETTA than with placebo.
Hypoglycemia was similar for both groups; major hypoglycemia occurred twice in
one patient receiving insulin glargine without BYETTA.

In November 2011, Lilly and Amylin announced that they amicably terminated their
decade-long collaboration. As part of the transition plan outside the U.S.,
Amylin will assume responsibility for exenatide product commercialization
efforts on a market-by-market basis by the end of 2013. Amylin will work with
Lilly on plans for markets outside the U.S. during the transition period. Amylin
intends to provide uninterrupted patient supply in all markets where exenatide
products are launched, as well as additional markets in the future. Both
companies are committed to ensuring a seamless transition of global product
responsibility to Amylin while maintaining continuity of patient care. Amylin
anticipates 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.

About Diabetes

Diabetes affects an estimated 347 million adults worldwide and nearly 26 million
people in the U.S.[2],[3]Approximately 90-95 percent of those affected have type
2 diabetes. In the U.S., diabetes costs more than $174 billion per year in
direct and indirect medical expenses.[4]

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.[5] In addition, 85 percent of type 2 diabetes patients are
overweight and 55 percent are considered obese.[6] Data indicate that weight
loss (even a modest amount) supports patients in their efforts to achieve and
sustain glycemic control.[7],[8]

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

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 may
cause or worsen problems with kidney function, including kidney failure.
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. 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

For additional important safety information about BYETTA, please see the full
Prescribing Information ( and Medication Guide

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 is committed to delivering novel therapies that
transform the way diabetes, obesity and related metabolic disorders are treated.
Amylin is headquartered in San Diego and has a commercial manufacturing facility
in Ohio. More information about Amylin Pharmaceuticals is available at

About Lilly

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.

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 BYETTA and the revenues generated from BYETTA may be affected by
competition; unexpected new data; safety and technical issues; clinical trials
not confirming previous results or not being predictive of real-world use;
pre-clinical trials not predicting future results; label expansion requests not
being submitted in a timely manner or receiving regulatory approval; approved
label expansions not producing the results we expect, or manufacturing and
supply issues. The potential for BYETTA 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
commercialization of pharmaceutical products including those inherent in the
collaboration with and dependence upon Amylin and/or Lilly. 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.

BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc. All other marks
are the marks of their respective owners.


[1] Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in
basal insulin-treated patients with type 2 diabetes: A randomized, controlled
trial. Ann Intern Med. 2011;154:103-112.

[2] Danaei G, Finucane MM, Lu Y, et al. National, regional, and global trends in
fasting plasma glucose and diabetes prevalence since 1980: systematic analysis
of health examination surveys and epidemiological studies with 370 country-years
and 2.7 million participants. Lancet. 2011;DOI:10.1016/S0140-6736(11)60679-X.

[3] Diabetes Statistics. American Diabetes Association. Available at: Accessed February
15, 2012.

[4] Direct and Indirect Costs of Diabetes in the United States. American
Diabetes Association. Available at:
Accessed February 15, 2012.

[5] Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular
disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.

[6] 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.

[7] Nutrition Recommendations and Interventions for Diabetes: a position
statement of the American Diabetes Association. Diabetes Care. 2008;31 Suppl

[8] 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.

SOURCE Amylin Pharmaceuticals, Inc. and Eli Lilly and Company

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