January 17, 2018
Announcement of manufacturing and sales transfer of
Rasilez® Tablets 150mg
As of January 29, 2018, OrphanPacific, Inc. (Headquarters: Minato-ku, Tokyo; President, Representative Director: Philippe Auvaro) will be taking over the manufacturing and marketing authorization in Japan of Rasilez® Tablets 150mg (aliskiren) from Novartis Pharma K.K. (Headquarters: Minato-ku, Tokyo; Representative Director and President: Kazunari Tsunaba).
This transfer is based on an agreement in July of 2016 between Novartis and Noden, in which Novartis committed to sell the worldwide manufacturing and marketing rights of Rasilez® to Noden Pharma DAC, Inc., headquartered in Ireland. Noden concluded a contract with OrphanPacific as the marketing authorization holder of Rasilez® in Japan.
Rasilez® is the only direct renin inhibitor for the indication of hypertension sold in over 50 countries worldwide up until now. In Japan, the product has been approved since July of 2009 and was launched in October of the same year.
OrphanPacific, a member of the CMIC Group, is pivotal to the Group’s Innovative Pharma Model (IPM) strategy that is designed to provide support and expertise to global specialty pharmaceutical companies, like Noden, which focus on acquiring the manufacturing and marketing rights of prescription medicines across a broad range of therapeutic areas worldwide but has no legal presence in Japan.
OrphanPacific holds the marketing license on behalf of Noden with the support of its parent, CMIC Holdings, to ensure continuous and specific advisory services to global companies willing to introduce or maintain prescription medicines in the Japanese market. OrphanPacific will contribute to the supply of not only orphan drugs as its core mission but also essential drugs of high medical needs and unique mode of action as in the case of the stable supply of Rasilez® to Japanese patients, thereby providing more treatment options for Japanese physicians.
[Contact departments of inquiries for this announcement]
Corporate Planning Department