Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

Oxford, UK and Warren, NJ, USA, 3 May 2012 – Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, today announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin.  The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas.  Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin.  Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd.

A. Mark Schobel, Co-President and CEO of MonoSol Rx, said “These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm. The rapid onset of action surpassed our expectations and we look forward to further clinical development of this exciting and new groundbreaking product.  Based on the success of this in-man study, which unequivocally validates the utility of our diverse pre-clinical animal models, we look forward to accelerating the entire product development program.”

Professor Thomas Rademacher, CEO and Chairman of Midatech, remarked:  “The success of Midaform Insulin PharmFilm demonstrates its safety, tolerability and potential use in treating diabetes, particularly meal-dependent hyperglycemia. This study is a significant step forward for the commercialization of this novel, non-injectable insulin formulation.  This trial shows the success of the MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings us closer to using nanomedicines in clinical practice.”

About Diabetes
Diabetes is a disease associated with high levels of blood glucose resulting from defects in insulin production, insulin action, or both. It is the seventh leading cause of death in the United States and can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations. According to the Centers for Disease Control, nearly 24 million people in the United States are currently living with diabetes. Globally, more than 230 million people are living with the disease and this number is expected to rise to 350 million within 20 years.

About MidaSol Therapeutics LLC.
MidaSol Therapeutics LLC. is a joint venture formed by Midatech Ltd. of Oxford, England and MonoSol Rx LLC of Warren, New Jersey. The JV company is dedicated to the development of new products for the treatment of diabetes, including existing therapeutics such as insulin and GLP-1, as well as new molecules. The JV utilizes proprietary technology of the parents in the fields of nanoparticles sourced from Midatech (Midaform™ )  and film technology from MonoSol Rx (PharmFilm® ) . All partnering for development and commercialization in the field of diabetes will be through MidaSol Therapeutics LLC, which is being advised by Ferghana Partners, a specialist investment bank in the biotech field.

About Midatech Ltd.
Midatech Ltd., UK, is a world leader in the design, synthesis and manufacture of glycan-coated biocompatible gold-nanoparticles. These nanoparticles can be used to create a wide variety of products with novel characteristics, functions and applications for a number of industry segments including life sciences, electronics and fine chemicals.

Founded in 2000, Midatech Ltd. is a private company headquartered in Abingdon, Oxford, UK. In 2005 it registered its manufacturing facility – Midatech Biogune S.L. – in Bilbao, Spain, which became fully operational for cGMP standard design and manufacturing of API nanoparticles In March 2007. In 2008 Midatech Ltd. further expanded with the opening of PharMida AG in Basel, Switzerland, which is responsible for clinical development of Midatech’s products. Midatech’s biocompatible nanoparticles possess a number of unique properties that make them ideal for diagnostic and therapeutic applications.

The nanoparticles are water soluble and can be designed to either diffuse freely in vivo, or to target specific cells. With a diameter of less than 5nm, unbound nanoparticles are freely excreted from the kidneys, reducing the likelihood of non-specific in vivo accumulation. Their size potentially enables drug delivery via different routes of administration, such as parental, transdermal, mucosal, intradermal transbuccal, sublingual or intranasal/inhalation. Their stability to enzymatic digestion may also permit oral therapy. Nanoparticles can be designed to be invisible to the host immune system with multiple ligands attached to a single nanoparticle allowing multivalent drug or multi-drug delivery on a single particle. In addition, as the nanoparticles self-assemble in a single step chemical process manufacturing is simple, safe, scalable and low cost.

Midatech Ltd. has exclusive world-wide IP for the technology covering design, manufacture and application/use of nanoparticles in both diagnostic and therapeutic pharmaceutical areas as well as in other industries. It also has exclusive world-wide rights for technology relating to the synthesis and applications of self-assembling nanoparticles.

For further company information see www.midatechgroup.com.

About MonoSol Rx LLC 

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone®  sublingual film, the first combination sublingual film product for the treatment of opioid dependence.

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