DENVER, May 2 /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 the Commission of the European
Communities, with a favorable opinion of the Committee for Orphan Medicinal
Products of the European Medicines Agency (EMEA), has granted orphan drug
designation to ambrisentan for the treatment of pulmonary arterial
hypertension (PAH) and chronic thromboembolic pulmonary hypertension. In
August 2004, Myogen announced that the United States Food and Drug
Administration (FDA) granted orphan drug designation to ambrisentan for the
treatment of PAH. Myogen is currently evaluating ambrisentan for the
treatment of patients with PAH in two pivotal Phase 3 trials, ARIES-1 & -2.
Regulation (EC) No 141/2000 of the European Parliament and of the Council
of the European Union of 16 December 1999 on orphan medicinal products is
intended to introduce incentives for research, development and marketing of
medicinal products for the prevention, diagnosis and cure of rare diseases and
disorders, in particular by granting exclusive marketing rights for a ten-year
period. Orphan medicinal products have access to protocol assistance and the
"centralized" marketing procedure. The sponsor of an orphan medicinal product
can be exempted from payment of the fees payable to the EMEA. Marketing
exclusivity does not prevent the marketing of similar medicinal products if
the holder of the marketing authorization of the original orphan product gives
consent to the other applicants or is unable to supply sufficient quantities
of product, or if another product proves safer, more effective or otherwise
clinically superior to the first. Orphan medicinal products can be eligible
for further incentives made available by the European Commission and the
individual member countries to support the research, development and
availability of orphan medicinal products.
About Ambrisentan
Ambrisentan is a type-A selective endothelin receptor antagonist and
potent inhibitor of endothelin-induced vasoconstriction. Endothelin is a
small peptide hormone that is believed to play a critical role in the control
of blood flow and cell growth. Elevated endothelin blood levels are
associated with several cardiovascular disease conditions, including pulmonary
arterial hypertension, chronic renal disease, coronary artery disease,
hypertension and chronic heart failure. Therefore, the company believes that
agents that block the detrimental effects of endothelin may provide
significant benefits in the treatment of these conditions. Ambrisentan is
selective for the ET(A) receptor versus the ET(B) receptor and demonstrates a
half-life that may be suitable for once a day dosing.
About Myogen
Myogen currently markets one product (Perfan(R) I.V.) 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 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 the statements relating to the
potential benefits of orphan drug designation. 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, orphan drug designation does not increase the
likelihood of eventual regulatory approval for a product candidate.
Ambrisentan is not registered for sale for any indication in the United States
or abroad. If ambrisentan does not meet safety and efficacy endpoints in
clinical evaluation, it will not receive regulatory approval. In addition,
the company's operating and financial results may be affected by difficulties
or delays in its clinical trials, competition from other pharmaceutical and
biotechnology companies, regulatory developments involving current and future
products, its effectiveness at managing its financial resources and its
ability to successfully develop and market its current products. Delays in
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. Even if the company's product
candidates, including ambrisentan, 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 product 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,
Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
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