Experts Highlight that Immune System Activation in Aging Patients Living with HIV/AIDS Triggers Effects Such as "Leaky Gut", Which Can Lead to Diarrhea
Mytesi for HIV-related Diarrhea Now on ADAP Formularies in 22 States
SAN FRANCISCO, CA / ACCESSWIRE / April 19, 2018 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company"), a commercial stage natural-products pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, announced today that a recently published article in The Washington Postsubstantiates the fact that, even with suppression of the HIV virus with antiretroviral therapies (ARVs), people living with HIV (PLWH) experience a long period of immune system activation, which, as these individuals age, triggers effects such as "leaky gut", which is when microbes in the GI tract enter into the bloodstream, causing chronic inflammation which can lead to diarrhea.
The article, titled "Decades of living with HIV can lead to health issues," was published in the The Washington Post on April 17, 2018, and highlights that "leaky gut" happens quickly after infection, even when patients are treated early and with the newest ARVs. This may explain why recent surveys of PLWH show that 1 in 5 suffer with diarrhea.
The article contains quotes by a number of leading HIV experts and researchers, including Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and Dr. Carl Dieffenbach, director of NIAID's AIDS division.
Update Regarding U.S. AIDS Drug Assistance Programs (ADAPs)
Mytesi® (crofelemer), Jaguar's first-in-class anti-secretory prescription drug approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, is currently on 22 state ADAP formularies and is under review by other state ADAPs. Each year, ADAPs provide life-saving HIV treatments to more than half a million low income, uninsured, and underinsured individuals living with HIV/AIDS in all U.S. states and territories.
As announced on April 10, 2018, Napo Pharmaceuticals, Inc. (Napo), Jaguar's wholly-owned human health subsidiary, has signed an agreement (the Agreement) with the ADAP Crisis Task Force ("Task Force"). Per the terms of the Agreement, a Task Force price has been established for Mytesi®, which means ADAPs in all U.S. states and territories are guaranteed the same reduced price for the drug.
Mytesi® is a prescription treatment for diarrhea that works differently, by acting locally in the GI tract to normalize the flow of water. Mytesi® does not have drug-drug interactions with ART, does not affect GI motility, and has side effects that are similar to placebo.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage natural-products 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.
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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the review of Mytesi® by state ADAPs. 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.
Jaguar Health, Inc.
SOURCE: Jaguar Health, Inc.