SAN FRANCISCO--(BUSINESS WIRE)--Sep. 28, 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 veterinary use on a global basis, announced today
that its wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (Napo), has
filed a Chemistry, Manufacturing, and Controls (CMC) supplement with the
U.S. Food & Drug Administration (FDA) for six-tablet bottles of Mytesi®,
Napo’s FDA-approved human drug, in preparation for Napo’s planned
national sample campaign.
Mytesi® is approved by the U.S. FDA for the symptomatic
relief of noninfectious diarrhea in adults with HIV/AIDS on
antiretroviral therapy. Jaguar and Napo are pursuing a follow-on
indication for Mytesi® in chemotherapy-induced diarrhea
(CID), an important supportive care indication for patients undergoing
primary or adjuvant chemotherapy for cancer treatment. Mytesi®
is also in development for rare disease indications for infants and
children with congenital diarrheal disorders and short bowel syndrome
(SBS); for irritable bowel syndrome (IBS) (Mytesi® has
demonstrated benefit to IBS-D patients in published Phase 2 studies);
for supportive care for inflammatory bowel disease (IBD); and as a
second-generation anti-secretory agent for use in cholera patients.
Mytesi® has received orphan-drug designation for SBS.
The planned sample bottles will contain enough Mytesi®
tablets for three days of use. To implement the filing, Napo produced
stability data in support of a one-year shelf life for the contents of
the sample bottles.
As announced earlier this month, Napo significantly expanded the
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. Napo’s new sales
representatives are based in and will cover New York, Miami, Atlanta,
Los Angeles, Houston, San Francisco and the surrounding regions. A
dedicated Mytesi® salesperson has been based in the St.
Louis/Chicago area since this past March. All of these regions are key
markets for HIV-related drug sales.
“Chronic diarrhea remains a significant complaint of people living with
HIV/AIDS, particularly those who are older and have lived the virus in
their gut for over 10 years. This is a growing demographic of the HIV
community, and 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,” Pete
Riojas, Napo’s national sales director for Mytesi®, stated.
“Driving patient awareness about Mytesi® is one of our key
goals, and we expect our planned sample program to be highly impactful
in this regard.”
Mytesi® is currently covered by Medicaid in all 50 states. It
is also currently covered on 100% of the top 10 commercial insurance
plans, representing more than 245 million U.S. lives. Additionally, Napo
operates a co-pay coupon to ensure that no participating patients have a
Mytesi® co-pay greater than $25. Information about the
NapoCares Patient Assistance Program, which assists patients with
benefit verification, prior authorization, and claims appeals, can be
found at mytesi.com/mytesi-savings.html.
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 the expectation that the
planned Mytesi® sample program will be highly impactful in
driving patient awareness about Mytesi®, and about the
development of potential Mytesi® follow-on indications. 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/20170928005762/en/
Source: Jaguar Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
