SAN FRANCISCO--(BUSINESS WIRE)--May 24, 2017--
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170524005633/en/
Source: Jaguar Animal Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
