BIOCON LIMITED SIGNS
A LICENSING AGREEMENT WITH BENTLEY PHARMACEUTICALS,
INC.TO DEVELOP AND MARKET BENTLEY’S INTRANASAL INSULIN
SPRAY IN 85 COUNTRIES
ANNOUNCES THE SIGNING OF A COMMERCIAL SUPPLY AGREEMENT
FOR INSULIN API
Bangalore,
November 16, 2005
Biocon Limited, India’s premier biotechnology company today announced that it has signed a product licensing agreement with Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe 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 throughout Asia, Africa, and the Middle East.
Biocon also announced that it has entered into a long term supply agreement with Bentley which will provide Bentley, and its licensees, with a competitive supply of insulin for worldwide markets. The terms of the agreement assure Bentley of a commercial supply of Insulin for worldwide markets.
Biocon and Bentley will work together in the clinical
development of the intranasal insulin product to meet
the requirements of various international regulatory
authorities including USA, EU and ROW. The two partners
will share the cost of clinical development and regulatory
filings in their respective territories. The specific
terms of the agreement were not disclosed.
Commenting on the landmark agreement, Dr. Kiran Mazumdar
Shaw, Chairman and Managing Director, Biocon Limited,
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. As one of the largest producers of insulin,
this cooperation is of great strategic importance to
us”.
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 the product for commercialization.
Biocon has had several years of experience in the development
and manufacturing of various dosage forms of insulin
and research in oral absorption. Biocon is a very valuable
and experienced strategic partner for Bentley, not only
providing a consistent source of insulin, but highly
experienced in insulin development and regulatory expertise
through its wholly-owned and accredited clinical research
organization (Clinigene). 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 received regulatory approval to continue our clinical development program and initiate our first study in Asia. Clinical supplies have already been produced utilizing Biocon’s raw material and the studies will begin shortly.”
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
and immuno-suppresants with strongly growing sales and
profits. We employ more than 600 highly qualified scientists
at our 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 USFDA and EMEA acceptance. For more information:
visit us at
www.biocon.com
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
News Release Contact (Biocon Limited):
Paula Sengupta
Tel: +91 80 2852 3434
Fax: +91 80 2852 3423
E-mail:
paula.sengupta@biocon.com
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