Jaguar Animal Health Announces Positive Topline Results of University Study of Second-Generation Formulation of Neonorm Calf and Commercialization Strategy Updates
Advances commercialization strategy for equine and companion animal
drug product candidates
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 positive topline
results today from its study conducted in conjunction with researchers
from Cornell University College of Veterinary Medicine (“Cornell”) to
evaluate the efficacy of the prophylactic use of a second-generation,
powder formulation of Neonorm™ Calf, administered in liquid,
on naturally occurring diarrhea in preweaned dairy calves and to
investigate the possible prebiotic benefit of the product.
Neonorm™ Calf, one of the Company’s lead non-prescription
products, has been formulated and clinically tested to help proactively
retain fluid in dairy calves and reduce the severity of diarrhea—aiding
the animals in avoiding debilitating, dangerous levels of dehydration
associated with scours. The powder form of the product allows for ease
of administration for entire herd management.
The double-blind, randomized study conducted in association with Cornell
involved 40 Holstein bull calves that were affected with naturally
occurring diarrhea. The study compared prophylactic use of Neonorm™
Calf against a placebo, administered twice daily. Data regarding fecal
dry matter (“FDM”) was used to measure water loss due to secretory
diarrhea. Body weight measurements were performed daily to determine
average daily weight gain during the 25-day study. Blood and fecal
samples were also collected, along with data related to bacterial genus
prevalence in the intestinal microbiome.
“Based on the FDM findings, which are an objective measurement of
hydration and improvement in diarrheal disease, the topline results of
the study show a significant effect in decreasing the severity of the
disease, along with an improvement in the hydrating of the
patients. Over the next several weeks, a detailed analysis will be
conducted on specific endpoints. Additionally, characterization of the
fecal microbiome throughout the study period will allow us to determine
if, under natural conditions, the product may positively alter the
intestinal microbiome to the benefit of the host—possibly resulting in
improved efficiency of feed conversion and increased weight gain,”
commented Dr. Rodrigo Bicalho, Associate Professor of Dairy Production
Medicine at Cornell Veterinary School, and the principal investigator of
the study.
The microbiome is a community of microorganisms that live normally in
the gut and are vital to maintenance of gut health. In October of last
year Jaguar announced that a study by Cornell researchers supports a
benefit of Neonorm™ Calf on the optimization of the
intestinal microbiome profile in preweaned dairy calves.
Commercialization Strategy Updates for Jaguar’s Equine and Companion
Animal Drug Product Candidates
The reception among users of Neonorm™ Foal, the
anti-diarrheal for newborn horses that Jaguar launched early this year
with a nationwide campaign offering samples, has been overwhelmingly
positive. User feedback regarding Neonorm™ Calf also
continues to be very favorable. Commercialization of these two
non-prescription products has provided numerous benefits that the
Company intends to leverage during the expected introductions of high
value, first-in-class prescription drug products into the U.S.
marketplace and beyond. The commercialization process has allowed Jaguar
to extend to animals the clinical utility of the novel mechanism of
action of Croton lechleri-derived anti-secretory products, refine
messaging to veterinarians, fine-tune internal processes, forge
commercial manufacturing relationships, and develop commercial
infrastructure with important distributors relevant to both prescription
and non-prescription products.
“The clinically-proven performance of Neonorm™ Foal, in
combination with our heightened understanding of the vast and unmet need
for novel and differentiated ulcer treatment within the equine athlete
space, is driving our increased focus on equine product and market
development. As part of our equine franchise, we will continue
commercial efforts around Neonorm™ Foal, and focus on
preparations for the expected commercial launch of SB-300, our drug
product candidate for equine gastric ulcer syndrome. We believe SB-300
will be an important product introduction, with performance attributes
differentiated from proton pump inhibitors such as omeprazole. We are
also focusing resources on the expected commercial launch of Canalevia™,
our drug product candidate for acute diarrhea in dogs,” stated Lisa
Conte, Jaguar’s president and CEO.
“In addition to being the Jaguar drug product candidates that are
furthest in development, Canalevia™ and SB-300 offer the
largest market opportunities, in our opinion. As a result, considering
the difficult capital markets, we are focusing our resources on these
nearer-term expected value drivers, and are therefore shifting our
planned development activities for several other products into late-2016
and 2017,” Conte said.
In order to focus the Company’s resources on its nearer-term expected
value drivers, Jaguar is shifting the planned development activities for
drug product candidates to treat acute diarrhea in cats and for feline
herpes virus from 2016 to 2017.
The Company will also delay commercial planning activities for the
conditional approval of Canalevia™ for the indication of
chemotherapy-induced diarrhea (“CID”) in favor of concentrating more
heavily on the expected commercial launch, in 2017, of Canalevia™
for acute diarrhea in dogs. Although Jaguar has received MUMS
designation for Canalevia™ for the treatment of CID in dogs,
the Company believes there is a much larger market opportunity for the
treatment of acute diarrhea in dogs. The Company’s pivotal field trial
of Canalevia™ for acute diarrhea in dogs is currently
underway. Additionally, Jaguar intends to address the important unmet
medical need of chemotherapy-induced diarrhea with a pilot program to
investigate the best programs for management of diarrhea in dogs with
certain novel cancer agents, such as tyrosine kinase inhibitors,
commonly used in long-term canine and human cancer management.
Canalevia™ and SB-300 are under license for exclusive global
rights to Jaguar from Napo Pharmaceuticals, Inc. (“Napo”). Napo and
Jaguar have been engaged in exploratory discussions since February 2016
regarding a potential merger and/or other ways to cooperate with their
respective business endeavors. A human formulation of crofelemer was
approved by the FDA in 2012 for the symptomatic relief of non-infectious
diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Neonorm™ Calf remains an important asset for the Company and
is the focus of future business development activities. Jaguar is also
focused on business development discussions for other indications of its
products, in particular in the international arena.
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 possibility that the
second-generation, powder formulation of Neonorm™ Calf may
positively alter the intestinal microbiome to the benefit of the host,
the possible beneficial effects of this product on the efficiency of
feed conversion and on weight gain, the expected commercial launch of
SB-300, the Company’s belief that SB-300 will be an important product
introduction, with performance attributes differentiated from proton
pump inhibitors such as omeprazole, the expected commercial launch of
Canalevia™ for acute diarrhea in dogs, Jaguar’s assumption
that Canalevia™ and SB-300 offer the largest market
opportunities, the Company’s plans to address the unmet medical need of
CID with a pilot program to investigate the best programs for management
of diarrhea in dogs, future business development activities, 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
