News Release Details
News Release Details
Jaguar Completes Study in Dogs with Chemotherapy-Induced Diarrhea with Commercial Formulation of Canalevia
Jaguar Targeting First Prescription Product Launch in Early 2016
Canalevia™, the Company’s lead prescription drug candidate,
is a canine-specific formulation of crofelemer, a novel, first-in-class,
anti-secretory active pharmaceutical ingredient 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 objective of the multi-site study was to determine the safety and
tolerability of enteric-coated crofelemer tablets in dogs with CID when
administered orally twice daily for six treatments at the recommended
dose range of 2-4mg/kg. The eight dogs that participated in the study
were enrolled based on current or historical episodes of diarrhea
correlating to chemotherapy treatment. The study was a safety assessment
as requested by the FDA’s
Jaguar initiated a rolling New Animal Drug Application (NADA) with the CVM at the end of 2014, and the recent safety study is expected to be the final animal study requirement for completing this application. The Company is pursuing a Minor Use, Minor Species (MUMS) approval from the CVM for Canalevia™ for CID in dogs to shorten the timeframe to commercialization. Members of Jaguar’s development team met recently with the CVM regarding the MUMS regulatory pathway, and, if the Company receives conditional approval from the CVM for an indication for CID, Jaguar expects to launch Canalevia™ for CID in dogs by early 2016.
The Company completed a canine proof-of-concept study in
“We are moving forward with the MUMS pathway for Canalevia™
for CID in dogs to complement our general watery diarrhea development
plan in order to make this treatment and potential relief available to
suffering patients as soon as possible. As we saw anecdotally in this
study, patients and their owners respond quite favorably to this new
tool to manage the dehydration and discomfort of dogs undergoing
chemotherapy. We are excited and grateful to have this opportunity to
bring this new product, with its novel mechanism of action for the
management of diarrhea, to the companion animal veterinary community,”
explained Jaguar’s CEO
“There is currently no
About Canalevia™
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.
About
For more information, please visit www.jaguaranimalhealth.com.
Forward-Looking Statements
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, and the possible future expansion of labeled indications for Canalevia™ beyond CID to include general watery diarrhea. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150701005278/en/
Source:
Investor Contact:
KCSA Strategic Communications
Garth Russell,
212-896-1250
grussell@kcsa.com
or
Tram
Bui, 212-896-1290
tbui@kcsa.com
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