NOT FOR DISTRIBUTION TO EUROPE OR US MEDIA
TOKYO, May 27, 2014 _ Ube Industries, Ltd. announced today that antiplatelet agent Efient® 3.75mg/5mg Tablets (JAN: prasugrel hydrochloride; approval to market: March 24, 2014) has been launched in Japan by Daiichi Sankyo Company, Limited. The agent was jointly developed by the two companies.
Efient® is an oral antiplatelet agent discovered by Ube Industries and its research partner, Daiichi Sankyo. The results of clinical trials in Japanese patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI) demonstrated that Efient® reduces the incidence of ischemic events from the perioperative period of PCI by rapidly reducing platelet aggregation activity.
Outside of Japan, based on co-development by Daiichi Sankyo and Eli Lilly and Company, the European Commission and the US FDA granted marketing authorization for Efient®/Effient® for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing PCI, in combination with aspirin, in 2009. To date prasugrel has been approved in more than 70 countries worldwide.
Under the "Change & Challenge - Driving Growth" medium-term management plan, Ube Industries has positioned its pharmaceutical business as a strategic growth business which targets rapid expansion in scale and profitability. The Company is conducting R&D with the aim of creating useful proprietary pharmaceuticals that contribute to society.
In 2000 and 2003, Ube Industries launched two new drugs in Japan. The first was Talion®, an anti-allergy agent developed jointly with Tanabe Seiyaku Co., Ltd. (now Mitsubishi Tanabe Pharma Corporation), and the second was Calblock®, an antihypertensive agent developed jointly with Sankyo Co., Ltd. (now Daiichi Sankyo Company, Limited). Following the success of these two drugs, there are high expectations for today's launch of Efient® in Japan, as a product that will further spur the growth of the pharmaceutical business of Ube Industries.
|Product Name||Efient® 3.75mg/5mg Tablets|
|Generic name (JAN)||Prasugrel hydrochloride|
|Price Listing||Efient® 3.75mg: ¥282.70 per tablet
Efient® 5mg: ¥359.80 per tablet
|Indication||Prasugrel is indicated for the following ischemic cardiac diseases, which require PCI:
|Dosage and administration||Prasugrel should be initiated orally with a single 20-mg loading dose and then continued at a 3.75-mg once daily dose for adults.|
|Approval date||March 24, 2014|
|Manufacturing and marketing||Daiichi Sankyo Company, Limited|
ACS includes heart attacks and unstable angina (chest pain). Myocardial infarction (heart attack) is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot which may partially or totally block the blood supply to portions of the heart, resulting in ACS.