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Diabetology Ltd and USV Limited, a Leading Indian Pharmaceutical Company, Announce an Exclusive Licence Agreement to Develop and Commercialise Oral Insulin for the Indian Market


7/31/2012 11:39:54 AM

July 31, 2012 - Diabetology Limited, the award-winning diabetes biopharmaceutical company, and Mumbai-based USV Limited, India’s leading pharmaceutical company, which has a leadership position in the Indian oral anti-diabetic market, are pleased to announce that they have entered into a licence agreement to complete the development and commercialisation of Diabetology’s Oral Insulin for the Indian market.

Under the terms of the agreement, Diabetology will receive milestone payments and royalties on sales as the product completes development, regulatory and commercialisation milestones. USV will spearhead the development process in India and, once regulatory approval is gained, will be responsible for the commercialisation of Diabetology’s Oral Insulin within the large and rapidly growing Indian diabetes market. The collaboration looks forward to offering an important new therapeutic product to the more than 60 million people with diabetes in India.

Diabetology’s Oral Insulin offers potential major benefits to those with diabetes as well as to their clinicians and carers. Diabetology’s Oral Insulin candidate benefits not only from the opportunity of administering insulin in a convenient, easy-to-swallow capsule, especially important for the young, elderly or needlephobic, but also from important potential safety and efficacy benefits due to its route of delivery mimicking the body’s natural route of insulin production.

Dr Roger New, Diabetology’s CSO and Co-Founder, explained “through its use of the innovative Axcess™ delivery system, Diabetology’s Oral Insulin carries insulin into the body via the liver, the primary organ of glycemic control, and thereby offers the potential for reduced glucose fluctuations and reducing debilitating long-term side-effects.”

Commenting on the licensing of oral insulin from Diabetology, Mr. Prashant Tewari, Managing Director, USV Limited said, “this is a significant event for USV, bringing together an important new candidate treatment for the millions of Indians with diabetes. Being the leader in the oral diabetic segment in India it has been our endeavour to bring the best possible therapeutic solutions to the vexed and growing problem of diabetes in India. We believe that an Oral Insulin preparation will be a major leap forward and we plan to put our Research and Development capabilities in carrying forward the promising technology that Diabetology has worked on and bringing it to the Indian patients through our sales and marketing network.”

Diabetology’s Co-founder and Chairman, Glen Travers, added, “we see this is an important event for Diabetology and for all those with or affected by diabetes; having successfully taken our lead product Oral insulin through clinical proof of concept studies, and received international recognition of its potential, we now look forward to seeing USV take this important treatment option forward to the many Indian patients that require improved management of their diabetes.” The management team of Diabetology is pleased to be announcing this transaction with a substantial Indian diabetes company and wishes to recognise the support extended by the UK Trade & Investment (UKTI), UK BioIndustry Association (BIA) and the UK India Business Council.

About Diabetology Limited

Diabetology is an award-winning specialty biopharmaceutical company employing a proprietary oral delivery system to administer known bioactives as well as novel compounds for the comprehensive management of diabetes.

Diabetology's lead project is Capsulin Oral Insulin, an oral encapsulated formulation of recombinant human insulin for the treatment of patients with type 1 and type 2 diabetes. Diabetology intends to develop Capsulin both as a novel oral anti-diabetic agent for the treatment of patients with type 2 diabetes (Capsulin OAD) and as an alternative to injected insulin for insulin dependent patients suffering from type 1 and type 2 diabetes (Capsulin IR).

Diabetology also has in development an Oral GLP-1 programme that has shown promise in preclinical studies. The company’s innovative drug delivery technology, Axcess™ Oral Drug Delivery System, significantly increases the absorption of peptides, proteins and other macromolecules across the intestinal wall when delivered orally without any chemical modification of the active compounds. It is based on a simple mixture of components consisting entirely of registered pharmacopoeial or GRAS excipients with a long history of pharmaceutical use. The absorption enhancing activities obtained from the formulation of these excipients is entirely novel and forms the basis of five international patent families. Diabetology has in licensed exclusive rights to Axcess™ for the formulation of oral therapies for diabetes.

For more information, please visit www.diabetology.co.uk.

About USV Limited

USV Ltd is a leading Indian pharmaceutical company with product presence in markets around the globe including USA & Europe. In India, USV Ltd is a market leader in Diabetes, Cardiology & Probiotic segments and has a good presence in nutritionals segment. For more information, please visit www.usvindia.com.

For more information contact:

Timothy P. Broke-Smith

Chief Operating Officer

Diabetology Limited

Tel: +44 (0)20 7193 8363

Email: t.broke-smith@diabetology.co.uk


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