DENVER, Feb. 10 /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 two abstracts describing the
effects of ambrisentan in patients with pulmonary arterial hypertension (PAH)
were selected for presentation at ATS 2005 - San Diego, the annual
International Conference of the American Thoracic Society.
These abstracts summarize additional results from the Phase II study of
ambrisentan in 64 patients with PAH (AMB-220) and the subsequent open-label
extension study (AMB-220-E). One-year follow-up safety and efficacy results,
as well as comparable effects of ambrisentan in WHO functional Class II and
Class III PAH patients, will be presented. The one-year data demonstrate that
ambrisentan produced a significant and durable benefit on exercise capacity
and other clinical measures of PAH. These data also indicate a survival
benefit to patients treated with ambrisentan when compared with predicted
survival based on the National Institutes of Health Registry formula. Data
from the second abstract demonstrate that WHO Class II and III PAH patients
have significant and comparable improvement in exercise capacity, which
suggests that the effects of ambrisentan are not limited by a "ceiling effect"
in patients with less severe PAH symptoms.
Nazzareno Galie, M.D., will present "Ambrisentan Long-Term Safety and
Efficacy in Pulmonary Arterial Hypertension One Year Follow-Up." This
abstract has been selected for an oral presentation at a Mini Symposium
Session, B16, "Advances in the Management of Pulmonary Arterial Hypertension
(Jack Reeves Memorial Symposium)," Monday, May 23, 2005, between 8:15 a.m. and
11:00 a.m. (Pacific). Dr. Galie is Professor of Cardiology at the University
of Bologna and a principal investigator for AMB-220.
Adaani E. Frost, M.D., will present "Ambrisentan Improves 6-Minute Walk
Distance Comparably for WHO Class II and III PAH Patients." This abstract has
been selected for poster presentation at a Thematic Poster Session, A57,
"Pulmonary Hypertension: Clinical," Sunday, May 22, 2005, between 8:15 a.m.
and 4:15 p.m. Dr. Frost is Professor of Medicine at Baylor University and a
principal investigator for AMB-220.
ATS 2005 - San Diego, the annual International Conference of the American
Thoracic Society will be held May 20-25, 2005 at the San Diego Convention
Center in San Diego, California. Additional conference information is
available at http://conference.thoracic.org/ic/ic2005.
Myogen completed "AMB-220 - A Phase II, Randomized, Double-Blind,
Dose-Controlled, Dose-Ranging, Multicenter Study of Ambrisentan Evaluating
Exercise Capacity in Patients with Moderate to Severe Pulmonary Arterial
Hypertension" in September 2003 and the initial study results were presented
at ATS 2004 - Orlando in May 2004. This study demonstrated a statistically
significant increase in the primary efficacy endpoint, change from baseline in
the 6-minute walk distance after 12 weeks of treatment, for all dose groups
evaluated. Clinically meaningful improvements were observed in several
secondary endpoints, including dyspnea (breathlessness) score, WHO functional
class and cardiopulmonary hemodynamics. The subsequent open-label extension
study titled, "AMB-220-E - An Open-Label, Long-term Study of Ambrisentan in
Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220,"
remains on going with a mean ambrisentan exposure of nearly two years.
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 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 statements
relating to the company's ambrisentan clinical data. No forward-looking
statement can be guaranteed and actual events and results may differ
materially from those projected. Data from earlier ambrisentan clinical
trials are not necessarily predictive of future clinical results, including
the results of the company's current ARIES 1 & 2 clinical trials. Results of
the company's current and former ambrisentan clinical trials 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 clinical trials and 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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