Napo Appoints Veteran Pharmaceutical Sales Leader to Head National
Sales
SAN FRANCISCO--(BUSINESS WIRE)--Aug. 7, 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 animals on a global basis, announced today that
Mytesi® (crofelemer), a product of Jaguar’s wholly-owned
subsidiary Napo Pharmaceuticals (Napo), has received orphan-drug
designation from the U.S. Food and Drug Administration (FDA) for the
treatment of short bowel syndrome (SBS).
SBS is a complex condition characterized by malabsorption of fluids and
nutrients due to congenital deficiencies, association with premature
birth, or surgical resection of small bowel segments. Consequently,
patients suffer from symptoms such as debilitating diarrhea,
malnutrition, dehydration and imbalances of fluids and salts.
Mytesi® is approved by the 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.
Additionally, the ODA provides a seven-year period of marketing
exclusivity to the first sponsor who obtains marketing approval for a
designated orphan drug.
In countries such as the United Arab Emirates and Saudi Arabia, SBS
occurs with much higher incidence, and Napo has visited with medical
centers in this region.
“With the early and extreme morbidity and mortality suffered by SBS
patients, we welcome the opportunity to participate in the investigation
of a novel drug to address the devastating diarrhea and dehydration
caused by this lifelong disease for which there is currently no
available treatment except parenteral nutrition, and help limit the
suffering of patients and their family members,” Dr. Mohamad Miqdady,
Chief of Pediatric Gastroenterology, Hepatology & Nutrition at Sheikh
Khalifa Medical City in Abu Dhabi and a medical advisor to Napo,
recently stated.
Dr. Pravin Chaturvedi, Chair of Napo’s Scientific Advisory Board,
commented, “Crofelemer, the active pharmaceutical ingredient in Mytesi®,
is a first-in-class anti-secretory agent with a novel physiological
mechanism of action of regulating the functions of the chloride ion
channels—which we believe may have considerable potential for managing
the fluid loss and dehydration associated with chronic diarrhea that
leads to devastating health implications in these pediatric patients.”
Napo Appoints Veteran Pharmaceutical Sales Leader to Head National
Sales
Napo has hired Pete Riojas, a 29-year pharmaceutical industry veteran,
to lead Mytesi® sales as National Sales Director. Prior to
joining Napo, Mr. Riojas served as a regional sales director with
Sanofi, and as a national sales director with UCB Pharma. He spent
nearly nine years in a sales leadership role with Boehringer Ingelheim,
and 13 years in sales with Pharmacia Corporation. During his career, he
has worked closely with populations living with HIV/AIDS and addressed
diversity considerations in patient populations with unmet needs. Mr.
Riojas graduated from the University of Texas–Pan American with a
bachelor’s degree in biology and a minor in chemistry, and attended the
University of Houston College of Pharmacy.
“We’re delighted to have identified a seasoned pharmaceutical executive
of Pete’s stature to lead Mytesi® sales,” Lisa Conte,
Jaguar's president and CEO, stated. “Pete brings a wealth of marketing,
strategic planning, operations and sales management experience to the
team, and I’m confident that his depth of knowledge and record of
success will prove highly beneficial as we work to expand Mytesi®
sales and market awareness. We plan to have six dedicated Napo sales
representatives in place under Pete’s leadership to address our sales
guidance through Q1, 2018.”
Jaguar estimates the potential U.S. market for Mytesi® to be
approximately $100 million in gross annual sales, and anticipates that
Mytesi® will generate approximately $7.0 million in revenue
by April 2018 for its current, FDA-approved specialty indication. Jaguar
holds global unencumbered rights to key indications for Mytesi®,
and is pursuing a follow-on indication for Mytesi® in
chemotherapy-induced diarrhea, an important supportive care indication
for patients undergoing primary or adjuvant chemotherapy for cancer
treatment. Mytesi® is in development as a second-generation
anti-secretory agent for use in cholera patients; for supportive care
for irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD);
as well as for an orphan-drug indication for infants and children with
SBS. Mytesi® has shown activity in D-IBS patients in
published Phase 2 studies.
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, the merger of Jaguar Animal Health, Inc. and
Napo became effective July 31, 2017, at which point Jaguar Animal
Health’s name changed to Jaguar Health, Inc. and Napo began operating as
a wholly-owned subsidiary of Jaguar focused on human health and the
ongoing commercialization of Mytesi®.
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 the potential of Mytesi®
for managing the fluid loss and dehydration that leads to devastating
health implications in SBS patients, plans to have six dedicated Napo
sales representatives in place under the leadership of Mr. Riojas to
address Jaguar’s sales guidance through Q1, 2018, Jaguar’s estimate that
the potential U.S. market for Mytesi® is approximately $100
million in gross annual sales, Jaguar’s projection that Mytesi®
will generate approximately $7.0 million in revenue by April 2018, and
possible follow-on indications for Mytesi®. 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/20170807005300/en/
Source: Jaguar Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
