sIMB Drug Fails In PhIII

Novartis also disclosed in its 1Q report that investigational drug bimagrumab failed to meet its primary endpoint in a pivotal Phase IIb/III trial for the treatment of sporadic inclusion body myositis (sIMB). The company said it was "evaluating the complete dataset to inform decisions regarding ongoing development of bimagrumab." The drug is also in development for the treatment of musculoskeletal conditions and cachexia.

The sIMB program, which had been granted an orphan drug designation and breakthrough therapy status in the US, was considered high risk and there are only two other drugs in development for this disease. Milo Biotechnology is developing AAV1-FS344, currently in Phase I/II studies; and Sanofi has Campath, which is currently being studied in an investigator initiated trial. All three drugs have independent targets, so Novartis's Phase III failure is unlikely to impact the other two ongoing trials.

SIMB is an inflammatory muscle disorder, with slowly progressive weakness and wasting of distal and proximal muscles, most noticeable in the muscles of the arms and legs. There appears to be both autoimmune and degenerative processes going on and sIMB is thought to be the most common acquired myopathy in patients over 50 years old.

1Q 2016 (US $)	1Q 2015
Net Sales	11.6bn	11.9bn
Operating Income	2.5bn	2.8bn
Net Income	2bn	2.3bn
EPS	0.85	0.96
Pharma Sales	7.7bn	7.1bn
Sandoz Unit Net Sales	2.4bn	2.2bn
Alcon Unit Net Sales	1.4bn	2.6bn

Novartis's Entresto Doesn't Impress In 1Q; Orphan Drug Fails In PhIII

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