SAN DIEGO and INDIANAPOLIS, March 23,
2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:
AMLN) and Eli Lilly and Company (NYSE: LLY) announced today that
the European Commission has granted marketing authorization to
BYETTA® (exenatide twice-daily) as an adjunctive 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 marketing authorization for the use of BYETTA with basal
insulin provides a new option for the many patients with type 2
diabetes who are not achieving treatment goals," said Christian Weyer, M.D., senior vice president,
research and development, Amylin Pharmaceuticals. "In a clinical
trial, patients using fixed-dose BYETTA with titrated basal insulin
achieved better postprandial and overall glycemic control, without
weight gain or an increased risk of hypoglycemia, compared to
patients using titrated basal insulin without BYETTA."
The main study included in the EU marketing authorization
submission package was a double-blind, 30-week clinical trial
published in Annals of Internal Medicine.(1) In the 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. Change in fasting glucose 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.
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 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 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 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 is committed to
delivering novel therapies that transform the way diabetes 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
www.amylin.com.
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.
P-LLY
(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:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed March 22, 2012.
(4) 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 22, 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 1;S61-78.
(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. 2003;22:331-9.
SOURCE Amylin Pharmaceuticals, Inc.