Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for generic fomepizole, a treatment for ethylene glycol and methanol poisonings.

Fomepizole, an alcohol dehydrogenase inhibitor, is marketed and distributed by Paladin Labs Inc. in Canada and is the standard treatment for ethylene glycol and methanol poisonings. In May of 2011, Paladin and Takeda entered into a license and distribution agreement in Japan for the drug, which is an "Unapproved New Drug in Japan". Takeda submitted the NDA based on overseas clinical trial data, literature reports in Japan and overseas and other information. Fomepizole is one of the compounds which Ministry of Health, Labour, and Welfare requested pharmaceutical companies to develop in Japan in accordance with the result of the conference “Unapproved New Drugs and New Indications with High Medical Needs”. Takeda received a grant for development expenditures of the drug from the Pharmaceutical Development Support Centre.

Ethylene glycol and methanol poisonings occur from the organic acid created in the body when ethylene glycol or methanol is ingested. Without appropriate diagnosis and treatment, this may result in metabolic acidosis, renal failure and visual loss, or even death. The number of patients in Japan is estimated to be up to a few dozen per year.

“This NDA in Japan is a big step forward towards obtaining approval for fomepizole which is the standard treatment used outside Japan,” said Nancy Joseph-Ridge MD, general manager of Takeda’s Pharmaceutical Development Division. “We will continue to work closely with the regulatory agency to solve issues related to the ‘Unapproved New Drugs and New Indications in Japan.”

Under the terms of the agreement, Paladin granted Takeda an exclusive right to develop and commercialize fomepizole in Japan.

Paladin Labs Inc. is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets.