Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection
April 29 2005 - 8:30AM
PR Newswire (US)
Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide)
Injection --A New First-in-Class Treatment for Patients with Type 2
Diabetes-- SAN DIEGO, Calif. and INDIANAPOLIS, Ind., April 29
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN), and Eli Lilly and Company (NYSE:LLY) announce that
the U.S. Food and Drug Administration (FDA) has approved BYETTA(TM)
(exenatide) injection as adjunctive therapy to improve blood sugar
control in patients with type 2 diabetes who have not achieved
adequate control on metformin and/or a sulfonylurea, two common
oral diabetes medications. BYETTA (pronounced bye-A-tuh), the trade
name for exenatide, is the first in a new class of medicines known
as incretin mimetics. BYETTA will be available to pharmacies by
June 1, 2005. BYETTA improves blood sugar control by lowering both
postmeal and fasting glucose levels leading to better long-term
control as measured by hemoglobin A1C. BYETTA does this through
several actions, including the stimulation of insulin secretion
only when blood sugar is high and by restoring the first- phase
insulin response, an activity of the insulin-producing cells in the
pancreas that is lost in patients who have type 2 diabetes. Most
patients in the long-term BYETTA clinical studies also experienced
reductions in weight. "The availability of a treatment that lowers
blood sugar and has the potential to help restore the response of
the body's insulin-producing cells is an exciting advance for
patients with type 2 diabetes," said Dr. David Kendall, Medical
Director at International Diabetes Center in Minneapolis,
Minnesota, and an investigator for the BYETTA clinical studies.
"BYETTA is a truly unique tool for the management of type 2
diabetes and is an appropriate option to consider when patients
cannot control their blood sugar using one or more oral
medications." "Successfully managing diabetes is a daily struggle
for millions of Americans," said Ginger L. Graham, President and
Chief Executive Officer, Amylin Pharmaceuticals, Inc. "Often,
current treatments do not provide adequate blood sugar control
leaving patients and caregivers frustrated. BYETTA, a
first-in-class medicine, is a new therapy for those who are not
able to effectively control their blood sugar with their current
oral medications." "BYETTA offers an exciting new option for people
with type 2 diabetes and marks an important milestone for Amylin
and Lilly's successful collaboration," said Sidney Taurel, Chairman
and Chief Executive Officer, Eli Lilly and Company. "With BYETTA's
demonstrated effects on blood sugar and its safety profile,
physicians and patients now have a new approach to fight the
growing diabetes epidemic." In addition to approving BYETTA for use
as an adjunct to existing oral medicines, the FDA also stated that
BYETTA is approvable as a stand-alone therapy (monotherapy) for
patients with type 2 diabetes. Any additional data submitted to
support a monotherapy indication is expected to receive a six-
month review. BYETTA is formulated for self-administration as a
fixed dose, subcutaneous injection given prior to the morning and
evening meals. BYETTA will be made available in both a 5-microgram
per dose and a 10-microgram per dose prefilled pen-injector device.
Safety and Tolerability Information In the three 30-week controlled
trials, adverse events associated with BYETTA were generally mild
to moderate in intensity. The most frequently reported adverse
event was mild-to-moderate, dose-dependent nausea. With continued
therapy in most patients who initially experienced nausea, the
frequency and severity decreased over time. Patients receiving
BYETTA in combination with a sulfonylurea have an increased risk of
hypoglycemia; to reduce this risk, reduction in the dose of the
sulfonylurea should be considered. In the 30-week controlled
clinical trials, hypoglycemia appeared to be dependent on the doses
of both BYETTA and a sulfonylurea. Most episodes of hypoglycemia
were mild to moderate in intensity and all were resolved with oral
administration of carbohydrate. No increased risk of hypoglycemia
was observed in the 30-week controlled studies with BYETTA when
used in combination with metformin compared to placebo. Patients
should also be advised that treatment with BYETTA may result in a
reduction in appetite, food intake, and/or body weight and that
there is no need to modify the dosing regimen due to such effects.
BYETTA should not be used in patients with type 1 diabetes or for
the treatment of diabetic ketoacidosis, nor is BYETTA a substitute
for insulin in insulin-requiring patients. Use of BYETTA is not
recommended in patients with end-stage renal disease or severe
renal impairment, or in patients with severe gastrointestinal
disease. BYETTA should be used with caution in patients receiving
oral medications that require rapid gastrointestinal absorption.
For full Prescribing Information, visit http://www.byetta.com/ .
