DENVER, Sept. 8 /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 Arthur M. Feldman, M.D., Ph.D.,
will present detailed results of EMOTE, the non-pivotal Phase III study of
enoximone capsules in chronic heart failure ("CHF"), at the 8th Annual
Scientific Meeting of the Heart Failure Society of America ("HFSA"). Myogen
previously disclosed preliminary results of the study in March 2004. Dr.
Feldman's abstract has been selected for presentation at the "Late Breaking
Clinical Trials" session, Wednesday, September 15, 2004, at 8:30 a.m.
(Eastern). Dr. Feldman is Magee Professor and Chair of the Department of
Medicine at Jefferson Medical College of Thomas Jefferson University and the
principal investigator for EMOTE.
The 8th Annual Scientific Meeting of the HFSA will be held Sunday,
September 12, through Wednesday, September 15, 2004 at the Metro Toronto
Convention Centre (North Building) in Toronto, Ontario, Canada. Additional
conference information is available at http://www.hfsa.org/annual_meeting.asp.
EMOTE is a non-pivotal Phase III trial of enoximone capsules in 201
patients in the most advanced stage of CHF who are dependent on intravenous
(i.v.) inotrope therapy. The study was designed to evaluate the effectiveness
of enoximone capsules to wean patients off of i.v. inotrope therapy.
ESSENTIAL I & II, the Company's two pivotal Phase III trials of enoximone
capsules in patients with CHF, completed enrollment of over 1,800 patients in
May 2004. The trials will continue until there have been a total of 956
primary endpoint events (cardiovascular hospitalization or all-cause
mortality). The Company expects that the specified number of events will have
occurred by the end of this year.
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
systolic 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 our 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. 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,
Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
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