Zogenix & DURECT Announce Agreement for Antipsychotic Product Candidate
Zogenix, Inc., a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and DURECT Corporation, a specialty pharmaceutical company focused on the development of pharmaceutical systems based upon its proprietary drug delivery platform technologies, recently announced a development and license agreement.
Under the agreement, Zogenix will be responsible for the clinical development and commercialization of a proprietary, long-acting injectable formulation of risperidone using DURECT’s SABER controlled-release formulation technology in combination with Zogenix’s DosePro needle-free, subcutaneous drug delivery system. The Companies will also share non-clinical development responsibilities. Zogenix expects to initiate clinical studies for the new product candidate, Relday, in patients with schizophrenia in early 2012 following filing of an
Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia and bipolar I disorder in adults and teenagers 13 years of age and older. Relday will be developed to address unmet clinical needs in this large patient population.
The companies expect that, if approved, Relday will be the first once-monthly, subcutaneous antipsychotic product available in a needle-free delivery system to enter the long-acting injectable antipsychotic market. The existing long-acting injectable risperidone product, which achieved global net sales of $1.5 billion in 2010, requires twice-monthly, 2-mL intramuscular injections with a 21-gauge or larger needle. The companies also expect that, if approved, Relday will provide a new long-acting treatment option for patients that currently use daily oral antipsychotic products. The combined market for oral and injectable antipsychotic products is estimated at more than $16 billion in 2010. The companies believe the SABER controlled-release technology will allow Relday to be delivered subcutaneously without a needle on a once-monthly basis with a simplified dosing regimen, improved pharmacokinetic profile, and significant reduction in injection volume. This will be enabled by DosePro’s unique ability to deliver highly viscous formulations.
“Relday is the result of a focused preclinical formulation development effort with DURECT,” said Roger L. Hawley, CEO of Zogenix. “We believe Relday has best-in-class potential because it consists of a proven drug with improved attributes that our market research indicates are preferred by psychiatrists. The target audience of US psychiatrists can be covered efficiently with a relatively small sales force. Outside the
“Consummation of this collaboration further demonstrates the flexibility and broad potential associated with our SABER depot technology platform, which we are also employing in our POSIDUR program in Phase III as well as with proteins and peptides in multiple feasibility projects,” added James E. Brown, DVM, President and CEO of DURECT Corporation. “In conjunction with the DosePro delivery system, our goal is to develop a product that meets psychiatrists’ and patients’ preferences for a long-acting, subcutaneous, needle-free antipsychotic medication. Zogenix has successfully developed and commercialized a CNS product, and we are pleased to work with them on this exciting opportunity with Relday.”
Under the terms of the agreement, Zogenix will make an up-front payment of $2.25 million to DURECT, with the potential to pay DURECT up to an additional $103 million in future clinical, regulatory, and commercial milestone payments based upon successful achievement of certain events. Zogenix will have exclusive global rights to commercialize Relday and will pay DURECT a royalty on Relday product sales.
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