About BYETTA BYETTA is the first in a new class of drugs for the
treatment of type 2 diabetes called incretin mimetics and exhibits
many of the same effects as the human incretin hormone
glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to
food intake, has multiple effects on the stomach, liver, pancreas
and brain that work in concert to regulate blood sugar.(1) BYETTA
was approved by the FDA for use by people with type 2 diabetes who
are unsuccessful at controlling their blood sugar levels despite
using the commonly prescribed oral medications metformin, a
sulfonylurea or both. For full Prescribing Information, visit
http://www.byetta.com/ . About Incretin Mimetics Incretin mimetics
is a new class of therapeutics for use in the fight against type 2
diabetes. An incretin mimetic works to mimic the antidiabetic or
glucose-lowering actions of naturally occurring human hormones
called incretins. These actions include stimulating the body's
ability to produce insulin in response to elevated levels of blood
sugar, inhibiting the release of a hormone called glucagon
following meals, slowing the rate at which nutrients are absorbed
into the bloodstream and reducing food intake. BYETTA is the first
FDA-approved agent of this new class of medications. About Diabetes
Diabetes affects an estimated 194 million adults worldwide(2) and
more than 18 million in the United States.(3) Approximately 90 to
95 percent of those affected have type 2 diabetes, a condition
where the body does not produce enough insulin and/or the cells in
the body do not respond normally to insulin.(3) Diabetes is the
fifth leading cause of death by disease in the United States(4) and
costs approximately $132 billion per year in direct and indirect
medical expenses. Type 2 diabetes usually occurs in adults over the
age of 40, but is increasingly common in younger people.(3)
According to the Centers for Disease Control and Prevention's
National Health and Nutrition Examination Survey, approximately 60
percent of diabetes patients do not achieve target hemoglobin A1C
levels (less than 7 percent according to American Diabetes
Association guidelines(5)) with their current treatment regimen.(6)
Amylin to Webcast Investor Conference Call Amylin Pharmaceuticals
will webcast a conference call to discuss the BYETTA approval and
commercialization plans on Friday, April 29, 2005 at 12:00 p.m. ET
(9:00 a.m. PT). Ginger L. Graham, President and Chief Executive
Officer of Amylin Pharmaceuticals, will lead the call. The call
will be webcast live through 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 http://www.amylin.com/
approximately fifteen minutes prior to the call to register,
download and install any necessary audio software. A recording will
be available by phone for 24 hours beginning approximately one hour
after the close of the call and can be accessed at 888-286-8010
(domestic) or 617-801-6888 (international), conference ID number
65243380. About Amylin and Lilly Amylin Pharmaceuticals is a
biopharmaceutical company committed to improving lives through the
discovery, development and commercialization of innovative
medicines. Further information on Amylin Pharmaceuticals, its
marketed products, and its pipeline in metabolism is available at
http://www.amylin.com/ . 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 health care professionals improve the lives of people with
diabetes, and research continues on innovative medicines to address
the unmet needs of patients. For more information about Lilly's
current diabetes products visit http://www.lillydiabetes.com/ .
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/ .
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 may not prove to
be an important new therapeutic option, additional indications for
BYETTA may not be received, BYETTA may not be commercially
available when planned and/or may be affected by unexpected new
data or technical issues. The potential for BYETTA may also be
affected by government and commercial reimbursement and pricing
decisions, the pace of market acceptance and any issues related to
manufacturing and supply. These and additional risks and
uncertainties are described more fully in Amylin and Lilly's most
recently filed SEC documents such as their Annual Reports on Form
10-K. Amylin and Lilly undertake no duty to update these
forward-looking statements. REFERENCES (1) Kolterman, O, Buse J,
Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna
M, Wang Y, Baron A. Synthetic exendin-4 (exenatide) significantly
reduces postprandial and fasting glucose in subjects with type 2
diabetes. Journal of Clinical Endocrinology & Metabolism. 2003;
88(7):3082- 3089. (2) The International Diabetes Federation
Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed April 12, 2005. (3) Centers for Disease Control and
Prevention, National Diabetes Fact Sheet. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf. (4) Kochanek
KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002.
National vital statistics reports; vol 53 no 5. Hyattsville,
Maryland: National Center for Health Statistics. 2004. (5) American
Diabetes Association. Standards of medical care in diabetes.
Diabetes Care 2005;28:S4-36S. (6) Harris MI, Eastman RC, Cowie CC,
Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic
control of adults with type 2 diabetes. Diabetes Care.
1999;22:403-408. P-LLY (Logo:
http://www.newscom.com/cgi-bin/prnh/20050427/LILLYAMYLINLOGO )
http://www.newscom.com/cgi-bin/prnh/20050427/LILLYAMYLINLOGO
DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
CONTACT: Jamaison Schuler of Lilly, +1-317-655-2111; or Eric
Shearin of Amylin, +1-858-552-2200, ext. 7177
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