Jaguar Animal Health, Inc. (NASDAQ: JAGX) (Jaguar), 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 entered an exclusive, 60-day evaluation period,
commencing April 3, 2017, with a leading multinational animal
health pharmaceutical firm regarding Equilevia™ (formerly referred
to as SB-300), Jaguar’s drug product candidate for Equine Gastric
Ulcer Syndrome (EGUS). Equilevia™ is a pharmaceutical formulation
of a standardized botanical extract.
Jaguar completed a dose determination study of the target
commercial paste formulation of Equilevia™ in the fourth quarter of
last year. The equine veterinarians who performed the study were
blinded to the treatment assignment, and Jaguar was also blinded to
the data at that time. A full analysis of the study data with
scoring of squamous and glandular ulcers has undergone independent,
blinded review by Dr. Frank Andrews, DVM, MS, Dipl. ACVIM,
Professor and Director of the Equine Health Studies Program at
Louisiana State University College of Veterinary Medicine, an
equine internist specializing in gastric ulcer disease. All data
from the dose determination study will remain confidential during
the 60-day evaluation period.
The third-party review Dr. Andrews conducted of the study data
involved viewing gastroscopy videos for all participating horses
and evaluating each horse against three separate EGUS grading
scales: the McAllister scoring system (which assesses the number
and severity of ulcers), the EGUS Council scoring system (which is
relevant only for squamous ulcers), and a new visual analog scoring
system, relevant for both squamous and glandular ulcers, developed
by Dr. Andrews.
"This study showed consistency in the evaluation of gastric
ulcers by the newly developed visual analog scoring system compared
to the published McAllister and EGUS Council grading scales,”
stated Dr. Andrews. “The visual analog scoring system could be an
important tool in providing greater precision in gastric ulcers of
differing tissue type, such as glandular lesions."
As Jaguar announced in January 2016, topline results from the
Company’s proof-of-concept study to evaluate the safety and
effectiveness of Equilevia™ indicate that 78 to 89% of horses
treated with Equilevia™ (depending on dose) had resolution or
improvement of glandular ulcers as soon as 14 days during
treatment. The proof-of-concept study evaluated a dose of 10 grams
of Equilevia™ given orally four times daily (total daily dose of 40
g) and five grams of Equilevia™ given twice daily (total daily dose
of 10 g). The horses studied were in training but were not actively
racing.
As Jaguar announced in February 2016, further analysis of the
results of the proof-of-concept study indicates that Equilevia™ did
not alter gastric pH during the 28-day trial or for seven days
after therapy. A treatment for EGUS that does not alter gastric pH
is important because maintaining low gastric pH may be helpful for
digestion, for gut immunity and first line defense against
pathogens, for the absorption of vitamins and minerals, and for
potentially additional downstream effects. As Jaguar announced in
May 2016, standard drug testing in race horses that received
Equilevia™ did not detect any substances commonly disallowed by
horse racing authorities.
In November 2016 Jaguar issued a summary of racing data for
horses taking part in the Company’s Equilevia™ dose determination
study. Racing results in horses treated with Equilevia™ are of
interest because ulcers are a particular problem in equine
athletes. In races during the study treatment period, horses on
treatment with Equilevia™ had higher average winnings, higher
average total dollar winnings, and a higher likelihood of finishing
a race in the top 3 or in the top 5, compared with the period in
which they raced prior to the study.
Data from the American Horse Council states that there are
currently 9.2 million horses in the U.S., a population that
includes 844,531 race horses, more than 2.7 million show horses,
and more than 3.9 million recreational horses. Data from the Food
and Agriculture Organization of the United Nations indicate that
there were approximately 5.7 million horses in Europe in 2013 and
nearly 60 million horses in 2013 worldwide. According to a
third-party 2005 study, as many as 55% of performance horses have
both colonic and gastric ulcers, and 97% of performance horses have
either a gastric (87%) or a colonic (63%) ulcer.1
“The partnering strategy of both Jaguar and Napo is focused on
bringing novel gastrointestinal medicines from the two company’s
extremely broad pipelines to market in a productive and efficient
manner, and entering a possible collaboration with a leading animal
health company focused on equine athletes would be an important
component of this strategy,” commented Lisa Conte, Jaguar’s
president and CEO and Napo’s interim CEO.
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. Equilevia™ (formerly referred to as SB-300) is Jaguar’s
prescription drug product candidate for the treatment of
gastrointestinal ulcers in horses. Canalevia™ and Equilevia™
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 Equilevia™ 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” within the meaning of section 27A of
the Securities Act of 1933 and section 21E of the Securities
Exchange Act of 1934. These include statements regarding the belief
that the visual analog scoring system developed by Dr. Andrews
could be an important tool in providing greater precision in
gastric ulcers of differing tissue type, such as glandular lesions,
Jaguar’s plan to develop formulations of Equilevia™ in horses and
species-specific formulations of Neonorm™ in additional target
species, and Jaguar’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.
1Pellegrini FL. Results of a large-scale necroscopic study of
equine colonic ulcers. J Equine Vet Sci. 2005;25(3):113-117.
GASTROGARD® is a registered trademark of Merial.
Jaguar-JAGX
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version on businesswire.com: http://www.businesswire.com/news/home/20170328005370/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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