Potential First Needle-Free Subcutaneous Treatment Option in $2 Billion Long-Acting Injectable Antipsychotic Market
SAN DIEGO, May 30, 2012 (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 that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) for Relday™, which is a combination of Zogenix's DosePro® needle-free, subcutaneous drug delivery system plus a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. In July 2011, Zogenix licensed from DURECT (Nasdaq:DRRX) exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT's SABER® depot technology. Initial clinical trials are currently planned to begin in the second half of the year, with results expected by year-end.
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, with currently approved products using a 21-gauge or larger needle for intramuscular injections. The leading product in the category requires twice-a-month dosing and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $16 billion in 2010.
If approved, Relday will be the first subcutaneous, needle-free antipsychotic product that allows for once-monthly dosing. Zogenix believes that Relday will offer an improved pharmacokinetic profile, significant reduction in injection volume and a simplified dosing regimen due to DURECT's SABER controlled-release formulation technology in combination with Zogenix's DosePro needle-free subcutaneous drug delivery system.
Roger L. Hawley, chief executive officer of Zogenix, said, "We are encouraged by Relday's potential of improving patient compliance due to the safety and convenience provided by DosePro's needle-free delivery system combined with a long-acting formulation of an established antipsychotic. Our market research indicates that psychiatrists prefer a subcutaneous, needle-free, once-monthly treatment option over products that are currently available."
Hawley continued, "We anticipate having study results toward the end of the year which could position us to begin discussions regarding a rest-of-world development and commercialization partner. Should Relday receive FDA approval, it will also further validate the potential use of DosePro to enable the delivery of viscous drug formulations such as biologics."
The DosePro system is a first-in-class, easy-to-use drug delivery system that includes a pre-filled, single dose of liquid drug, and is administered subcutaneously, without a needle. The platform is currently used by Zogenix's first commercial product, SUMAVEL® DosePro®, and its investigational candidate, Relday. The Company believes that DosePro offers several benefits to patients compared to other subcutaneous delivery methods, and that it has the potential to become a preferred delivery option for patients and physicians. These benefits include less anxiety or fear due to the lack of a needle, easier disposal without the need for a sharps container, no risk of needle stick injury or contamination, an easy-to-use three step process, no need to fill or manipulate the device, reliable performance, discreet use and portability. In several clinical trials and market research studies, DosePro has been shown to be preferred by patients over conventional needle-based systems.
Zogenix has entered into an agreement with Battelle, an independent research and development organization, to co-market the DosePro technology to potential pharmaceutical and government clients with the objective of licensing the system for use with innovative therapeutics that would be enabled or enhanced by DosePro's unique needle-free delivery system. Compared to other delivery technologies, DosePro has the potential to solve the significant challenges of delivering viscous drug formulations, such as high concentration biologics, which cannot be delivered with traditional needle-based injection. The DosePro drug delivery technology is covered by more than 46 internationally issued patents extending through 2026.
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™ (hydrocodone bitartrate) is a novel, oral, single-entity (without acetaminophen) extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix submitted an NDA to the FDA for Zohydro in May 2012. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.
For additional information, please visit www.zogenix.com.
Forward Looking Statements
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 development of a commercially successful product, the initiation of clinical trials and results from such trials and the timing thereof, the ability of such product to address the global anti-psychotic market, the ability to develop a once-monthly injectable product with improved pharmacokinetics and significant reduction in injection volume, ability to achieve first-in-class status, partnering opportunities for Relday outside the United States, and leveraging the DosePro technology. 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 the timing and outcome of the FDA's review of the IND for Relday; difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to Relday; the market potential for anti-psychotics, and Zogenix's ability to compete within that market; 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 are trademarks of Zogenix, Inc.
SABER® is a trademark of DURECT Corporation.
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