Medinox and Fuso in Collaboration to Develop New Sepsis Drug
SAN DIEGO, CALIFORNIA and OSAKA, JAPAN - May 10, 2000. Medinox, Inc., a privately-held San Diego-based pharmaceutical company, and Fuso Pharmaceutical Industries, Ltd., a leading Japanese manufacturer and supplier of dialysate for artificial kidneys and transfusion solutions, today announced that they have entered into a collaborative agreement to develop a new sepsis drug.
The collaboration will commercialize NOX-100 (I.V.), a novel nitric oxide neutralizing compound from Medinox.
Under the terms of the Agreement, Fuso will have exclusive rights to develop and market NOX-100 (I.V.) for sepsis and one additional indication in Japan. Fuso also made an equity purchase of Medinox stock. Medinox may receive pre-commercialization payments from Fuso, including an up-front payment and milestones. Medinox will retain manufacturing rights to NOX-100 (I.V.) and will supply the product to Fuso for a royalty on net sales.
Sepsis is a systemic inflammatory response syndrome that results in the failure of the circulation to provide blood and oxygen to vital organs of the body. During sepsis, nitric oxide is overproduced, which leads to low blood pressure and decreased blood flow to vital organs. When the circulation cannot provide enough blood to vital organs, this can result in multiple organ failure and death.
Sepsis can arise from a number of causes including bacterial infections as well as from non-infectious causes such as hemorrhagic shock, traumatic injury, burns, ischemia, as well as from the inhalation of toxic substances.
Commenting on the license agreement, Dr. Monte Lai, Medinox's President & CEO, said "We are very pleased with this collaboration with Fuso and the fact that it will help move NOX-100 through clinical trials in Japan."
Mr. Mikio Toda, President of Fuso Pharmaceutical Industries, Ltd., commented, "Upon execution of the Agreement with Medinox, we will vigorously carry out our role to research and develop NOX-100 (I.V.) in Japan. We will use our best efforts to launch and market NOX-100 (I.V.) as soon as possible as a leading and much needed therapeutic for sepsis."
Other clinical trials for NOX-100 (I.V.)
Since late September 1999, Medinox has been conducting a Phase I/II clinical trial at the University of California, San Diego Medical Center to evaluate how NOX-100 (I.V.) might alleviate the condition of intradialytic hypotension in hemodialysis patients. Intradialytic hypotension is the episode of low blood pressure that is the most common adverse side effect of routine hemodialysis. Numerous studies have implicated the excessive production nitric oxide, a key biological signaling molecule, with this condition.
Medinox will also evaluate NOX-100 (I.V.) for the sepsis indication in a US Phase I/II clinical trial to begin later this year.
Medinox, Inc. is the leading developer in small molecule nitric oxide neutralizing therapeutics. The technology is being applied to the treatment of a wide range of human diseases and disorders including intradialytic hypotension, hemorrhagic and septic shock, and the complications from cardiopulmonary bypass surgery. Also under development at Medinox are new non-steroidal anti-inflammatory drugs that have greatly improved gastrointestinal side-effect profiles and a new therapeutic for sickle cell anemia.
Founded in 1937, Fuso Pharmaceutical Industries, Ltd. is headquartered in Osaka, Japan. The company is a leading manufacturer and supplier of dialysate for artificial kidneys and transfusion solutions in Japan. Fuso also manufactures and supplies many kinds of injectable solutions and pharmaceuticals, and markets medical devices and portable blood analyzers. In its 1999 fiscal year, Fuso had 45 billion yen in sales.