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Our Strategy

Our core strategy is to commercialize and develop differentiated CNS and pain therapeutics that can address significant unmet medical needs and overcome limitations of existing products. Key elements of our strategy include:

  • Increasing sales and continuing to drive patient and physician adoption of Sumavel DosePro in the United States. Sumavel DosePro has demonstrated consistent monthly growth since its launch inJanuary 2010. We are leveraging our established commercial infrastructure, our collaborationwith Astellas and our investment in sales and marketing programs to increase awareness andadoption of, and access to, Sumavel DosePro with prescribers, patients, third-party payors,pharmacists and employers.
  • Developing and commercializing Zohydro (hydrocodone bitartrate) extended-release capsules for the treatment of moderate to severe chronic pain. Our ongoing Phase 3 clinical program for Zohydro is focused on establishing safety and efficacy of extended-release single-entity hydrocodone to treat moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. If our clinical program is successful and we receive FDA approval, we intend to expand our sales and marketing infrastructure, including expanding our field sales force to 250 or more representatives, to allow us to reach a broad range of opioid prescribers in our target market.
  • Expanding our product pipeline in CNS disorders and/or pain. We are utilizing our proprietary DosePro technology to add to our internal product pipeline. We have initiated pre-clinical development work on a proprietary long-acting formulation of an injectable CNS drug product and are also evaluating the market potential, formulation requirements and clinical development pathway of an additional CNS compound that could be paired with DosePro to enhance its commercial attractiveness. If these efforts are successful, we may be able to submit an IND for one or both product candidates in 2011.
  • Obtaining regulatory approvals for Sumavel DosePro outside of the United States. We have a partnership for Sumavel DosePro with Desitin in order to accelerate development and regulatory approvals in Europe and enhance the global commercial potential of Sumavel DosePro. We also continue to evaluate potential partnerships to commercialize Sumavel DosePro in additional markets outside of Europe and the United States.
  • Out-licensing our proprietary DosePro technology. We are evaluating opportunities to out-license the DosePro needle-free drug delivery technology to partners seeking to enhance, differentiate or extend the life-cycle of their injectable products. These opportunities include biologics and small molecules that are both currently marketed products and development stage product candidates.
  • Securing rights to complementary products and product candidates that address CNS disorders and/or pain. To strategically leverage our commercial resources and generate additionalrevenue, we are seeking third-party co-promotion opportunities. In the future, we will alsoconsider in licensing or acquisition opportunities with a focus on product candidates that utilizenovel technologies to improve the profile of existing compounds for CNS disorders and/or pain.
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