Myogen (NASDAQ:MYOG)
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Myogen, Inc. (Nasdaq:MYOG) today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track designation
to ambrisentan, the Company's type-A selective endothelin receptor
antagonist (ERA), currently in Phase 3 clinical evaluation for the
treatment of patients with pulmonary arterial hypertension (PAH).
Fast Track programs are designed to facilitate the development and
expedite the review of new drugs that are intended to treat serious or
life-threatening conditions and that demonstrate the potential to
address unmet medical needs.
The FDA designated ambrisentan as a Fast Track product for the
following reasons:
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1. Ambrisentan is intended to treat PAH, a life-threatening,
progressive, and incurable disease of the pulmonary
vasculature.
2. The ambrisentan development program has been designed to
address the unmet medical needs of patients with PAH, by
demonstrating the following:
a. Ambrisentan has the potential for improved effects on
exercise capacity, an efficacy measure that has been
shown to correlate with and be prognostic of long-term
survival.
b. Ambrisentan appears to delay the clinical worsening of
PAH, a progressive and ultimately fatal disease.
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"We are pleased to receive Fast Track designation for
ambrisentan," stated Michael J. Gerber, MD, Senior Vice President of
Clinical Development and Regulatory Affairs for Myogen. "Based on
clinical trial results to date and the properties of ambrisentan,
Myogen believes that, if ambrisentan is ultimately approved, it may
offer significant clinical benefit to PAH patients."
Fast Track regulations are based on the FDA Modernization Act of
1997 (FDAMA) as a formal process to enhance interactions with the FDA
during drug development. A drug with Fast Track designation would be
eligible for consideration for some or all of the following programs
for expediting development and review: scheduled meetings to seek FDA
input into development plans, priority review of the New Drug
Application (NDA) and the option of submitting portions of an NDA
prior to submission of the complete application.
About Pulmonary Arterial Hypertension
PAH is a highly debilitating disease characterized by severe
constriction of the blood vessels in the lungs leading to very high
pulmonary arterial pressures. These high pressures make it difficult
for the heart to pump blood through the lungs to be oxygenated.
Patients with PAH suffer from extreme shortness of breath as the heart
struggles to pump against these high pressures causing such patients
to ultimately die of heart failure. PAH can occur with no known
underlying cause, or it can occur secondary to diseases such as
connective tissue disease, congenital heart defects, cirrhosis of the
liver and HIV infection. PAH afflicts approximately 200,000 patients
worldwide.
About Ambrisentan
Ambrisentan is an investigational drug being developed as a
once-daily oral therapy for patients with PAH and has been granted
orphan drug designation for the treatment of PAH in both the United
States and the European Union.
Ambrisentan is a non-sulfonamide, propanoic acid-class, type-A
selective endothelin receptor antagonist. Endothelin is a small
peptide hormone that plays a critical role in the control of blood
flow and cell growth. Elevated endothelin blood levels are associated
with several cardiovascular disease conditions, including PAH, chronic
renal disease, coronary artery disease, hypertension and chronic heart
failure. The Company believes that agents that block the detrimental
effects of endothelin may provide significant benefits in the
treatment of these conditions.
Myogen has licensed ambrisentan ex-U.S. rights to GlaxoSmithKline.
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 has two
product candidates in late-stage clinical development: ambrisentan for
the treatment of patients with pulmonary arterial hypertension (PAH)
and darusentan for the treatment of patients with resistant
hypertension. The Company 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 www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that
involve significant risks and uncertainties, including summary
statements relating to the profile and potential of ambrisentan.
Actual results could differ materially from those projected and the
Company cautions investors not to place undue reliance on the
forward-looking statements contained in this release.
FDA Fast Track designation does not represent or imply the FDA's
view on the potential approvability of ambrisentan. Results from prior
clinical trials, including the Company's ARIES-2 trial and AMB-222,
are not necessarily predictive of future clinical results, including
results of the ARIES-1 trial of ambrisentan in patients with PAH. If
the Company's product candidates do not meet safety or efficacy
endpoints in clinical evaluations, they will not receive regulatory
approval and the Company will not be able to market them. Even if the
Company's product candidates meet safety and efficacy endpoints,
regulatory authorities may not approve them, the Company may not be
able to successfully market them, or the Company may face
post-approval problems that require the withdrawal of its product from
the market. There can be no assurance that Myogen's product
candidates, including ambrisentan, will be proven safe and effective
for use in humans. Abnormal elevations of liver function test results,
including elevated serum aminotransferase concentrations, have been
reported in trials of other endothelin receptor antagonists. The
Company's results may be affected by its effectiveness at managing its
financial resources, its ability to successfully develop and market
its product candidates, its ability to obtain and enforce patent
protection for its products, competition from other biotechnology and
pharmaceutical companies, difficulties or delays in manufacturing its
products, and regulatory developments involving current and future
products. Delays in initiating or conducting clinical trials, whether
caused by competition, adverse events, patient enrollment rates,
regulatory issues or other factors, could adversely affect the
Company's financial position and prospects. 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.
Additional risks and uncertainties relating to the Company and its
business can be found in the "Risk Factors" section of Myogen's Form
10-K for the year ended December 31, 2004 and Myogen's reports on Form
10-Q and Form 8-K. It is Myogen's policy to only update or reconfirm
its public guidance by issuing a press release or filing a periodic or
current report with the Securities and Exchange Commission. The
Company generally plans to provide guidance as part of its annual and
quarterly earnings releases but reserves the right to provide guidance
at different intervals or to revise its practice in future periods.
All information in this press release is as of March 9, 2006. Myogen
undertakes no duty or obligation to update any forward-looking
statements contained in this release as a result of new information,
future events or changes in the Company's expectations. The Company
also disclaims any duty to comment upon or correct information that
may be contained in reports published by the investment community.