Merck, Sanofi endocrine/metabolic news

Sanofi filed a suit in the U.S. District Court for the District of Delaware alleging that Merck infringed 10 Orange Book-listed patents covering Sanofi’s Lantus insulin glargine and Lantus SoloStar pen. Last month, Merck said FDA accepted for review an NDA for MK-1293 to treat Type I and Type II diabetes. The candidate is a follow-on biologic of Lantus, a synthetic sustained-release subcutaneous insulin analog.

FDA is reviewing MK-1293 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or previously approved products. It will not be reviewed as a biosimilar. An MAA for MK-1293 is under EMA review. ...