Zogenix, Inc., a pharmaceutical company commercializing and developing products for the treatment of CNS disorders and pain, and Battelle, the largest independent research and development organization, finalized their previously announced collaborative agreement to advance out-licensing opportunities and development of Zogenix's DosePro 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 DosePro, 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.
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, 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.