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Napo Pharmaceuticals Expands Mytesi (Crofelemer) Patient Support Program

  • NapoCares patient support program provides FDA-approved, plant-based non-opioid Mytesi® to treat non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy
  • Launch of expanded NapoCares program during COVID-19 pandemic should especially benefit Mytesi patients who may have lost jobs or health insurance
  • Napo, a subsidiary of Jaguar Health, is committed to discovering and developing novel, safe, effective, and responsibly harvested plant-based prescription medicines to meet urgent global health needs

SAN FRANCISCO, CA / ACCESSWIRE / April 2, 2020 / Napo Pharmaceuticals, Inc., a wholly owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company"), today announced it will expand NapoCares, its patient support program for Mytesi® (crofelemer), the Company's FDA-approved plant-based, non-opioid prescription drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients living with HIV (PLWH) on antiretroviral therapy.

The expansion raises income limits on patients eligible for the uninsured, free-drug program and significantly increases co-pay support for commercially insured patients, allowing the co-pay amount to remain the same whether a patient fills a 30-day or 90-day prescription of Mytesi. These changes are effective April 1, 2020.

"We want to do what we can to help all Mytesi patients - and the fact that our expanded patient support program is launching during the COVID-19 pandemic should especially benefit Mytesi patients who may have lost jobs or health insurance during the crisis. It is of paramount importance to help keep Mytesi patients safe during this unprecedented public health crisis and help patients remain on treatment to prevent debilitating HIV-related diarrhea," Lisa Conte, Jaguar's president and chief executive officer, stated.

Under the terms of the expanded access program, the income limit for the Patient Assistance Program (PAP), which offers free drug for uninsured patients, has increased from two-times the Federal Poverty Limit to five-times the Federal Poverty Limit - a 150% increase - and the Mytesi copay benefit for commercially insured patients has increased from an annual maximum of $1,200 to $6,000, a 400% increase. Additionally, co-pay patients can now refill Mytesi prescriptions earlier than every 30 days, fast-start prescriptions will soon be available to provide immediate access to Mytesi for patients facing reimbursement challenges, and a bridge drug program will soon be available for patients who have a lapse in insurance coverage.

To prevent a lapse in treatment, and help patients avoid unnecessary trips to the pharmacy during the pandemic, patients are encouraged to use their pharmacy's home delivery service and make use of telemedicine or telehealth services, if available, to stay connected to their provider.

Many PLWH who become infected with the coronavirus will be considered at high risk due to their age. According to the U.S. Centers for Disease Control and Prevention, there are more than 190,000 PLWH in the U.S. over age 60, a high-risk category for COVID-19 infection, and the percent of PLWH in the U.S. over age 50 is expected to reach 70 percent this year. Diarrhea is a chronic, life-altering condition that one in five HIV patients on ART experience.

"We are removing barriers for patients to access Mytesi and the changes we've instituted should help ensure patients can employ good social distancing practices while still obtaining their medication," Conte said.

To support providers' patients with access services from reimbursement and prior authorization support to appeals and patient assistance dispensing for Mytesi, Napo is working with Florida-based AssistRx to design and implement a comprehensive patient support services program. AssistRx has extensive experience supporting HIV patients and has developed an industry-leading technology platform called iAssist to streamline therapy initiation.

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.

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.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that the launch of the expanded patient support program during the COVID-19 pandemic will especially benefit Mytesi patients who may have lost jobs or health insurance during the crisis, the expectation that fast-start prescriptions and a bridge drug program will soon be available, and the belief that the changes the Company has instituted will help ensure Mytesi patients can employ good social distancing practices while still obtaining their medication. 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.


Peter Hodge
Jaguar Health, Inc.

SOURCE: Jaguar Health, Inc.