Takeda Announces New Drug Application Approval of Fomepizole Intravenous Infusion 1.5g "Takeda" in Japan for Treatment of Ethylene Glycol and Methanol Poisonings

Takeda Announces New Drug Application Approval of Fomepizole Intravenous Infusion 1.5g "Takeda" in Japan for Treatment of Ethylene Glycol and Methanol Poisonings

September 26, 2014

Osaka, Japan, September 26, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare (“MHLW”) has approved the New Drug Application (“NDA”) of Fomepizole Intravenous Infusion 1.5g "Takeda" (generic name: fomepizole, hereafter “fomepizole”) for the treatment of ethylene glycol and methanol poisonings.

Fomepizole, an alcohol dehydrogenase inhibitor, is marketed and distributed by Paladin Labs Inc. (“Paladin”) 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 was an “Unapproved New Drug in Japan” at that time. In December of 2013, Takeda submitted the NDA to the MHLW. Fomepizole is one of the drugs which the MHLW 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.” Therefore, Takeda developed the drug with a grant for development expenditures of the drug from the Pharmaceutical Development Support Center.

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 several dozen per year.

Takeda contributed to initiatives to solve issues related to the 'Unapproved New Drugs and New Indications in Japan' through this approval. The company will continue to deliver medicines which patients and healthcare professionals need and contribute to healthcare.

Takeda will conduct All Cases Surveillance for patients with fomepizole over a period of time to collect safety and efficacy data of the drug after it is launched.

Japanese Brand NameFomepizole Intravenous Infusion 1.5g "Takeda"
Generic NameFomepizole
IndicationEthylene Glycol and Methanol Poisonings
Dosage and AdministrationIn the usual case, the first dose of 15mg/kg of fomepizole is administered, followed by the second to fifth doses of 10mg/kg each. The sixth and subsequent doses are 15mg/kg each. The interval of the intravenous doses is 12 hours with one dose taking more than 30 minutes. In the case of combined use of hemodialysis, administer a dose of fomepizole in accordance with the dosing regimen defined separately.

About Paladin Labs Inc.

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc, a global specialty healthcare company focused on improving the lives of patients while creating value. For more information about Paladin, please visit the Company's web site at www.paladin-labs.com.