Ambrisentan Receives FDA Fast Track Designation for PAH Development
09 Mars 2006 - 2:00PM
Business Wire
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: -0- *T 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. *T "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.
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