Under terms of the agreement and subject to the successful completion of clinical trials, the device will be distributed exclusively in Japan by Terumo under Terumo's name and incorporating Terumo's delivery catheter. Terumo will also have non-exclusive distribution rights elsewhere in the world outside of the U.S. Although specific monetary terms were not disclosed, the agreement calls for Biosensors to receive an up-front payment, additional payments tied to clinical trial milestones and royalty payments. Clinical trials of the device in Japan are targeted to begin in 2004.
The drug-eluting stent is designed to reverse the narrowing of coronary arteries that is the hallmark of many cases of coronary artery disease. Implanted in an artery following balloon angioplasty, it uses the strength of its cylindrical metal mesh wall to maintain restored blood flow. Following implantation, it gradually releases ("elutes") into surrounding tissues an anti-proliferative drug called Biolimus A-9.
Biolimus A-9 is formulated to inhibit excessive tissue formation around the stent following implantation, a common side effect called restenosis which often threatens to reverse the clinical benefits of the angioplasty and stent implantation procedures. Biolimus A-9 is proprietary to Biosensors and is being evaluated in clinical trials of its MATRIX™ stent in Europe, code-named the STEALTH trial.
The stent structure used in the device for Japan is derived from Biosensors' bare-metal S-Stent, which features a smaller, more flexible configuration than most stents currently on the market or in clinical trials, and which was specially designed for the smaller, more tortuous blood vessels characteristic of Asian physiques. S-Stent is an approved product widely distributed in Asia.
"We are pleased to reach this agreement with Terumo, the largest medical products company in Japan," commented Yoh-Chie Lu, President and CEO of Biosensors International. "It is gratifying to receive this validation of our product development efforts by a company with Terumo's outstanding leadership profile. The combination of Biosensors' innovations and proprietary technologies with Terumo's brand reputation and excellent stent and catheter technologies puts us on a path to become one of the major suppliers of complete DES systems in Japan and Asia in the next few years."
"We are delighted to enter into this partnership with Biosensors International. Introduction of the new-generation drug-eluting stent developed Biosensors International will strengthen our product portfolio in Europe, Asia and Japan," commented Koji Nakao, Managing Executive Officer & Group President of CV Systems / Interventional Systems of Terumo Corporation.
The drug-eluting stent for Japan referred to in this press release is an investigational device and is not approved for sale by the Ministry of Health, Labor and Welfare in Japan.
Terumo Corporation is a premier global medical company with 2003 annual sales in excess of $1.7 billion. Terumo Corporation develops, manufactures, and markets a wide range of medical products including I.V. solutions, blood bags, disposable medical devices, therapeutic catheters, cardiovascular systems, peritoneal dialysis systems, diabetes care systems, medical electronic products, etc. in more than 160 countries.
For more information, please visit www.terumo.com
Biosensors focuses its research in the fields of new drug discovery, stent design and local drug delivery coating development for interventional cardiology markets worldwide. Biosensors International is a subsidiary of Sun Biomedical Limited, and seeks to become a leading company specializing in cardiovascular technology.
For more information, please visit www.biosensors.com