Knight Therapeutics Inc. (TSX: GUD) (“
Knight”), a
Canadian-based specialty pharmaceutical company focused on
acquiring, in-licensing, selling and marketing innovative
prescription and over-the-counter pharmaceutical products, and
Jaguar Health, Inc. (NASDAQ: JAGX) (“
Jaguar” or
the “
Company”), a commercial stage pharmaceutical
company focused on developing novel, sustainably derived
gastrointestinal products on a global basis, today announced that
they have entered into a Distribution, License and Supply Agreement
(the Agreement) that grants Knight the exclusive right to
commercialize Mytesi
® (crofelemer 125 mg
delayed-release tablets) and related products in Canada and Israel
and a right of first negotiation to commercialize Mytesi and
related products in specified Latin American countries.
Mytesi is an FDA-approved product in the U.S.
indicated for the symptomatic relief of noninfectious diarrhea in
adult patients with HIV/AIDS on antiretroviral therapy (ART).
Jaguar is also pursuing possible follow-on indications for
Mytesi in cancer therapy-related diarrhea (CTD), an important
supportive care indication for patients undergoing cancer
treatment; for rare disease indications for infants and children
with congenital diarrheal disorders and short bowel syndrome (SBS);
for irritable bowel syndrome (IBS); for supportive care for
inflammatory bowel disease (IBD); and as a second-generation
anti-secretory agent for use in cholera patients.
Under the terms of the Agreement, Knight will be responsible for
all regulatory and commercial activities for Mytesi and related
products in the licensed territories. Upon achievement of certain
regulatory and sales milestones defined in the Agreement, Jaguar
may receive payments from Knight Therapeutics in an aggregate
amount of up to USD $18,019,743 (based on September 23, 2018
USD-CAD exchange rates) payable throughout the initial 15-year term
of the Agreement.
“We are pleased to enter into this strategic
transaction with Jaguar for Mytesi," said Jonathan Ross Goodman,
Chief Executive Officer of Knight." Mytesi will strengthen Knight’s
portfolio of GI products and will be an important treatment option
for Canadian and Israeli patients, if Mytesi is approved in these
markets. We are excited to support Jaguar as they seek to
develop Mytesi for follow-on indications such as cancer
therapy-related diarrhea."
"Our collaboration with Knight is an important
step towards unlocking value and making our products available in
global markets," said Lisa Conte, president and chief executive
officer of Jaguar. "The Knight team is highly experienced and has a
strong track record of successful partnerships.”
About
MytesiMytesi® (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%).
See full Prescribing Information 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 commercial stage pharmaceuticals company focused
on developing novel, sustainably derived gastrointestinal products
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.
For more information about Jaguar, please visit
jaguar.health. For more information about Napo, visit
napopharma.com.
About Knight Therapeutics
Inc.Knight Therapeutics Inc., headquartered in Montreal,
Canada, is a specialty pharmaceutical company focused on acquiring
or in-licensing innovative pharmaceutical products for the Canadian
and select international markets. Knight Therapeutics Inc.'s shares
trade on TSX under the symbol GUD. For more information about
Knight Therapeutics Inc., please visit the company's web site at
www.gudknight.com or www.sedar.com.
Jaguar Forward-Looking
StatementsCertain statements in this press release
constitute "forward-looking statements." These include statements
regarding possible follow-on indications for Mytesi, milestone
payments that Jaguar may receive from Knight Therapeutics, and the
potential for Mytesi to receive marketing approval in Canada,
Israel or any Latin American countries. 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.
Knight Forward-Looking
StatementThis document contains forward-looking statements
for Knight Therapeutics Inc. and its subsidiaries. These
forward-looking statements, by their nature, necessarily involve
risks and uncertainties that could cause actual results to differ
materially from those contemplated by the forward-looking
statements. Knight Therapeutics Inc. considers the assumptions on
which these forward-looking statements are based to be reasonable
at the time they were prepared, but cautions the reader that these
assumptions regarding future events, many of which are beyond the
control of Knight Therapeutics Inc. and its subsidiaries, may
ultimately prove to be incorrect. Factors and risks, which could
cause actual results to differ materially from current expectations
are discussed in Knight Therapeutics Inc.'s Annual Report and in
Knight Therapeutics Inc.'s Annual Information Form for the year
ended December 31, 2017. Knight Therapeutics Inc. disclaims any
intention or obligation to update or revise any forward-looking
statements whether as a result of new information or future events,
except as required by law.
CONTACTS:
Jaguar Health Contact Peter
Hodge Senior Director of Investor Relations & Special
Eventsphodge@jaguar.health
Knight Therapeutics Inc.
Contact: Samira Sakhia President & Chief
Financial Officer T: 514-678-8930 F: 514-481-4116
info@gudknight.com www.gudknight.com
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