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SEC Filings

10-Q
OREXIGEN THERAPEUTICS, INC. filed this Form 10-Q on 05/12/2017
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consumer acceptance and market adoption. We believe that the successful commercialization of Contrave in the United States may depend on the willingness of patients to use telemedicine to get access to Contrave.  Negative publicity concerning this aspect of our strategy or the telemedicine market as a whole could limit market acceptance of this as a way to access Contrave.  Similarly, patient and healthcare provider concerns or negative publicity regarding patient confidentiality and privacy in the context of telemedicine could limit market acceptance of this aspect of our strategy.

If our commercialization of Contrave in the United States is unsuccessful or perceived as disappointing, our stock price could decline significantly and the long-term success of the product and our Company could be harmed.

*Certain aspects of our U.S. commercialization strategy for Contrave are dependent upon third parties and 100% of the commercialization of Contrave/Mysimba in foreign countries is dependent upon third parties.  If these third parties do not successfully carry out their contractual duties or fail to comply with laws and regulations, we may not be successful in such commercialization.  If we do not enter into additional collaboration, distribution or co-promotion arrangements, we may not be able to effectively market and sell Contrave/Mysimba outside the United States and our ability to generate revenues may be delayed or limited.

We have entered into an agreement with a contract sales organization to sell Contrave in the United States. We also have an agreement with a telemedicine provider, which is available to patients in certain geographies in the United States as part of our telemedicine pilot program.   We have an agreement with Valeant Pharmaceuticals for the commercialization of Contrave in certain Central and Eastern European countries, Turkey, Australia, New Zealand and Canada, an agreement with Kwang Dong for commercialization of Contrave in South Korea, an agreement with Consilient for the commercialization of Mysimba in the United Kingdom and Ireland, an agreement with Bruno for commercialization in Italy, an agreement with Rovi for commercialization of Mysimba in Spain, an agreement with Biologix in the Middle East Countries and an agreement with Navamedic for the commercialization of Mysimba in Denmark, Finland, Norway, Sweden and Iceland. (Together, the Central and Eastern European countries, Turkey, Australia, New Zealand, Canada, South Korea, Spain, the United Kingdom and Ireland, and the Middle East Countries are referred to as the Partnered Regions.)  These third parties are not our employees, and we have limited ability to control the amount or timing of resources that they devote to our product.  If these third parties fail to provide adequate resources to our product, fail to meet their contractual obligations to us or fail to comply with applicable laws and regulations, our business will suffer.  Moreover, these third parties may also have relationships with other commercial entities, some of which may compete with us. If these third parties also contract with our competitors, it could adversely affect our business.

In order to expand the market opportunity for Contrave outside the Partnered Regions, we must either establish additional sales and marketing collaborations, additional distribution or co-promotion arrangements or continue to expend significant resources to develop our own sales and marketing presence. We may not be able to enter into additional collaboration, distribution or co-promotion arrangements on acceptable terms, if at all. If we are unable to enter into additional collaboration, distribution or co-promotion arrangements for Contrave/Mysimba in additional geographies and we must develop our own sales and marketing presence to address the physicians in these geographic areas, we will require additional capital and our ability to market and sell our product and generate revenues from our product may be delayed or limited. Even if we do enter into additional collaboration, distribution or co-promotion arrangements with third parties, we will be reliant on such third parties to successfully develop and/or commercialize our product in these areas. These third parties may fail to develop or effectively commercialize our product because they cannot obtain the necessary regulatory approvals, decide to pursue a competitive potential product that may be developed outside of the collaboration or fail to devote the resources necessary to realize the full commercial potential of our product, especially in light of the resources being devoted by our competitors’ collaboration and co-promotion partners. Any such failures would negatively affect our ability to generate revenues from sales of Contrave/Mysimba outside the United States.

We also face competition in our search for collaborators, co-promoters and distributors. If our competitors are able to establish collaboration, distribution or co-promotion arrangements with pharmaceutical companies who have substantially greater resources than we have, our ability to successfully commercialize Contrave/Mysimba outside the United States will be limited and as a result our competitors may be more successful in marketing and selling their products in these geographic areas.

*Even though Contrave received regulatory approval from the FDA, the EC and South Korea, it will still be subject to ongoing and continued regulatory review and post-marketing requirements in these countries and elsewhere, which may result in significant expense and limit our ability to commercialize this product.

Even though U.S. regulatory approval has been obtained for Contrave, the FDA has imposed restrictions on its indicated uses and marketing and has imposed ongoing requirements for post-marketing studies and other activities. For example, the approved use of Contrave is limited as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition. The label also contains a “boxed” warning regarding the potential for suicidal thoughts and behaviors as a side effect of the drug. We are also required to conduct a number of post-marketing studies including a series of studies in obese pediatric

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