Biocon Ltd on February 20, 2007 has announced that its licensing partner, Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical Company, has received approval from the Drug Controller General of India (DCGI) to proceed with a Phase II clinical evaluation of NasulinTM in Type II diabetic patients. NasulinTM is Bentley's intranasal insulin product utilizing its proprietary delivery technology CPE-215. As per the licensing agreement, the Company is responsible for developing and marketing NasulinTM in India and select territories. The Company provides a source of insulin powder and 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 NasulinTM studies in India. The Phase II study will be initiated in March 2007 and is expected to be completed before the end of the year.
Mr. Rakesh Bamzai, President Marketing, of the Company said "We are very excited about the progress made in the nasal insulin program with Bentley. Biocon truly believes that non injectable insulins will drive the future of diabetes therapy the world over."
Clinigene, a CAP accredited CRO and wholly-owned subsidiary of the Company., will administer the complex program.
Data received from the NasulinTM Phase II program in India will supplement Bentley's Phase II studies already underway in the U.S. under the direction of Dr. Sherwyn Schwartz at the Diabetes & Glandular Disease Clinic (DGD) in Texas. Bentley also expects to complete a significant portion of the U.S. Phase II studies before the end of 2007.