SAN FRANCISCO--(BUSINESS WIRE)--Mar. 28, 2017--
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170328005370/en/
Source: Jaguar Animal Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
