Maruho Succeeds Manufacturing and Marketing Approval and Marketing Rights for Reduction of Malodor Generated in Cancerous Cutaneous Ulcers Treatment "Rozex® Gel 0.75%"
Osaka and Tokyo (Japan), March 1, 2018 - Maruho Co., Ltd. ("Maruho", Head Office: Osaka, Japan, President and CEO: Koichi Takagi) and Galderma KK (Head Office: Tokyo, Japan, Representative Director: Tomonori Azuma) announce that from March 1, 2018, Maruho will succeed the manufacturing and marketing approval and marketing rights in Japan from Galderma KK for reduction of malodor generated in cancerous cutaneous ulcers treatment "Rozex® Gel 0.75%" (INN: metronidazole, hereinafter referred to as "Rozex").
Rozex is the only topical gel in Japan approved for "sterilization of cancerous cutaneous ulcers and reduction of associated malodor". Malodor associated with cancerous cutaneous ulcers generates from a tumor in advanced cancer and is strong and unique. This strong smell significantly disturbs the quality of life (QOL) of patients and their families. The cause of cancerous cutaneous ulcer malodor is mainly anaerobic bacteria (gram positive and gram negative) in an ulcer lesion. Metronidazole, the active ingredient of Rozex, reduces the odor associated with cancerous cutaneous ulcers by exerting its antibacterial action against anaerobic bacteria. In December 2010, Galderma KK developed Rozex at the request of the Ministry of Health, Labour and Welfare. Galderma KK received manufacturing and marketing approval in December 2014, then began marketing Rozex in May 2015.
Maruho and Galderma Pharma S.A. ("Galderma SA", Headquarters: Lausanne, Switzerland, CEO: Stuart Raetzman) agreed to enter into a comprehensive set of agreements to form a strategic alliance focused on the development and commercialization of Galderma SA's prescription drugs for dermatology in Japan. From August 2016, Maruho has appropriately provided and collected medical information for Rozex in Japan. From March 1, 2018, Maruho will appropriately provide and collect information as the manufacturer and distributor of Rozex in Japan and will ensure a stable supply of this product.
As a pharmaceutical company specializing in dermatology, Maruho hopes to further contribute to improving the QOL of cancer patients and their families through the succession of manufacturing and marketing approval and marketing rights for Rozex in Japan.