Full Press Release Details
Jaguar Health Announces Plan to Develop
and Commercialize Crofelemer, the Company's Novel Proprietary Drug, for the Indication of Inflammatory Diarrhea, Initially
in Long-Hauler' COVID-19 Recovery Patients
A significant percentage of COVID-19
recovery patients suffer from long-term diarrhea or other gastrointestinal disfunctions
Non-binding terms to fund activities
San Francisco, CA (November 30, 2020): Jaguar Health, Inc.
(NASDAQ: JAGX) ("Jaguar" or the "Company") and the Company's wholly-owned subsidiary, Napo Pharmaceuticals, Inc.
(Napo), announced today that Jaguar and Napo are planning to develop and commercialize crofelemer, the Company's novel proprietary
drug, for an indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to be studied in a long-hauler'
COVID-19 recovery patient population in Europe.
As part of this plan, the Company is engaged in preliminary
discussions with Swiss Growth Forum, a sponsor of a European special purpose acquisition company, "Post Pandemic Recovery
Equity" ("the SPAC"), regarding the SPAC's potential merger with an operational subsidiary of the Company
to be established in Europe with an exclusive license to crofelemer and Mytesi for the indications of inflammatory
diarrhea and HIV-related diarrhea. The preliminary terms under discussion include an upfront cash license fee to Napo ranging
from approximately $2.0 million to $10.0 million; funding for the European operation of at least $20 million to pursue clinical
development of crofelemer for inflammatory diarrhea in a long-hauler COVID-19 recovery patient population; and equity ownership
in the European subsidiary by Napo ranging from 30% to 49.9% post-acquisition by the SPAC, with lower equity ownership in conjunction
with a higher up-front cash license fee received by Napo. Other customary financial terms include royalties and transfer pricing
on the supply of crofelemer and Mytesi to the European operation.
Management of Jaguar is currently on a road show in Europe
with Swiss Growth Forum seeking support for the anticipated European operation identified as a target for the Post Pandemic Recovery
Equity SPAC, for which Swiss Growth Forum is a promoter.
The terms "long-hauler" and "chronic COVID"
refer to COVID-19 survivors who suffer with symptoms which may include gastrointestinal distress (i.e. diarrhea, constipation,
nausea, pain), fatigue, brain fog, forgetfulness, cardiovascular effects, and arthritis, for an extended period after recovery.
It is theorized that these symptoms may result when the immune system in COVID-19 survivors continues to overreact even though
the infection has passed. Long-hauler syndrome appears to be predominant in younger COVID-19 recovery patients and those who experienced
a mild/asymptomatic case.
Inflammation in the GI track often manifests as diarrhea, and
chronic diarrhea may be an observable symptom that can provide for early diagnosis of long-hauler syndrome. Early diagnosis of
chronic COVID syndrome could help limit the burden of long-term chronic illness in COVID-19 recovery patients.
"Our focus on the new potential indication of prophylaxis
and/or symptomatic relief of inflammatory diarrhea for crofelemer is driven primarily by the emergence of the long-hauler COVID-19
recovery patients," Lisa Conte, Jaguar's president and CEO, commented. "Enteropathy, an inflammatory chronic syndrome
typically affecting long-term HIV/AIDS survivors, brings on chronic diarrhea. We believe this situation is analogous to what we're
seeing right now in COVID-19 recovery patients who are suffering from long-term diarrhea or other gastrointestinal disfunctions."
Endpoints being explored for possible clinical trials of crofelemer
would include prophylaxis and/or symptomatic relief of diarrhea, reduction in inflammatory gut markers, gut biome restoration,
and reduction in viral fecal shedding.
"Our exploratory discussions with Swiss Growth Forum
in the European Post Pandemic Recovery Equity SPAC matches well to our intention to focus clinical exploration for this development
project in Europe, where single-payer healthcare systems focus on preventative measures to diagnose and treat symptoms that can
be a precursor to potentially chronic illness," Conte said. "It is estimated that up to 25% of people in the United
Kingdom, for example, have already been infected with SARS-CoV-2, the virus that causes COVID-19, and it appears to be the general
consensus that around 30% of COVID-19 patients end up suffering from long-hauler syndrome," added Conte. "With infection
rates growing the way they are, we believe it's possible that 10% to 15% of the global population is at risk of experiencing
long-hauler syndrome."
Napo has conducted intellectual property filings in support
of the development of crofelemer for the potential indication of addressing inflammatory diarrhea, including specifically in a
long-hauler post-COVID recovery situation. As with all potential follow-on indications, Napo prioritizes IP protection. Napo currently
holds approximately 144 patents, the majority of which do not expire until 2027 - 2031, and approximately 39 patents pending.
Mytesi (crofelemer) is a novel, first-in-class
anti-secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to
benefit multiple disorders. Mytesi is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is
approved in the U.S. by the Food and Drug Administration (FDA) for the symptomatic relief of noninfectious diarrhea in adults
with HIV/AIDS on antiretroviral therapy.
The only oral plant-based prescription medicine approved under
FDA Botanical Guidance, Mytesi is also in development for multiple possible follow-on indications, including cancer therapy-related
diarrhea, a rare disease indication for adult patients with short bowel syndrome (SBS), supportive care for inflammatory bowel
disease (IBD), irritable bowel syndrome (IBS), and idiopathic/functional diarrhea. As previously disclosed, Napo initiated its
pivotal Phase 3 clinical trial of crofelemer (Mytesi) for prophylaxis of diarrhea in adult cancer patients receiving targeted
therapy ("cancer therapy-related diarrhea" (CTD)) this past October. Crofelemer in pediatric liquid formulation is
in development for a rare disease indication for infants and children with congenital diarrhea disorders (CDD) and pediatric SBS.
About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals
company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals
with GI distress, specifically chronic, debilitating diarrhea. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses
on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly
from 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 and the only oral plant-based prescription medicine
approved under FDA Botanical Guidance.
For more information about Jaguar, please visit https://jaguar.health.
For more information about Napo, visit www.napopharma.com.
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.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking
statements." These include statements regarding the expectation that Jaguar and Napo plan to develop and commercialize crofelemer,
the Company's novel proprietary drug, for an indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea,
initially to be studied in a long-hauler COVID-19 recovery patient population in Europe, the SPAC's potential merger with
an operational subsidiary of the Company to be established in Europe with an exclusive license to crofelemer and Mytesi for the
indications of inflammatory diarrhea and HIV-related diarrhea, the Company's belief that chronic diarrhea may be an observable
symptom that can provide for early diagnosis of long-hauler syndrome, the Company's belief that early diagnosis of chronic
COVID could help limit the burden of long-term chronic illness in COVID-19 recovery patients, the Company's expectations
regarding possible endpoints for possible clinical trials of crofelemer in Europe, and development efforts related to other possible
Mytesi or crofelemer 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