Myogen Achieves Three Milestones Under the Collaboration
DENVER, May 26 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG) today
announced two developments related to its heart muscle disease drug discovery
collaboration with Novartis (NYSE: NVS). First, the collaboration has been
expanded to include Myogen's histone deacetylase inhibitor (HDACi) program.
Second, Myogen announced that it had achieved three development milestones
under the parties' existing research collaboration for the discovery and
development of novel drugs for the treatment of cardiovascular disease.
"We are delighted with the progress made to date under our partnership
agreement and we are pleased to broaden the collaboration to include HDAC
inhibitors," said J. William Freytag, President and Chief Executive Officer of
Myogen, Inc. "We believe the HDACi program has significant potential
therapeutic value. Through this partnership, we have an exciting opportunity
to advance the discovery and development of novel small molecule compounds
that selectively inhibit HDACs for treatment of cardiac diseases."
"Novartis has focused on developing a deep understanding of diseases of
the heart. Our collaboration with Myogen is an important part of our efforts
to explore innovative and potentially important targets for drug discovery,"
said Dr. Jeremy Levin, Global Head of Strategic Alliances of Novartis. "This
expansion underlies our commitment to work with Myogen and to expand the
productive relationship established in 2003."
The expansion of the collaboration extends research funding for a minimum
of three years and includes undisclosed signing fees, milestone payments and
royalty payments on sales of products that are successfully commercialized.
Upon the completion of Phase 2 clinical trials of certain HDACi product
candidates Novartis has licensed under the collaboration, Myogen has an option
to enter into a co-promotion and profit sharing agreement in certain markets,
subject to the Company reimbursing Novartis for certain costs incurred through
the completion of Phase 2 trials as well as a commensurate portion of future
development and marketing costs and the elimination of the associated royalty.
The three milestones achieved reflect Novartis' and Myogen's continued
progress in validation of high throughput assays relating to current
collaboration targets. Achievement of these milestones will trigger payments
to Myogen in accordance with the terms of the parties' 2003 research
collaboration agreement.
About HDAC Inhibitors
Recent research at Myogen suggests that HDAC inhibitors represent a valid
approach to the development of novel, disease-modifying cardiac therapeutics.
In work published recently, Myogen scientists have shown that HDAC inhibitors
block pathological cardiomyocyte hypertrophy and up-regulate the expression of
alpha myosin heavy chain while decreasing beta myosin isoform expression.
Myogen believes that this research holds promise for the discovery of small
molecule drugs that halt, or reverse, pathological cardiac remodeling and its
underlying gene reprogramming and have the potential to improve the function
of the failing heart. Myogen has identified and patented (US 6,706,686)
therapeutic uses of HDAC inhibitors for the prevention and treatment of
cardiac hypertrophy and heart failure.
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 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 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
potential to discover collaboration targets and small molecule development
candidates through Myogen's discovery research program and Myogen's
collaboration with Novartis. 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.
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. The
discovery research program and the company's collaboration with Novartis may
not succeed in identifying additional therapeutic targets, product candidates
or products. Novartis may choose to terminate or not renew the collaboration
agreement with the company, possibly delaying Myogen's development programs
and increasing its operating loss. If the company's product candidates,
including darusentan, ambrisentan 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. 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.
 back to top
Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations
of Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
|
