Full Press Release Details
GEN to Commercialize Jaguar Health's Crofelemer
in Turkey and Eight Neighboring Countries and Invest $2 Million in Jaguar Stock at 75% Premium to Market
Agreement terms to include payment of double-digit
royalties to Jaguar on all Crofelemer products sold in the licensed territory
San Francisco, CA (March 20, 2024):
Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar") today announced that it has signed a binding term sheet covering the
exclusive license and commercialization agreement ("the Agreement") for Jaguar's novel plant-based, FDA-approved prescription
drug crofelemer with Turkish specialty pharmaceutical company Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S. ("GEN")
The Agreement will entail a $2 million
investment by GEN in Jaguar stock at a 75% premium to the market price, payment of double-digit royalties to Jaguar on all finished crofelemer
products sold in the licensed territory, and transfer pricing terms for crofelemer supplied by Jaguar. As a result of this investment,
GEN will own 6.7% of the shares of Jaguar common stock outstanding as of March 18, 2024.
The Agreement will cover Jaguar's
FDA-approved indication of crofelemer (trade name Mytesi ) for HIV-related diarrhea and all potential crofelemer follow-on
indications, including cancer therapy-related diarrhea - the subject of Jaguar's placebo-controlled pivotal Phase 3 OnTarget
trial, as well as the rare disease indications short bowel syndrome (SBS) and microvillus inclusion disease (MVID), and any other possible
future human indications for crofelemer.
The Agreement will allow GEN to manufacture
crofelemer finished product and market the drug for all above-referenced indications in Turkey, Belarus, Ukraine, Azerbaijan, Uzbekistan,
Kazakhstan, Turkmenistan, Russia, and Georgia following GEN's receipt of regulatory approval for crofelemer for these indications
"We are very happy about the commitment
Jaguar and GEN have made to enter an exclusive license and commercialization agreement," said Lisa Conte, Jaguar's president and
CEO. "This initiative underscores Jaguar's mission and common vision with GEN to provide patients around the world with access
to prescription pharmaceuticals for essential supportive care and management of neglected symptoms across multiple complicated disease
states such as cancer, SBS, and MVID."
"We are thrilled about our license
and commercialization agreement for crofelemer with Jaguar," said Abidin G lm , GEN's CEO. "GEN's
business model centers on partnering with global innovator pharmaceutical companies like Jaguar to bring therapies to our territories
to serve significant unmet medical needs."
GEN is a publicly traded (GENIL.IS) specialty
pharmaceutical company headquartered in Ankara, Turkey with more than 25 years of experience. With a mission of providing solutions to
unmet medical needs through innovation and partnerships, the company supplies products used in the treatment of rare diseases and disorders
in neurology, endocrinology, nephrology, oncology, and hematology. GEN operates a GMP-certified production facility in Turkey and employs
more than 600 people. GEN also has offices in Germany, Russia, Kazakhstan, Uzbekistan and Azerbaijan and Georgia. For more information
about GEN, visit https://en.genilac.com.tr.
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%).
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 the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals
company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people
and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating
diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing
human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple
complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal
Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy.
Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding
crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences,
a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI),
is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit Jaguar on LinkedIn: https://www.linkedin.com/company/jaguar-health/
Visit Jaguar on X: https://twitter.com/Jaguar_Health
Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking
statements." These include statements regarding the expectation that the Agreement will entail a $2 million investment by GEN in
Jaguar stock at a 75% premium to the market price, payment of double-digit royalties to Jaguar on all finished crofelemer products sold
in the territory covered by the Agreement, and transfer pricing terms for crofelemer supplied by Jaguar, the expectation that the Agreement
will cover Jaguar's FDA-approved indication of crofelemer for HIV-related diarrhea and all potential crofelemer follow-on indications,
and the expectation that the Agreement will allow GEN to manufacture crofelemer finished product and market the drug for all above-referenced
indications in Turkey, Belarus, Ukraine, Azerbaijan, Uzbekistan, Kazakhstan, Turkmenistan, Russia, and Georgia following GEN's receipt
of regulatory approval for crofelemer for these indications in these 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
Source: Jaguar Health, Inc.