DENVER, Aug. 3 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disorders, today announced that the United States Food and Drug
Administration (FDA) has granted orphan drug designation to ambrisentan for
the treatment of pulmonary arterial hypertension (PAH). Ambrisentan is
currently being evaluated for PAH in two pivotal Phase III trials,
ARIES-1 & -2.
"The FDA's grant of orphan drug designation to ambrisentan for PAH
strengthens our development program by offering regulatory, clinical
development and commercial benefits," said J. William Freytag, Ph.D.,
President and Chief Executive Officer of Myogen.
The U.S. Orphan Drug Act is intended to assist and encourage companies to
develop safe and effective therapies for the treatment of rare diseases and
disorders. Under the Orphan Drug Act, upon marketing authorization, the FDA
does not accept or approve other applications to market the same medicinal
product for the same therapeutic indication for a seven-year period. In
addition to potential market exclusivity, orphan drug designation provides
protocol assistance, advice on the conduct of clinical trials, tax credits for
clinical research expenses, grant funding for research of rare disease
treatments and waiver of the Prescription Drug User Fee Act (PDUFA) filing
fee.
About Ambrisentan
Ambrisentan is a type-A selective endothelin receptor antagonist and
potent inhibitor of endothelin-induced vasoconstriction. Endothelin is a
small peptide hormone that is believed to play a critical role in the control
of blood flow and cell growth. Elevated endothelin blood levels are
associated with several cardiovascular disease conditions, including pulmonary
arterial hypertension, chronic kidney disease, hypertension, chronic heart
failure, stroke and reclosure of coronary arteries after balloon angioplasty
or stent implantation. Therefore, many scientists believe that agents that
block the detrimental effects of endothelin will provide significant benefits
in the treatment of these conditions. Ambrisentan is selective for the ET(A)
receptor versus the ET(B) receptor and demonstrates a half-life that may be
suitable for once a day dosing.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe for the treatment of acute decompensated heart failure and has three
product candidates in late-stage clinical development: enoximone capsules for
the treatment of chronic heart failure, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
hypertension. The Company, in conjunction with Novartis, also conducts a
target and drug discovery research program focused on the development of
disease-modifying drugs for the treatment of chronic heart failure and related
cardiovascular disorders. Please visit Myogen's website at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's Annual
Report on Form 10-K filed on March 1, 2004. Myogen is providing this
information as of the date of this release and does not undertake any
obligation to update any forward-looking statements contained in this document
as a result of new information, future events or otherwise.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. No
forward-looking statement can be guaranteed and actual events and results may
differ materially from those projected. The Company's results may be affected
by its effectiveness at managing its financial resources, its ability to
successfully develop and market current and new products, difficulties or
delays in its clinical trials, difficulties or delays in manufacturing its
products, and regulatory developments involving current and future products.
Delays in clinical trials, whether caused by adverse events, patient
enrollment rates, regulatory issues or other factors, could adversely affect
the Company's financial position and prospects. Results from earlier clinical
trials are not necessarily predictive of future clinical results. Receiving
orphan drug designation does not increase the likelihood of eventual
regulatory approval for a product candidate. Ambrisentan is not registered
for sale for any indication in the United States or abroad. If ambrisentan
does not meet safety and efficacy endpoints in clinical evaluation, it will
not receive regulatory approval. If the Company is unable to raise additional
capital when required or on acceptable terms, it may have to significantly
delay, scale back or discontinue one or more of its drug development or
discovery research programs. Myogen is at an early stage of development and
may not ever have any products that generate significant revenue.
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com, or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen, Inc.
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