Zogenix Reports Positive Top-Line Results From Relday(TM) Phase 1b Multi-Dose Clinical Trial

Zogenix, Inc.

, a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced positive top-line pharmacokinetic results from its Phase 1b multi-dose clinical trial of Relday™, a proprietary, once-monthly subcutaneous investigational formulation of risperidone for the treatment of schizophrenia. If approved, Relday has the potential to be the first subcutaneous antipsychotic product that achieves therapeutic drug levels on the first day of administration, allows for once-monthly dosing and does not require reconstitution. Zogenix has retained Locust Walk Partners of Cambridge, MA, a transaction advisory firm for life sciences companies, to provide transaction advisory and support services for Relday, and has now initiated efforts to secure a global strategic development and commercialization partner for Relday. The Phase 1b multi-dose parallel group clinical trial enrolled 60 subjects comprised of three cohorts of patients receiving four monthly injections of Relday, at dose levels of either 60, 90 or 120 mg of risperidone per month. A fourth cohort received five bi-weekly intramuscular injections of Risperdal® Consta®. Risperdal Consta requires oral supplementation for the first three weeks following dosing initiation, and requires at least four doses to reach steady state. The results for Relday demonstrated that risperidone plasma concentrations in the therapeutic range were achieved on the first day of dosing, reached steady state levels following the second dose and consistently maintained therapeutic levels throughout the four-month period. In addition, dose proportionality was confirmed across the dose range intended for clinical practice (60 to 120 mg). Relday was generally safe and well-tolerated, with results consistent with the profile of risperidone and the Company's previous Phase 1 single-dose clinical trial. "With the positive top-line results from the Phase 1b multi-dose trial, Relday is now well-positioned to begin a Phase 3 program once a development and commercialization partner is secured," said Stephen Farr, Ph.D., President and CEO of Zogenix. "Our market research indicates that Relday, if approved, has the potential to address a medical need within the schizophrenia treatment landscape by becoming the first monthly subcutaneous antipsychotic product that achieves therapeutic drug levels on the first day of administration, thereby eliminating the need for loading dose regimens upon therapy initiation or following a missed dose." Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia in adults and teenagers 13 years of age and older. The injectable formulation of risperidone, Risperdal Consta, requires twice-a-month dosing, oral supplementation during therapy initiation, intramuscular injection and drug reconstitution prior to use.