Neuvivo, a biopharmaceutical company dedicated to ALS treatments, has initiated cGMP manufacturing of NP001 for the treatment of ALS (Lou Gehrig’s Disease).  The company expects to have product available by the end of the year for clinical use. 
 
NP001 received FDA’s Fast Track and Orphan Drug designation.  It has been shown to be safe and effective in clinical trials. Data show a 38% slowing of disease progression as measured by ALSFRS-R score and importantly, a 51% slowing of the decline in lung function compared to placebo, with no serious adverse events reported in clinical trials.
 
Neuvivo is partnering with Patheon, Thermo Fisher’s API contract development and manufacturing organization (CDMO).  Manufacturing will be performed at Patheon’s facility in Florence, SC, a site acquired from Roche Holdings.
 
“We spent the past months evaluating manufacturing options and are pleased to announce our drug development partnership with ThermoFisher to produce NP001 for clinical use,” said Ari Azhir, PhD, Founder and CEO, Neuvivo. “We anticipate having quantities of drug available by the end of the year and possibly sooner.  All at Neuvivo recognize the nature of this terrible disease and the need to make more effective treatments available as soon as possible.”


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