NOVARTIS - String of Pearls- LDK378, Serelaxin followed by breakthrough designation for BYM338 (bimagrumab)
Novartis received break through designation from FDA for its third pipeline molecule BYM338 based on PhII proof of concept study data targeting rare, serious debilitating disease - sporadic inclusion body myositis (sIBM). Earlier it has received the break through designation for serelaxin in acute heart failure and LDK378 for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic NSCLC. Company planned to start Ph2/3 – 52 wk study targeted to enroll 240 patients by next month and the drug is expected to launch in 2016. Considering no medical option exists and rarity of disease, we expect bimagrumab to generate the global peak sales of $500m.
