Jaguar Animal Health Inc, a US-based animal health company focused on developing and commercialising first-in-class gastrointestinal products for companion and production animals, has signed a four-year manufacturing and supply agreement with Glenmark Pharmaceuticals Ltd. (Glenmark), a research-driven, global, integrated pharmaceutical company. With the execution of the agreement, Jaguar intends to use Glenmark as its primary manufacturer of crofelemer for animal health use.
Crofelemer is an active pharmaceutical ingredient (API) isolated and purified from the Croton lechleri tree, which is sustainably harvested by Jaguar. Crofelemer is the API in Canalevia, Jaguar’s lead prescription drug product candidate for the treatment of various forms of watery diarrhoea in dogs. Jaguar is also developing formulations of Canalevia for cats and horses.
A human-specific formulation of crofelemer, Fulyzaq, was approved by the US FDA in 2012 for the symptomatic relief of noninfectious diarrhoea in adults with HIV/AIDS on antiretroviral therapy. Members of Jaguar’s management team developed crofelemer while working at Napo Pharmaceuticals, Inc. (Napo), and Glenmark is the current manufacturer of crofelemer for Fulyzaq. In 2014 Jaguar entered into a license agreement with Napo granting Jaguar a Right of Reference to the entirety of the information included in the US FDA-approved human new drug application of crofelemer.
As Jaguar announced this past August, it has submitted to the US FDA all required major technical sections of its New Animal Drug Application (NADA) for Canalevia. “Given Glenmark’s long-term experience in the manufacture of crofelemer, we expect this relationship to allow us to bring Canalevia to market in the most efficient, rapid and cost-effective manner possible,” explained Lisa Conte, Jaguar’s president and CEO.
“The chemistry, manufacturing and controls section of our Canalevia NADA leverages the fact that we will be utilising the same cGMP-compliant manufacturer that produces the crofelemer product approved for human use. This plan is in line with our expectations, which were discussed during our meeting with the US FDA’s Center for Veterinary Medicine earlier this year.”
“Our agreement with Glenmark supplements our previously announced manufacturing agreement with Milan, Italy-based Indena S.p.A. for Neonorm, the standardized botanical extract in our non-prescription products, Neonorm Calf and Neonorm Foal Plus. We intend to eventually use Indena as an alternative supplier for crofelemer,” stated Conte.