J&J's Janssen Pharma Seeks Razadyne Approval In Japan
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Janssen Pharmaceutical K.K., a Johnson & Johnson pharmaceutical subsidiary in Japan, applied for distribution and marketing approval for its Alzheimer's disease drug Razadyne (galantamine) with Japan's Ministry of Health, Labor and Welfare, in a market currently monopolized by Eisai's Aricept, a company spokesman said March 2
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TOKYO - Janssen Pharmaceutical K.K., a Johnson & Johnson pharmaceutical subsidiary in Japan, applied for distribution and marketing approval for its Alzheimer's disease drug Razadyne (galantamine) with Japan's Ministry of Health, Labor and Welfare, in a market currently monopolized by Eisai's Aricept , a company spokesman said March 2. The application with the ministry, which proceeds Chuikyo's approval for National Health Insurance reimbursement listing, came after Daiichi Sankyo subsidiary Asubio Pharma's application with MHLW for memantine, also an Alzheimer's disease treatment, in early February. In light of the recent approval pattern, MHLW is expected to give the go-ahead to the two drugs in a year and Chuikyo is expected to list the drugs for NHI shortly afterwards. Galantamine, an acetylcholinesterase inhibitor, was launched in Europe in 2000 and to date has been distributed in more than 70 countries, according to Janssen. Asked about the prospect of penetration in the Japanese and other markets where Aricept (donepezil) is the top seller, a Janssen spokesman said that if approved by MHLW and "depending on the NHI listing price," the company's neurodrug division medical representatives, which account for the largest marketing force out of the company's total 900 reps, would actively market the drug. Worldwide galantamine revenue is approximately $400 million, the spokesman said. - Toshio Aritake ([email protected]) |