Myogen (NASDAQ:MYOG)
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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 a scientific presentation describing the effects
of ambrisentan in patients with pulmonary arterial hypertension (PAH)
was given at ATS 2006 -- San Diego, the annual International
Conference of the American Thoracic Society.
The oral presentation highlighted efficacy and safety results from
ARIES-2, the Phase 3 trial of ambrisentan in 192 patients with PAH.
The data demonstrate that ambrisentan improved exercise capacity,
delayed clinical worsening and improved symptoms in patients with PAH.
Ambrisentan was well tolerated and was not associated with any
clinically significant serum aminotransferase abnormalities or
drug-drug interactions with warfarin-type anticoagulants. Myogen
reported the top line results of the trial in December 2005.
Horst Olschewski, M.D., presented "Ambrisentan Improves Exercise
Capacity and Time to Clinical Worsening in Patients with Pulmonary
Arterial Hypertension: Results of the ARIES-2 Study." Dr. Olschewski
is Professor of Medicine, Division of Pulmonology, Medical University
Graz, Austria and a principal investigator for ARIES-2.
Patients in this trial were primarily women (75%). The etiology of
the PAH was 65% idiopathic and 35% associated with other causes.
Patients entered the trial in World Health Organization (WHO)
Functional Class I/II (47%) and Class III/IV (53%). The patients were
enrolled from Western Europe/Israel (52%), Eastern Europe (24%) and
South America (24%). Mean six-minute walk distance (6MWD) at baseline
was 348 meters +/- 84 meters.
The primary efficacy endpoint of the ARIES-2 trial was the
placebo-corrected mean change in 6MWD at week 12 compared to baseline.
Results of the trial demonstrated that with once-daily dosing, 5 mg of
ambrisentan improved the placebo-corrected mean 6MWD by 59.4 meters (p
= 0.0002) and 2.5 mg of ambrisentan improved the placebo-corrected
mean 6MWD by 32.3 meters (p = 0.0219). For the placebo group, the mean
6MWD at week 12 decreased from baseline by 10.1 meters.
Improvements in time to clinical worsening compared to placebo
were observed for both the 5 mg dose group (p=0.0076) and the 2.5 mg
dose group (p=0.0048). Improvements in Borg dyspnea index compared to
placebo were observed for both the 5 mg dose group (p = 0.0384) and
the 2.5 mg dose group (p=0.0367). Improvements in SF-36 Health
Survey(R) compared to placebo were observed for both the 5 mg dose
group (p=0.040) and the 2.5 mg dose group (p=0.005). The pre-specified
analysis of WHO functional class did not reach statistical
significance; however, deterioration of at least one class was
observed in 18% of placebo patients, compared to 5% of patients in the
2.5 mg ambrisentan dose group and 3% of patients in the 5 mg
ambrisentan dose group.
The trial safety results demonstrated ambrisentan was well
tolerated. The most frequent adverse event was headache, which
occurred in 12.7% of patients in the 5 mg dose group and 7.8% in the
2.5 mg dose group, compared to 6.2% in the placebo group. There were
four deaths in the placebo arm compared to two deaths (unrelated to
drug) in the 2.5 mg ambrisentan dose group and none in the 5 mg
ambrisentan dose group. Ambrisentan had no apparent effect on the
activity or dosage of warfarin-type anticoagulants commonly prescribed
for patients with PAH.
No patients treated with ambrisentan developed serum
aminotransferase concentrations greater than three-times the upper
limit of the normal range (3xULN), compared to one patient (1.5%) in
the placebo group. As of May 2006, patients in the long-term follow-up
study have a maximum drug exposure of 2.4 years and a mean drug
exposure of one year. During this long-term treatment, the incidence
of serum aminotransferase concentrations greater than 3xULN was less
than 2% (0.6% confirmed upon re-test).
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 has two
product candidates in late-stage clinical development: ambrisentan for
the treatment of patients with pulmonary arterial hypertension and
darusentan for the treatment of patients with resistant hypertension.
Myogen and GlaxoSmithKline have entered into a global PAH
collaboration in which Myogen has distribution and marketing rights to
GlaxoSmithKline's Flolan (epoprostenol sodium) in the United States
and GlaxoSmithKline has sublicensed ambrisentan from Myogen for all
territories outside of the United States, where Myogen retains
exclusive rights. Myogen 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 www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that
involve significant risks and uncertainties, including summary
statements relating to the results of the Company's ARIES-2 clinical
trial. Actual results could differ materially from those projected and
the Company cautions investors not to place undue reliance on the
forward-looking statements contained in this release.
Results from clinical trials, including the Company's ARIES-2
trial, are not necessarily predictive of future clinical results. Top
line results may not be confirmed upon full analysis of the detailed
results of a trial and additional information relating to the safety,
efficacy or tolerability of the Company's product candidates,
including ambrisentan, may be discovered upon further analysis of
trial data and upon review and analysis of additional trial data,
including data from the Company's ARIES-1 clinical trial and ARIES
long-term study. If the Company's product candidates do not meet
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, the
Company may not be able to successfully market them, or the Company
may face post-approval problems that require the withdrawal of its
product from the market. The Company's results may be affected by its
effectiveness at managing its financial resources, its ability to
successfully develop and market its product candidates, its ability to
obtain and enforce patent protection for its products, competition
from other biotechnology and pharmaceutical companies, difficulties or
delays in manufacturing its products, and regulatory developments
involving current and future products. Delays in initiating or
conducting 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.
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 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, 2005 and Myogen's reports on Form
10-Q and Form 8-K. It is Myogen's policy to only update or reconfirm
its public guidance by issuing a press release or filing a periodic or
current report with the Securities and Exchange Commission. All
information in this press release is as of May 24, 2006. Myogen
undertakes no duty or obligation to update any forward-looking
statements contained in this release as a result of new information,
future events or changes in the Company's expectations.