ZOGENIX REPORTS POSITIVE TOP-LINE RESULTS FROM EXTENDED RELDAY(™) PHASE 1 CLINICAL TRIAL
SAN DIEGO, May 2, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX
), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced positive top-line results from its extended Phase 1 clinical trial of Relday™, an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. If approved, Relday has the potential to be the first subcutaneous antipsychotic product that allows for once-monthly dosing. Efforts are now underway to secure a strategic development and commercialization partner for Relday.
The extended Phase 1 clinical trial included a 100 mg dose of Relday, following
previously reported positive results with 25 and 50 mg doses
. The results for the 100 mg dose showed that risperidone blood concentrations in the therapeutic range were achieved on the first day of dosing, and maintained throughout the one-month period. In addition, dose proportionality has now been established across the full dose range that would be anticipated to be used in clinical practice (50 to 100 mg). The 100 mg dose was safe and well-tolerated, with no unexpected adverse events, including injection site reactions, as compared to the initial Phase 1 clinical trial with the 25 and 50 mg doses. The adverse events were generally mild to moderate and consistent with other risperidone products.
"With the positive top-line results from the Relday Phase 1 extension, we believe that we have now confirmed the product candidate's viability across the anticipated commercial dosing range," said Stephen Farr, Ph.D., president of Zogenix. "We are well positioned to begin a multi-dose clinical trial to provide steady-state pharmacokinetic and safety data, once a partner is secured, prior to initiating Phase 3 development studies."
Roger L. Hawley, chief executive officer of Zogenix, said, "We now have sufficient data to formalize our business development discussions, with a goal of securing a strategic development and commercialization partner. While we plan to retain U.S. rights to Relday, based on the 505(b)(2) NDA regulatory pathway and previous discussions, we believe there is strong partnering interest in Relday."
In connection with these partnering activities, Zogenix has retained Locust Walk Partners of Cambridge, MA, a transaction advisory firm for life sciences companies, to provide exclusive transaction advisory and support services. For information about Relday partnering opportunities, contact Jay Mohr, Managing Director, at (617) 300-0174,
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 global long-acting injectable antipsychotic market was approximately $2 billion in 2011. The leading injectable product in the category requires twice-a-month dosing, intramuscular injection and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $17 billion in 2011.
If approved, Relday has the potential to be the first subcutaneous antipsychotic product that allows for once-monthly dosing. Zogenix believes that Relday will offer an improved pharmacokinetic (PK) profile, significant reduction in injection volume and a simplified dosing regimen (e.g., no need for loading dose) due to DURECT's (Nasdaq:DRRX
) SABER® controlled-release depot technology. In July 2011, Zogenix licensed from DURECT exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT's SABER® depot technology.
The Phase 1 clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 40 patients with chronic, stable schizophrenia or schizoaffective disorder across a dose range of 25, 50 and 100 mg.
Zogenix, Inc. (Nasdaq:ZGNX
), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro™ ER (hydrocodone bitartrate), is an oral, extended-release formulation of various strengths of hydrocodone, without acetaminophen, intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER. Zogenix's second investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia; an investigational new drug application was submitted to the FDA in May 2012.
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding delivery and dosing benefits of Relday to both the patient and clinician, the viability of Relday, initiation of a multi-dose clinical trial and Phase 3 development studies for Relday, discussions with potential partners for rest-of-world development and commercialization of Relday, the interest in Relday by potential partners, the introduction of DosePro technology and the timing thereof, the ability of such product to address the global anti-psychotic market, and the ability to develop a once-monthly injectable product with improved pharmacokinetics and significant reduction in injection volume. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as Relday, including potential delays in enrollment and completion of clinical trials; Zogenix's dependence on its collaboration with DURECT Corporation to develop Relday; inadequate therapeutic efficacy or unexpected adverse side effects relating to Relday that could prevent its development or commercialization; difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to Relday; the terms of any development or commercialization partnership for Relday may not be favorable, and the partner may not perform as expected; the market potential for anti-psychotics, and Zogenix's ability to compete within that market; Zogenix's ability to obtain and the validity and duration of patent protection and other intellectual property rights for Relday; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM ER are trademarks of Zogenix, Inc.
SABER® is a trademark of DURECT Corporation.
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