SAN FRANCISCO--(BUSINESS WIRE)--Oct. 18, 2017--
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/
Source: Jaguar Health, Inc.
KCSA Strategic Communications
Kate Tumino, 212-896-1252
ktumino@kcsa.com
or
Lisa
Lipson, 508-843-6428
llipson@kcsa.com
