MonoSol to Form JV with Midatech to Commercialize Therapeutic Insulin Dose

MonoSol Rx, the developer of PharmFilm® drug delivery technology, and Midatech Group Ltd., a global leader and centre of excellence for the design, development, synthesis and manufacture of nanomedicines, today announced their intent to form a joint venture that will focus on the development and commercialization of products combining the two companies' respective technologies in the diabetes field.

Initially, the joint venture will focus on commercializing buccally delivered insulin with an appropriate partner.

Preclinical testing in multiple species has demonstrated the companies' ability to deliver active insulin across the buccal mucosa and to decrease circulating levels of glucose in all animal models. Additionally, the companies have successfully 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. The companies plan to initiate Phase I clinical trials during the second quarter of 2011.

A. Mark Schobel, president and CEO of MonoSol Rx, stated, "Based on the results of our pre-clinical studies to date, Midatech and MonoSol Rx intend to accelerate the development of Nanoinsulin™ PharmFilm, which we believe has the potential to offer an unprecedented treatment option for diabetes sufferers around the world. The strength of the data generated so far, and the early indications from our primate study, give us confidence that our nanoparticle oral film platform is capable of delivering a therapeutic insulin dose into the systemic circulation and thus look forward to initiating human clinical trials in early 2011. For the future, it's important to acknowledge that the combination of our respective technologies is applicable to other biologics, and we look forward to exploring additional opportunities together."

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. Nanoinsulin PharmFilm has the potential to offer diabetic patients the first-ever truly-oral alternative to injectable insulin, and to revolutionize the growing multi-billion dollar global diabetes treatment market.

Professor Tom Rademacher, Chairman of the Midatech Group, remarked, "Following preclinical proof-of-mechanism studies for Nanoinsulin PharmFilm, our collaboration with MonoSol Rx has achieved groundbreaking results in delivering proteins across the buccal mucosa utilizing PharmFilm and our 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.

"Based on the existing bioavailability data, the companies believe that the Nanoinsulin PharmFilm offers a significant commercial opportunity and are committed to moving the product into the clinic. Forming a joint venture represents an important step forward in our collaboration and in the pursuit of delivering a predictable dose of insulin in a convenient, transbuccal dosage form for millions of diabetics worldwide."



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