SAN DIEGO, Feb. 29, 2012 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that it is
participating in the fifth annual international Rare Disease Day to
demonstrate the Company's support for patients and families who are
impacted by rare diseases. Celebrated around the world today, Rare
Disease Day aims to raise awareness of the more than 7,000 known
rare diseases and the effects of these diseases on patients' lives,
and to provide a platform of unity for rare disease patient
communities.
(Logo:
http://photos.prnewswire.com/prnh/20101020/LA85062LOGO-a)
In the U.S., a disease is considered rare, or orphan, if it
affects fewer than 200,000 individuals. According to the
National Institutes of Health Office of Rare Diseases Research, an
estimated 25 to 30 million people in the U.S. have a rare disease.
Most rare diseases have limited or no associated treatment options
– and, to date, there are no known cures for these diseases.
"We are honored to participate in activities to draw heightened
attention to rare diseases and the critical need to drive research
to better understand these diseases and develop effective therapies
for patients," said Daniel M.
Bradbury, president and chief executive officer of Amylin
Pharmaceuticals. "At Amylin, we are proud to be advancing the
development of a potential therapy for rare forms of lipodystrophy,
an 'ultra-orphan' disease. We believe all patients – whether they
are impacted by one of the world's most prevalent diseases, like
type 2 diabetes, or one of the rarest – deserve better treatment
options."
Amylin launches disease awareness website –
mylipodystrophy.com
To coincide with Rare Disease Day, Amylin also announced today
the launch of mylipodystrophy.com, a disease awareness website that
is dedicated to rare forms of lipodystrophy, and serves as a
resource for information about the disease for patients, caregivers
and healthcare providers.
People with lipodystrophy lack fat tissue. This can be partial,
affecting select areas of the body, or generalized, affecting the
entire body. The physical appearance of people with lipodystrophy
can therefore vary considerably. Fat tissue is a major endocrine
organ producing important metabolic hormones such as leptin. A lack
of functioning fat tissue can lead to relative deficiency of
leptin. Without adequate leptin function, the metabolic
system, which regulates food intake, energy storage, and energy
production, falls out of balance. Fat accumulates in the blood or
organs, which can lead to life-threatening complications including
insulin-resistant diabetes, hypertriglyceridemia, acute
pancreatitis and hepatic steatosis or steatohepatitis, also known
as fatty liver disease. There are no approved drugs to adequately
treat the metabolic abnormalities that occur in lipodystrophy.
To help raise public awareness of rare diseases, Amylin is also
featuring a Rare Disease Day series on its corporate blog, Building
Blocks, available at www.amylinbuildingblocks.com. This series
includes contributions from several experts in the rare disease
field describing efforts underway to understand and combat rare
diseases, as well as initiatives that are providing support for
patient communities. Amylin is also participating in the Global
Genes Project's "Wear that you Care™" denim campaign, encouraging
its employees to wear jeans to work today to show support for the
rare disease cause.
Amylin is developing metreleptin as a potential treatment option
for diabetes and/or hypertriglyceridemia in pediatric and adult
patients with rare forms of lipodystrophy. The Company plans to
complete the rolling Biologics License Application (BLA) submission
to the U.S. Food and Drug Administration (FDA) in the first half of
this year.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to
improving lives of patients through the discovery, development and
commercialization of innovative medicines. Amylin is committed to
delivering novel therapies that transform the way diabetes and
other metabolic disorders are treated. Amylin is headquartered in
San Diego, Calif. and has a
commercial manufacturing facility in
Ohio. More information about 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 metreleptin as a potential
treatment option for diabetes and/or hypertriglyceridemia in
pediatric and adult patients with rare forms of lipodystrophy will
not be approved by the FDA; 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 or sNDAs for
label expansion requests may not be submitted timely or receive FDA
approval; risks that we will not submit the remaining components of
the BLA mentioned in this press release in a timely manner; and
other risks inherent in the drug development and commercialization
process. These and additional risks and uncertainties are described
more fully in the Company's recently filed Form 10-K. Amylin
disclaims any obligation to update these forward-looking
statements.
SOURCE Amylin Pharmaceuticals, Inc.