Napo Pharmaceuticals, Inc. (Napo), a human health company
developing and commercializing novel gastrointestinal prescription
products from plants used traditionally in rainforest areas, and a
wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ: JAGX)
(Jaguar), announced today that it has joined more than 400
organizations from 59 countries in supporting the U=U Consensus
Statement. The Prevention Access Campaign’s Undetectable =
Untransmittable message underscores that a person living with HIV
who is on antiretroviral therapy (ART), and has a sustained
undetectable viral load for at least six months, has a negligible
risk of sexual transmission of HIV. This scientific consensus
statement has been endorsed by leading HIV experts and researchers
from around the world and Napo supports this message to raise
global awareness about the effectiveness of HIV treatment and to
destigmatize the disease.
“Napo has been and continues to be an advocate for the HIV
community and their healthcare providers through our endorsement of
the U=U Consensus Statement, our sponsorship of the My HIV Thank
You platform, and our educational awareness programs. We firmly
believe that living with HIV requires access to the most up-to-date
research and experts,” said Lisa Conte, CEO, Napo Pharmaceuticals.
“In addition, we have launched educational awareness programs
targeting chronic diarrhea, as it continues to be a significant,
neglected symptom in HIV/AIDS patients. Relevant to the U=U
movement, diarrhea can lead patients to interrupt or discontinue
their ART. Educating people living with HIV and their healthcare
providers about Mytesi®—and providing them with access to this
FDA-approved prescription drug—underpins everything we do.”
“U=U is a life-changing message for people living with HIV but
not enough people know about it yet,” said Bruce Richman, who was
diagnosed in 2003 and is the Executive Director of Prevention
Access Campaign. “We’re thrilled that Napo is joining the U=U
campaign to empower people with HIV with knowledge that changes
lives, dismantles stigma, and gets us closer to ending the
epidemic.”
“Even though patients are undetectable, and cannot transmit the
virus to a partner, the effects of the virus on the GI tract, known
as HIV enteropathy, may remain in spite of viral suppression in the
blood. CD4 counts are slower to recover in the gut and don’t
recover to the same level as in the plasma. HIV enteropathy is
chronic persistent diarrhea in PLWHA and is a problem that affects
as many as twenty percent of HIV patients,” stated Dr. Gary Blick,
Chief Medical Officer, Health Care Advocates International and
Co-Founder of HIV Advocates.
While Napo recognizes that many people living with HIV/AIDS are
undetectable, one in five still suffer from diarrhea1.
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.
As announced last month, Napo significantly expanded its
national salesforce for Mytesi® through the recent hire in key U.S.
markets of six sales representatives experienced in the sale of
drugs to HIV physicians and gastroenterologists. With the
equivalent of seven dedicated, full-time sales representatives now
reporting to a newly hired national sales manager, supported by
concomitant marketing, promotional and medical education
initiatives, Jaguar and Napo expect a proportional response in the
number of patients treated with Mytesi®. Jaguar and Napo estimate
the potential U.S. market for Mytesi® to be approximately $100
million in gross annual sales and anticipate that Mytesi® will
generate approximately $7.0 million in revenue by April 2018 for
its current FDA-approved specialty indication.
To learn more about what you can do about HIV-related diarrhea,
visit Mytesi.com.
For more information on the U=U campaign and to view a full list
of partners click here.
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 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 and Napo’s belief that, with the equivalent of seven
dedicated, full-time sales representatives now reporting to a newly
hired national sales manager, supported by concomitant marketing,
promotional and medical education initiatives, there will be a
proportional response in the number of patients treated with
Mytesi®, Jaguar’s and Napo’s estimate that the potential U.S.
market for Mytesi® is approximately $100 million in gross annual
sales, the expectation that Mytesi® will generate approximately
$7.0 million in revenue by April 2018 for its current FDA-approved
specialty indication, 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.
1Brenchley JM1, Douek DC. HIV infection and the gastrointestinal
immune system. Mucosal Immunol. 2008 Jan;1(1):23-30. doi:
10.1038/mi.2007.1.
Jaguar-JAGX
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171018005849/en/
KCSA Strategic CommunicationsKate Tumino,
212-896-1252ktumino@kcsa.comorLisa Lipson,
508-843-6428llipson@kcsa.com
Jaguar Health (NASDAQ:JAGX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Jaguar Health (NASDAQ:JAGX)
Historical Stock Chart
From Apr 2023 to Apr 2024