Jaguar Animal Health Submits All Required Major Technical Sections of New Animal Drug Application for Canalevia
Company Prepares for New Prescription Drug Launch in First Half of 2016 for Dogs Suffering from Chemotherapy-Induced Diarrhea
Canalevia is a canine-specific formulation of crofelemer, a novel,
first-in-class, anti-secretory active pharmaceutical ingredient that has
been isolated and purified from the Croton lechleri tree.
Numerous animal and human clinical trials have shown significant
beneficial results in the use of crofelemer in the treatment of acute
watery diarrhea induced by various infectious pathogens. A
human-specific formulation of crofelemer was approved by the
The regulatory review process for an animal drug requires the sponsor,
the entity assuming responsibility for compliance with applicable
regulatory provisions as well as marketing of a new drug, to submit an
NADA to the CVM for approval prior to marketing. For companion animals,
there are four major technical sections to the NADA that must be filed,
including 1.) Target Animal Safety, 2.) Effectiveness 3.) Chemistry,
Manufacturing and Controls, and 4.) Environmental Impact. In a Phased
Review submission, each technical section can be submitted independently
and thus reviewed independently. The Phased Review option speeds the
approval process by allowing the CVM to review each section as they are
submitted by the sponsor. When all required sections are deemed complete
by the CVM, the sponsor files an Administrative NADA for full or
conditional approval, which the CVM’s
“The Phased Review was the most appropriate route for Jaguar in order to
initiate the earliest review for Canalevia. While certain technical
sections were being reviewed, it provided us with ample time to schedule
and conduct a pre-submission conference with the CVM prior to finalizing
the submission of our CMC section. We look forward to leveraging the
approval of crofelemer’s Active Pharmaceutical Ingredient with data
regarding our plan to utilize the same manufacturers that produce the
crofelemer product approved for human use. The complete submission of
all major technical sections for the NADA is in line with our
expectations when we met with the CVM earlier this summer,” commented
Jaguar received acknowledgement from the CVM that an initial technical section the Company submitted is complete.
The Company is pursuing a MUMS approval from the CVM for Canalevia™ for
CID in dogs to shorten the timeframe to commercialization. MUMS is an
Jaguar is preparing for the expected commercial launch of Canalevia for CID in the first half of 2016.
Canalevia™ is Jaguar’s lead prescription drug product candidate for the treatment of various forms of watery diarrhea in dogs. Canalevia™ is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree that is sustainably harvested and contains anti-secretory properties. The product is an oral, enteric-coated, twice daily formulation of crofelemer that Jaguar is developing for the treatment of chemotherapy-induced diarrhea, or CID, in dogs. The product is not absorbed systemically at the therapeutic dose, but acts locally in the gastrointestinal tract. It acts at the last physiological step, conserved across mammalian species, in the manifestation of watery diarrhea.
For more information, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the anticipated receipt from the FDA’s CVM of conditional approval for an indication for CID, and the expected commercial launch of Canalevia™ for CID in dogs by early 2016. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.