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Zogenix and Battelle to Present Positive, New Data Demonstrating Value of Needle-Free Injection for Biologics

SAN DIEGO and COLUMBUS, Ohio, May 20, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX) and Battelle Memorial Institute today announced new data supporting the value of the DosePro® needle-free injection technology in the delivery of biologics. The positive, new data will be presented in four poster presentations, including two posters co-authored by MedImmune, LLC, the worldwide biologics research and development arm of AstraZeneca plc, and Zogenix; and two posters co-authored by Battelle and Zogenix, at the 2013 American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference, May 20-22, 2013 in San Diego.

The data presented in these posters show that the DosePro technology is compatible with monoclonal antibodies formulations and a range of biologic formulation viscosities which are challenging to deliver via standard autoinjector technologies. The studies found that injection of these formulations were within the acceptable criteria for injection time and peak pressure and that there were no changes in molecular integrity, observable tertiary structure, purity or potency following injection. The data also show that needle-free technology such as DosePro has the potential to positively impact patient acceptance of self-injectable therapies, leading to greater adoption and adherence of subcutaneously administered biologics.

John Turanin, Vice President and General Manager, DosePro Technology, at Zogenix, commented, "This new data represents an important step in addressing the need for delivery technology for biologics by demonstrating DosePro's compatibility with the viscous formulations and the impact of needle-free delivery on patient confidence. We believe the AAPS National Biotechnology Conference will be an excellent forum to introduce the DosePro system to potential biopharmaceutical partners looking for innovative delivery technology solutions for their current and future self-injection therapies."

The four posters to be presented at the AAPS National Biotechnology Conference include:

  • In Vitro Integrity of Two Recombinant Human Monoclonal Antibodies after Instantaneous Injection by DosePro® Delivery Technology; Poster# M1012
  • Injection Performance Assessment of Monoclonal Antibody Formulation Viscosity mimics Using an Instantaneous Injection Technology; Poster# M1013
  • Adoption, Adherence, and Preferences Regarding Injectable Drug Delivery by Patients with Rheumatoid Arthritis: Results of a Research Survey; Poster# T2010
  • Devices for Delivery of Viscous Protein Formulations and their Impact on Protein Structure; Poster# T2012

Battelle will feature the DosePro system at its booth (#413) at the AAPS National Biotechnology Conference. For more information on licensing opportunities using the DosePro platform contact Battelle at 1-800-201-2011 or solutions@battelle.org.

About DosePro®

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 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.

About Zogenix

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.

About Battelle

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.

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," "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 potential benefits of needle-free technology such as DosePro and the potential to partner the DosePro technology with biopharmaceutical companies. 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 may not be predictive of future pre-clinical or clinical results; and 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.

SODAS® is a trademark of Alkermes Pharma Ireland Limited.

FPR

CONTACT: Zogenix Contacts: Investors Zack Kubow | The Ruth Group 646.536.7020 | zkubow@theruthgroup.com Media Caitlin Cox | The Ruth Group 646.536.7033 | ccox@theruthgroup.com Battelle Contacts: Katy Delaney 614.424.7208 | delaneyk@battelle.org T.R. Massey 614.424.5544 | masseytr@battelle.orgSource:Zogenix;Battelle Memorial Institute