MonoSol Rx partners on film flu vaccine development

MonoSol Rx says oral film vaccine collaboration could deliver product with compliance and storage benefits.

The idea behind the new partnership is to use MonoSol’s PharmaFilm platform to create a needle-free version of Israel-based vaccines developer BiondVax’s M-001, which is currently being examined in Phase II clinical trials.

MonoSol CEO Mark Schobel, said: "We have believed for some time in the significant advantages PharmFilm can offer in the delivery of a broad range of vaccines.

“We view this partnership with BiondVax as an opportunity to demonstrate the clear advantages our proprietary PharmFilm technology platform offers the vaccine industry.

He also suggested that: “Storage and distribution will also be enhanced by the film formulation, which is stable at room temperature, making vaccination easier for large numbers of patients.”

The collaboration – financial terms of which were not disclosed – follows just two months after MonoSol said it was using its oral film technology to develop a candidate treatment for migraine.

Patent spat

In other PharmaFilm news, MonoSol Rx recently announced that challenges to its technology patents brought by competitor BioDelivery Sciences International have been defeated.

Schobel said: “We are pleased that MonoSol Rx has successfully resolved the two reexaminations originally brought by BDSI in an attempt to delay a pending patent infringement suit brought by MonoSol Rx regarding Onsolis.

"The bottom line is that BDSI's attempt to have the PTO invalidate two of MonoSol Rx's PharmFilm patents has been unsuccessful. As we move forward as a company, we understand that, as competitors seek to copy our patented technologies, we will face additional validity challenges, especially where our competitors know they are infringing our patents.

MonoSol and BioDelivery have been involved in a number of patent disputes over the years. The heart of the issue is that while BDSI holds patents for the BEMA technology, it does not hold any for the manufacturing processes it and contract manufacturing organisation (CMO) Aveva use to make Onsolis. Instead BDSI regards these methods as a company trade secret.