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OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
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We are a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system, or CNS, disorders, with an initial focus on obesity. Our lead product candidates targeted for obesity are Contrave, which we plan to advance into Phase III clinical trials in the first half of 2007, and Excalia, which is in late Phase II clinical trials. Each of our product candidates is a combination of generic drugs, which we have systematically screened for synergistic CNS activity. We seek to combine chemical entities that, individually, have already received regulatory approval and have been commercialized previously, into new product candidates that we believe address unmet medical needs and are patentable. We are testing these combinations in an effort to demonstrate adequate efficacy and safety for potential regulatory approval. We have not yet received regulatory approval of any product candidate. In addition, we plan to continue to screen drugs for synergistic CNS activity and, based on the results, we may advance other potential combination product candidates into clinical trials.
We have selected our product candidates based on our research regarding CNS regulation of appetite and energy expenditure, as well as the reward-based mechanisms in the brain that reinforce unhealthy eating behaviors. These product candidates exhibited strong synergy within our screening model, which enabled us to prioritize them over others considered. In particular, we have focused our clinical development programs on drug combinations that we expect will generate weight loss and attenuate, or limit the effect of, the pathways in the brain that prevent extended weight loss. Our combination approach contrasts with most currently-approved weight loss drug therapies, which utilize a single active ingredient and have typically shown early weight loss followed by a plateau after several months of treatment. We believe that our approach to obesity drug development will permit a more sustained, clinically-relevant pattern of weight reduction. Results from our clinical trials to date for both Contrave and Excalia have supported this hypothesis. We believe that our strategy will increase our probability of technical success while reducing both the time and cost associated with development.
In addition, we are seeking to improve the profiles of our product candidates by developing proprietary sustained release, or SR, drug delivery formulations for their constituent drugs. To date, compositions of Contrave and Excalia using these proprietary SR formulations for the constituents naltrexone and zonisamide, respectively, have demonstrated improved patient tolerability compared to those using previously approved immediate release, or IR, formulations of naltrexone and zonisamide. Because of differences in pharmacokinetics between the generically available formulations and our proprietary SR formulations, we believe we can enhance patient outcomes and our competitive position.
We maintain an aggressive intellectual property strategy, which includes patent and trademark filings in multiple jurisdictions including the United States and other commercially significant markets. We hold exclusive licenses to two issued U.S. patents covering the Contrave composition and an exclusive license to an issued U.S. patent covering the Excalia composition. In addition, we own or have exclusive rights to 14 patent applications currently pending in the United States with respect to various compositions, methods of use and formulations relating to Contrave and/or Excalia.
In April 2006, we met with the U.S. Food and Drug Administration, or FDA, to discuss the clinical trial requirements for submission of new drug application, or NDA, filings for both Contrave and Excalia. Based on feedback from the FDA, we intend to conduct clinical development programs to provide active drug exposure among 1,500 patients for one year, under double-blind, placebo-controlled conditions for each product candidate. We expect to file an NDA with the FDA in the second half of 2009 for Contrave and in 2011 for Excalia, assuming that our clinical trials proceed as planned and are successful.
We currently retain worldwide marketing rights for both Contrave and Excalia. If approved, we may consider marketing these product candidates to select specialists; however, we expect that Contrave and Excalia have the potential to be prescribed to a significant extent by primary care physicians. In order to target this large group of potential prescribers, we may consider entering into a collaboration with a pharmaceutical company with the sales force and marketing resources to adequately address this physician audience. We