Our Strategy

At Zogenix, our core strategy is to develop and commercialize differentiated Central Nervous System (CNS) and pain therapeutics that can address significant unmet medical needs or overcome limitations of existing products. Key elements of our strategy include:

Obtain regulatory approval for our most advanced product candidate, sumatriptan DosePro™ for the treatment of migraine.

We submitted our NDA for sumatriptan DosePro in December 2007, and we anticipate receiving tentative approval from the FDA in late 2008. We expect to receive final approval and launch this product candidate after the expiration of GlaxoSmithKline’s Imitrex^® sumatriptan succinate patent in February 2009.

Build a focused sales and marketing infrastructure to commercialize sumatriptan DosePro.

We intend to establish our commercial infrastructure, including marketing and sales management, in 2008. We plan to build a targeted sales force of approximately 100 representatives in the U.S. to promote sumatriptan DosePro at its commercial launch. Our sales force will target the top triptan prescribers including neurologists, headache specialists and key primary care physicians. We intend to launch this product candidate as soon as possible after receiving final FDA approval.

Expand the market opportunity for sumatriptan DosePro through commercial partnerships.

In order to expand the U.S. commercial opportunity of sumatriptan DosePro, we will seek to establish partnerships with pharmaceutical companies or contract sales organizations to market and sell to a broader physician audience than can be reached by our planned sales force alone. Outside the U.S., we will seek to establish commercial partnerships for sumatriptan DosePro in order to accelerate development and regulatory approvals in those countries and further enhance the commercial potential of this product candidate.

Develop and commercialize ZX002 for the treatment of moderate to severe chronic pain.

Pending the outcome of our End of Phase 2 meeting with the FDA, we plan to initiate the Phase 3 clinical trial program for ZX002 in the second half of 2008. Our Phase 3 clinical program for ZX002 will focus on establishing safety and efficacy of controlled-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 to support the commercialization of ZX002.

Expand our product pipeline in CNS and/or pain.

We intend to expand our pipeline by leveraging our proprietary DosePro technology and by in-licensing or acquiring products and product candidates. We are evaluating compounds that could be paired with DosePro to enhance their benefits and commercial attractiveness. We also continue to evaluate in-licensing or acquisition opportunities in the areas of CNS and/or pain, with a focus on product candidates that utilize novel technologies to improve the profile of existing compounds. In both cases, we plan to focus on marketed compounds whose commercial potential has been limited by safety concerns, relative efficacy or patient adherence.

Seek to out-license our proprietary DosePro technology.

We will seek opportunities to out-license the DosePro needle-free drug delivery technology to partners looking to enhance, differentiate, or extend the life-cycle of their injectable products. These opportunities include both currently marketed products and development stage product candidates. We believe the results of preliminary pre-clinical and clinical studies support the use of DosePro for the delivery of small molecules and biological products, including therapeutic proteins, monoclonal antibodies and growth factors. We believe DosePro may have significant market potential across a broad range of therapeutic areas, including those typically treated with injectable products, such as hepatitis, infertility, multiple sclerosis and rheumatoid arthritis.