Puff the magic drug-delivery system

SAN DIEGO, Calif.—Zogenix Inc., a pharmaceutical companythat specializes in products for the treatment of central nervous systemdisorders and pain, and Battelle, an independent research and developmentorganization headquartered in Columbus, Ohio, have announced what they havecharacterized as a unique collaboration with the objective of advancing thedevelopment and commercialization of Zogenix's DosePro drug deliverytechnology. Battelle has been evaluating DosePro over the past year based onthe collaboration that was set in motion by individuals in the twoorganizations who had worked together before.

The companies have signed a letter of intent to enter intoan exclusive co-marketing and technology development agreement to utilizeZogenix's DosePro needle-free drug delivery technology for new commercialout-licensing opportunities. DosePro enables needle-free medication deliveryunder the skin. Instead of a needle injection, DosePro uses a small amount ofcompressed gas to deliver a liquid formulation through the skin as a thin jetof medication. According to Zogenix, DosePro is the world's only commerciallyavailable, single-use, disposable, needle-free, subcutaneous deliverytechnology.

"This is part one of a longer-term relationship envisionedby the two parties," says John Turanin, vice president and general manager ofDosePro Technology at Zogenix. "Battelle will represent the technology to itsclients at conferences, in advertising and published papers. We will setBattelle up as a center of excellence where pharma can test products and whereBattelle will perform studies on behalf of clients."

In the joint marketing arrangement, Zogenix and Battelleintend to offer Zogenix's novel DosePro technology to pharmaceutical andbiotechnology firms to develop and commercialize innovative drug deliveryproducts for development pipelines and for lifecycle management of marketedprescription drugs and biologics, subject to Zogenix and Battelle executing adefinitive agreement on the terms contemplated by the non-binding letter ofintent. In addition, Battelle will have the option to participate directly infurther development of DosePro technology. This work, for which Zogenix hascompleted prototype design, is intended to broaden the capability of thetechnology to deliver larger-dose volumes required for high-dose biologicalproducts. The Zogenix prototype currently delivers a 0.5 ml dose, while theZogenix-Battelle joint venture version hopes to deliver 1.2 ml.

Zogenix's DosePro has received regulatory approvals in theUnited States and Europe, and is covered by more than 46 international issuedpatents extending through 2026. Zogenix has shipped in excess of 1.5 millionDosePro units of the company's approved migraine therapy, SUMAVEL DosePro, andpatient experience has demonstrated that they will switch from oral toinjectable formulations when provided the option of using DosePro.

"Safety and efficacy provide the basis for preference," saysTuranin, who notes that in migraine, maximum dosage is reached faster withDosePro than with oral administration. "DosePro can provide sustainablecompetitive advantages for many injectable drugs, especially biologics,"Turanin adds.

He notes that up to 100 monoclonal antibodies are currentlydelivered parenterally and are candidates for DosePro. In situations whereviscosity prevents needle/syringe delivery, DosePro administration works "justlike it's water," Turanin says. "With Battelle's expertise in productdevelopment and strong relationships with biopharmaceutical companies, we cannow match DosePro technology to drug candidates in a more efficient manner byproviding customizable drug delivery solutions that can effectively deliverbiologics, vaccines and other critical drugs. We believe this arrangement willaccelerate entry into licensing agreements with major pharmaceuticalcompanies."

"We believe DosePro features market-leading technology forthe safe and effective delivery of biologics, especially high-viscosityformulations, which is critically important to our customers," states BarbaraKunz, president of Battelle Health and Life Sciences Global Business. "Thiscollaboration will enhance our ability to extend our leadership in drugdelivery technology development to create innovative solutions for thepharmaceutical industry."