1347178--3/13/2008--Vanda_Pharmaceuticals

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, operating}

{stock, price, share}

{control, financial, internal}

{cost, operation, labor}

{personnel, key, retain}

{cost, regulation, environmental}

We face heavy government regulation, and FDA regulatory approval of our products is uncertain. We intend to seek regulatory approvals for our products in foreign jurisdictions, but we may not obtain any such approvals. Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or limit their marketability. Our product candidates may never achieve market acceptance even if we obtain regulatory approvals. If we fail to obtain the capital necessary to fund our research and development activities, we may be unable to continue operations or we may be forced to share our rights to commercialize our product candidates with third parties on terms that may not be attractive to us. We have incurred operating losses in each year since our inception and expect to continue to incur substantial and increasing losses for the foreseeable future. If our contract research organizations do not successfully carry out their duties or if we lose our relationships with contract research organizations, our drug development efforts could be delayed. We rely on a limited number of manufacturers for our product candidates and our business will be seriously harmed if these manufacturers are not able to satisfy our demand and alternative sources are not available. Materials necessary to manufacture our product candidates may not be available on commercially reasonable terms, or at all, which may delay the development, regulatory approval and commercialization of our product candidates. We face substantial competition which may result in others developing or commercializing products before or more successfully than we do. We have no experience selling, marketing or distributing products and no internal capability to do so. We will need to increase the size of our organization, and we may experience difficulties in managing our growth. If we cannot identify, or enter into licensing arrangements for, new product candidates, our ability to develop a diverse product portfolio may be limited. If we lose key scientists or management personnel, or if we fail to recruit additional highly skilled personnel, it will impair our ability to identify, develop and commercialize product candidates. Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products. Legislative or regulatory reform of the healthcare system in the U.S. and foreign jurisdictions may affect our ability to sell our products profitably. Recently enacted legislation may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, to market and to distribute our existing products. Our quarterly operating results may fluctuate significantly. Risks related to intellectual property and other legal matters Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses or sublicenses granted to us by other pharmaceutical companies. With respect to VEC-162 and VSF-173, these terms and conditions include options in favor of these pharmaceutical companies to reacquire rights to commercialize and develop these product candidates in certain circumstances. If our efforts to protect the proprietary nature of the intellectual property related to our products are not adequate, we may not be able to compete effectively in our markets. If we do not obtain protection under the Hatch-Waxman Act and similar foreign legislation to extend our patents and to obtain market exclusivity for our product candidates, our business will be materially harmed. Litigation or third-party claims of intellectual property infringement could require us to divert resources and may prevent or delay our drug discovery and development efforts. If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages. Risks related to our common stock Our stock price has been volatile and may be volatile in the future, and purchasers of our common stock could incur substantial losses. If there are substantial sales of our common stock, our stock price could decline. If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, our stock price and trading volume could decline.

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1347178--3/13/2008--Vanda_Pharmaceuticals_Inc.