Bentley Announces Approval and Expansion of Its Nasulin Phase II Studies in India
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- Published on Wednesday, 21 February 2007 02:00
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EXETER, NH, USA | Feb 20, 2007 | Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced that it has received approval from the Drug Controller General of India (DCGI) to proceed with a Phase II clinical evaluation of its Nasulin(TM) in Type II diabetic patients. Nasulin(TM) is the Company's intranasal insulin product utilizing its proprietary CPE-215(R) delivery technology.
This approval follows the completion of its pharmacokinetic clinical studies of Nasulin(TM) studies in India. This twelve week Phase II study will be initiated in March and expected to be completed before the end of 2007.
John Sedor, President of Bentley commented, "This expansion marks an incremental milestone in the clinical development of our Nasulin(TM). We are encouraged by the progression of data we've accumulated in the insulin program which further validates our intranasal delivery technology platform and its potential to deliver other therapeutic peptides in similar formulations to insulin."
Clinigene, a CAP (College of American Pathologists) accredited CRO and wholly-owned subsidiary of Biocon Ltd., will administer the complex program. Biocon is Bentley's licensing partner for developing and marketing Nasulin(TM) in India and other select territories. Biocon, India's largest Insulin producer has provided the source of insulin powder and Cardinal Health has manufactured the clinical supplies for this Phase II study under contract with Bentley.
Mr. Rakesh Bamzai, President Marketing, Biocon 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."
Dr. Arvind Atignal, Chief Operating Officer, Clinigene International Private Limited said, "Phase II clinical studies for this product will consist of 80 patients and will be conducted in six centers in India under the direction of top clinical investigators. The patients will self-administer Nasulin(TM) 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 hemoglobin, used to measure effectiveness of the therapy)."
Chairman and CEO of Bentley, James Murphy, remarked, "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(TM)."
Data received from the Nasulin(TM) 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.
Established in 1978, Biocon Limited is one of India's premier biotechnology companies. Biocon and its two subsidiary companies, Syngene International Pvt Ltd and Clinigene International Pvt Ltd form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research, clinical research and enzymes. With successful initiatives in clinical development, bio-processing and global marketing, Biocon delivers products and solutions to partners and customers across the globe. Many of these products have USFDA and EMEA acceptance. Biocon launched the world's first recombinant human insulin, INSUGEN(TM) using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR(R). Visit us at www.biocon.com.
Bentley Pharmaceuticals, Inc. 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 -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.
Additional information regarding Bentley Pharmaceuticals and Biocon Limited may be obtained through their respective web sites at www.bentleypharm.com and www.biocon.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward looking statements, including without limitation, statements regarding the timelines for Bentley's intranasal insulin development program and the potential benefits of the intranasal insulin product candidate. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to risks associated with the efficacy and safety of Bentley's intranasal insulin product candidate and its drug delivery technology, the timing and nature of clinical trials and regulatory approvals, development and commercialization of the intranasal insulin product candidate using Bentley's drug delivery technology, competition from other manufacturers of new insulin products and drug delivery technologies, intellectual property litigation, our relationships with our strategic partners, the unpredictability of patent protection, risks associated with international clinical trials and operations, and other risks detailed under Item 1A "Risk Factors" in Bentley's most recent annual report on Form 10-K and its subsequent periodic reports filed with the Securities and Exchange Commission. Bentley cautions investors not to place undue reliance on the forward-looking statements.
SOURCE: Bentley Pharmaceuticals, Inc