Jaguar Health Subsidiary Napo Pharmaceuticals Signs License Agreement with its Italian Subsidiary, Napo EU S.p.A., to Develop and Commercialize Crofelemer and Lechlemer in Europe
Per the terms of the agreement,
Napo EU's initial focus is on accelerated conditional approval for orphan disease: short bowel syndrome with intestinal failure
Napo EU was formed with the mission to expand access to crofelemer and lechlemer to
The license agreement grants Napo EU the right to study, develop, and commercialize crofelemer for SBS-IF, HIV-related diarrhea, and the symptomatic relief and treatment of IF-related diarrhea in patients with congenital disorders.
"We are very happy that this license agreement has been executed," stated
Per the terms of the license agreement, in exchange for an additional payment to Napo of
For more information about Jaguar, please visit https://jaguar.health. For more information about
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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's belief that crofelemer will be eligible for the EMA's conditional marketing authorization pathway for SBS-IF, and the expectation that Jaguar's shareholders will benefit from license fees and revenue expected to be driven by Napo EU product commercialization. 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.