Biocon' US partner bags DGCI nod for diabetes drug

New Delhi, Feb 20 (UNI) Biocon Ltd today said its United States-based licensing partner Bentley Pharmaceuticals has been approved by the Drug Controller General of India (DCGI) to proceed with a phase II clinical evaluation of insulin drug, Nasulin.

Nasulin is Bentley's intranasal insulin product for type II diabetes formed by utilising its proprietary delivery technology CPE-215.

As per the licensing agreement, the company is responsible for developing and marketing Nasulin in India and select territories.

The company provides a source of insulin powder and US-based outsourced pharmaceutical development services provider Cardinal Health has manufactured the clinical supplies for this phase II study under contract with Bentley.

This 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.

''We are very excited about the progress made in the nasal insulin programme with Bentley. Biocon truly believes that non- injectable insulins will drive the future of diabetes therapy world over,'' company President (Marketing) Rakesh Bamzai said Clinigene, a CAP accredited CRO and wholly-owned subsidiary of the company, will administer the complex programme.

Data received from the Nasulin phase II programme in India will supplement Bentley's phase II studies already underway.

UNI