Collaboration Opens Possibilities for New DosePro Applications That Offer Validated Needle-Free Subcutaneous Drug Delivery to Bio-Pharma Community
SAN DIEGO and COLUMBUS, Ohio, Mar 29, 2012 -- Zogenix, Inc., 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 finalized their previously announced collaborative agreement to advance out-licensing opportunities and development of Zogenix's DosePro(R) drug delivery technology. Battelle and Zogenix will co-market 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.
DosePro offers increased safety and convenience compared to needle-based injection via syringes or auto-injectors by providing a pre-filled, single-use, disposable, needle-free drug delivery system that is easy to use and preferred by patients. 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 has produced in excess of 1.5 million units of the company's migraine therapy, SUMAVEL(R) DosePro(R), which has received approval in the United States and Europe using the DosePro technology. Patient experience has demonstrated that patients will switch from oral to injectable formulations when provided the option of using SUMAVEL DosePro, despite the availability of a needle-based product for over a decade.
John Turanin, Vice President and General Manager, DosePro Technology, at Zogenix, states, "Battelle has a strong reputation for product development that has earned them a 'who's who' client list in the pharmaceutical industry. Collaborating on DosePro provides additional support of our technology and the backing of a significant technical business partner. We expect the out-licensing effort to accelerate now that we are working with Battelle. We have already trained their business development team and are expanding laboratory capabilities to begin working on DosePro product candidates."
Barbara Kunz, President of Battelle Health and Life Sciences Global Business, said, "This collaboration enables Battelle to expand our platform of innovative drug delivery solutions to our pharmaceutical customers. We believe DosePro will be able to assist our clients with addressing many of the challenges they face today, in particular, the delivery of highly viscous drug formulations."
Battelle's business development professionals responsible for life and health sciences will market DosePro to their customers in strategic product planning meetings, at conferences, in trade publications, and through other marketing communications. The technical teams from both Battelle and Zogenix are working together to create a center of excellence for DosePro technology development and testing within Battelle's laboratories. Battelle has the option to enter into an agreement with Zogenix to jointly develop and commercialize an iteration of the DosePro technology which delivers a larger dose (1.2mL) than the current dose size of 0.5mL.
For more information on licensing opportunities using the DosePro platform contact Michael Chansler from Battelle at (206) 588-9827 or [email protected]
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 liquid drug, subcutaneously, without a needle. The platform is currently used by Zogenix's first commercial product, SUMAVEL DosePro(R), 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, Inc. ZGNX +5.00% , 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(R) DosePro(R) (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(TM) (hydrocodone bitartrate), is a novel, oral, 12-hour extended-release formulation of hydrocodone without acetaminophen for the treatment of moderate to severe chronic pain requiring around the clock opioid therapy which has recently completed Phase 3 clinical trials. Zogenix's second DosePro investigational product candidate, Relday(TM), is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.
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 and 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.
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 ability to successfully out-license the DosePro technology and the timing thereof, the ability of DosePro to solve the significant challenges of delivering viscous drug formulations, Battelle's exercise of the DosePro 1.2 mL option, the expected duration of patent protection for the DosePro technology and the likelihood that patients will switch from oral to injectable formulations when provided the option. 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: 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; and the scope, validity and duration of patent protection and other intellectual property rights for DosePro; 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(R), DosePro(R), Relday(TM) and Zohydro(TM) are trademarks of Zogenix, Inc.