|
|
 |
|
Date: April
29, 2005
For Immediate Release in the United States
Media contacts: Lilly – Jamaison Schuler
(317) 655-2111
Amylin – Eric Shearin
(858) 552-2200 x7177
|
 |
Amylin and Lilly Announce FDA Approval of BYETTA™ (exenatide)
injection
--A New First-in-Class Treatment for Patients with Type 2 Diabetes--
San Diego, CA and Indianapolis, IN – April 29, 2005 – 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 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 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 States4 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
guidelines5) 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 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 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 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 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.
|
 |
   |
Exenatide Once Weekly Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study |
   |
Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection |
   |
Additional diabetes links |
   |
Additional diabetes links |
   |
American Diabetes Association |
   |
American Diabetes Association |
   |
European Association for the Study of Diabetes |
   |
European Association for the Study of Diabetes |
   |
International Diabetes Federation |
   |
International Diabetes Federation |
|