Glenmark Will Continue to Serve as the cGMP-compliant Commercial
Manufacturer of Crofelemer for Jaguar and Napo at its FDA-Approved
Facilities in India
Agreement Also Provides Napo with Commercial Rights to the Existing
Regulatory Approvals for Crofelemer in Brazil, Ecuador, Zimbabwe &
Botswana
SAN FRANCISCO--(BUSINESS WIRE)--Sep. 25, 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
entered into a Termination, Asset Transfer and Transition Agreement (the
Agreement) with India-based Glenmark Pharmaceuticals Ltd. (Glenmark).
Glenmark is Napo’s primary manufacturer of crofelemer, the active
pharmaceutical ingredient (API) in Mytesi®, Jaguar’s and
Napo’s FDA-approved human prescription drug product. The Agreement
returns to Napo certain rights which Napo licensed to Glenmark in 2005
related to the development and commercialization of crofelemer for
certain specified human indications in India and 140 other countries
largely in developing regions. As a result of the execution of the
Agreement, Jaguar, through Napo, now controls commercial rights for
Mytesi® for all indications, territories and patient
populations globally, and also holds commercial rights to the existing
regulatory approvals for crofelemer in Brazil, Ecuador, Zimbabwe and
Botswana.
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.
Pursuant to Napo’s settlement with Salix Pharmaceuticals, Inc. in May
2016, Napo has held global commercial rights to Mytesi® for
certain proposed follow-on indications, including CID, IBS and IBD.
Crofelemer, which was developed by members of Jaguar’s management team
while working at Napo, is isolated and purified from the Croton
lechleri tree, which is sustainably harvested by Jaguar. Crofelemer
is also the API in Canalevia™, Jaguar’s prescription drug
product candidate for treatment of various types of diarrhea in dogs. As
previously announced, Jaguar signed a four-year manufacturing and supply
agreement with Glenmark in September 2015 for the manufacture of
crofelemer.
“We highly value our relationship with Glenmark, given their expertise
and long-term experience in the cGMP-compliant manufacturing of
crofelemer. Although the transfer of rights covered by the Agreement for
the specified emerging economies has for some time been agreed to in
principle between Jaguar and Glenmark—as part of our joint negotiations
on the global manufacturing and supply of crofelemer—we are very pleased
about the signing of this new Agreement,” Lisa Conte, Jaguar's president
and CEO, stated. “As a result of the execution of the Agreement, Jaguar
is now free to design and implement a truly global strategy to bring
Mytesi® to approval for potentially millions of patients for
our proposed follow-on indications, and for the corresponding
opportunities for financial return that we expect will result for our
various stakeholders.”
Glenmark manufactures crofelemer for Jaguar and Napo at its facilities
located in Ankleshwar, India, and in Aurangabad, India.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global,
integrated pharmaceutical organization. It is ranked among the top 75
Pharma & Biotech companies of the world in terms of revenue (SCRIP 100
Rankings published in the year 2017). Glenmark is a leading player in
the discovery of new molecules—both NCEs (new chemical entity) and NBEs
(new biological entity). Glenmark has several molecules in various
stages of clinical development and is focused in the areas of oncology,
dermatology and respiratory.
The company has significant presence in the branded generics markets
across emerging economies including India. Glenmark has 16 manufacturing
facilities across five countries and has six R&D centers. The Generics
business of Glenmark services the requirements of the US and Western
European markets. The API business sells its products in over 80
countries, including the US, various countries in the EU, South America
and India.
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 development of
potential Mytesi® follow-on indications, and the Company’s
development of a global strategy to bring Mytesi® to approval
for potentially millions of patients for the Company’s proposed
follow-on indications, and the corresponding opportunities for financial
return that the Company expects will result for its various
stakeholders. 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/20170925005703/en/
Source: Jaguar Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
