Napo Pharmaceuticals, Inc. (Napo), a human health company
developing and commercializing novel gastrointestinal prescription
products from plants used traditionally in rainforest areas, which
launched Mytesi® in April, 2017, and Jaguar Animal Health, Inc.
(NASDAQ: JAGX) (Jaguar), an animal health company which has
licensed worldwide veterinary rights to Mytesi® and is focused on
developing and commercializing first-in-class gastrointestinal
products for companion and production animals, foals, and high
value horses, today announced Napo’s launch of a Mytesi® video
featuring commentary from people living with HIV/AIDS describing
the challenges of living for years with HIV-related diarrhea and
the impact that diarrhea has on their daily lives.
Napo’s Mytesi® product is approved by the U.S. FDA for the
symptomatic relief of noninfectious diarrhea in adults with
HIV/AIDS on antiretroviral therapy. The 2.5-minute video,
containing quotes from HIV patients recently interviewed by Napo,
is being used by Napo’s national salesforce to broaden awareness
about Mytesi® and HIV-related diarrhea among healthcare providers
and people suffering from HIV. The video can be viewed at
www.napopharma.com.
“Chronic, symptomatic diarrhea remains a major, underreported
consequence of HIV and a significant burden for HIV patients. In
fact, a recent study shows that one in five people living with HIV
experience diarrhea1. Many HIV patients are only aware of
over-the-counter drugs as treatments for diarrhea. These agents
have not been studied specifically in people living with HIV/AIDS.
In addition, Imodium® and Lomotil®—opioids that work by slowing
movement through the GI tract—can cause constipation.
Mytesi® is the only drug studied in and FDA-approved for
relief of diarrhea in HIV+ patients,” stated Lisa Conte, Napo’s
interim CEO and Jaguar’s president and CEO. “The active
pharmaceutical ingredient in Mytesi®, crofelemer, is a
first-in-class anti-secretory agent offering a natural solution and
a novel, normalizing mechanism of action in both humans and
animals.”
A communication disconnect between physicians and their patients
may be one of the major reasons diarrhea among people living with
HIV/AIDS remains underrecognized. These patients have often been
dealing with diarrhea due to HIV enteropathy for a long time and
just assume it is something they must live with. Physicians don’t
typically have diarrhea at the top of their list of issues to
discuss with patients. Additionally, it is estimated that only
one-third of HIV patients with diarrhea receive treatment, and they
may be inappropriately and unsatisfactorily using an
over-the-counter drug that their healthcare provider is unaware
of1. Many physicians and HIV patients may not be aware that a
specific treatment, Mytesi®, is available. The “Enough is
Enough” Mytesi® tagline appearing in the video is meant to indicate
that diarrhea does not have to become the new normal.
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.
Proposed Merger
As announced March 31, 2017, Napo and Jaguar Animal Health, Inc.
(NASDAQ: JAGX) have entered a definitive merger agreement. The
companies underscore their expectation that the merger will close
by the end of July, 2017. Napo and Jaguar are in the process of
evaluating potential human and animal follow-on indications for
Mytesi® (crofelemer) as part of the anticipated combination
of the product pipelines of the two companies. Upon the
consummation of the merger, Jaguar’s name will be changed to Jaguar
Health, Inc., and Napo will operate as a wholly-owned subsidiary of
Jaguar, focused on human health. Following consummation of the
proposed merger, it is expected that there will be approximately 65
million shares outstanding in the combined entity. The balance of
the outstanding fully diluted equity of the combined entity, when
factoring in convertible debt funding as part of the merger, is
expected to be approximately 93 million shares.
Jaguar has filed with the SEC a Registration Statement on Form
S-4 that includes proxy solicitation materials. Stockholders of
Jaguar and Napo are urged to read the proxy solicitation/prospectus
contained in the Registration Statement when it becomes available
and any other relevant materials filed with the SEC because these
materials will contain important information about the potential
merger.
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals, Inc., focuses on the
development and commercialization of proprietary pharmaceuticals
from rainforest resources for the global marketplace in
collaboration with local partners.
About Jaguar Animal Health, Inc.
Jaguar Animal Health, Inc. is an animal health company focused
on developing and commercializing first-in-class gastrointestinal
products for companion and production animals, foals, and high
value horses. Canalevia™ is Jaguar’s lead prescription drug product
candidate, intended for the treatment of various forms of diarrhea
in dogs. Equilevia™ (formerly referred to as SB-300) is Jaguar’s
prescription drug product candidate for the treatment of
gastrointestinal ulcers in horses. Canalevia™ and Equilevia™
contain ingredients isolated and purified from the Croton lechleri
tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™
Foal are the Company’s lead non-prescription products. Neonorm™ is
a standardized botanical extract derived from the Croton lechleri
tree. Canalevia™ and Neonorm™ are distinct products that act at the
same last step in a physiological pathway generally present in
mammals. Jaguar has nine active investigational new animal drug
applications, or INADs, filed with the FDA and intends to develop
species-specific formulations of Neonorm™ in six additional target
species, formulations of Equilevia™ in horses, and Canalevia™ for
cats and dogs.
For more information about Jaguar, please visit
www.jaguaranimalhealth.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements.” These include statements regarding
the proposed merger of Jaguar and Napo, the expectation that the
proposed merger will close by the end of July 2017, Jaguar’s
intention to develop species-specific formulations of Neonorm™ in
additional target species, and Jaguar’s plan to develop
formulations of Canalevia™ for cats, horses and dogs. 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.
1Gehrig, M. et al. Actual versus perceived use of
pharmacokinetic (primarily absorption) influential OTC agents and
ART tolerability in a nationwide matched cohort of HIV patients and
their healthcare providers, IDWeek 2016 Poster Abstract Session:
HIV: Antiretroviral Therapy. October 28, 2016.
Jaguar-JAGX
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version on businesswire.com: http://www.businesswire.com/news/home/20170524005633/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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