DENVER, Feb. 2 /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 updated its guidance for the ambrisentan
clinical development program.
In January 2004, Myogen announced the initiation of patient enrollment in
ARIES 1 & 2, the two 186-patient pivotal Phase III trials evaluating
ambrisentan in pulmonary arterial hypertension (PAH). ARIES-1 is currently
being conducted in North America and Australia. ARIES-2 is being conducted in
Western and Eastern Europe, Israel and South America. The company's initial
goal was to complete patient enrollment in both trials by the end of the first
half of 2005. ARIES-2 continues to progress in line with prior guidance and
is expected to complete enrollment by the end of June 2005. However, based on
recent enrollment in ARIES-1, the company now expects enrollment in this trial
will be completed in the fourth quarter of 2005. The company expects to
report preliminary results of each trial approximately six months following
completion of patient enrollment.
The company believes enrollment in ARIES-1 has been affected by a number
of factors, including a decline in the availability of treatment naive PAH
patients due to increasing market penetration of bosentan as well as the
expanded use of sildenafil following the release of clinical data in October
2004. Additionally, other clinical trials are competing for this group of
patients.
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 advanced chronic
heart failure, ambrisentan for the treatment of pulmonary arterial
hypertension and darusentan for the treatment of resistant hypertension. The
company, in collaboration 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 Form
10-K for the year ended December 31, 2003, Myogen's Form S-3 filed on October
29, 2004 and in Myogen's periodic reports on Form 10-Q and Form 8-K. 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 release as a result of new information, future events or otherwise.
Myogen cautions investors not to place undue reliance on the
forward-looking statements contained in this release, including projected
ambrisentan enrollment timeframes. There is significant competition for
patients in PAH clinical trials due to the limited number of leading
specialist physicians and the geographic concentration of major clinical
centers. A number of factors may decrease the rate of enrollment in our Phase
III trials of ambrisentan in PAH from what we have projected. These factors
include the inclusion of placebo control groups, which may decrease the rate
of enrollment compared to our Phase II trial; competing trials being conducted
by Encysive Pharmaceuticals Inc. of sitaxsentan in substantially similar PAH
patient populations; the expected Phase IV trial of Tracleer in PAH patients
with Class II symptoms to be conducted by Actelion Ltd; and the continued or
increased off-label prescription of sildenafil (Viagra) in patients with PAH
based on the results of a Phase III trial conducted by Pfizer and reported at
the annual conference of the American College of Chest Physicians in October
2004.
No forward-looking statement can be guaranteed and actual events and
results may differ materially from those projected. Delays in 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. Results from earlier clinical
trials are not necessarily predictive of future clinical results. Preliminary
results may not be confirmed upon full analysis of the detailed results of a
trial. If the company's product candidates, including ambrisentan, do not
meet the 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, or the company may face
post-approval problems that require the withdrawal of its product from the
market. In addition, the company's results may be affected by its ability to
successfully develop and market current and new products (including
ambrisentan), difficulties or delays in manufacturing the company's products,
the company's effectiveness at managing its financial resources, and
regulatory developments involving current and future products. 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. The company 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
of Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
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