Jaguar Expects to Conduct the Commercial Launch of Canalevia in the
First Half of 2018 for EID and CID (Chemotherapy-Induced Diarrhea) in
Dogs, Dependent on Receiving Conditional Approval for These Indications
SAN FRANCISCO--(BUSINESS WIRE)--Sep. 20, 2017--
Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), a natural-products
pharmaceuticals company focused on developing and commercializing novel,
sustainably-derived gastrointestinal products for both human
prescription use and veterinary use on a global basis, announced today
that the U.S. Food & Drug Administration’s Center for Veterinary
Medicine (CVM) has indicated that the use of Canalevia™ for
treatment of exercise-induced diarrhea (EID) in dogs qualifies as a
“minor use”, per the requirements of The Minor Use and Minor Species
Animal Health Act of 2004 (MUMS Act), which means that Canalevia™
is eligible for conditional approval for the indication of EID in dogs.
Canalevia™, Jaguar’s lead veterinary drug product candidate,
is under investigation for treatment of various types of diarrhea in
dogs. EID is a distinct physiological manifestation that has been
recorded in dogs, humans and horses.
“EID is a common problem among working dogs, such as sled dogs and
military dogs, when subjected to periods of intense, long-duration
off-leash exercise,” Dr. Michael Guy, DVM, MS, PhD, Jaguar’s vice
president and clinical veterinarian, explained. “Several mammalian
species that train for 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 heat.”
“The best-known examples of these incredible canine athletes are those
that participate in the Iditarod sled dog race—The Last Great
Race—across Alaska every March. Teams of up to 16 dogs mush over 1,000
miles across Alaska in only 8-10 days, and approximately 40% of these
dogs will experience severe diarrhea,” commented Dr. Guy.
The purpose of the MUMS Act is to encourage development and availability
of animal drugs intended as a minor use 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 seven 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.
FDA established, and periodically reassesses, a specific “small number
of animals'' (defined as <1% of the total U.S. population of the
specified species) for each of the seven major animal species in order
to determine whether any particular intended use in a major species
qualifies as a minor use. For dogs, this number is currently 70,000.
Jaguar believes Canalevia™ will qualify for MUMS designation
for EID because, in Jaguar’s estimate, the total number of dogs in the
United States affected by EID on an annual basis is less than 70,000.
Jaguar has already received MUMS designation for Canalevia™
for use in dogs with chemotherapy-induced diarrhea (CID), which provides
a possible opportunity to shorten the timeframe to commercialization for
the CID indication. If Canalevia™ receives conditional
approval for CID and EID in dogs, Jaguar expects to conduct the
commercial launch of Canalevia™ for both indications in the
first half of 2018.
Canalevia™ is a canine-specific formulation of crofelemer, an
active pharmaceutical ingredient (API) isolated and purified from the Croton
lechleri tree, which is sustainably harvested. Canalevia™
is the subject of a previously announced collaboration between Jaguar
and Elanco US Inc. (Elanco), a wholly-owned subsidiary of Eli Lilly. Per
the terms of the agreement between Jaguar and Elanco, the two companies
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 proposed indication
of acute diarrhea in dogs in the U.S. Jaguar has retained commercial
responsibility for the proposed CID and EID indications of Canalevia™
in dogs.
“We believe there is an important unmet medical need for the treatment
of CID and EID in dogs,” Lisa Conte, Jaguar's president and CEO, stated.
“We believe Canalevia™ is an ideal treatment for both
indications because of its demonstrated novel anti-secretory mechanism
of action. Canalevia™ acts locally in the gut and is
minimally absorbed systemically. It does not alter gastrointestinal
motility, has no significant effects on normally-functioning intestinal
ion channels or the transport of electrolytes or fluids, and has no side
effects different from placebo. With regard to CID, these features are
further augmented by the lack of effects of Canalevia™ on the
absorption and/or metabolism of co-administered chemotherapy drugs,
orally or by other routes of administration. Canalevia™ acts
by normalizing the flow of excess ions and water in the intestinal
lumen. The flow of excess ions and water into the intestinal lumen is
the last step common to the manifestation of acute diarrhea. As a
result, we believe Canalevia™ may be effective in the
treatment of acute diarrhea, regardless of cause, including CID and EID.”
To obtain conditional approval of a MUMS drug, the company must submit
Chemistry, Manufacturing, and Controls (CMC) and safety data similar to
that required for a new animal drug application (NADA) as well as data
suggesting a reasonable expectation of effectiveness. After the
submission and the review of the application, the FDA through the CVM
can then 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. A sponsor that gains approval or conditional approval for a
MUMS-designated drug receives seven years of marketing exclusivity.
In June 2015 Jaguar completed a multi-site pilot safety study involving
the anticipated commercial formulation of Canalevia™ for both
CID and EID, and Jaguar expects to complete submission of all required
major technical sections for the NADA for CID and EID to the FDA for
phased review by the end of next month. Jaguar expects to receive FDA
acknowledgment of the completion of all required technical sections in
support of conditional approval of Canalevia™ in the first
half of 2018 for CID and EID in dogs. 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 conditional approval to generate the data required for
full NADA approval.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a natural-products pharmaceuticals company
focused on developing and commercializing novel, sustainably derived
gastrointestinal products for both human prescription use and animals on
a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc.,
focuses on developing and commercializing proprietary human
gastrointestinal pharmaceuticals for the global marketplace from plants
used traditionally in rainforest areas. Our Mytesi®
(crofelemer) product is approved by the U.S. FDA for the symptomatic
relief of noninfectious diarrhea in adults with HIV/AIDS on
antiretroviral therapy. Mytesi® is in development for
multiple possible follow-on indications, including chemotherapy-induced
diarrhea; orphan-drug indications for infants and children with
congenital diarrheal disorders and short bowel syndrome; supportive care
for inflammatory bowel disease (IBD); irritable bowel syndrome (IBS);
and as a second-generation anti-secretory agent for use in cholera
patients. Canalevia™ is our lead animal prescription drug
candidate, intended for treatment of various forms of diarrhea in dogs.
Equilevia™ is Jaguar’s non-prescription product for total gut
health in equine athletes. Canalevia™ and Equilevia™
contain ingredients isolated and purified from the Croton lechleri
tree, which is sustainably harvested. Neonorm™ Calf and
Neonorm™ Foal are Jaguar’s lead non-prescription animal
products. Mytesi®, Canalevia™, Equilevia™
and Neonorm™ are distinct products that act at the same last
step in a physiological pathway generally present in mammals.
For more information about Jaguar, please visit jaguar.health.
For more information about Napo, visit napopharma.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking
statements.” These include statements regarding Jaguar’s expectation
that it will conduct the commercial launch of Canalevia™ for
the indications of CID and EID in the first half of 2018, the belief
that Canalevia™ may be effective in the treatment of acute
diarrhea, regardless of cause, including CID and EID, Jaguar’s
expectation that it will complete submission of all required major
technical sections for the NADA for CID to the FDA for phased review by
the end of next month, Jaguar’s expectation that it will receive FDA
acknowledgment of the completion of all required technical sections in
support of conditional approval of Canalevia™ in the first
half of 2018 for CID and EID in dogs, and the development of potential
Mytesi® follow-on indications. 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/20170920005740/en/
Source: Jaguar Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
