MYOG Myogen

Myogen, Inc. (Nasdaq:MYOG) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ambrisentan, the Company's type-A selective endothelin receptor antagonist (ERA), currently in Phase 3 clinical evaluation for the treatment of patients with pulmonary arterial hypertension (PAH). Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The FDA designated ambrisentan as a Fast Track product for the following reasons: -0- *T 1. Ambrisentan is intended to treat PAH, a life-threatening, progressive, and incurable disease of the pulmonary vasculature. 2. The ambrisentan development program has been designed to address the unmet medical needs of patients with PAH, by demonstrating the following: a. Ambrisentan has the potential for improved effects on exercise capacity, an efficacy measure that has been shown to correlate with and be prognostic of long-term survival. b. Ambrisentan appears to delay the clinical worsening of PAH, a progressive and ultimately fatal disease. *T "We are pleased to receive Fast Track designation for ambrisentan," stated Michael J. Gerber, MD, Senior Vice President of Clinical Development and Regulatory Affairs for Myogen. "Based on clinical trial results to date and the properties of ambrisentan, Myogen believes that, if ambrisentan is ultimately approved, it may offer significant clinical benefit to PAH patients." Fast Track regulations are based on the FDA Modernization Act of 1997 (FDAMA) as a formal process to enhance interactions with the FDA during drug development. A drug with Fast Track designation would be eligible for consideration for some or all of the following programs for expediting development and review: scheduled meetings to seek FDA input into development plans, priority review of the New Drug Application (NDA) and the option of submitting portions of an NDA prior to submission of the complete application. About Pulmonary Arterial Hypertension PAH is a highly debilitating disease characterized by severe constriction of the blood vessels in the lungs leading to very high pulmonary arterial pressures. These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated. Patients with PAH suffer from extreme shortness of breath as the heart struggles to pump against these high pressures causing such patients to ultimately die of heart failure. PAH can occur with no known underlying cause, or it can occur secondary to diseases such as connective tissue disease, congenital heart defects, cirrhosis of the liver and HIV infection. PAH afflicts approximately 200,000 patients worldwide. About Ambrisentan Ambrisentan is an investigational drug being developed as a once-daily oral therapy for patients with PAH and has been granted orphan drug designation for the treatment of PAH in both the United States and the European Union. Ambrisentan is a non-sulfonamide, propanoic acid-class, type-A selective endothelin receptor antagonist. Endothelin is a small peptide hormone that plays a critical role in the control of blood flow and cell growth. Elevated endothelin blood levels are associated with several cardiovascular disease conditions, including PAH, chronic renal disease, coronary artery disease, hypertension and chronic heart failure. The Company believes that agents that block the detrimental effects of endothelin may provide significant benefits in the treatment of these conditions. Myogen has licensed ambrisentan ex-U.S. rights to GlaxoSmithKline. 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 (PAH) and darusentan for the treatment of patients with resistant hypertension. The Company 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 profile and potential of ambrisentan. 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. FDA Fast Track designation does not represent or imply the FDA's view on the potential approvability of ambrisentan. Results from prior clinical trials, including the Company's ARIES-2 trial and AMB-222, are not necessarily predictive of future clinical results, including results of the ARIES-1 trial of ambrisentan in patients with PAH. 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. There can be no assurance that Myogen's product candidates, including ambrisentan, will be proven safe and effective for use in humans. Abnormal elevations of liver function test results, including elevated serum aminotransferase concentrations, have been reported in trials of other endothelin receptor antagonists. 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 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 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. The Company generally plans to provide guidance as part of its annual and quarterly earnings releases but reserves the right to provide guidance at different intervals or to revise its practice in future periods. All information in this press release is as of March 9, 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. The Company also disclaims any duty to comment upon or correct information that may be contained in reports published by the investment community.