EXETER, N.H.--(BUSINESS WIRE)--Nov. 14, 2005---Bentley Pharmaceuticals, Inc. (NYSE: BNT - News), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, today announced that it has signed a product licensing agreement with Biocon Limited for Bentley’s intranasal spray formulation for administering insulin. The license agreement covers 85 countries granting Biocon exclusive as well as co-exclusive rights to develop and market Bentley’s formulation throughout Asia, Africa, and the Middle East.
Bentley also announced that it has entered into a long term supply agreement with Biocon, which will provide Bentley, and its licensees, with a competitive commercial supply of insulin for worldwide markets.
Bentley and Biocon will work together in the clinical development of the intranasal insulin product to meet the requirements of various international regulatory authorities in Biocon’s territories and potentially in other parts of the world. The two partners will co-administer the clinical development and regulatory filings in their respective territories. The specific terms of the agreement were not disclosed.
James R. Murphy, Bentley’s Chairman and CEO, commented, “We are pleased to have teamed with one of the world’s largest producers of insulin and look forward to shaping an aggressive plan to develop our product formulation for commercialization. Biocon has years of experience in the development and manufacturing of various dosage forms of insulin, including oral administration. Biocon is a very valuable and experienced strategic partner for Bentley, not only providing a source of insulin, but highly experienced in insulin development and regulatory expertise through its wholly-owned and accredited clinical research organization (Clinigene) in India. We believe that this collaboration has laid a foundation that will significantly support the strategic developmental and commercial objectives of Bentley.”
Murphy continued, “We have also recently received regulatory approval to continue our clinical development program and initiate our first study in India. Clinical supplies have already been produced utilizing Biocon raw material and the studies will begin shortly.”
Commenting on the landmark agreement, Dr. Kiran Mazumdar Shaw, Chairman and Managing Director of Biocon Ltd. said, “Biocon believes that non-injectable insulins will drive the future of diabetes therapy. Along with our own program in oral delivery of insulin, this development agreement will give us the breadth of opportunity to straddle the entire domain of non-injectable insulin delivery. Biocon has made a large commitment to the insulin segment and this cooperation is of great strategic importance to us.”
About Bentley Pharmaceuticals Inc.
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. Bentley’s proprietary drug technologies enhance or facilitate the absorption of pharmaceutical compounds across various membranes. Bentley also manufactures and markets a growing portfolio of generic and branded pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar; and manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API. Copies of Bentley Pharmaceuticals’ press releases and other information may be obtained through Bentley’s web site at www.bentleypharm.com.
About Biocon Limited
Established in 1978, Biocon Limited is one of India’s premier biotechnology companies. The company has a robust product portfolio of recombinant biotherapeutics, statins & immuno-suppresants with strongly growing sales & profits. It employs more than 600 highly qualified scientists at its campus in Bangalore. Biocon and its two subsidiary companies, Syngene International Pvt Ltd and Clinigene International Pvt. Ltd form a fully integrated biopharmaceutical company, specializing in custom research, clinical research, biopharmaceuticals and enzymes. With successful initiatives in clinical development, bioprocessing and global marketing, Biocon delivers products and solutions to partners and customers across 50 countries. Many of these products have US FDA and EMEA acceptance. For more information, visit us at 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 Bentley’s intranasal insulin program. 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 timing and nature of regulatory approvals, changes in third-party reimbursement and government mandates which impact pharmaceutical pricing, development and commercialization of Bentley’s proprietary products and formulations, competition from other manufacturers of generic and proprietary pharmaceuticals, intellectual property litigation, the efficacy and safety of Bentley’s products, the unpredictability of patent protection, risks associated with international operations, and other uncertainties detailed in Bentley’s most recent Annual Report on Form 10-K and its other subsequent periodic reports filed with the Securities and Exchange Commission. Bentley cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Bentley undertakes no obligation to update or revise the statements, except as may be required by law.
Contact: Bentley Pharmaceuticals, Inc. Michael D. Price, 603-658-6100 Fax: 603-658-6101 or Porter, LeVay & Rose, Inc. Investor Relations: Linda Decker, 212-564-4700 or Editorial: Jeff Myhre, 212-564-4700 or Media Relations: Tom Gibson, 201-476-0322 or Biocon Limited Paula Sengupta, +91 80 2852 3434 Fax: +91 80 2852 3423 paula.sengupta@biocon.com
Source: Bentley Pharmaceuticals, Inc.