Jaguar and Napo Comment on Potential
Follow-on Indications for Mytesi, Napo’s “Pipeline Within a
Product”
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 the
appointment of Dr. Pravin Chaturvedi, a highly experienced drug
development veteran who has spent more than 25 years in the
pharmaceutical/biotech industry, as Chair of the combined company’s
Scientific Advisory Board, following the expected close of the
proposed merger of Jaguar and Napo. Dr. Chaturvedi has served as
Chair of Napo’s Scientific Advisory Board since March 27, 2017. Dr.
Chaturvedi is responsible for providing direction on strategy,
tactics and oversight regarding advancing the development and
commercialization of the companies’ drug pipelines, including, but
not limited to, Mytesi® and SB-300.
From 2006 to 2013, Dr. Chaturvedi served as Napo's Chief
Scientific Officer and has remained a scientific adviser to the
company since 2014. His track record of successful development
includes participating in and/or leading development efforts for
seven drugs, including Napo’s Mytesi® (crofelemer) product, which
is approved by the U.S. FDA for the symptomatic relief of
noninfectious diarrhea in adults with HIV/AIDS on antiretroviral
therapy. For this indication, Dr. Chaturvedi led the key opinion
leader efforts that contributed to the successful use of adaptive
clinical trial design for the Mytesi® pivotal trial and its
approval by the FDA.
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. Dr. Chaturvedi is chairing the investigation of Mytesi®
for possible follow-on indications, which include
chemotherapy-induced diarrhea, irritable bowel syndrome (IBS), for
which proof of concept data is already in hand, inflammatory bowel
diseases (IBD) and diarrhea resulting from hospital-acquired
infections such as Clostridium difficile, a bacterium that is the
most common cause of infectious diarrhea in hospital settings.
Napo recently convened a Scientific Advisory Board meeting with
expert gastroenterologists, who provided advice on study
populations and designs in IBS and IBD. As Douglas Drossman, MD,
Professor Emeritus at the University of North Carolina, who is a
gastroenterologist in private practice at Drossman
Gastroenterology, noted, “The safety profile of crofelemer
constitutes an advantage that differentiates it from many other
gastrointestinal products.”
Mytesi® is also being explored for treatment of important orphan
gastrointestinal indications such as congenital diarrheal disorders
(CDD) and diarrhea associated with short-bowel syndrome (SBS). CDDs
are a group of rare, chronic intestinal channel diseases
characterized by large, watery stools containing an excess of
chloride and sodium, lifelong diarrhea, and a lifelong need for
nutritional intake with a feeding tube. CDDs are related to
specific genetic defects inherited as autosomal recessive traits,
and the incidence of CCDs is much more prevalent in regions where
consanguineous marriage is part of the culture.
Patients with SBS are born with a substantial shortening of the
small intestine, to a mean length of 50 cm, compared with a normal
length at birth of 190-280 cm. This could be due to either a
genetic disorder or pre-mature birth. In regions such as the United
Arab Emirates and Saudi Arabia, both CDD and SBS occur with much
higher incidence. Napo has 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.
Dr. Chaturvedi is also providing oversight for development of
Napo’s proprietary second-generation anti-secretory agent for
cholera—a possible indication that may present Napo with an
opportunity for an FDA tropical disease priority review voucher.
Under FDA regulations, the sponsor of a human drug application for
a qualified tropical disease may be eligible for a priority review
voucher, which can be used to obtain priority review for any
subsequent human drug application submitted to FDA. These vouchers,
which are transferable, have recently sold for $125 million - $350
million, and provide an immediate return on investment for the
development of a novel product for important indications.
“I am thrilled to be supporting Napo’s and Jaguar’s shared
mission to change the global standard of care for gastrointestinal
diseases,” stated Dr. Chaturvedi. “I look forward to evaluating
potential multiple follow-on gastrointestinal indications for
Mytesi®, and leveraging the collective expertise of our team in
advancing drug development through innovative approaches such as
the adaptive clinical trial design that led to the FDA approval of
Mytesi® for its current indication of treating noninfectious
diarrhea in adults with HIV/AIDS on antiretroviral therapy.”
“We are very pleased that Dr. Chaturvedi has returned to support
these principal development activities,” Conte commented, “which,
if approved, will complement our current sales of Mytesi® for
noninfectious diarrhea in adult HIV/AIDS patients on antiretroviral
therapy. We consider Mytesi® a ‘pipeline within a product’, and
Napo has global unencumbered rights to this novel first-in-class
anti-secretory agent with multiple potential follow-on
indications.”
Dr. Chaturvedi has co-founded and led multiple biotech
enterprises including Scion, IndUS and Oceanyx, and has served as
the CEO or CSO for Scion, IndUS, Napo, and Oceanyx and is the CEO
for Pivot Pharmaceuticals. Over his career, Dr. Chaturvedi led
discovery and/or development activities for several new chemical
entities (NCEs) and has participated in the discovery and/or
development of novel drugs for treatment of HIV, hepatitis C,
epilepsy and Alzheimer's disease. Earlier in his career, Dr.
Chaturvedi was head of lead evaluation at Vertex Pharmaceuticals
and was in the preclinical group at Alkermes. He started his career
in the product development group at Parke-Davis/Warner-Lambert
Company (now Pfizer). Dr. Chaturvedi holds a Ph.D. in
Pharmaceutical Sciences from West Virginia University and a
Bachelor's in Pharmacy from the University of Bombay.
Proposed Merger
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. Subject to the conditions to closing, the proposed
merger is expected to close by the end of July 2017.
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.
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 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 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 development, approval and sales of potential follow-on
indications of Mytesi®, the proposed merger between Jaguar and
Napo, Jaguar’s intention to develop species-specific formulations
of Neonorm™ in additional target species, and the Company’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/20170510005840/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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