1047188--3/16/2009--PENWEST_PHARMACEUTICALS

related topics

{product, liability, claim}

{product, candidate, development}

{property, intellectual, protect}

{cost, contract, operation}

{interest, director, officer}

{provision, law, control}

{personnel, key, retain}

{acquisition, growth, future}

{stock, price, share}

We may require additional funding which may be difficult to obtain Our ability to generate revenues depends heavily on the success of Opana ER Our success depends on our ability, or our collaborator s ability, to protect our patents and other intellectual property rights We are dependent on our collaborators to manufacture and commercialize our products We have limited experience in developing, manufacturing, marketing and selling pharmaceutical 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 Misuse and/or abuse of Opana ER , which contains a narcotic ingredient, could subject us to additional regulations, including compliance with risk management programs, which may prove difficult or expensive for us to comply with, and we and Endo may face lawsuits 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 such as A0001 Even if we are able to obtain regulatory approvals for any of our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims 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 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 The market price of our common stock may be volatile Specific provisions of our Shareholder Rights Plan, Articles of Incorporation and Bylaws and the laws of Washington State make a takeover of Penwest or a change in control or management of our Company more difficult Proxy contests pursued by dissident shareholders may be costly and disruptive to our business operations

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1047188--3/16/2009--PENWEST_PHARMACEUTICALS_CO