Signing the letter of intent (LOI) gives Zogenix a partner with the capabilities and contacts to expand use of DosePro. Zogenix uses the device with its in-house portfolio and is now seeking out-licensing deals.
“[The LOI] allows Zogenix to leverage Battelle’s marketing capabilities and existing relationships. Battelle has an existing worldwide client base in life sciences”, Victoria Aguiar, a spokesperson for Zogenix, told in-PharmaTechnologist.
DosePro consists of a prefilled drug capsule and a nitrogen gas-powered actuator. When primed and pressed against the skin the device delivers a blast of the drug at high pressure. This penetrates the skin and allows the rest to be delivered at a lower pressure to ensure accurate administration.
If the device is out-licensed Battelle will have the option to participate in further development of DosePro. The role of Zogenix in further development of the device is “subject to negotiations in conjunction with other terms of a license agreement”, Aguiar said.
Efforts to make the device more attractive to potential licensees have already begun though. “Before signing an LOI with Battelle, Zogenix has been pursuing development of a 1ml delivery device”, Aguiar said.
Increasing the device’s capacity above 0.5ml is the “next logical step” in development of DosePro, Aguiar said, and would “fulfil the requirements for most biologic formulations”.
Zogenix has designed DosePro to work with liquid and highly viscous formulations. The device is also suitable for self-administration and Zogenix has data demonstrating delivery without shear induced degradation.
Zogenix uses the device for its in-house portfolio and will keep the rights for use of DosePro in its core therapeutic areas, which include migraine, epilepsy and anti-psychotics. Out-licensing DosePro for use in other therapeutic areas could give Zogenix a revenue source to supplement product sales.
In the first nine months of the year Zogenix doubled its revenues but still posted an operating loss of $55.8m (€42.5m). Over this period Zogenix “did not recognise any product revenues...in sales under license arrangements”, the company said in a regulatory filing.
Asked if Zogenix was trying to out-license the device before the deal with Battelle, Aguiar said: “Zogenix believes that the advantages brought by Battelle will substantially accelerate success in DosePro technology out-licensing.”