Jaguar Animal Health Obtains Protocol Concurrence From FDA for Canalevia Drug Product Candidate for Treatment of Acute Diarrhea in Dogs

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, foals, and high value horses, announced today that it has
obtained protocol concurrence from the Center for Veterinary Medicine
(“CVM”) of the U.S. Food and Drug Administration (“FDA”) to amend the
protocol for the Company’s ongoing clinical field study for Canalevia
and utilize a 125-mg tablet of a formulation manufactured according to
processes and quality standards currently approved by the FDA.

Canalevia is Jaguar’s lead prescription drug product
candidate, intended for the treatment of diarrhea in dogs. Jaguar’s
pivotal field study (CANA-003) is being conducted in support of the
Company’s filing of a new animal drug application (“NADA”) for Canalevia
for the treatment of acute diarrhea in dogs. This prospective, blinded,
randomized, placebo-controlled study was initiated in December of last
year and is being conducted on an inpatient basis at animal shelters and
animal rescues across the U.S. The study will enroll at least 150 dogs
exhibiting watery diarrhea, and is expected to be completed in the
second half of 2016.

Jaguar has submitted to the FDA all required major technical sections
towards conditional approval of Canalevia for dogs suffering
from chemotherapy-induced diarrhea, or “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. Canalevia will be the same
commercial formulation for both the CID and acute diarrhea indications.

“Utilizing a 125-mg tablet simplifies the product presentation to just
one tablet strength—allowing users to safely administer one or two
tablets depending on dog weight, reduces product development costs for
registration batches and stability studies, and leverages the Chemistry
Manufacturing and Controls filing, used in both the conditional approval
of Canalevia and in the broader NADA acute diarrhea
program,” commented Philippe Brianceau, DVM, Jaguar’s chief veterinary
officer.

Lisa Conte, Jaguar’s president and CEO, added, “Obtaining protocol
concurrence by CVM is a key milestone that aligns the development of the
125-mg crofelemer tablet for both the treatment of CID and the treatment
of acute diarrhea in dogs with the same dosage form for the human
FDA-approved formulation of crofelemer.”

Diarrhea is one of the most common reasons for veterinary office visits
for dogs and is the second most common reason for visits to the
veterinary emergency room, yet there are currently no FDA-approved
anti-secretory agents to treat canine diarrhea. According to the
American Veterinary Medical Association, there were approximately 70
million dogs in the United States in 2012. Jaguar estimates that U.S.
veterinarians see approximately six million annual cases of acute and
chronic diarrhea in dogs. Devastating dehydration can occur rapidly for
the animal, and the lack of control in urban settings where owners don’t
have easy access to outdoor facilities is a significant problem for
families with dogs.

About Canalevia

Canalevia is Jaguar’s lead prescription drug product
candidate for the treatment of various forms of diarrhea in dogs.
Canalevia is a canine-specific formulation of crofelemer, an
active pharmaceutical ingredient isolated and purified from Croton
lechleri
, a tree that is sustainably harvested and contains
anti-secretory properties. The product is an oral, enteric-coated, twice
daily formulation of crofelemer that acts locally in the
gastrointestinal tract. It acts at the last physiological step,
conserved across mammalian species, in the manifestation of acute
diarrhea.

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, foals, and high value horses.
Canalevia is Jaguar’s lead prescription drug product
candidate, intended for the treatment of various forms of diarrhea in
dogs. SB-300 is Jaguar’s prescription drug product candidate for the
treatment of gastrointestinal ulcers in horses. Canalevia
and SB-300 contain ingredients isolated and purified from the Croton
lechleri
tree, which is sustainably harvested. Neonorm
Calf and Neonorm Foal are the Company’s lead
non-prescription products. 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
nine active investigational new animal drug applications, or INADs,
filed with the FDA and intends to develop species-specific formulations
of Neonorm in six additional target species, formulations of
SB-300 in horses, and Canalevia for cats 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 anticipated
conditional approval of Canalevia, Jaguar’s intention to
develop formulations of SB-300 in horses and species-specific
formulations of Neonorm in additional target species, and
the Company’s plan to develop formulations of Canalevia for
cats 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.

Jaguar-JAGX

Contacts

KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
Allison
Soss, 212-896-1267
asoss@kcsa.com