1012270--3/16/2007--COLLAGENEX_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{regulation, government, change}

{stock, price, operating}

{acquisition, growth, future}

{product, market, service}

We are depending heavily on the commercial success of Oracea. If we are unable to successfully commercialize Oracea our business will be materially harmed. We cannot rely on regulatory protections to prevent the approval of generic equivalents of our products. If we are not able to obtain and enforce patent protection for Oracea or our other discoveries, our ability to commercialize our product candidates successfully will be harmed and we may not be able to operate our business profitably. We cannot assure you that our pursuit of business in the dermatology market will be successful. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired. If we lose our sole supplier of doxycycline or our manufacturer of Oracea, our sales of Oracea will be interrupted, halted or less profitable. If the federal regulatory status of Alcortin or Novacort changes, we may be unable to continue to market one or both of these products. Our products could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements. Both before and after approval or clearance, we, our products and product candidates and our manufacturers are subject to extensive regulatory requirements. Failure to comply with these requirements could subject us to administrative and judicial sanctions. We may be unable to raise additional capital if needed, which would force us to delay, reduce or eliminate our product development programs and commercialization efforts. We cannot assure you that our clinical trials will be completed in a timely manner or will meet agreed upon end-points. If we infringe or are alleged to infringe intellectual property rights of third parties, it will adversely affect our business. We depend upon third party researchers and providers of clinical services to perform as contractually required if we are to be successful in bringing new products to market. We depend upon certain key relationships to generate much of the technology required to maintain our competitive position in the marketplace. If our products cause injuries, we may incur significant expense and liability. Our stock price is highly volatile and, therefore, the value of your investment may fluctuate significantly.

Full 10-K form ▸

1012270--3/16/2007--COLLAGENEX_PHARMACEUTICALS_INC