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, announced today that it has signed a four-year manufacturing
and supply agreement with Glenmark Pharmaceuticals Ltd. (“Glenmark”).
With the execution of the agreement, Jaguar intends to use Glenmark as
its primary manufacturer of crofelemer for animal health use.
Crofelemer is an active pharmaceutical ingredient (“API”) isolated and
purified from the Croton lechleri tree, which is sustainably
harvested by Jaguar. Crofelemer is the API in Canalevia™,
Jaguar’s lead prescription drug product candidate for the treatment of
various forms of watery diarrhea in dogs. Jaguar is also developing
formulations of Canalevia™ for cats and horses.
A human-specific formulation of crofelemer, Fulyzaq®1, was
approved by the U.S. FDA in 2012 for the symptomatic relief of
noninfectious diarrhea in adults with HIV/AIDS on antiretroviral
therapy. Members of Jaguar’s management team developed crofelemer while
working at Napo Pharmaceuticals, Inc. (“Napo”), and Glenmark is the
current manufacturer of crofelemer for Fulyzaq. In 2014 Jaguar entered
into a license agreement with Napo granting Jaguar a Right of Reference
to the entirety of the information included in the U.S. FDA-approved
human new drug application of crofelemer.
As Jaguar announced this past August, it has submitted to the U.S. FDA
all required major technical sections of its New Animal Drug Application
(“NADA”) for Canalevia™. “Given Glenmark’s long-term
experience in the manufacture of crofelemer, we expect this relationship
to allow us to bring Canalevia™ to market in the most
efficient, rapid and cost-effective manner possible,” explained Lisa
Conte, Jaguar’s president and CEO. “The Chemistry, Manufacturing and
Controls section of our Canalevia™ NADA leverages the fact
that we will be utilizing the same cGMP-compliant manufacturer that
produces the crofelemer product approved for human use. This plan is in
line with our expectations, which were discussed during our meeting with
the U.S. FDA’s Center for Veterinary Medicine earlier this year.”
“Our agreement with Glenmark supplements our previously announced
manufacturing agreement with Milan, Italy-based Indena S.p.A. for Neonorm™,
the standardized botanical extract in our non-prescription products,
Neonorm™ Calf and Neonorm™ Foal Plus. We intend to
eventually use Indena as an alternative supplier for crofelemer,” stated
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. is a research-driven, global, integrated
pharmaceutical company and ranked among the top 80 Pharma & Biotech
companies of the world in terms of revenues. Glenmark is a leading
player in the discovery of new NCE and NBE molecules. Glenmark has
several molecules in various stages of clinical development and is
primarily focused on the areas of inflammation, pain and oncology. The
company has significant presence in branded formulations across emerging
economies including India. Glenmark also has a significant presence in
the generic pharmaceuticals markets in the U.S. and Europe.
About Indena S.p.A.
Indena S.p.A. is dedicated to the identification, development and
production of high-quality active principles derived from plants, for
use in the pharmaceutical, health food and personal care industries.
Headquartered in Milan and founded in 1921, Indena has five production
sites, five international branches throughout the world, manages
distribution operations in more than 70 countries, and employs more than
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 watery 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 U.S.
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.
Certain statements in this press release constitute “forward-looking
statements.” These include statements regarding Jaguar’s planned
development of formulations of Canalevia™ for cats and
horses, the Company’s expectation that its relationship with Glenmark
will allow Jaguar to bring Canalevia™ to market in the most
efficient, rapid and cost-effective manner possible, and Jaguar’s
intention to eventually use Indena S.p.A. as an alternative supplier for
crofelemer. 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.
1Fulyzaq® is a registered trademark of and is marketed by
Salix Pharmaceuticals, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250