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 submitted a formal request to the U.S. Food & Drug
Administration’s Center for Veterinary Medicine (CVM) for a
determination about whether or not Canalevia™ qualifies as a “minor
use”, per the requirements of The Minor Use and Minor Species
Animal Health Act (MUMS Act), for the indication of
exercise-induced diarrhea (EID) in dogs. EID is a distinct
physiological manifestation that has been recorded in dogs, humans
and horses. EID may occur before, during or after sustained
physical exertion.
The MUMS Act became effective in 2004. The purpose of the Act is
to encourage development and availability of animal drugs intended
to be used in a major species (defined as dogs, cats, cattle,
horses, chickens, turkeys and pigs) to treat diseases which occur
infrequently or in limited geographic areas, and to encourage
development and availability of animal drugs for use in minor
species (defined as all animals other than humans that are not one
of the major species). MUMS designation is modeled on the orphan
drug designation for human drug development and offers possible
financial incentives to encourage MUMS drug development, such as
the availability of grants to help with the cost of developing the
MUMS drug.
Canalevia™, Jaguar’s lead drug product candidate, under
investigation for various types of diarrhea in dogs, is a
canine-specific formulation of crofelemer, an active pharmaceutical
ingredient isolated and purified from the Croton lechleri tree,
which is sustainably harvested. Numerous animal and human clinical
trials have shown significant beneficial results in the use of
crofelemer in the treatment of secretory diarrhea.
Jaguar has already received MUMS designation for Canalevia™ for
use in dogs with Chemotherapy-Induced Diarrhea (CID), which the
Company expects will be the first indication available commercially
in the next year.
“If we are successful in obtaining MUMS designation for
Canalevia™ for use in dogs with EID, it is our hope that this could
lead to access to Canalevia™, under conditional approval, for dogs
for this indication also within a year,” commented Lisa Conte,
Jaguar’s president and CEO.
Dr. Michael Guy, DVM, MS, PhD, Vice President and Clinical
Veterinarian of Jaguar, added, “EID is a common problem among
working dogs, such as sled dogs and military dogs, when subjected
to periods of intense, long-duration exercise off-leash. Several
mammalian species that physically train and run in competitive
events can push themselves to extreme physical demands. At this
highest level of physical exertion, secretory diarrhea is a common
result, and the diarrhea can be debilitating enough to require
medical attention and removal from competition or training.
Diarrhea can have serious consequences for the canine athlete due
to their high capacity for metabolic heat generation and reliance
on evaporative cooling to dissipate that heat.”
FDA established, and periodically reassesses, a specific “small
number of animals'' for each of the seven major animal species to
be used in determining whether any particular intended use in a
major species qualifies as a minor use. For dogs, this number is
currently 70,000. Jaguar believes that Canalevia™ will qualify for
MUMS designation for EID because, in the Company’s estimate, the
total number of dogs in the United States affected by EID on an
annual basis is less than 70,000. If CVM decides that the
indication of Canalevia™ for EID is an acceptable minor use, then
Jaguar will be eligible to apply for MUMS designation for this
indication.
To obtain conditional approval of a MUMS drug, Jaguar must
submit CMC (Chemistry, Manufacturing and Controls) and safety data
similar to that required for an NADA (New Animal Drug Application),
as well as data suggesting a reasonable expectation of
effectiveness. After the submission and review of the application,
the FDA through the CVM can grant a conditional approval (CA-1).
This approval allows for commercialization of the product while the
sponsor continues to collect the substantial evidence of
effectiveness required for a full NADA approval. The sponsor of a
designated MUMS drug has up to five years to demonstrate
substantial evidence of effectiveness. A sponsor that gains
approval or conditional approval for a MUMS designated drug
receives seven years of marketing exclusivity.
With conditional approval under MUMS designation for Canalevia™
for use in dogs with EID, Jaguar would be required to initiate a
pivotal field study in the five years following such conditional
approval to generate the data required for full NADA approval.
Canalevia™ is the subject of a recently forged collaboration
with Elanco US Inc. Jaguar and Elanco US Inc. will collaborate on
the global development of Canalevia™ for treatment of acute
diarrhea in dogs, as well as on co-promotion and commercialization
of Canalevia™ for the canine acute diarrhea indication in the U.S.
Jaguar has retained commercial responsibility for the CID and EID
indications of Canalevia™ in dogs.
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 Jaguar’s
belief that Canalevia™ for use in CID in dogs will be the first
indication available commercially in the next year, the possible
availability of Canalevia™, under conditional approval, for dogs
for the indication of EID in dogs within a year, Jaguar’s belief
that Canalevia™ will qualify for MUMS designation for EID, 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.
Jaguar-JAGX
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version on businesswire.com: http://www.businesswire.com/news/home/20170314005879/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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