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."