Conference Call to be Held 9:00 a.m. Eastern, Tuesday, May 24, 2005
DENVER, May 23 /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 presented at ATS 2005 - San Diego, the annual International Conference of
the American Thoracic Society. These abstracts summarize additional results
from the Phase 2 study of ambrisentan in 64 patients with PAH (AMB-220) and
the subsequent open-label long-term 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, were presented.
On Sunday, May 22, 2005, Adaani E. Frost, M.D., presented "Ambrisentan
Improves 6-Minute Walk Distance Comparably for WHO Class II and III PAH
Patients." Dr. Frost is Professor of Medicine at Baylor University and a
principal investigator for AMB-220. This abstract reported on the relative
efficacy observed for ambrisentan following treatment in patients classified
as having WHO Class II symptoms at the start of treatment versus those
classified with WHO Class III symptoms. Of the 64 patients enrolled in the
study, 23 patients had WHO Class II symptoms and 41 patients had WHO Class III
symptoms. The mean baseline six-minute walk distance for these two groups of
patients were substantially different: the patients with Class II symptoms
had a mean six-minute walk distance at baseline of 390 meters and the patients
with Class III symptoms had a mean six-minute walk distance at baseline of
316 meters. The data showed that both patient populations benefited equally
in their improvement in six-minute walk distance at 12 weeks (37.7 meters for
patients with Class II symptoms and 35.2 meters for patients with Class III
symptoms) and at 24 weeks (58.3 meters for patients with Class II symptoms and
51.9 meters for patients with Class III symptoms). There were no
statistically significant differences between the two groups in the change
from baseline at either time point.
Improvements in six-minute walk distance at week 12 and week 24 were
accompanied with sustained or improved levels of dyspnea (or breathlessness)
compared to baseline for both classes. Class III patients had a significant
improvement from baseline in dyspnea following exercise at week 12 and
week 24, while Class II patients maintained a similar level of dyspnea
compared to baseline, even though they were walking substantially further in
the six-minute walk test. The improvements in Borg dyspnea index between the
two groups were significantly greater for the Class III patients at week 24,
but not at week 12.
On Monday, Nazzareno Galie, M.D., presented "Ambrisentan Long-Term Safety
and Efficacy in Pulmonary Arterial Hypertension One Year Follow-Up."
Dr. Galie is Professor of Cardiology at the University of Bologna and a
principal investigator for AMB-220. 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 indicated a survival
benefit to patients treated with ambrisentan when compared to predicted
survival based on the National Institutes of Health Registry formula.
Dr. Galie reported the Phase 2 safety and efficacy results for the first year
of ambrisentan therapy. Fifty-four of the original 64 patients enrolled in
the open-label long-term study, the majority of whom are still receiving
ambrisentan monotherapy today, all with a minimum exposure of at least
2 years. The 48-week analysis reported by Dr. Galie was for all 64 patients,
including patients who discontinued therapy prior to week 48. The mean dose
for these patients was 7.5 mg of ambrisentan once daily, with all patients
being maintained on ambrisentan monotherapy.
At week 48, the mean improvement from baseline in six-minute walk distance
was 54.5 meters; similar to what was observed at week 24 (54.2 meters) and
significantly better than the improvement observed at week 12 (36.1 meters).
There was also a significant and durable benefit observed in the Borg dyspnea
index after exercise, similar to improvement seen at weeks 12 and 24.
During the 48-week period, 57% of patients experienced an improvement in
WHO functional class, while only 5% had a worsening of functional status.
This resulted in 59% of patients being assessed as WHO Class I or II at Week
48; 11% of which were WHO Class I, or asymptomatic. The remainder of the
patients were WHO Class III. No patients worsened to Class IV.
Also of note, the one-year survival observed for 39 patients with
idiopathic PAH was 92% compared to an NIH registry predicted survival of 74%.
One-year survival of the patients with secondary PAH was 95%, although there
is no NIH registry against which to benchmark these results.
The adverse events in these patients observed over the entire 48 weeks of
treatment were comparable to that reported for the first 12 weeks of
treatment, with the majority of the events occurring in the first 12 weeks.
No additional elevations in AST and/or ALT >3xULN were observed during the
first year. There were no alterations in prothrombin time, international
normalized ratio (INR) or warfarin dose.
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 long-term study
titled, "AMB-220-E - An Open-Label, Long-term Study of Ambrisentan in
Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220,"
remains ongoing with a mean ambrisentan exposure of two years.
Conference Call
J. William Freytag, President and CEO, and other members of Myogen's
senior management will discuss the data presentations via webcast and
conference call on Tuesday, May 24, 2005 at 9:00 am Eastern. To access the
live webcast, please log on to the company's website at http://www.myogen.com and go
to the Investor Relations section. Alternatively, callers may participate in
the conference call by dialing 800-240-6709 (domestic) or 303-262-2130
(international). Webcast and telephone replays of the conference call will be
available approximately two hours after the completion of the call through
Friday, June 3, 2005. Callers can access the replay by dialing 800-405-2236
(domestic) or 303-590-3000 (international). The passcode is 11031385#.
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 patients with advanced chronic heart failure,
ambrisentan for the treatment of patients with pulmonary arterial hypertension
and darusentan for the treatment of patients with 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 the statements relating to the
Company's ambrisentan clinical data. Actual results could differ materially
from those projected and Myogen cautions investors not to place undue reliance
on the forward-looking statements contained in this release.
The results of Myogen's prior clinical trials of its product candidates,
including ambrisentan, do not necessarily predict the results of later-stage
clinical trials, including the results of the Company's current ARIES-1 &
ARIES-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. There can be no assurance that Myogen's product
candidates, including ambrisentan, have better safety profiles than competing
products, including a lower incidence of liver toxicity or liver toxicity that
is not dose dependent. Among other things, Myogen's results may be affected
by competition from other pharmaceutical and biotechnology companies, Myogen's
ability to successfully develop and market its current products, difficulties
or delays in its clinical trials, regulatory developments involving current
and future products and its effectiveness at managing its financial resources.
If the Company's product candidates, including ambrisentan, darusentan, and
enoximone, 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 Myogen'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
products from the market. 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 periodic reports on Form 10-Q
and Form 8-K. Myogen is providing the information contained in this release
as of the date of the release and does not undertake any obligation to update
any forward-looking statements as a result of new information, future events
or otherwise.
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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