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
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
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version on businesswire.com: http://www.businesswire.com/news/home/20170920005740/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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