Apr 16 2009
BioSphere Medical, Inc. (NASDAQ: BSMD) - a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy - today announced that the Company has signed an exclusive agreement with Nippon Kayaku Co., Ltd. for the planned distribution of HepaSphere™ Microspheres and Embosphere® Microspheres in Japan.
According to the agreed-upon terms, Nippon Kayaku will be responsible for regulatory strategy and seeking to obtain requisite product registrations, including performing any clinical studies that may be required as a condition to product registration, and will bear the related cost for these activities. Assuming either or both of the products receive market clearance and the government reimbursement rate is set, BioSphere will provide the approved product to Nippon Kayaku for distribution and sale based on a predetermined formula indexed to the final Japanese government reimbursement rate. The agreement calls for BioSphere to receive a $1.0 million milestone payment in 2009. Also, Nippon Kayaku has agreed to pay up to $3.0 million in additional milestone payments in subsequent periods based on achievement of product registration goals and revenue targets.
“Japan is one of the major world markets for the treatment of liver cancer with approximately 75,000 transcatheter arterial embolizations performed in 2008,” commented Richard Faleschini, chief executive officer of BioSphere. “As a leading, well-respected chemical and pharmaceutical company in Japan with a substantial oncology franchise, we believe that Nippon Kayaku is well positioned to gain regulatory approval for our embolic products and drive market adoption with interventional oncologists in this significant market.”
BioSphere Medical, Inc. seeks to pioneer and commercialize minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products continue to gain acceptance in this rapidly emerging procedure, as well as in a number of other new and established medical treatments.