Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and
Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today
announced results from long-term extensions of the DURATION-1 and 3
studies evaluating BYDUREON™ (exenatide extended-release for
injectable suspension), an investigational medication for type 2
diabetes. The studies will be presented at the 71st Scientific
Sessions of the American Diabetes Association.
Data from the DURATION-1 study showed that after three years,
patients receiving BYDUREON experienced a significant reduction in
A1C (1.6 percentage points), a measure of average blood sugar over
three months, and weight (5.1 pounds) compared to baseline.
(BYDUREON is not being studied as a weight-loss product.)
BYDUREON-treated patients also experienced improvements from
baseline in several cardiometabolic risk markers, including
systolic blood pressure (-2.1 mmHg), total cholesterol (-9.9
mg/dL), LDL cholesterol (-7.0 mg/dL) and triglycerides (-12
percent).
Separately, results from the DURATION-3 study showed that at 84
weeks, patients treated with BYDUREON experienced significantly
greater A1C reduction from baseline, sustained weight loss and a
lower risk of hypoglycemia than patients treated with Lantus®
(insulin glargine). A1C reduction was 1.2 percentage points for
BYDUREON compared with 1.0 percentage points for Lantus. Also,
significantly more patients taking BYDUREON achieved an A1C of less
than or equal to 6.5 percent. Patients on BYDUREON lost an average
of 4.5 pounds while those on Lantus gained an average of 5.3
pounds, a difference of 9.8 pounds between the treatments.
“Faced with the progressive nature of type 2 diabetes as a
life-long disease marked by the relentless worsening of glucose
control, many patients and their physicians struggle to find
treatments that help control blood sugar over time,” said Christian
Weyer, M.D., senior vice president, research and development,
Amylin Pharmaceuticals. “In these extension studies, patients using
BYDUREON for several years showed an improvement in glycemic
control, with weight loss, with just one dose per week.”
BYDUREON is the proposed brand name for exenatide
extended-release for injectable suspension. It is an
investigational 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® (exenatide) injection, which has been
available in the U.S. since June 2005 and is used in more than 70
countries worldwide to improve glycemic control in adults with type
2 diabetes. BYDUREON received marketing authorization in the
European Union earlier this month.
Study and Presentation Details (All
Times Pacific Daylight Time)
DURATION-1 (969-P)General Poster Presentation –
Saturday, June 25, 11:30 a.m. to 1:30 p.m.Audio Poster Tour
– Monday, June 27, 12-1 p.m.The 30-week controlled portion of
the DURATION-1 trial, which compared the efficacy of BYDUREON to
BYETTA, was followed by an open-ended extension period in which all
patients either continued treatment with BYDUREON or switched from
BYETTA to BYDUREON. Approximately 64 percent (n=194) of the 295
intent-to-treat patients completed three years of treatment, 57
percent of whom achieved an A1C 7 percent or below. BYDUREON was
well tolerated throughout the treatment period. Nausea was the most
common adverse event during the initial controlled period (27
percent) and the incidence decreased to 16 percent from week 30 to
week 156. No major hypoglycemia was observed.
DURATION-3 (277-OR)Oral Presentation – Monday, June
27, 9-9:15 a.m.Of the patients enrolled in the DURATION-3
study, 390 entered the open-label, comparator-controlled extension
study after 26 weeks of treatment with either BYDUREON or Lantus,
and 173 patients in each treatment group completed the 84-week
extension. A similar proportion of patients in each treatment group
achieved the study endpoint of A1C less than 7 percent (BYDUREON:
45 percent; Lantus: 37 percent; p=0.084). However, a higher
proportion of patients on BYDUREON achieved A1C less than or equal
to 6.5 percent compared to those on Lantus (BYDUREON: 31 percent;
Lantus: 20 percent; p=0.009).
BYDUREON was well tolerated during the treatment period. The
most common adverse event was nasopharyngitis in both treatment
arms, as well as nausea in the BYDUREON group and headache in the
Lantus group. Patients taking BYDUREON reported significantly fewer
episodes of confirmed hypoglycemia.
About Diabetes
Diabetes affects nearly 26 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 costs more
than $174 billion per year in direct and indirect medical
expenses.3
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 control.6,7
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 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, Lilly and Alkermes
Amylin and Lilly partnered to develop and market BYDUREON, which
is based on proprietary technology for long-acting medications
developed by Alkermes, Inc. BYDUREON is approved in the EU and is
under regulatory review in the U.S.
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.
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.
Alkermes, Inc. is a fully integrated biotechnology company
committed to developing innovative medicines to improve patients'
lives. Alkermes' robust pipeline includes extended-release
injectable and oral products for the treatment of prevalent,
chronic diseases, such as central nervous system disorders,
addiction and diabetes. Headquartered in Waltham, Mass., 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 as soon as anticipated or at all;
the companies’ response to the FDA’s complete response letter may
not be submitted in a timely manner and/or the information provided
in such 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, including those mentioned in
this press release, 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 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™ and BYETTA® are trademarks of Amylin
Pharmaceuticals, Inc. All other marks are the marks of their
respective owners.
1 Diabetes Statistics. American Diabetes Association. Available
at http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed June 17, 2011.
2 The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed June 17, 2011.
3 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 June 17, 2011.
4 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.
5 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.
6 Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association. Diabetes
Care 2008; 31 Suppl 1; S61-78.
7 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.
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