SAN DIEGO and CUPERTINO, Calif.—Zogenix, Inc. and specialtypharmaceutical company DURECT Corporation has announced the establishment of adevelopment and license agreement. Under the terms of the agreement, Zogenixwill be responsible for the clinical development and commercialization of aproprietary, long-acting injectable form of risperidone, one of the most widelyprescribed drugs for treating the symptoms of schizophrenia and bipolar Idisorder in adults and teens aged 13 and up. The formulation, to be known asRelday, will use DURECT's SABER controlled-release formulation technologycombined with Zogenix's DosePro needle-free, subcutaneous drug delivery system.
Zogenix and DURECT will share non-clinical developmentresponsibilities. Per the terms of the agreement, Zogenix will pay DURECT $2.25million in an upfront payment, with the potential of an additional $103 millionavailable in clinical, regulatory and commercial milestone payments based onspecific achievements. Zogenix will hold exclusive global rights for thecommercialization of Relday, and DURECT will receive a royalty on Reldayproduct sales. Following the filing of an Investigational New Drug application,Zogenix plans to begin clinical studies for Relday in schizophrenia patientsearly next year.
"Relday is the result of a focused preclinical formulationdevelopment effort with DURECT. We believe Relday has best-in-class potentialbecause it consists of a proven drug with improved attributes that our marketresearch indicates are preferred by psychiatrists," said Roger L. Hawley, chiefexecutive officer of Zogenix, in a press release about the agreement. "Thetarget audience of U.S. psychiatrists can be covered efficiently with arelatively small sales force. Outside the United States, we expect Relday willbe of great interest to prospective commercial partners."
If Relday receives approval, DURECT and Zogenix expect itwill be the first once-monthly, subcutaneous antipsychotic product to be madeavailable in a needle-free delivery system in the long-acting injectableantipsychotic market. The combined market for injectable and oral antipsychoticproducts was estimated at over $16 billion in 2010, and risperidone itselfrecorded global net sales of $1.5 billion last year.
The current injectable risperidone product requiresintramuscular injections of 2 mL twice monthly, administered with a 21-gauge orlarger needle. Zogenix and DURECT expect that Relday will provide a new optionfor patients using either the bi-monthly injections or daily oral antipsychoticproducts, based on the SABER controlled-release technology, which will allowRelday to be administered subcutaneously without a needle. The product willhave a simplified, once-monthly dosing regimen, a better pharmacokineticprofile and a significant reduction in the required injection volume, thanks toDosePro's ability to administer highly viscous formulations.
"Consummation of this collaboration further demonstrates theflexibility and broad potential associated with our SABER depot technologyplatform," said James E. Brown, D.V.M., president and chief executive officerof DURECT, in a press release. "In conjunction with the DosePro delivery system,our goal is to develop a product that meets psychiatrists' and patients'preference for a long-acting, subcutaneous, needle-free antipsychoticmedication."
DURECT is "pleased to work with [Zogenix] on this excitingopportunity with Relday," Brown added.
Zogenix is a San Diego-based pharmaceutical companyspecializing in developing products for central nervous system disorders andpain, while DURECT, with its headquarters in Cupertino, Calif., is focused ondeveloping pharmaceutical systems based on its proprietary drug deliveryplatform technologies.