Exenatide New Drug Application Accepted for Review by the FDA
September 01 2004 - 8:30AM
PR Newswire (US)
Exenatide New Drug Application Accepted for Review by the FDA SAN
DIEGO, and INDIANAPOLIS, Sept. 1 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc., (NASDAQ:AMLN) and Eli Lilly and Company
(NYSE:LLY) today announced that the New Drug Application (NDA) for
exenatide has been accepted for review by the Food and Drug
Administration (FDA). Exenatide is the first potential therapy in a
new class of drugs under investigation for the treatment of type 2
diabetes known as incretin mimetics. The NDA for exenatide was
submitted to the FDA on June 29, 2004. The Prescription Drug User
Fee Act (PDUFA) goal date is April 30, 2005. "This is an important
step in the regulatory process as we work to transition exenatide
from an investigational agent to the marketplace, providing an
additional therapy to people living with type 2 diabetes," said
Ginger Graham, President and CEO of Amylin Pharmaceuticals. The
exenatide NDA is made up of three major components; chemistry and
manufacturing, preclinical and clinical. The clinical component of
the submission is based on 30-week data from three blinded pivotal
trials of exenatide involving more than 1,400 patients who were
unable to control their blood sugar on common oral therapies
including metformin, sulfonylurea or a combination of both. The
submission also includes 52-week open-label data from the
extensions of these pivotal studies and from an additional
open-label study. About Diabetes Diabetes affects an estimated 194
million adults worldwide(1) and more than 18 million in the United
States.(2) Approximately 90-95 percent of those affected have type
2 diabetes, in which the body does not produce enough insulin and
the cells in the body do not respond normally to the insulin.
According to the US Center for Disease Control and Prevention's
National Health and Nutrition Examination Survey, approximately 60
percent of diabetes patients do not achieve target A1C levels with
their current treatment regimen. According to the ADA, patients
with A1Cs above target are more likely to develop diabetes-related
complications, such as kidney disease, blindness and heart
disease.(3) About Amylin and Lilly Amylin Pharmaceuticals is
committed to improving the lives of people with diabetes and other
metabolic diseases through the discovery, development and
commercialization of innovative, cost-effective 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, which involve risks and uncertainties. Actual results
could differ materially from those discussed or implied in this
press release, including risks that the FDA may request additional
information or data regarding exenatide, risks that exenatide may
not receive FDA approval or that such approval may be delayed or
limited, or risks that exenatide may not prove to be commercially
successful. These and additional risks and uncertainties are
described more fully in Lilly and Amylin's most recently filed SEC
documents, such as their annual reports on Form 10-K for the fiscal
year ended December 31, 2003 under the heading "Risk Factors
Related to Our Business", their subsequently filed Quarterly
Reports on Form 10-Q, and Amylin's recently filed Form S-3. (1) The
International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
87B73F80BC22682A. Accessed August 31, 2004. (2) American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed August 31,
2004. (3) Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson
TJ, Narayan KM. A diabetes report card for the United States:
Quality of care in the 1990s. Ann Intern Med. 2002; 136:565-574.
DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
CONTACT: Eric Shearin of Amylin Pharmaceuticals, Inc.,
+1-858-552-2200; or Jamaison Schuler of Eli Lilly and Company,
+1-317-917-3313 Web site: http://www.amylin.com/
http://www.lillydiabetes.com/ http://www.lilly.com/
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