1047188--3/16/2006--PENWEST_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{cost, contract, operation}

{stock, price, share}

We depend heavily on the success of our lead product candidate, oxymorphone ER, and if the NDA for oxymorphone ER is not approved on a timely basis or at all, it would have a material adverse effect on our business, financial condition and results of operations If oxymorphone ER or one of our other product candidates is approved by the FDA, it 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 conduct clinical trials of, obtain regulatory approvals for, and manufacture, market, and sell oxymorphone ER, and are and in the future expect to be dependent on other collaborators with respect to conducting clinical trials of, obtaining regulatory approvals for, and manufacturing, marketing, and selling additional products We face significant competition, which may result in others discovering, developing or commercializing products before 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 drug delivery technologies rely on the ability to control the release of the active drug ingredient and our business would be harmed if it was determined that there were circumstances under which the active ingredient 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 Oxymorphone ER contains a narcotic ingredient. As a result of reports of misuse or abuse of prescription narcotics, the sale of oxymorphone ER may be subject to new regulations, including the development and implementation of risk management programs which may prove difficult or expensive to comply with, and we and Endo may face lawsuits Our controlled release products that are generic versions of approved products that are covered by one or more patents may be subject to litigation, which could delay FDA approval and commercial launch of our products Our success depends on our protecting our patents and patented rights We may become involved in patent litigation or other intellectual property proceedings relating to our products or processes, which could result in liability for damages or stop our development and commercialization efforts 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 material If we or our collaborators fail to obtain an adequate level of reimbursement by third party payors for our products, we may not be able to successfully commercialize controlled release products We will be exposed to product liability claims and may not be able to obtain adequate product liability insurance The market price of our common stock may be volatile

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1047188--3/16/2006--PENWEST_PHARMACEUTICALS_CO