Jaguar Health Enters Non-dilutive Binding Term Sheet for $6.0 Million Sale of Partial Rights to Possible Tropical Disease Priority Review Voucher
This additional non-dilutive financing will support development program for lechlemer for the indication of the symptomatic relief of diarrhea and dehydration in cholera patients
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Priority review vouchers are transferable and, in past transactions by other companies, have sold for prices ranging from
"We at Jaguar and Napo find it very rewarding to work in the pharmaceutical industry and be in a position to possibly help address such an important global health need and meet stakeholder expectations," stated
"We believe the funds generated by the proposed transaction described in the Term Sheet will fully fund clinical development of lechlemer for the cholera-related indication. Moving this second-generation anti-secretory agent into clinical development gives the Company ‘another shot on goal' - and we believe that lechlemer, which has the same mechanism of action as crofelemer and is significantly less costly to produce, may support development efforts to receive a TDPRV and provide long-term pipeline management of the novel anti-secretory mechanism of action of both crofelemer and lechlemer. Proof of concept trial design was achieved with a study in cholera patients with crofelemer at the renowned
Per the terms of the Term Sheet, the Note shall bear interest at prime per annum, and interest shall be prepaid each 12 months at the beginning of the period. The Note shall be due 48 months after its issue date. While the Note is outstanding, the Investor shall be entitled to 18% of the gross proceeds from the sale of the TDPRV (the "Return Bonus"). Jaguar has the right to buy out the Investor's 18% right by redeeming the Note at a 12.5% premium after six months of entering into a final agreement, and before the release of data from a pivotal lechlemer trial for the cholera-related indication. Once the Note is paid in full, the Return Bonus will decrease to 1.0% in perpetuity.
In the event that, prior to redeeming the Note, the Company abandons the clinical trial with lechlemer for an indication of the symptomatic relief of diarrhea in cholera patients (such abandonment, which is deemed to include (i) failure to start the Phase 1 clinical trial by
Priority review vouchers are granted by the
Cholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae. According to the
As recently announced, Napo is receiving preclinical services support from the
Lechlemer is a drug candidate under the botanical guidance of the FDA. It is a standardized and proprietary Napo botanical extract that is distinct from crofelemer, the active pharmaceutical agent in Mytesi®, the Company's FDA-approved drug product. Lechlemer is sustainably derived from the same source as Mytesi: the Croton lechleri tree.
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Mytesi (crofelemer delayed release tablets), the only oral plant-based prescription medicine approved under FDA Botanical Guidance, 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 chloride ion channel modulating antidiarrheal medicine that is approved in the
Mytesi® (crofelemer delayed release tablets) 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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Napo's plans to pursue a TDPRV for the development of lechlemer for the indication of the symptomatic relief of diarrhea in cholera patients, the Company's belief that the funds generated by the proposed transaction described in the Term Sheet will fully fund clinical development of lechlemer for the cholera-related indication, the Company's belief that lechlemer may support development efforts to receive a TDPRV and provide long-term pipeline management of the novel anti-secretory mechanism of action of both crofelemer and lechlemer, and the Company's plan to host an investor webcast on