Jaguar Health, a commercial stage pharmaceutical company focused on developing gastrointestinal products, said that Indena S.p.A., one of the two contract manufacturers of the active pharmaceutical ingredient (API) in crofelemer, has developed and implemented an improved crofelemer manufacturing process, effectively increasing yield and realizing reduced cost through increased manufacturing efficiencies while retaining the same phytochemical profile without compromising product quality, safety, purity and efficacy.
 
The modified process allows Jaguar’s wholly-owned human-health subsidiary, Napo Pharmaceuticals, to support the increased crofelemer manufacturing demand expected if crofelemer receives FDA approval for new indications, including approval for the symptomatic relief of cancer therapy-related diarrhea (CTD).
 
The potential CTD indication is the primary focus of the company’s ongoing crofelemer-related development efforts.
 
“We’re very pleased that Indena has completed process development activities at the lab scale and pilot scale and that they have the equipment and in-depth expertise in place to transfer the process into their industrial facility,” said David Sesin, chief manufacturing officer, Jaguar. “The improved process supports our goal of increasing product yield, lowering cost of goods, and securing manufacturing capacity to support future growth.”
 
Headquartered in Milan, Italy, Indena is a CDMO provider with a focus on complex small molecules and natural derivatives.