Napo Applications Request Orphan Drug
Designation for Mytesi for Congenital Diarrheal Disorders and
Diarrhea Associated with Short Bowel Syndrome
Pursuit of Orphan Drug Designations
Parallels Jaguar’s Focus on MUMS (Minor Use and Minor Species)
Indications for Canalevia in Dogs
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, and Napo
Pharmaceuticals, Inc. (Napo), a human health company developing and
commercializing novel gastrointestinal prescription products from
plants used traditionally in rainforest areas, today announced
Napo’s filing of orphan drug designation applications with the U.S.
Food & Drug Administration (FDA) for Mytesi® for two areas of
serious unmet medical needs: Congenital diarrheal disorders and
diarrhea associated with short bowel syndrome.
Napo’s 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. The Orphan Drug Act (ODA)
provides for granting special status to a drug or biological
product to treat a rare disease or condition upon request of a
sponsor. This status is referred to as orphan designation (or
sometimes “orphan status”). Orphan designation qualifies the
sponsor of the drug for various development incentives, including
tax credits for qualified clinical testing and relief of filing
fees.
Congenital diarrheal disorders (CDD) are a group of rare,
chronic intestinal channel diseases, occurring exclusively in early
infancy, that are characterized by severe, lifelong diarrhea and a
lifelong need for nutritional intake either parenterally or with a
feeding tube. CDDs are related to specific genetic defects
inherited as autosomal recessive traits, and the incidence of CDDs
is much more prevalent in regions where consanguineous marriage is
part of the culture. CDDs are directly associated with serious
secondary conditions including dehydration, metabolic acidosis, and
failure to thrive, prompting the need for immediate therapy to
prevent death and limit lifelong disability.
Short bowel syndrome (SBS) is a complex condition characterized
by malabsorption of fluids and nutrients due to congenital
deficiencies or surgical resection of small bowel segments.
Consequently, patients suffer from symptoms such as debilitating
diarrhea, malnutrition, dehydration and imbalances of fluids and
salts. This could be due to either a genetic disorder or premature
birth. In countries such as the United Arab Emirates and Saudi
Arabia, both CDD and SBS occur with much higher incidence. Napo
recently visited with medical centers in this region.
“With the early and extreme morbidity and mortality suffered by
CDD and SBS patients, we welcome the opportunity to participate in
the investigation of a novel drug to address the devastating
diarrhea and dehydration caused by these lifelong diseases for
which there is currently no available treatment except parenteral
nutrition, and help limit the suffering of patients and their
family members,” stated Dr. Mohamad Miqdady, Chief of Pediatric
Gastroenterology, Hepatology & Nutrition at Sheikh Khalifa
Medical City in Abu Dhabi.
“Our focus for the orphan drug designation applications is to
provide symptomatic relief for the secretory diarrhea, which begins
shortly after birth and continues as a lifelong condition,”
commented Dr. Pravin Chaturvedi, Chair of Napo’s Scientific
Advisory Board. “Crofelemer, the active pharmaceutical ingredient
in Mytesi®, is a first-in-class anti-secretory agent with a novel
mechanism of action—which we believe may have considerable
potential for managing the fluid loss and dehydration that leads to
devastating health implications in these patients.”
Lisa Conte, Jaguar's President and CEO and Napo’s interim CEO,
stated, “CDD and SBS patients who survive after birth face
devastating, lifelong morbidity and a significantly diminished
quality of life—including a lifelong need for feeding tubes. We
believe Mytesi® may have considerable potential to help manage the
severe diarrhea and dehydration symptomatic of CDD and SBS and thus
reduce the associated morbidity and mortality, with the added goal
of lessening the need for parenteral nutrition. We’re grateful for
the existence of the orphan drug designation regulatory pathway,
which may allow us to receive approval for Mytesi® to address these
important and grievous unmet medical needs in small populations of
pediatric and youthful patients, while we simultaneously pursue
approval of Mytesi® for use in the large populations of patients
suffering from chemotherapy-induced diarrhea (CID), irritable bowel
syndrome, and inflammatory bowel disease. In a similar fashion,
Jaguar’s focus on MUMS (Minor Use and Minor Species) indications
for Canalevia™ for CID in dogs and exercise-induced diarrhea (EID)
in dogs complements Jaguar’s collaboration with Elanco US Inc. on
the global development of Canalevia™ for treatment of diarrhea in
the general dog population and other companion animals.”
Napo holds global unencumbered rights to key indications for
Mytesi®, and is continuing development of Mytesi® for other
antidiarrheal indications, with investigational studies completed
in irritable bowel syndrome, cholera, traveler’s diarrhea, and in
pediatric patients, and two planned investigator-initiated trials
of the product in breast cancer patients suffering from CID.
About Mytesi®
Mytesi® (crofelemer) is an antidiarrheal indicated for the
symptomatic relief of noninfectious diarrhea in adult patients with
HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated
for the treatment of infectious diarrhea. Rule out infectious
etiologies of diarrhea before starting Mytesi®. If infectious
etiologies are not considered, there is a risk that patients with
infectious etiologies will not receive the appropriate therapy and
their disease may worsen. In clinical studies, the most common
adverse reactions occurring at a rate greater than placebo were
upper respiratory tract infection (5.7%), bronchitis (3.9%), cough
(3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are
available at Mytesi.com. Crofelemer, the active ingredient in
Mytesi®, is a botanical (plant-based) drug extracted and purified
from the red bark sap of the medicinal Croton lechleri tree in the
Amazon rainforest. Napo has established a sustainable harvesting
program for crofelemer to ensure a high degree of quality and
ecological integrity.
As previously announced, Jaguar has already received MUMS
designation for Canalevia™ for use in dogs with CID, which Jaguar
expects will be the first indication available commercially in Q1,
2018. Canalevia is Jaguar’s lead drug product candidate, under
investigation for various types of diarrhea in dogs. Canalevia™ 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.
“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,” Conte added.
Proposed Merger
As announced March 31, 2017, Napo and Jaguar have entered a
definitive merger agreement. Napo and Jaguar are in the process of
evaluating potential follow-on indications for Mytesi® as part of
the anticipated combination of the product pipelines of the two
companies and an S-4/A was filed with the SEC on May 26, 2017.
The proposed merger of Jaguar and Napo remains subject to
customary conditions to closing. Upon the consummation of the
merger, Jaguar’s name will be changed to Jaguar Health, Inc., and
Napo will operate as a wholly-owned subsidiary of Jaguar, focused
on human health. As previously stated, Jaguar and Napo expect the
merger to close by the end of July 2017.
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals, Inc. focuses on the
development and commercialization of proprietary pharmaceuticals
for the global marketplace in collaboration with local
partners.
For more information, please visit www.napopharma.com.
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 Jaguar’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 about Jaguar, please visit
www.jaguaranimalhealth.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements.” These include statements regarding
the commercial availability of Canalevia™ for use in dogs with CID
and EID, possible MUMS designation of Canalevia™ for use in dogs
with EID, the potential of Mytesi® for reducing morbidity and
mortality in patients suffering from CDDs and SBS, the development,
approval and sales of potential follow-on indications of Mytesi®,
the proposed merger between Jaguar and Napo, the expectation that
the proposed merger will close by the end of July 2017, Jaguar’s
intention to develop species-specific formulations of Neonorm™ in
additional target species, and Jaguar’s plan to develop
formulations of Canalevia™ for cats, horses 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/20170605005399/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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