In a major development in the intranasal insulin development programme between Biocon Limited and its licensing partner, Bentley Pharmaceuticals, Inc., Drugs Controller General of India (DCGI) has cleared the companies to proceed with a phase II clinical evaluation of 'Nasulin' in type II diabetic patients. This approval follows the completion of Bentley's pharmacokinetic clinical studies of Nasulin studies in India. The intranasal insulin product is a one-of-a kind in the world.

The phase II clinical studies for this product will have 80 patients and will be conducted in six centres in India under the direction of top clinical investigators. The patients will self-administer Nasulin spray three times per day for twelve weeks. They will be monitored for control of their post-prandial blood sugar and HbA1c (a subtype of haemoglobin, used to measure effectiveness of the therapy). The study will be initiated in March 2007 and is expected to be completed before the end of the year.

Biocon, is of the view that non injectable insulin would drive the future of diabetes therapy globally, stated Rakesh Bamzai, president marketing, Biocon Limited.

On the market potential for the one-of-the-kind product in the world, Bamzai added that the potential was huge which at the moment could not be estimated. But with the completion of the study and patient compliance to the product, we ill analyse the market size and logistics of promotion thereafter, he informed.

"However, the product positioning is unique in the sense that the delivery of insulin via the nasal mucous membrane is our key differentiating factor with a high safety profile. "We are looking at huge market potential with insulin and its delivery systems, he stated.

Data received from the Nasulin phase II programme in India will supplement Bentley's phase II studies already underway in the US under the direction of Dr Sherwyn Schwartz at the Diabetes and Glandular Disease Clinic (DGD) in Texas. Bentley also expects to complete a significant portion of the US phase II studies before the end of 2007.

Nasulin from the Bentley stables was developed utilizing its proprietary delivery technology CPE-215. According to the licensing agreement, Biocon is responsible for developing and marketing Nasulin in India and select territories. The Indian biotech major provides a source of insulin powder and Cardinal Health has manufactured the clinical supplies for this phase II study under contract with Bentley.

According to John Sedor, president, Bentley Pharmaceuticals the clinical development of Nasulin has allowed the company to accumulate data in the insulin programme. "This would further validate our intranasal delivery technology platform and its potential to deliver other therapeutic peptides in similar formulations to insulin."

Biocon subsidiary, Clinigene, a CAP accredited CRO led by Dr. A S Arvind, chief operating officer, would administer the complex programme .

James Murphy, chairman and CEO, Bentley stated "Biocon has been a reliable partner for several years and has significant experience in developing insulin products. The Bentley researchers together with the clinicians and regulatory staff of Biocon and its subsidiaries are fully committed to the clinical advancement of Nasulin."

Bentley Pharmaceuticals is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and central nervous system diseases through its subsidiaries -- Laboratories Belmac, Laboratories Davur, Laboratories Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API