MonoSol Rx, a developer of PharmFilm drug delivery technology, and Midatech Group, a provider of nanomedicines, has reported their intent to form a joint venture that will focus on the development and commercialisation of products combining the two companies' respective technologies in the diabetes field.
Initially, the joint venture will focus on commercialising buccally delivered insulin with an appropriate partner.
Additionally, the companies have evaluated the safety of the nanoparticles in tolerability, acute and chronic toxicity studies in multiple species with no evidence of adverse effects.
In support of an investigational new drug (IND) submission for human clinical studies, Midatech and MonoSol Rx are concluding additional pre-clinical studies of buccally delivered insulin in diet-induced diabetic primates and expect to announce data by year’s end 2010.
MonoSol Rx president and CEO Mark Schobel said based on the results of their pre-clinical studies to date, Midatech and MonoSol Rx intend to accelerate the development of Nanoinsulin PharmFilm, which they believe has the potential to offer an unprecedented treatment option for diabetes sufferers around the world.
The mission of the joint venture will be to address the longstanding unmet need of millions of diabetics who are dependent on insulin injections and who lack a convenient, non-invasive delivery option.
Midatech Group professor and chairman Tom Rademacher said following preclinical proof-of-mechanism studies for Nanoinsulin PharmFilm, their collaboration with MonoSol Rx has achieved results in delivering proteins across the buccal mucosa utilising PharmFilm and their nanoparticle technology.
"Bioavailability studies in multiple species have demonstrated repeatedly that Nanoinsulin PharmFilm delivers significantly more bioactive insulin than all previous attempts to deliver insulin across the oral mucosa or the gastrointestinal tract," Rademacher said.