The largest cholera outbreak in recorded history recently occurred in Yemen. Without treatment, death can occur within hours. In these people, rapid loss of body fluids leads to dehydration and shock.
Approximately one in 10 of infected persons will have severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps. The infection is often mild or without symptoms but can sometimes be severe. Department of Health & Human Services, an estimated 3‑5 million cholera cases and more than 100,000 cholera-related deaths occur each year around the world.
According to the Centers for Disease Control and Prevention of the U.S. Priority review vouchers are transferable and, in past transactions by other companies, have sold for prices ranging from $67 million to $350 million.Ĭholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae. The FDA awards a priority review voucher following approval of a treatment for a neglected disease, rare pediatric disease, or medical countermeasure. The voucher entitles the bearer to regulatory review by the FDA in approximately six months rather than the standard ten months. Food and Drug Administration (FDA) as an incentive to develop treatments for neglected diseases and rare diseases. Priority review vouchers are granted by the U.S.
4PLAY 6.0 ADDITIONAL DARES TRIAL
Proof of concept trial design was achieved with an anti-secretory mechanism of action study in cholera patients at the renowned International Centre for Diarrhoeal Disease Research (icddr,b) in Bangladesh." 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. "We plan to use funds generated by the Agreement to fund clinical development of lechlemer for the planned cholera-related indication. ("Napo"), plans to pursue as incentive for the development of Napo's lechlemer drug product candidate for the indication of the symptomatic relief of diarrhea in cholera patients. Per the terms of the Agreement, in addition to return of principal and accrued interest at prime interest rate on the Note, the Investor has a right to 18% of the gross proceeds (the "Return Bonus") from the sale of a possible tropical disease priority review voucher ("TDPRV") that Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc. The sale of the Note closed on January 19, 2021. (NASDAQ:JAGX) ("Jaguar" or the "Company") announced today that the Company has signed a definitive agreement (the "Agreement") related to the previously announced term sheet for the issuance and sale of a secured promissory note in the principal amount of $6.0 million (the "Note") to Streeterville Capital, LLC (the "Investor"). SAN FRANCISCO, CA / ACCESSWIRE / Janu/ Jaguar Health, Inc. 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 and severe acute watery diarrhea
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