Takeda debuts Copaxone subcutaneous injection in Japan

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that the multiple sclerosis drug Copaxone (glatiramer acetate) subcutaneous injection 20mg syringe has become available in Japan.

This drug has been developed by Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) as a subcutaneous injection administered once daily, to prevent the relapse of multiple sclerosis. Copaxone was designated as an orphan drug by the Japanese Ministry of Health, Labour and Welfare (MHLW) in March 2009, and a request was received from the MHLW in May 2010 for its development as an "unapproved drug highly needed in medical care." In March 2013, Takeda and Teva entered into a licensing agreement for commercialization of this drug in Japan, and on September 28, 2015. Takeda obtained approval of its New Drug Application. It was listed in the National Health Insurance (NHI) Price List on Thursday.

More than 80% of patients are categorized as having the relapsing-remitting type. Multiple sclerosis is estimated to affect approximately 18,000 individuals in Japan, with its prevalence tending to increase.

"Copaxone, one of the most frequently used drugs in multiple sclerosis, is approved in more than 50 countries worldwide, and is expected to represent a new treatment option for Japanese patients," said Masato Iwasaki, director and president of the Japan Pharma Business unit of Takeda.

Teva reported global Copaxone sales of $1.09 billion for the third quarter of 2015.The drug accounts for nearly 20% of Teva’s total revenue and 50% of profit. The value of the multiple sclerosis therapeutics market (across the top-10 countries including Japan) will rise slowly from $17.2 billion in 2014 to around $20 billion by 2024, at a compound annual growth rate (CAGR) of 1.5%, according to a recent report from research and consulting firm GlobalData’s (The Pharma Letter October 7). However, the market is expected to plateau between 2018 and 2020, as the generic erosion of key branded products, such as Teva’s Copaxone and Novartis’ Gilenya (fingolimod), offsets the uptake of pipeline agents.