1101052--3/15/2006--MYOGEN

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{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{regulation, change, law}

{operation, international, foreign}

{stock, price, operating}

{competitive, industry, competition}

{acquisition, growth, future}

{loan, real, estate}

{personnel, key, retain}

{cost, regulation, environmental}

{system, service, information}

{cost, operation, labor}

{product, market, service}

{regulation, government, change}

We may experience delays in our clinical development programs that could adversely affect our financial position and our commercial prospects. Adverse events in our clinical trials may force us to stop development of our product candidates or prevent regulatory approval of our product candidates. Our applications for regulatory approval could be delayed or denied due to problems with studies conducted before we in-licensed our product candidates. If our product candidates do not meet safety or efficacy endpoints in clinical evaluations, they will not receive regulatory approval and we will be unable to market them. There can be no assurance that our Phase 3 clinical development program for darusentan will be acceptable to the FDA, EMEA or other similar agencies for regulatory approval of the compound. Our Phase 3 clinical trial designs for darusentan differ from the design of our prior Phase 2b trial of darusentan. Even if our products meet safety and efficacy endpoints in clinical trials, regulatory authorities may not approve them or we may face post-approval problems that require withdrawal of our products from the market. Abnormal liver function test results have been reported as complications in trials of ERAs. ERAs, including ambrisentan and darusentan, have demonstrated toxicity, including teratogenicity, in animals. ERAs have been shown to increase peripheral edema and cardiovascular adverse events. If approved, our products may be subject to significant restrictions or we may be subject to stringent post-marketing commitments that could affect our ability to market our products. Market size and market acceptance of our product candidates is uncertain. Our attempts to distribute Flolan or to increase future sales of Flolan may be unsuccessful. If we become subject to product liability claims, the damages may exceed our insurance. If we are unable to develop adequate sales, marketing or distribution capabilities or enter into agreements with third parties to perform some of these functions, we will not be able to commercialize our products effectively. Since we will rely on third-party manufacturers, we may be unable to control the availability or cost of producing our products. Our third-party manufacturers and their manufacturing facilities and processes are subject to regulatory review, which may delay or disrupt our development and commercialization efforts. Due to our reliance on contract research organizations and other third parties to conduct clinical trials, we are unable to directly control the timing, conduct and expense of our clinical trials. If we do not find development and commercialization collaborators for our product candidates, we may have to reduce or delay product development and commercialization and increase our expenditures. Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and review. Our success depends on retention of our President and Chief Executive Officer and other key personnel. If our discovery research program is not successful, we may be unable to develop additional product candidates. Our operations may be impaired unless we can successfully manage our growth. If we engage in any acquisition, we will incur a variety of costs, and we may never realize the anticipated benefits of the acquisition. Following the sublicense of Perfan I.V., our operating losses have increased and will continue to increase. Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable regulations. Our operations involve hazardous materials, and compliance with environmental laws and regulations is expensive. Changes in the economic, political, legal and business environments in foreign countries in which we do business could limit or disrupt our current and future international sales and operations. Currency fluctuations may negatively affect our financial condition. Risks Related to Our Industry Our competitors may develop and market drugs that are less expensive, more effective or safer than our product candidates. Our products may face significant price pressures due to competition from similar products. The status of reimbursement from third-party payors for newly approved health care drugs is uncertain and failure to obtain adequate reimbursement could limit our ability to generate revenue. Health care reform measures could adversely affect our business. Failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our products abroad. Ambrisentan s orphan drug designation may be challenged by competitors or withdrawn by the FDA or the EMEA. Changes in or interpretations of accounting rules and regulations, including recently enacted changes relating to the expensing of stock options, could result in unfavorable accounting charges or require us to change our compensation policies. Risks Related to Our Intellectual Property We rely on compounds and technology licensed from third parties and termination of any of those licenses would result in the loss of significant rights. If we are unable to protect our proprietary technology, we may not be able to compete effectively. We may be accused of infringing on the proprietary rights of third parties, which could impair our ability to successfully commercialize our product candidates. Risks Related to Our Stock The market price of our common stock has been and may continue to be highly volatile.

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1101052--3/15/2006--MYOGEN_INC