SAN FRANCISCO--(BUSINESS WIRE)--Nov. 15, 2017--
Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar), a commercial stage
natural-products pharmaceuticals company focused on developing novel,
sustainably derived gastrointestinal products for both human
prescription use and animals on a global basis, announced today that Dr.
Roscoe Moore Jr., DVM, MPH, Ph.D., DSc has joined the HIV Scientific
Advisory Board recently established by Jaguar’s wholly-owned subsidiary,
Napo Pharmaceuticals, Inc. (Napo), for Mytesi® (crofelemer),
Napo’s FDA-approved, first-in-class anti-secretory human prescription
drug.
Napo’s HIV Scientific Advisory Board will focus primarily on physician
education, and community and global awareness regarding the importance
and availability of solutions for neglected comorbidities, such as the
first-in-class anti-secretory mechanism of action of Mytesi®
for its currently approved indication.
Launched by Napo in October 2016, Mytesi® is the only
antidiarrheal studied in and U.S. FDA-approved for the symptomatic
relief of noninfectious diarrhea in adults living with HIV/AIDS on
antiretroviral therapy (ART). Mytesi® is a prescription
treatment for diarrhea that works differently, by acting locally in the
GI tract to normalize the flow of water. Mytesi® does not
have drug-drug interactions with ART, does not affect GI motility, and
has side effects that are similar to placebo.
According to data from The Joint United Nations Programme on HIV/AIDS
(UNAIDS), approximately 36.7 million people globally were living with
HIV in 2016, of which an estimated 19.5 million people were accessing
antiretroviral therapy—up from approximately 17.1 million in 2015 and an
estimated 7.7 million in 2010—and approximately 1.8 million people
became newly infected with HIV in 2016.
Dr. Moore is a former Assistant United States Surgeon General and a Rear
Admiral (Retired) in the U.S. Public Health Service. Dr. Moore was
involved in the creation of PEPFAR (the U.S. President's Emergency Plan
for AIDS Relief). PEPFAR was launched in 2003 by President George W.
Bush, and is dedicated to fighting HIV/AIDS in developing nations. The
organization is credited with saving millions of lives by expanding
access to HIV prevention, care and treatment in low-resource settings.
Of the approximately $6.80 billion appropriated to PEPFAR for fiscal
year 2017, $5.21 billion is allocated for HIV.
Dr. Moore served in the Office of the US Secretary of Health and Human
Services (HHS), and operated as Principal Liaison between the HHS and
Ministries of Health in Africa with regard to the development of
infrastructure and technical support for the delivery of preventive and
curative health needs for the continent. He also served as chief
epidemiologist with the FDA’s Center for Devices and Radiological
Health, and as the ranking veterinarian across all of the uniformed
services, including the armed forces. Dr. Moore has taken leadership
roles in the surveillance of emerging and re-emerging diseases
worldwide, bioterrorism issues, and the safety of bioengineered foods.
He has written or co-authored more than 100 publications covering a
broad range of public health issues. Dr. Moore founded PH RockWood
Corporation and serves as its President, and he serves as the CEO of
Medical Security Incorporated. He also serves as a board member,
director, or advisor for a number of companies in the health field. Dr.
Moore holds a Ph.D. in Epidemiology from The Johns Hopkins University,
an M.P.H. in Epidemiology from the University of Michigan, and a Doctor
of Veterinary Medicine and a B.S. degree from Tuskegee Institute.
“Neglected comorbidities such as HIV-related diarrhea play a significant
role in patient adherence to ART. Although ART failure or success is
based on a number of factors, including genetic differences in drug
metabolism, prior drug resistance, severe baseline immune suppression,
and concurrent opportunistic infections, ART adherence is of critical
importance because is it one of the few potentially alterable factors
determining outcomes for HIV patients,” Dr. Moore stated. “Efforts to
expand awareness about available solutions, such as Mytesi®,
that address specific comorbidities play an important role in maximizing
health and wellness in this population.”
“We are very honored that Dr. Moore—a globally recognized leader in the
field of human health and HIV—has joined Jaguar’s HIV Scientific
Advisory Board,” Lisa Conte, Jaguar's president and CEO, stated. “We
expect Dr. Moore’s expertise and decades of experience in the HIV field
to prove immensely beneficial as we work to grow awareness among
physicians and the HIV community regarding the first-in-class
anti-secretory mechanism of action of Mytesi® for its
currently approved indication.”
Dr. Pravin Chaturvedi, chair of Napo’s scientific advisory boards,
added, “We are greatly pleased that Dr. Moore has joined our scientific
advisory board for HIV. He brings a wealth of experience, and we look
forward to leveraging his insights and guidance.”
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 Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage natural-products
pharmaceuticals company focused on developing 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 cancer
therapy-related 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 expectation that Dr.
Moore’s expertise and decades of experience in the HIV field will prove
immensely beneficial as Jaguar and Napo work to grow awareness among
physicians and the HIV community regarding the first-in-class
anti-secretory mechanism of action of Mytesi® for its
currently approved indication, and about planned, potential 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/20171115005835/en/
Source: Jaguar Health, Inc.
Jaguar Health, Inc.
Peter Hodge
phodge@jaguar.health
