Jaguar Animal Health Signs Crofelemer Formulation Development and Manufacturing Contract with Patheon
Contract Secured in Preparation for Pivotal Trial & Expected Launch
of Jaguar’s Prescription Drug Candidate, Canalevia, for Acute Diarrhea
in Dogs
Jaguar to Leverage Patheon’s Experience Manufacturing FDA-approved,
Human-specific Formulation of Crofelemer
SAN FRANCISCO–(BUSINESS WIRE)–Jaguar Animal Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”), an
animal health company focused on developing and commercializing
first-in-class gastrointestinal products for companion and production
animals, announced today that it has signed a crofelemer formulation
development and manufacturing contract with Patheon, a leading global
provider of drug development and delivery solutions to the global
pharmaceutical and biopharma industries. Crofelemer is an active
pharmaceutical ingredient (API) in Canalevia™, Jaguar’s
prescription drug product candidate for the treatment of various forms
of acute diarrhea in dogs.
Under the terms of the contract, Patheon will provide enteric-coated
crofelemer tablets for Jaguar for use in animals. The tablets will be
used in Jaguar’s pivotal efficacy trial for Canalevia™,
scheduled to begin in the fourth quarter of this year. Jaguar expects to
use safety and effectiveness data from this trial in support of the
initiation of the filing of a new animal drug application (NADA) with
the FDA for Canalevia™ in 2016 for the indication of acute
diarrhea in dogs. A Jaguar proof-of-concept study completed earlier this
year provided statistically significant results indicating that Canalevia™
is superior to a placebo for the treatment of acute diarrhea in dogs.
Crofelemer is isolated and purified from the Croton lechleri
tree, which is sustainably harvested by Jaguar. Jaguar is also
developing formulations of Canalevia™ for cats and horses.
Patheon is the manufacturer of Fulyzaq®1, a human-specific,
enteric-coated formulation of crofelemer that was approved by the FDA in
2012 for the symptomatic relief of noninfectious diarrhea in adults with
HIV/AIDS on antiretroviral therapy. Members of Jaguar’s management team
developed crofelemer while working at Napo Pharmaceuticals, Inc. (Napo),
where the drug was initially developed. In 2014 Jaguar entered into a
license agreement with Napo which, among other things, assigned to
Jaguar Napo’s rights of reference to the information included in the
FDA-approved human new drug application of crofelemer to support
Jaguar’s regulatory submissions for global veterinary purposes.
As Jaguar announced this past August, it has submitted to the FDA all
required major technical sections towards a conditional NADA for
Canalevia™ for dogs suffering from chemotherapy-induced
diarrhea (CID), a minor use in a major species (MUMS). MUMS is an FDA
drug designation, similar to the orphan drug designation in humans,
which is typically limited to the use of a drug to treat disease that
occurs infrequently or in a small number of animals. FDA encourages
sponsors to seek MUMS designation and conditional approval of qualifying
drugs to address unmet medical needs in the veterinary industry. Jaguar
is preparing for the expected commercial launch of Canalevia™
for CID in the first half of 2016.
“Our contract with Patheon is a key component of our carefully-crafted
formulation and manufacturing plan for Canalevia™,” stated
Lisa Conte, Jaguar’s president and CEO. “The Chemistry, Manufacturing
and Controls section of our NADA for Canalevia™ for CID
leverages the fact that we will be utilizing the same cGMP-compliant
manufacturers that produce the crofelemer product approved for human
use, and we plan to take the same approach with our Canalevia™
NADA for acute canine diarrhea. This plan was discussed during our
meeting with the FDA’s Center for Veterinary Medicine earlier this year.”
The Company announced last month that it recently signed a manufacturing
and supply agreement with a leading, India-based pharmaceutical company,
and Jaguar intends to use this firm as its primary manufacturer of the
crofelemer API for animal health use.
About Patheon
Patheon is a leading global provider of outsourced pharmaceutical
development and manufacturing services. With approximately 8,700
employees worldwide, Patheon provides a comprehensive, integrated and
highly customizable set of solutions to help customers of all sizes
satisfy complex development and manufacturing needs at any stage of the
pharmaceutical development cycle.
About Jaguar Animal Health, Inc.
Jaguar Animal Health, Inc. is an animal health company focused on
developing and commercializing first-in-class gastrointestinal products
for companion and production animals. Canalevia™ is Jaguar’s
lead prescription drug product candidate for the treatment of various
forms of diarrhea in dogs. Neonorm™ Calf is the Company’s
lead non-prescription product. Canalevia™ is a
canine-specific formulation of crofelemer, an active pharmaceutical
ingredient isolated and purified from the Croton lechleri tree,
which is sustainably harvested. Neonorm™ is a standardized
botanical extract derived from the Croton lechleri tree. Canalevia™
and Neonorm™ are distinct products that act at the same last
step in a physiological pathway generally present in mammals. Jaguar has
filed nine investigational new animal drug applications, or INADs, with
the FDA and intends to develop species-specific formulations of Neonorm™
in six additional target species, and formulations of Canalevia™
for cats, horses and dogs.
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 expected launch of
Canalevia™ for acute diarrhea in dogs, the initiation of
Jaguar’s pivotal efficacy trial for Canalevia™ in the fourth
quarter of this year, Jaguar’s expectation of using safety and
effectiveness data from the pivotal trial in support of the initiation
of the filing of an NADA with the FDA for Canalevia™ in 2016
for the indication of acute diarrhea in dogs, Jaguar’s expected
commercial launch of Canalevia™ for CID in the first half of
2016, the Company’s intention to leverage, in the Chemistry,
Manufacturing and Controls section of its NADA for Canalevia™
for acute diarrhea in dogs, its plan to utilize the same cGMP-compliant
manufacturers that produce the crofelemer product approved for human
use, Jaguar’s intention to use the India-based pharmaceutical firm as
its primary manufacturer of the crofelemer API for animal health use,
the Company’s intention to develop species-specific formulations of
Neonorm™ in six additional target species, and Jaguar’s
planned development of formulations of Canalevia™ for cats,
horses, and dogs. 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.
1Fulyzaq® is a registered trademark of and is
marketed by Salix Pharmaceuticals, Inc.
Jaguar-JAGX
Contacts
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
