Japan approves metreleptin along with others
Japan's Ministry of Health, Labor and Welfare (MHLW) approved a number of drugs on Monday, including metreleptin from Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507) to treat lipodystrophy. Shionogi has Japanese rights to the product from Amylin Pharmaceuticals Inc., which Bristol-Myers Squibb Co. (NYSE:BMY) acquired last year. A BLA is under FDA review to treat diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy. Japan also approved an NDA from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) for Onglyza saxagliptin to treat Type II diabetes. The Japanese approval triggers a Y8.2 billion ($86.9 million) milestone to Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan), through which Kyowa has exclusive Japanese development and commercialization rights. Otsuka has Japanese rights to saxagliptin f rom Bristol-Myers.
MHLW also approved Arzerra ofatumumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat relapsed/refractory CD20-positive chronic lymphocytic leukemia (CLL). The Japanese approval triggers a DKK20 million ($3.5 million) milestone payment to Genmab A/S (CSE:GEN) from GSK. The pharma has worldwide co-development and commercialization rights to the product from Genmab, which was up DKK4 to DKK133 on Monday. ...