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 four abstracts describing the effects of ambrisentan in
patients with pulmonary arterial hypertension (PAH) and healthy
volunteers have been selected for presentation at CHEST 2006, the
scientific assembly of the American College of Chest Physicians (ACCP),
to be held Oct. 21-26, 2006, at the Salt Palace Convention Center in
Salt Lake City, Utah. Myogen expects to submit the ambrisentan New Drug
Application to the U.S. Food and Drug Administration (FDA) in the fourth
quarter of 2006.
Ronald Oudiz, M.D., will present “ARIES-1: A
Placebo-Controlled, Efficacy and Safety Study of Ambrisentan in Patients
with Pulmonary Arterial Hypertension.” This
abstract has been selected for publication in CHEST and for oral
presentation at a session titled “Pulmonary
Vascular: Pulmonary Hypertension,” Convention
Center 255 D, on Tuesday, Oct. 24, 2006, from 10:30 a.m. to 12 p.m.
(Mountain). Dr. Oudiz is Director of Pulmonary Hypertension, Associate
Professor, Department of Medicine, Division of Cardiology, Harbor-UCLA
Medical Center, and was a principal investigator for the ARIES-1 study.
Three additional abstracts have been selected for publication in CHEST
and for poster presentations on Wednesday, Oct. 25, 2006, from 12:30
p.m. to 2 p.m. (Mountain), in the Exhibit Hall.
Michael McGoon, M.D., will present “Ambrisentan
Rescue Therapy in Patients with Pulmonary Arterial Hypertension Who
Discontinued Bosentan or Sitaxsentan Due to Liver Function Abnormalities.”
The results of this study and long-term follow-up will be presented. Dr.
McGoon is Professor of Medicine, Mayo Clinic College of Medicine, and is
a principal investigator for this AMB-222 study.
Michael Gerber, M.D., will present “Ambrisentan
Has No Clinically Relevant Effect on the Pharmacokinetics or
Pharmacodynamics of Warfarin.” Dr. Gerber is
Senior Vice President of Clinical Development and Regulatory Affairs at
Myogen.
Christopher Dufton, Ph.D., will present “Ambrisentan
Has No Clinically Relevant Pharmacokinetic Interaction Between
Ambrisentan and Sildenafil.” Dr. Dufton is
Associate Director of Clinical Science at Myogen.
About Myogen
Myogen has two product candidates in late-stage clinical development:
ambrisentan for the treatment of patients with pulmonary arterial
hypertension (PAH) and darusentan for the treatment of patients with
resistant hypertension. Myogen and GlaxoSmithKline have entered into a
global PAH collaboration in which Myogen has marketing and distribution
rights to GlaxoSmithKline's Flolan®
(epoprostenol sodium) for Injection in the United States and
GlaxoSmithKline has licensed 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 statements relating to
ambrisentan clinical data and expected timing of submission of the
ambrisentan NDA. 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.
Among other things, the results of Myogen's prior clinical trials of its
product candidates, including ambrisentan, do not necessarily predict
the results of future clinical trials. Preliminary results 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 and darusentan 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.
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 periodic reports
on Form 10-Q and Form 8-K. Myogen does not undertake any obligation to
update any forward-looking statements contained in 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.
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 four abstracts describing the effects of ambrisentan in
patients with pulmonary arterial hypertension (PAH) and healthy
volunteers have been selected for presentation at CHEST 2006, the
scientific assembly of the American College of Chest Physicians
(ACCP), to be held Oct. 21-26, 2006, at the Salt Palace Convention
Center in Salt Lake City, Utah. Myogen expects to submit the
ambrisentan New Drug Application to the U.S. Food and Drug
Administration (FDA) in the fourth quarter of 2006.
Ronald Oudiz, M.D., will present "ARIES-1: A Placebo-Controlled,
Efficacy and Safety Study of Ambrisentan in Patients with Pulmonary
Arterial Hypertension." This abstract has been selected for
publication in CHEST and for oral presentation at a session titled
"Pulmonary Vascular: Pulmonary Hypertension," Convention Center 255 D,
on Tuesday, Oct. 24, 2006, from 10:30 a.m. to 12 p.m. (Mountain). Dr.
Oudiz is Director of Pulmonary Hypertension, Associate Professor,
Department of Medicine, Division of Cardiology, Harbor-UCLA Medical
Center, and was a principal investigator for the ARIES-1 study.
Three additional abstracts have been selected for publication in
CHEST and for poster presentations on Wednesday, Oct. 25, 2006, from
12:30 p.m. to 2 p.m. (Mountain), in the Exhibit Hall.
Michael McGoon, M.D., will present "Ambrisentan Rescue Therapy in
Patients with Pulmonary Arterial Hypertension Who Discontinued
Bosentan or Sitaxsentan Due to Liver Function Abnormalities." The
results of this study and long-term follow-up will be presented. Dr.
McGoon is Professor of Medicine, Mayo Clinic College of Medicine, and
is a principal investigator for this AMB-222 study.
Michael Gerber, M.D., will present "Ambrisentan Has No Clinically
Relevant Effect on the Pharmacokinetics or Pharmacodynamics of
Warfarin." Dr. Gerber is Senior Vice President of Clinical Development
and Regulatory Affairs at Myogen.
Christopher Dufton, Ph.D., will present "Ambrisentan Has No
Clinically Relevant Pharmacokinetic Interaction Between Ambrisentan
and Sildenafil." Dr. Dufton is Associate Director of Clinical Science
at Myogen.
About Myogen
Myogen has two product candidates in late-stage clinical
development: ambrisentan for the treatment of patients with pulmonary
arterial hypertension (PAH) and darusentan for the treatment of
patients with resistant hypertension. Myogen and GlaxoSmithKline have
entered into a global PAH collaboration in which Myogen has marketing
and distribution rights to GlaxoSmithKline's Flolan(R) (epoprostenol
sodium) for Injection in the United States and GlaxoSmithKline has
licensed 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 statements
relating to ambrisentan clinical data and expected timing of
submission of the ambrisentan NDA. 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.
Among other things, the results of Myogen's prior clinical trials
of its product candidates, including ambrisentan, do not necessarily
predict the results of future clinical trials. Preliminary results 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 and darusentan 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.
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 periodic
reports on Form 10-Q and Form 8-K. Myogen does not undertake any
obligation to update any forward-looking statements contained in 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.