Paladin Labs Inc. and Takeda Pharmaceutical Company Limited announced today that they have entered into a licensing and distribution agreement under which Paladin has granted Takeda an exclusive right to develop and commercialize fomepizole (marketed and distributed by Paladin under the trademark Antizol in Canada and the United States) for the treatment of ethylene glycol and methanol poisonings in Japan. Under the terms of the agreement, Paladin will receive from Takeda an undisclosed upfront payment for the product together with royalty payments based on fomepizole sales in Japan. Further financial terms of the agreement were not disclosed.
The ingestion of ethylene glycol or methanol is a medical emergency characterized by central nervous system depression, severe metabolic acidosis, renal failure and coma. Untreated ingestions can be lethal if left untreated or undiagnosed. In Japan, the annual prevalence of ethylene glycol and methanol poisonings is reported in excess of approximately two dozen cases.
Takeda will be solely responsible for the development and commercialization of fomepizole in Japan as part of the Ministry of Health, Labour and Welfare's initiative "Unapproved New Drugs and New Indications with High Medical Needs" held on April 27, 2010 to help promote the development of unapproved medications and treatments for indications that are not approved in Japan despite their being approved in Europe and the United States.
"Antizol serves a critical care need in the treatment of ethylene glycol and methanol poisoning," said Jonathan Ross Goodman, President and CEO of Paladin. "This product has proven its value in the marketplace in both Canada and the United States and is a truly innovative product. We believe that Antizol will fulfill a need not currently being met within the emergency treatment landscape in Japan."
"It is significant for a pharmaceutical company to make effective treatments commonly used outside Japan available for Japanese patients as early as possible," said Yasuchika Hasegawa, President and CEO of Takeda. "We will accelerate development of this drug, and will continue initiatives to reduce concerns of unapproved new drugs and new indications in Japan."