Relday, the first once a month, subcutaneous antipsychotic being developed: (Risperdal revisited)

Via ZOGENIX Press release-Zogenix: RELDAY

Potential to Address $16 Billion World-Wide Antipsychotics Market

SAN DIEGO and CUPERTINO, Calif., July 12, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and DURECT Corporation (Nasdaq:DRRX - News), a specialty pharmaceutical company focused on the development of pharmaceutical systems based upon its proprietary drug delivery platform technologies, announced today 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(TM) controlled-release formulation technology in combination with Zogenix's DosePro(R) 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(TM), in patients with schizophrenia in early 2012 following filing of an Investigational New Drug (IND) application.


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.

Roger L. Hawley, chief executive officer of Zogenix, said, "Relday is the result of a focused preclinical formulation development effort with DURECT. 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 U.S. psychiatrists can be covered efficiently with a relatively small sales force. Outside the United States, we expect Relday will be of great interest to prospective commercial partners. We look forward to working with DURECT to file an IND for Relday which will enable initiation of clinical development in early 2012."

James E. Brown, D.V.M., president and chief executive officer of DURECT Corporation, said, "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(TM) program which is in Phase III as well as with proteins and peptides in multiple feasibility projects. 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 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."


Mr. Hawley added, "We view this licensing deal as further validation of the value that our proprietary DosePro delivery system can provide to potential product candidates. We have demonstrated that physicians and patients are attracted to the technology with the launch of our first product, SUMAVEL DosePro, and we continue to focus on identifying new opportunities to more broadly leverage the technology."


Under the terms of the agreement, Zogenix will make an upfront 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."


DURECT press release, About DURECT:

"DURECT Corporation is a specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies to treat chronic debilitating diseases and enable biotechnology products. These platform technologies include the SABER™ Delivery System (a patented and versatile depot injectable useful for proteins, peptides and small molecule delivery), the ORADUR® sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the TRANSDUR® transdermal patch technology, the DURIN™ Biodegradable Implant (drug-loaded implant system) and the MICRODUR™ Biodegradable Microparticulates (microspheres injectable system). DURECT also partners with pharmaceutical and biotechnology companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has seven disclosed on-going development programs of which six are in collaboration with pharmaceutical partners."