1161924--3/26/2007--ADVANCIS_PHARMACEUTICAL

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{personnel, key, retain}

{product, market, service}

{cost, regulation, environmental}

{investment, property, distribution}

{stock, price, share}

{acquisition, growth, future}

{customer, product, revenue}

If we are unable to raise additional capital in the near term, we may not be able to continue to operate as a going concern. If we are unable to increase sales of our 750 mg Keflex product, our liquidity will be further adversely affected. Assuming we are able to obtain additional capital, our nearer term success will depend in large part on our receiving FDA approval of our Amoxicillin PULSYS product candidate, and we cannot assure you that the FDA will approve this product or, if approved, that it will be approved on a timely basis. Our PULSYS technology is based on a finding that could ultimately prove to be incorrect, or could have limited applicability. Our PULSYS delivery technology may not be effective, which would prevent us from commercializing products that are more effective than those of our competitors. If a competitor produces and commercializes an antibiotic that is superior to our PULSYS antibiotics, the market for our potential products would be reduced or eliminated. We have not conducted an extensive third party patent infringement, invalidity and enforceability investigation on pulsatile dosing and our PULSYS technology, and we are aware of at least one issued patent covering pulsatile delivery. We have not sought patent protection for certain aspects of the technology used in our PULSYS product candidates. If we are unable to develop and successfully commercialize our PULSYS product candidates, we may never achieve profitability. If clinical trials for our products are unsuccessful or delayed, we will be unable to meet our anticipated development and commercialization timelines. Even if Amoxicillin PULSYS or any of our other PULSYS products are approved for commercial sale, we will not be successful if these products are not accepted by the market. We have limited sales, marketing, and distribution capabilities, and currently depend in large part on a third party contract sales force for the marketing of our Keflex 750 mg product. If we fail to develop our own sales, marketing and distribution capabilities or fail to enter into arrangements with third parties, we will not be able to successfully commercialize our products. We rely upon a limited number of pharmaceutical wholesalers and distributors, which could impact our ability to sell our Keflex products or Amoxicillin PULSYS. The potential success of our products and product candidates, including our 750 mg Keflex product and, if approved for marketing by the FDA, Amoxicillin PULSYS, will be dependent upon successfully pricing the products in the marketplace. Generic pricing plans, such as that being implemented by Wal-Mart, may affect the market for our products. Our products are subject to therapeutic equivalent substitution, Medicaid reimbursement and price reporting. We are dependent on our contract manufacturers and suppliers to provide us with active pharmaceutical ingredients and finished products. Our ability to conduct clinical trials will be impaired if we fail to qualify our clinical supply manufacturing facility and we are unable to maintain relationships with current clinical supply manufacturers or enter into relationships with new manufacturers. Clinical trials for our product candidates may be delayed due to our dependence on third parties for the conduct of such trials. Our success may depend on our ability to successfully attract and retain collaborative partners. If we cannot enter into new licensing arrangements or otherwise gain access to products, our ability to develop a diverse product portfolio could be limited. We could be forced to pay substantial damage awards if product liability claims that may be brought against us are successful. Our executive officers and other key personnel are critical to our business and our future success depends on our ability to retain them. Risks Related to our Industry Any inability to protect our intellectual property could harm our competitive position. If we do not compete successfully in the development and commercialization of products and keep pace with rapid technological change, we will be unable to capture and sustain a meaningful market position. If we experience delays in obtaining regulatory approvals, or are unable to obtain or maintain regulatory approvals, we may be unable to commercialize any products. The manufacture and storage of pharmaceutical and chemical products is subject to environmental regulation and risk. Market acceptance of our products will be limited if users of our products are unable to obtain adequate reimbursement from third-party payors. Potential regulatory changes and the billing and reimbursement process applicable to underlying conditions may cause price erosion and reduce sales revenue for our products and our products may not be accepted by health care providers. HealthCare Ventures V, L.P., HealthCare Ventures VI, L.P., and HealthCare Ventures VII, L.P. have substantial control over our business, and the interests of the HealthCare Ventures partnerships may not be consistent with the interests of our other stockholders. Future sales of our common stock, or the perception that these sales may occur, could depress our stock price.

Full 10-K form ▸

1161924--3/26/2007--ADVANCIS_PHARMACEUTICAL_CORP