January - March 2011
March 22, 2011
Takeda Pharmaceutical Company Limited
Osaka, Japan, March 22, 2011 – Today, Takeda Pharmaceutical Company Limited (“Takeda”) announced the launch of Reminyl® (generic name: galantamine hydrobromide, hereinafter called “Reminyl”) for the treatment of patients with Alzheimer-type dementia in Japan, which is supplied by Janssen Pharmaceutical K.K. (Head Office: Tokyo, President: Toon Overstijns, hereinafter called “Janssen Pharma”) for co-marketing.
Reminyl was developed together by Johnson and Johnson Pharmaceutical Research and Development and Shire PLC., under the license agreement between Janssen Pharmaceutica N.V. and Synaptec Inc. Since its approval for clinical use in Sweden in 2000, it has been clinically used in more than 70 countries and regions around the world to treat patients with mild to moderate dementia of the Alzheimer’s type. In Japan, the clinical development of Reminyl was carried out by Janssen Pharma, to which its marketing approval was granted on January 21, 2011. The approval was for the first time in a decade in the area of the disease.
Under the co-marketing agreement with Janssen Pharma, Takeda will market Reminyl under the same brand name in Japan. Reminyl will be orally administered twice daily, available in three forms of dosage: tablet, orally-disintegrating tablet, and oral solution, allowing patients and caregivers to select an optimal form according to their needs and lifestyles.
“Today we launch Reminyl, a new treatment option for Alzheimer-type dementia, for Japanese patients in collaboration with Janssen Pharma. As a highly recognized unapproved medicine, the development of Reminyl was demanded. Due to its high expectation for meeting certain medical needs, the authorization process only took 11 months since its filing. We hope that better lives will be achieved by patients and their families, who have been waiting for this medicine for a long time” said Yasuhiko Yamanaka, Director and Senior Vice President of Pharmaceutical Marketing Division.
|Brand name||Reminyl® Tablet 4 mg, Reminyl® Tablet 8 mg, Reminyl® Tablet 12 mg
Reminyl® OD Tablet 4 mg, Reminyl® OD Tablet 8mg, Reminyl® OD Tablet 12mg
Reminyl® Oral Solution 4 mg/mL
|Generic name||Galantamine hydrobromide|
|Dosage and administration||The usual initial adult dose for oral use is 4 mg twice a day. After 4 weeks, the dose is increased to 8 mg twice a day. The dose can be increased up to 12 mg twice a day according to patients' symptoms. Furthermore, same dose should be administered at least 4 weeks before increase the dosage.|
|Indication||Suppression of progression of mild to moderate demential symptoms in dementia of the Alzheimer's type|
|Date of marketing business license||January 21, 2011|
|Drug tariff (including tax)||Reminyl tablet and OD tablet: 119.60 yen/tablet for 4 mg, 213.80 yen/table for 8 mg, 271.00 yen/tablet for 12 mg. Oral solution (4 mg/mL, 0.4%): 107.30 yen/mL (Date of NHI price listing: March 11, 2011)|
Galantamine, the active ingredient of Reminyl, is originated from a natural organic compound isolated from bulbs of snowflake, or snowdrop, Galanthus (Amaryllidaceae). It controls the progress of various symptoms of progressive Alzheimer-type dementia. It enhances the functions of nicotinic acetylcholine receptors in addition to inhibiting acetylcholinesterase. The dual mechanism of action increases the concentration of acetylcholine (neurotransmitter) in the brain, accelerates the release of the neurotransmitter, increases receptor sensitivity, and protects nerve cells. Major overseas treatment guidelines include Reminyl as a standard treatment for mild to moderate Alzheimer-type dementia.
Alzheimer-type dementia is a brain disease that affects the patients’ quality of life significantly. Beginning with impairment in memory, in advanced stages, the patients will often be confined to bed, which puts a tremendous burden on patients and their families who take care of them. As a super-aging society will come before long in Japan, in 2020, when most baby boomers reach the age of their 70s, it is estimated that the number of patients with dementia surpasses 3 million. (Source: Geriatric care in 2015. Report of geriatric care workshop, June 2003, issued by the Health and Welfare Bureau for the Elderly, Ministry of Health, Labour and Welfare)
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.