Jaguar Subsidiary Napo Pharmaceuticals Files CMC Supplement with FDA for Sample-Size Bottles of Mytesi, Napo’s FDA-Approved...
September 28 2017 - 9:13AM
Business Wire
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
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version on businesswire.com: http://www.businesswire.com/news/home/20170928005762/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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