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Puff the magic drug-delivery system
SAN DIEGO, Calif.—Zogenix Inc., a pharmaceutical company that specializes in products for the treatment of central nervous system disorders and pain, and Battelle, an independent research and development organization headquartered in Columbus, Ohio, have announced what they have characterized as a unique collaboration with the objective of advancing the development and commercialization of Zogenix's DosePro drug delivery technology. Battelle has been evaluating DosePro over the past year based on the collaboration that was set in motion by individuals in the two organizations who had worked together before.
The companies have signed a letter of intent to enter into an exclusive co-marketing and technology development agreement to utilize Zogenix's DosePro needle-free drug delivery technology for new commercial out-licensing opportunities. DosePro enables needle-free medication delivery under the skin. Instead of a needle injection, DosePro uses a small amount of compressed gas to deliver a liquid formulation through the skin as a thin jet of medication. According to Zogenix, DosePro is the world's only commercially available, single-use, disposable, needle-free, subcutaneous delivery technology.
"This is part one of a longer-term relationship envisioned by the two parties," says John Turanin, vice president and general manager of DosePro Technology at Zogenix. "Battelle will represent the technology to its clients at conferences, in advertising and published papers. We will set Battelle up as a center of excellence where pharma can test products and where Battelle will perform studies on behalf of clients."
In the joint marketing arrangement, Zogenix and Battelle intend to offer Zogenix's novel DosePro technology to pharmaceutical and biotechnology firms to develop and commercialize innovative drug delivery products for development pipelines and for lifecycle management of marketed prescription drugs and biologics, subject to Zogenix and Battelle executing a definitive agreement on the terms contemplated by the non-binding letter of intent. In addition, Battelle will have the option to participate directly in further development of DosePro technology. This work, for which Zogenix has completed prototype design, is intended to broaden the capability of the technology to deliver larger-dose volumes required for high-dose biological products. The Zogenix prototype currently delivers a 0.5 ml dose, while the Zogenix-Battelle joint venture version hopes to deliver 1.2 ml.
Zogenix's DosePro has received regulatory approvals in the United States and Europe, and is covered by more than 46 international issued patents extending through 2026. Zogenix has shipped in excess of 1.5 million DosePro units of the company's approved migraine therapy, SUMAVEL DosePro, and patient experience has demonstrated that they will switch from oral to injectable formulations when provided the option of using DosePro.
"Safety and efficacy provide the basis for preference," says Turanin, who notes that in migraine, maximum dosage is reached faster with DosePro than with oral administration. "DosePro can provide sustainable competitive advantages for many injectable drugs, especially biologics," Turanin adds.
He notes that up to 100 monoclonal antibodies are currently delivered parenterally and are candidates for DosePro. In situations where viscosity prevents needle/syringe delivery, DosePro administration works "just like it's water," Turanin says. "With Battelle's expertise in product development and strong relationships with biopharmaceutical companies, we can now match DosePro technology to drug candidates in a more efficient manner by providing customizable drug delivery solutions that can effectively deliver biologics, vaccines and other critical drugs. We believe this arrangement will accelerate entry into licensing agreements with major pharmaceutical companies."
"We believe DosePro features market-leading technology for the safe and effective delivery of biologics, especially high-viscosity formulations, which is critically important to our customers," states Barbara Kunz, president of Battelle Health and Life Sciences Global Business. "This collaboration will enhance our ability to extend our leadership in drug delivery technology development to create innovative solutions for the pharmaceutical industry. "