Company to Present at UBS Global Life Sciences Conference on Tuesday,
September 28, 2004
DENVER, Sept. 28 /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 disease, today updated its clinical development and financial
guidance.
ESSENTIAL I & II, the pivotal Phase III trials evaluating enoximone
capsules in patients with chronic heart failure, continue to progress in line
with expectations. In May, the Company announced the completion of enrollment
of 1,800 patients for the two trials, with patient treatment to continue until
956 patients have had a primary endpoint event (cardiovascular hospitalization
or all-cause mortality). The Company expects that the common termination date
for both trials will occur by the end of this year. At that time, the mean
treatment period will exceed 18 months. The Company expects to report
preliminary top-line results mid-year 2005.
In January 2004, Myogen announced the initiation of patient enrollment in
ARIES 1 & 2, the pivotal Phase III trials evaluating ambrisentan in pulmonary
arterial hypertension. The Company reiterates its goal of completing patient
enrollment in the ARIES trials by the end of the first half of 2005. The
Company announced in August 2004 that it was adding additional resources to
aid enrollment in the trials. Early indications suggest that the Company's
initiatives to accelerate enrollment to meet this target are having a positive
effect, although several additional months will be required to draw definitive
conclusions on the degree of impact. In addition, the Company expects to
report preliminary results of the trials approximately six months following
the completion of patient enrollment.
In July 2004, the Company announced the initiation of patient enrollment
in a Phase IIb clinical trial designed to evaluate the safety and efficacy of
darusentan in patients with resistant systolic hypertension. Enrollment in
the 105 patient trial is progressing in line with expectations. The Company
currently expects the trial to be completed mid-year 2005.
On September 27, 2004, the Company announced that it has entered into
definitive purchase agreements for a $60 million private placement of newly
issued shares of common stock and the concurrent issuance of warrants for the
purchase of additional shares of common stock to institutional and accredited
investors. Based on current spending projections, the Company believes its
cash, cash equivalents, investments and the net proceeds from this private
financing will be sufficient to fund operations through the end of 2005.
The Company also announced that J. William Freytag, President and CEO,
will present a corporate overview at the UBS Global Life Sciences Conference.
The presentation will take place at 4:00 p.m. (Eastern) on Tuesday, September
28, 2004. There will be a live webcast of the presentation from the
conference. The webcast will be accessible through a link posted on the
investor relations section of the Myogen website at
http://investor.myogen.com/. The webcast will be available for replay on
Myogen's website through October 15, 2004.
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 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 and the anticipated presentation contain
forward-looking statements that involve significant risks and uncertainties,
including those discussed in this release, those to be discussed in the
presentation and others that can be found in the "Risk Factors" section of
Myogen's Form 10-K for the year ended December 31, 2003 and in Myogen's
periodic reports on Form 10-Q and Form 8-K. Myogen does not undertake any
obligation to update any forward-looking statements contained in this document
or the anticipated presentation 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 or the
presentation. No forward-looking statement can be guaranteed and actual
events and results may differ materially from those projected.
Financial projections entail a high level of uncertainty due, among many
factors, to the variability involved in predicting clinical trial enrollment
rates, availability, terms and timing of additional financing transactions and
the potential for Myogen to enter into additional licensing or strategic
collaborations. Myogen is at an early stage of development and may not ever
have any products that generate significant revenue. 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.
The Company plans on updating financial guidance for 2004 when it releases
results for each quarter or upon the announcement of material corporate
events.
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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