Biocon partner gets nod for trial of diabetic drug

Bangalore-based biotech major Biocon has announced that its licensing partner, Bentley Pharmaceuticals, has received approval from the Drugs Controller General of India (DCGI) to proceed with a Phase II clinical evaluation of Nasulin in Type II diabetic patients.

Nasulin is Bentley's intranasal insulin product utilising its proprietary delivery technology (CPE-215) which enhances the absorption of drugs across membranes of the skin, mouth, nose, vagina and eye.

Biocon in a release said that as per the licensing agreement, the company is responsible for developing and marketing Nasulin in India and a few other markets and will provide a source of insulin powder and clinical supplies for this Phase II study under contract with Bentley.

The DGCI approval follows the completion of Bentley's pharmacokinetic clinical studies of Nasulin in India. The Phase II study will be initiated in March 2007 and is expected to be completed before the end of the year.

According to Rakesh Bamzai, president-marketing, Biocon: "We are very excited about the progress made in the nasal insulin programme with Bentley. Biocon believes that non-injectable insulins will drive the future of diabetes therapy the world over."

Clinigene, a clinical research organisation (CRO) and a subsidiary of Biocon, is expected to administer the programme.

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.