New Long-Term Agreement Reflects Significant Opportunities to Out-License DosePro Technology
SAN DIEGO and COLUMBUS, Ohio, Dec. 3, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX) and Battelle today announced that they have entered into a new long-term collaborative agreement regarding co-marketing of Zogenix's DosePro® needle-free drug delivery technology, advancing potential out-licensing opportunities for DosePro with biopharmaceutical clients, and expanding the application of the technology to higher-dose biologic therapies.
The new five-year contract also establishes Battelle as the preferred provider of development services for the DosePro technology. Zogenix plans to leverage the substantial technical resources and capabilities of Battelle's drug delivery business for expertise in self-injection system design, human factors and device engineering as the companies further develop DosePro targeting dose volumes in excess of 1mL to accommodate a greater number of biopharmaceutical drug candidates.
The companies began co-marketing and product testing in March 2012, and the agreement builds on the success of the companies' relationship since then. During this period, the companies launched the "Less is More" marketing campaign, completed and presented studies supporting the use of DosePro with biologics, and presented patient research demonstrating preference for needle-free injection technology. The research, which queried 300 rheumatoid arthritis patients, demonstrated a significant 30 percent increase in patient acceptance of self-injected medication when a needle-free option was offered. In addition, the companies completed a study that demonstrated the ability of the DosePro technology to effectively deliver a monoclonal antibody therapeutic, AbbVie Inc.'s Humira® (adalimumab). The in vitro study showed that DosePro can deliver Humira without incremental risk to protein denaturation and equivalent biological integrity as compared to delivery by pre-filled syringe.
John Turanin, Vice President and General Manager, DosePro Technology, at Zogenix, said, "Through our co-marketing agreement with Battelle, we have expanded awareness of the DosePro needle-free drug delivery system. Battelle has proved to be a strong technical and business development ally and interest in the DosePro technology from biopharmaceutical companies has significantly increased because of Battelle's support. We are pleased with our progress and continue to believe there is significant potential to out-license DosePro for the delivery of biologics. Our new 5-year agreement with Battelle underscores both companies' commitment to achieving this goal, which includes executing on near-term and future opportunities."
"The DosePro technology offers the opportunity to solve major challenges in self-administration of important biologic therapies," added William Dunlevy, Vice President and General Manager, Process and Product Development at Battelle. "DosePro's advantages in delivery of highly viscous formulations and its attributes which support protein stability are unmatched by standard autoinjector technology, and offer valuable options to our biopharmaceutical clients."
The DosePro system is a first-in-class, easy-to-use drug delivery system designed for self-administration of a pre-filled, single dose of sterile liquid drug, subcutaneously, without a needle. The platform is currently used by Zogenix's first commercial product, SUMAVEL® DosePro®. The Company believes that DosePro offers several benefits to patients compared to other subcutaneous needle-based delivery methods, and that it has the potential to become a preferred delivery option for patients and physicians. These benefits include instantaneous automatic delivery, 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 administration process, no need to fill the device prior to use, 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, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with central nervous system disorders and pain-related conditions who need innovative treatment alternatives to help them return to normal daily functioning. Zogenix recently received FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules, the first extended-release oral formulation of hydrocodone without acetaminophen. Zogenix developed and commercialized the first needle-free subcutaneous injection, SUMAVEL® DosePro® (sumatriptan injection) for migraine and cluster headache. The development pipeline for Zogenix includes a once-monthly subcutaneous injection for schizophrenia.
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.
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," "designed" 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 the ability to successfully co-market and out-license the DosePro technology and expand the application of the DosePro technology to higher-dose biologic therapies. 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 press release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to DosePro and obtaining regulatory approval for other DosePro products; risks associated with the development of a larger volume, second generation version of the DosePro technology to accommodate drug formulation volumes greater than 0.5 mL; the potential that earlier pre-clinical studies of DosePro may not be predictive of future pre-clinical or clinical results; the scope, validity and duration of patent protection and other intellectual property rights for DosePro; the impact of any inability to raise sufficient capital to fund ongoing operations; and other risks described in Zogenix's 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 press 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.
HUMIRA® is a trademark of AbbVie Inc.
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