Japan approves Lyxumia, Perjeta, subcutaneous Orencia

Japan's Ministry of Health, Labor and Welfare (MHLW) approved several products on Friday, including Lyxumia lixisenatide from Sanofi (Euronext:SAN; NYSE:SNY) for use in combination with basal insulin to treat Type II diabetes. The glucagon-like peptide-1 receptor ( GLP-1R) agonist is already approved in the EU and is under review in the U.S. with an undisclosed PDUFA date. Sanofi has global commercialization rights to Lyxumia from Zealand Pharma A/S (CSE:ZEAL) under an amended 2003 deal. Zealand, which is eligible for royalties and up to $175 million in milestones tied to lixisenatide, was up DKK2 to DKK69 on Friday.

MHLW also approved an NDA from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) for Perjeta pertuzumab to treat HER2-positive inoperable or recurrent breast cancer. Chugai, which is majority owned by Roche (SIX:ROG; OTCQX:RHHBY), has Japanese rights from the pharma to the humanized mAb HER dimerization inhibitor that prevents HER2 from binding to other HER receptors ( HER1/EGF, HER3 and HER4). The European Commission approved Perjeta in March, and FDA approved the breast cancer drug in June 2012. ...