SAN DIEGO and COLUMBUS, Ohio, March 27, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and Battelle, the world's largest independent research and development organization, today announced they have extended their co-marketing partnership for the DosePro® needle-free drug delivery system through March 29, 2014. The partnership is focused on advancing out-licensing opportunities for DosePro, with a focus on co-marketing the technology to potential biopharmaceutical and government clients.
William Dunlevy, Vice President and General Manager, Process and Product Development at Battelle, said, "Over the course of the past year, we have worked closely with Zogenix to develop and implement a focused co-marketing campaign that highlights key attributes of the DosePro needle-free delivery system. We have received positive feedback regarding our study of DosePro delivery of a monoclonal antibody and our self-injection survey of patients with rheumatoid arthritis. These findings clearly demonstrate the benefits and capabilities of the DosePro system. This has driven strong interest in the DosePro technology from our clients, particularly in the delivery of highly viscous formulations and biologics."
The campaign highlights a study by Battelle that demonstrates the ability of the DosePro system to effectively deliver a monoclonal antibody therapeutic, AbbVie'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, commented, "In the three years since its launch, we have produced more than 2 million commercial units of our first commercial DosePro product, SUMAVEL® DosePro®. The introduction of a needle-free delivery option has reinvigorated growth of injectable sumatriptan, including from patients that were previously not interested due to needle-phobia and/or the complexity of delivery. We are pleased to provide an enhanced needle-free option for these patients and look forward to continue working with Battelle to introduce the benefits of the DosePro system to potential partners in the biopharmaceutical and government sectors."
In accordance with the extension of their co-marketing partnership, Zogenix and Battelle will continue to market DosePro, using the "Less is More" campaign, to Battelle's clients in strategic product planning meetings, at medical and industry conferences, in trade publications, and through other marketing communications. The campaign, which was launched in July 2012, emphasizes the simplicity and benefits of the DosePro technology and its ability to provide instantaneous, needle-free, subcutaneous drug delivery. For more information on licensing opportunities using the DosePro platform contact Battelle at 1-800-201-2011 or firstname.lastname@example.org.
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.
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.
As the world's largest independent research and development organization, Battelle provides innovative solutions to the world's most pressing needs through its four global businesses: Laboratory Management; National Security; Health and Life Sciences; and Energy, Environment and Material Sciences. It advances scientific discovery and application by conducting $6.5 billion in global R&D annually through contract research, laboratory management and technology commercialization. Headquartered in Columbus, Ohio, Battelle oversees 22,000 employees in more than 130 locations worldwide, including seven national laboratories which Battelle manages or co-manages for the U.S. Department of Energy, the U.S. Department of Homeland Security, and a nuclear energy lab in the United Kingdom.
Battelle also is one of the nation's leading charitable trusts focusing on societal and economic impact, and actively supporting and promoting science, technology, engineering and mathematics (STEM) education.
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 out-license 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 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.
HUMIRA® is a trademark of AbbVie.
CONTACT: Zogenix Contacts: Investors Zack Kubow | The Ruth Group 646.536.7020 | email@example.com Media Caitlin Cox | The Ruth Group 646.536.7033 | firstname.lastname@example.org Battelle Contacts: Katy Delaney 614.424.7208 | email@example.com T.R. Massey 614.424.5544 | firstname.lastname@example.org
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