Protox Therapeutics Inc, leader in the development of receptor targeted fusion proteins, has entered into an exclusive US$ 75 million license agreement with Kissei Pharmaceutical Co, Ltd for the development and commercialization of its PSA-activated pro-drug, PRX302 in Japan for BPH, prostate cancer and other diseases of the prostate. Protox retains exclusive rights to PRX302 in all other territories.

Under the terms of the agreement, Protox will receive an upfront payment of US$ 3 million and is eligible to receive a near term milestone payment of US$ 5 million, as well as progressive payments of up to US$ 67 million upon achievement of specific development, regulatory and commercial milestones. In addition Protox will receive a double-digit royalty fee plus a drug supply fee based on product sales. Kissei will be responsible for all costs associated with further development, regulatory approvals, commercialization and marketing of PRX302 in Japan.

“This transaction represents strong validation of PRX302 given Kissei’s established leadership in the Japanese urology market and proven track record in drug development,” said Dr Fahar Merchant, president and CEO of Protox. “We are delighted to execute this license agreement and we are convinced that in Kissei we have found a partner who is fully committed to bring PRX302 to the Japanese market in a timely manner. For Protox, this significant milestone provides a non-dilutive infusion of cash while preserving our flexibility for developing and marketing PRX302 in the rest of the world.”

Kissei obtained Japanese regulatory approval of URIEFâ (silodosin), an alpha-blocker for dysuria associated with BPH in 2006. Kissei rapidly established robust growth of URIEFâ, which is now the second largest selling alpha blocker in Japan. Kissei also has another urology drug in late stage clinical development.

"This agreement reinforces our product pipeline and enhances our presence in the urological field in Japan,” said Mutsuo Kanzawa, president and CEO of Kissei. “We look forward to contributing to the well being of BPH patients by increasing their treatment choices and believe the in-licensing of PRX302 compliments the strong reputation of silodosin, our leading global strategic product in the BPH field.”

Kissei Pharmaceutical was founded in 1946 and has grown into one of Japan's leading pharmaceutical companies. Kissei's management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around world through developing and offering innovative drugs.

Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins.