SAN FRANCISCO--(BUSINESS WIRE)--Oct. 27, 2015--
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 a recently completed study by researchers
from Cornell University College of Veterinary Medicine (Cornell)
supports a benefit of Jaguar Animal Health’s Neonorm™ Calf
product on the optimization of the intestinal microbiome profile in
pre-weaned dairy calves. The microbiome is a community of microorganisms
that live normally in the gut and are vital to maintenance of gut health.
The objective of the study was to characterize the fecal microbiota of
newborn calves experiencing diarrhea induced by enterotoxigenic Escherichia
coli (E. coli) and identify possible relationships of
treatment with a standardized, enteric-coated botanical extract derived
from the Croton lechleri tree, the key composition of Neonorm™
Calf, and the altering of the intestinal microbiota profiles of the
calves. Neonorm™ Calf is the Company’s lead non-drug product,
which has been formulated and clinically tested to specifically address
the normalization of fecal formation and ion and water flow in the
intestinal lumen of newborn dairy calves.
The study was designed to analyze a subset of randomly selected fecal
samples collected during a challenge study conducted by Cornell in 2013
titled Effect of Crofelemer Extract on Severity and Consistency of
Experimentally Induced Diarrhea in Newborn Holstein Calves. The
results of the recently completed microbiome study show that the
relative abundance of Faecalibacterium, a bacteria genus regarded
as beneficial to the host, increased in treated calves when compared to
control calves. Additionally, treated calves had a higher relative
abundance of Faecalibacterium following cessation of treatment.
Dr. Rodrigo Bicalho, one of the authors of the Cornell microbiome study,
has conducted microbiome research in neonatal calves for the past five
years and has previously found positive associations of Faecalibacterium
with weight gain and lower incidence of diarrhea, as described in a
published study he co-authored titled Fecal Microbial Diversity in
Pre-Weaned Dairy Calves as Described by Pyrosequencing of Metagenomic
16S rDNA. Associations of Faecalibacterium Species with Health and Growth.
“There were no negative controls used in the 2013 Cornell challenge
study, as all calves were challenged with E. coli to bring on diarrhea.
Nevertheless, although this challenge could have altered the natural
course of the microbiome evolution, we were still able to see results in
the recently completed microbiome study supporting a beneficial
prebiotic mechanism of Neonorm™ Calf,” stated Lisa Conte,
Jaguar’s president and CEO. “This mechanism would supplement and is
potentially synergistic with the anti-secretory and weight gain benefits
of Neonorm™ Calf. This is an exciting new realm in gut biome
research, and the Cornell team will continue to investigate this
potential prebiotic benefit with the Company as we develop a Neonorm™
Calf Plus formulation for entire herd management that can be
administered in water and/or milk replacer.”
As the Company announced earlier this month, the results of the 2013
Cornell challenge study evaluating the effect of Neonorm™
Calf was recently published in the official journal of the American
Dairy Science Association, Journal of Dairy Science. The results
of the 2013 study suggest that Neonorm™ Calf can
significantly increase the fecal dry matter of neonatal calves with
experimentally-induced enterotoxigenic E. coli diarrhea, and indicated a
benefit of Neonorm™ Calf in supporting weight gain in calves.
This month the Company also announced the results of a recently
completed field study in Wisconsin, which further support the benefits
of Neonorm™ Calf in reducing water loss associated with
diarrhea and supporting weight gain in preweaned dairy calves.
Neonorm™ Calf contains the same standardized botanical
extract as Neonorm™ Foal Plus, an equine product that Jaguar
expects to launch this December. The Neonorm™ standardized
botanical extract is derived from the Croton lechleri tree, which
is sustainably harvested. Jaguar currently owns enough of this extract
to formulate a combination of approximately one million doses of Neonorm™
Calf or Neonorm™ Foal Plus.
About Neonorm™ Calf
Neonorm™ Calf is an enteric-coated tablet designed to be
orally administered to preweaned dairy calves twice daily for three
days. It has been formulated and clinically tested to specifically
address the normalization of fecal formation and ion and water flow in
the intestinal lumen of newborn dairy calves. The product acts locally
in the gut and is minimally absorbed systemically. It does not alter
gastrointestinal motility, and, to date, has shown no significant
effects on normally functioning intestinal ion channels and electrolyte
or fluid transport, nor shown any side effects different from placebo.
As a result, fecal formation is normalized in a short period of time,
weight loss is mitigated, and supportive care costs and rehydration
therapies such as oral rehydration solution, or ORS, are reduced. Neonorm™
Calf has not been evaluated by the FDA for use in animals.
On November 16th, Dr. Bicalho will be giving a presentation
titled Understanding Prebiotics and the Intestinal Microbiome of
Calves at Jaguar’s 2015 Analyst and Investor Day in New York City.
Parties interested in attending should contact Allison Soss at asoss@kcsa.com
or 212.896.1267.
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 potential prebiotic
benefit of Neonorm™ Calf, the expected launch of Neonorm™
Foal Plus this December, the intention for researchers from Cornell to
continue to investigate the potential prebiotic benefit of Neonorm™
Calf with Jaguar as the Company develops a Neonorm™ Calf Plus
formulation, Jaguar’s intention to develop species-specific formulations
of Neonorm™ in six additional target species, and the
Company’s plan to develop 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.
Jaguar-JAGX
View source version on businesswire.com: http://www.businesswire.com/news/home/20151027005153/en/
Source: Jaguar Animal Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
