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SEC Filings

OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
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claims, we could incur substantial liabilities. In addition, regardless of merit or eventual outcome, product liability claims may result in:
  •      decreased demand for our product candidates;
  •      impairment of our business reputation;
  •      withdrawal of clinical trial participants;
  •      costs of related litigation;
  •      distraction of management’s attention from our primary business;
  •      substantial monetary awards to patients or other claimants;
  •      loss of revenues; and
  •      the inability to commercialize our product candidates.
We have obtained product liability insurance coverage for our clinical trials with a $5 million annual aggregate coverage limit. Our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. If and when we obtain marketing approval for any of our product candidates, we intend to expand our insurance coverage to include the sale of commercial products; however, we may be unable to obtain this product liability insurance on commercially reasonable terms. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.
If any of our product candidates for which we receive regulatory approval does not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
The commercial success of our product candidates for which we obtain marketing approval from the FDA or other regulatory authorities will depend upon the acceptance of these products by the medical community. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally is also necessary for optimal commercial success. The degree of market acceptance of any of our approved products will depend on a number of factors, including:
  •      our ability to provide acceptable evidence of safety and efficacy;
  •      the relative convenience and ease of administration;
  •      the prevalence and severity of any adverse side effects;
  •      limitations or warnings contained in a product’s FDA-approved labeling, including, for example, potential “black box” warnings or pregnancy precautions associated with the active ingredients of Contrave and/or Excalia;
  •      availability of alternative treatments, including, in the case of Contrave and/or Excalia, a number of competitive products already approved for the treatment of weight loss or expected to be commercially launched in the near future;
  •      pricing and cost effectiveness;
  •      the effectiveness of our or any future collaborators’ sales and marketing strategies;
  •      our ability to obtain sufficient third-party coverage or reimbursement; and
  •      the willingness of patients to pay out of pocket in the absence of third-party coverage.
If our product candidates are approved but do not achieve an adequate level of acceptance by physicians, health care payors and patients, we may not generate sufficient revenue from these products, and