Protox signs $75 million license agreement with Kissei for commercialization of PRX302 in Japan for BPH and prostate disease
VANCOUVER, April 29 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has entered into an exclusive US $75 million license agreement with Kissei Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4547) 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 URIEF(R) (silodosin), an alpha-blocker for dysuria associated with BPH in 2006. Kissei rapidly established robust growth of URIEF(R), 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 Mr. 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."
About Kissei Pharmaceutical
Kissei Pharmaceutical Co., Ltd. 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. Kissei is actively pursuing collaboration with many companies to strengthen its R&D pipeline, and also promoting the global expansion by licensing out the original agents as an important management strategy. Kissei ranks urology as one of its major R&D areas and is putting a great deal of effort into the development of novel therapeutic agents. So far, an agent for treatment of dysuria associated benign prostatic hyperplasia, "silodosin" which was originally developed by Kissei was launched in the U.S., South Korea and approved in EU and filed for NDA in China. In addition, a therapeutic agent for over active bladder, KUC-7483 has been invented by Kissei, and currently Phase 3 clinical trials are ongoing. For more information on Kissei, please see the international website http://www.kissei.co.jp/.
PRX302 is the lead drug in the company's PORxin(TM) technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
BPH is a common urological condition characterized by painful and bothersome symptoms that include difficulty in initiating a urine stream, a sense of urgency, dribbling, incomplete emptying of the bladder, waking several times during the night to urinate and sometimes the presence of blood in the urine. More than half of all men will have symptoms of BPH by the age of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral therapies mainly provide symptomatic relief and can trigger a range of side effects including sexual dysfunction and hypotension. It is estimated that in the seven largest global markets approximately 10 million men are treated annually with oral therapies and these products encompass approximately U.S. $4 billion of sales each year. Surgical options, including minimally invasive procedures, can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require hospitalization, significant recovery time and requires catheterization for variable time intervals. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company's INxin(TM) and PORxin(TM) platforms are being developed in three clinical programs. Protox's lead program, PRX302 (PORxin), achieved its primary clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these positive results, data from the Phase 2a study demonstrated durability at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox' current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.For further information: James Beesley, Senior Director, Investor Relations, Protox Therapeutics, (604) 484-0975, firstname.lastname@example.org; Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241, email@example.com