Jaguar Health’s Mytesi Drug Product Now Approved for Sale in Puerto Rico
Puerto Rico Had the 7th Highest Cumulative Rate of HIV Infection in the Nation in 2016
SAN FRANCISCO, CA / ACCESSWIRE / September 16, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) announced today that the Drug and Pharmacy Division of the Government of Puerto Rico Health Department has approved the registration of Mytesi® (crofelemer 125 MG delayed-release tablets), the Company’s FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). The Company’s wholly-owned, human-health focused subsidiary, Napo Pharmaceuticals, Inc. (“Napo”) is now able to begin marketing and selling Mytesi in Puerto Rico, a U.S. territory with a population of approximately 3.4 million people.
Based on data from the Centers for Disease Control and Prevention (CDC) comparing all 50 U.S. states, the District of Columbia, and six U.S. dependent areas, in 2016, with an estimated 16,809 adults and adolescents living with an HIV diagnosis, Puerto Rico had the 7th highest cumulative rate of HIV infection in the nation, at a rate of 572.6 per 100,000 lives.1
”We’re excited to be able to bring Mytesi to the Puerto Rico HIV population,” Brian Sutton, Napo’s national business director, commented, “and we’re grateful to the multiple HIV treatment centers and clinical sites in Puerto Rico that supported development of Mytesi by participating in the pivotal ADVENT trial.”
About Mytesi®
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 Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in 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.
For more information about Jaguar, please visit jaguar.health. For more information about Napo, visit napopharma.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements.” 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.
1Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29.
http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published November 2018. Accessed June 20, 2019.
Contact:
Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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