Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now Available
June 09 2005 - 9:00AM
PR Newswire (US)
Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now
Available -- Amylin and Lilly Launch BYETTA(TM) (exenatide)
injection for type 2 diabetes patients unable to control disease
with common oral therapies -- SAN DIEGO, and INDIANAPOLIS, June 9
/PRNewswire-FirstCall/ -- BYETTA(TM) (exenatide) injection is now
available for Americans struggling to control their type 2
diabetes. BYETTA can help diabetes patients manage blood sugar
while potentially losing weight. Recently approved by the Food and
Drug Administration (FDA), BYETTA is now available in pharmacies
across the country. Developed by Amylin Pharmaceuticals, Inc.,
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY), BYETTA
(pronounced bye-A-tuh) is available as an 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 is the
first in a new class of diabetes treatment called incretin
mimetics. By mimicking the mechanisms of a naturally occurring
human hormone, BYETTA is a diabetes self regulating drug that stays
in the blood system, working actively only when blood sugar levels
are too high. In clinical trials, BYETTA was shown to help patients
regulate blood sugar levels. Most patients in the long-term BYETTA
clinical studies also experienced reductions in weight. "For a
disease where more than two-thirds of the patients aren't achieving
their target blood sugar levels, the availability of BYETTA is a
remarkable advancement for the diabetes medical community. BYETTA
addresses a core defect of type 2 diabetes, where the body fails to
respond normally to food intake, causing blood sugar levels to rise
and fluctuate in an unhealthy manner," said Dr. Carol Wysham,
Clinical Endocrinologist at Rockwood Clinic in Spokane, Washington
and Clinical Assistant Professor of Medicine at University of
Washington. Three different studies published since 2002
demonstrate the public health burden of diabetes and the challenge
patients face while trying to achieve adequate blood sugar control.
These studies, published by the American Association of Clinical
Endocrinologists, the Journal of the American Medical Association
and the American Diabetes Association (ADA), show that nearly two-
thirds of the 13 million Americans diagnosed with and being treated
for diabetes are still not achieving target blood glucose levels
recommended by ADA. This collective data further substantiates the
urgent need for new treatment options. "With BYETTA I feel in
charge, no longer having to revolve everything around when and what
I eat. Not only is my blood sugar under control, but BYETTA has
helped me lose weight," said David Anderson, a participant in the
clinical trials. Continuing Amylin's success in innovative
therapies and Lilly's leadership in diabetes care, BYETTA offers a
promising new approach to type 2 diabetes patients who, despite the
number of treatment options available, are still unable to
adequately manage the disease. BYETTA is formulated for easy
self-administration as a fixed dose injection given before meals in
the morning and in the evening, and is available in pharmacies
across the country in both a 5 microgram and a 10 microgram
pre-filled pen. Safety and Tolerability Adverse events associated
with BYETTA are generally mild to moderate in intensity. In
clinical trials, the most frequently reported adverse event was
mild-to-moderate, dose-dependent nausea. With continued therapy,
the frequency and severity of nausea decreased over time in most
patients. Patients receiving BYETTA in combination with a
sulfonylurea may be at a higher risk of hypoglycemia, or low blood
sugar. To reduce this risk, lowering the sulfonylurea dosage may be
considered. When patients begin taking BYETTA, the symptoms,
treatment, and conditions that predispose development of
hypoglycemia should be explained to them, and the patient's usual
instructions for hypoglycemia management should be reviewed and
reinforced. Patients should also be advised that treatment with
BYETTA may lead to 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 is not a substitute for insulin in
insulin-requiring patients. BYETTA should not be used in patients
with type 1 diabetes. 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 complete safety
profile and other important prescribing considerations, 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 intestine,
liver, pancreas and brain that work in concert to improve 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 agents in the fight against
diabetes. An incretin mimetic works to mimic the anti-diabetic 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 90-95 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. Diabetes
is the fifth leading cause of death by disease in the United States
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.
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 A1C levels (less
than 7.0% according to American Diabetes Association guidelines)
with their current treatment regimen. 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 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 and BYETTA 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. P-LLY (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) Center for Disease Control and
Prevention (CDC) National Diabetes Fact Sheet 2005. Available at
http://www.cdc.gov/nccdphp/aag/pdf/aag_ddt2005.pdf. Accessed June
6, 2005. (Logo:
http://www.newscom.com/cgi-bin/prnh/20050609/DETH001
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )
http://www.newscom.com/cgi-bin/prnh/20050609/DETH001
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO
DATASOURCE: Eli Lilly and Company; Amylin Pharmaceuticals, Inc.
CONTACT: Jamaison Schuler of Eli Lilly and Company,
+1-317-655-2111, cell: +1-317-457-2113; or Eric Shearin of Amylin
Pharmaceuticals, Inc., +1-858-552-2200, ext. 7177, cell:
+1-858-699-5514
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