PRODUCT CANDIDATES & TECHNOLOGY
sumatriptan DosePro™
Sumatriptan DosePro is a new drug-device combination that subcutaneously delivers sumatriptan utilizing DosePro – our proprietary needle-free drug delivery system — to treat migraine and cluster headache. Sumatriptan DosePro is a fast-acting, easy-to-use therapy that patients can self-administer. We submitted our New Drug Application (NDA) for sumatriptan DosePro in December 2007, and we anticipate receiving U.S. Food and Drug Administration (FDA) tentative approval in late 2008. We expect to receive final approval and launch sumatriptan DosePro after the expiration of GlaxoSmithKline’s Imitrex® sumatriptan succinate patent in February 2009. Given the unique attributes of sumatriptan DosePro, we believe it has the potential to be used as a replacement for other injectable forms of sumatriptan and also as a faster acting, more efficacious alternative to tablet and nasal triptans.
ZX002
ZX002 is our proprietary oral version of the opioid pain reliever hydrocodone for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy, and is designed to offer a controlled-release profile that combines immediate release and extended release properties, using Elan Pharma International Ltd.’s proprietary Spheroidal Oral Drug Absorption System (SODAS®). We believe these attributes have the potential to provide similar onset, but longer-lasting and more consistent pain relief with fewer daily doses than the commercially available formulations of hydrocodone. We believe ZX002 will generate sales from both the immediate release and extended release segments of the prescription opioid market. We anticipate having an End of Phase 2 meeting with the FDA in June 2008, and pending the outcome of that meeting, plan to initiate the Phase 3 clinical program in the second half of 2008. The program will evaluate the safety and efficacy of ZX002 for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.

