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GEN News Highlights : Jun 24, 2010

MonoSol Takes Equity Stake in Midatech as Firms Work to Combine Thin Film and Nanoparticle Therapeutics Technologies

Companies anticipate joint platform will allow targeted, oral delivery of proteins and peptides.

MonoSol Rx has made an equity investment in U.K.-based Midatech as part of the firms’ expanded agreement to combine Midatech’s nanoparticle-based therapeutic proteins and peptides with MonoSol’s PharmFilm® delivery technology. The new deal also sees MonoSol’s executive vp and CFO, Keith Kendall, join the Midatech board of directors.

Midatech and MonoSol have been working together since 2008 to marry their respective glyconanoparticle and PharmFilm technologies and formulate large, orally available molecules on film. MonoSol claims the expanded partnership follows on the back of positive preclinical data confirming the successful delivery of a 6,000 dalton polypeptide.

“Having demonstrated that the size and chemical composition of Midatech’ biocompatible nanocarriers are ideally suited for oral delivery using our PharmFilm technology we are continuing to jointly research and develop nanoparticle-based oral film formulations for certain peptides and proteins that are currently limited by their need to be injected or infused,” remarks A. Mark Schobel, MonoSol’s president and CEO.

“We believe that MonoSol’s PharmFilm technology is a stable and effective vehicle for delivering a therapeutic dose of our peptide carrying nanoparticles buccally or sublingually for specific indications, thereby eliminating the need for injection or more invasive delivery,” adds Tom Rademacher, Ph.D., Midatech chairman. “The synergy of our two technologies is particularly valuable in indications that can only be treated with injectables, as well as for certain proteins and peptides competing with small molecules for market share.”

Midatech is exploiting its self-assembling biocompatible nanoparticle technology to develop nanomedicines in fields including metabolic disorders and cancer. In addition to in-house projects the firm is working through partnerships to exploit the technology as a drug delivery platform.

It claims potential applications include the reformulation of drugs to extend patent life, increasing drug efficacy by overcoming toxicity or solubility issues, and enhancing drug uptake via novel delivery routes.

The expanded deal with MonoSol follows just a couple of weeks after Midatech reported teaming up with Mayo Clinic researchers to evaluate the feasibility of developing a nanoparticle-mediated delivery technology for the targeted delivery of plasmid DNA for therapeutic applications. Further clinical development of any programs resulting from the Mayo collaboration will be carried out at Midatech’s Switzerland-based drug development subsidiary PharMida.

MonoSol claims its thin film buccal or sublingual drug delivery technology is more stable, durable, and quicker dissolving than conventional dosage forms. Formulated to be about the size, shape, and thickness of a postage stamp, the film can carry from very low to large doses of highly uniform prescription products.

MonoSol has, to date, used its technology to commercialize seven products in the U.S. and Canadian OTC markets. In the field of prescription pharmaceuticals the firm is developing thin film formulations both in house and through collaborations with pharmaceutical partners.

The development programs are focused on approved drugs with expired or soon-to-be expired patents. Ongoing projects include thin film formulations of the asthma/allergy drug montelukast sodium, the nausea/vomiting treatment ondansetron, the antidepressant escitalopram, and the severe allergic reaction therapy epinephrine.

Strativa Pharmaceuticals acquired exclusive U.S. commercialization rights to MonoSol’s ondansetron oral soluble film (OSF) product in June 2008. The ondansetron product NDA was accepted for review by FDA in June 2009, and a response is expected this year. The drug will be marketed under the tradename Zuplenz™.

In January 2010 the MonoSol and Strativa announced a new licensing and development agreement granting the latter exclusive U.S. commercialization rights to three additional OSF products developed using MonoSol’s technology.