1047188--3/16/2007--PENWEST_PHARMACEUTICALS

related topics

{product, liability, claim}

{product, candidate, development}

{property, intellectual, protect}

{cost, contract, operation}

{personnel, key, retain}

We depend heavily on the success of Opana ER, which may not be widely accepted by physicians, patients, third-party payors, or the medical community in general We are dependent on our collaborator Endo to manufacture, market and sell Opana ER, and in the future expect to be dependent on other collaborators to manufacture, market, and sell our other products The Drug Enforcement Agency, or DEA, limits the availability of the active drug substances used in Opana ER. As a result, Endo s procurement quota may not be sufficient to meet commercial demand We face significant competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do If our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products Our controlled release drug delivery technologies rely on the ability to control the release of the active drug substances and our business would be harmed if it was determined that there were circumstances under which the active drug substances from one of our extended release products would be released rapidly into the blood stream We are subject to extensive government regulation including the requirement of approval before our products may be marketed. Even if we obtain marketing approval, our products will be subject to ongoing regulatory review Opana ER contains a narcotic ingredient. As a result of reported misuse and abuse of prescription narcotics, the sale of Opana ER is subject to additional regulations, including the compliance with risk management programs, which may prove difficult or expensive to comply with; and we and Endo may face lawsuits Our success depends on our ability to protect our patents and other intellectual property rights We may become involved in patent litigation or other proceedings relating to our products or processes, which could result in liability for damages or termination of our development and commercialization programs We have only limited manufacturing capabilities and will be dependent on third party manufacturers We are dependent upon a limited number of suppliers for the gums used in our TIMERx materials If we or our collaborators fail to obtain an adequate level of reimbursement by governmental or third party payors for Opana ER or any other products we develop, we may not be able to successfully commercialize the affected product We will be exposed to product liability claims and may not be able to obtain adequate product liability insurance If we are unable to retain our key personnel, and continue to attract additional professional staff, we may not be able to maintain or expand our business

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1047188--3/16/2007--PENWEST_PHARMACEUTICALS_CO