SAN FRANCISCO, Jan. 10, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) today outlined its strategic
corporate priorities for 2011, highlighting its continued focus on
strong fiscal discipline while maximizing the value of the
Company's diabetes franchise, notably through advancing the
investigational compound BYDUREON™ (exenatide extended-release for
injectable suspension) and other value-driving development
programs. Daniel M. Bradbury,
president and chief executive officer, provided an update on the
Company's strategy at the 29th Annual JPMorgan Healthcare
Conference in San Francisco.
"With evidence mounting daily about the incredible toll of the
diabetes epidemic, we continue to work with a great sense of
urgency to meet the needs of patients and secure approval for
BYDUREON, which we believe is a potential game changer for the way
people with type 2 diabetes manage their disease," said Bradbury.
"In 2011, we will continue to pursue operating efficiencies within
our business that will enable us to invest strategically in
BYDUREON and other value-creating opportunities, including
late-stage programs in obesity and lipodystrophy."
2011 Corporate Priorities
During his presentation, Bradbury highlighted the key corporate
priorities for the year ahead, including:
- Maximize the value of Amylin's established diabetes
franchise. Expand the use of BYETTA® (exenatide) injection, and
develop the value of SYMLIN® (pramlintide acetate) injection;
- Advance Amylin's metabolic pipeline. Key areas of focus
will include:
- Submit the reply to the U.S. Food and Drug Administration (FDA)
regarding the second complete response letter for BYDUREON by the
end of 2011;
- Advance new forms and delivery options for exenatide;
- Submit the remaining component of the rolling Biologics License
Application (BLA) for metreleptin to treat rare forms of
lipodystrophy;
- Advance the obesity program, in partnership with Takeda;
and
- Submit the Investigational New Drug (IND) application and
initiate the first clinical study of AC165198, a new fusion
peptide, under the Company's collaboration with Biocon;
- Manage expenses in line with expected revenue. The
Company will continue to drive efficiencies to further build
operating leverage and preserve cash to invest in high-value
opportunities.
A recording of the presentation is accessible through the
"Investors" section of Amylin's corporate website, located at
www.amylin.com.
About Amylin Pharmaceuticals, Inc.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN®(pramlintide acetate) injection and BYETTA® (exenatide)
injection. 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, California. Further
information on Amylin Pharmaceuticals is available at
www.amylin.com.
This press release contains forward-looking statements about
Amylin, which involve risks and uncertainties. Our actual results
could differ materially from those discussed herein due to a number
of risks and uncertainties, including risks that BYETTA or SYMLIN,
and the revenues generated from these products, may be affected by
competition, unexpected new data, safety and technical issues, or
manufacturing and supply issues; risks that our financial results
may fluctuate significantly from period to period and may not meet
market expectations; risks that any financial guidance we provide
may not be accurate; risks that our clinical trials will not be
completed when planned, may not replicate previous results, may not
be predictive of real world use or may not achieve desired
end-points; risks that our preclinical studies may not be
predictive; risks that our NDAs for product candidates, such as the
BYDUREON NDA, or sNDAs for label expansion requests may not be
submitted timely or receive FDA approval; risks that our
response to the FDA's BYDUREON complete response letter may not be
submitted in a timely manner and/or the information we provide in
our response may not satisfy the FDA; risks that the FDA may
request additional information prior to approving BYDUREON; risks
that we will not be successful in our efforts to advance new forms
and delivery options for exenatide; risks that we will not submit
the remaining components of the BLA mentioned in this press release
in a timely manner; risks that we will not submit the IND or
initiate the clinical study mentioned in this press release for
AC165198 in a timely manner; risks that our efforts to drive
operational efficiencies and preserve cash will not produce the
results we expect and other risks inherent in the drug development
and commercialization process. Commercial and government
reimbursement and pricing decisions and the pace of market
acceptance may also affect the potential for BYETTA or SYMLIN.
These and additional risks and uncertainties are described more
fully in the Company's recently filed Form 10-Q.
Amylin disclaims any obligation to update these
forward-looking statements.
SOURCE Amylin Pharmaceuticals, Inc.