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Napo Pharmaceuticals Endorses Prevention Access Campaign’s U=U Consensus Statement for People Living With HIV/AIDS (PLWHA)

SAN FRANCISCO--(BUSINESS WIRE)--Oct. 18, 2017-- Napo Pharmaceuticals, Inc. (Napo), a human health company developing and commercializing novel gastrointestinal prescription products from plants used traditionally in rainforest areas, and a wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar), announced today that it has joined more than 400 organizations from 59 countries in supporting the U=U Consensus Statement. The Prevention Access Campaign’s Undetectable = Untransmittable message underscores that a person living with HIV who is on antiretroviral therapy (ART), and has a sustained undetectable viral load for at least six months, has a negligible risk of sexual transmission of HIV. This scientific consensus statement has been endorsed by leading HIV experts and researchers from around the world and Napo supports this message to raise global awareness about the effectiveness of HIV treatment and to destigmatize the disease.

“Napo has been and continues to be an advocate for the HIV community and their healthcare providers through our endorsement of the U=U Consensus Statement, our sponsorship of the My HIV Thank You platform, and our educational awareness programs. We firmly believe that living with HIV requires access to the most up-to-date research and experts,” said Lisa Conte, CEO, Napo Pharmaceuticals. “In addition, we have launched educational awareness programs targeting chronic diarrhea, as it continues to be a significant, neglected symptom in HIV/AIDS patients. Relevant to the U=U movement, diarrhea can lead patients to interrupt or discontinue their ART. Educating people living with HIV and their healthcare providers about Mytesi®—and providing them with access to this FDA-approved prescription drug—underpins everything we do.”

“U=U is a life-changing message for people living with HIV but not enough people know about it yet,” said Bruce Richman, who was diagnosed in 2003 and is the Executive Director of Prevention Access Campaign. “We’re thrilled that Napo is joining the U=U campaign to empower people with HIV with knowledge that changes lives, dismantles stigma, and gets us closer to ending the epidemic.”

“Even though patients are undetectable, and cannot transmit the virus to a partner, the effects of the virus on the GI tract, known as HIV enteropathy, may remain in spite of viral suppression in the blood. CD4 counts are slower to recover in the gut and don’t recover to the same level as in the plasma. HIV enteropathy is chronic persistent diarrhea in PLWHA and is a problem that affects as many as twenty percent of HIV patients,” stated Dr. Gary Blick, Chief Medical Officer, Health Care Advocates International and Co-Founder of HIV Advocates.

While Napo recognizes that many people living with HIV/AIDS are undetectable, one in five still suffer from diarrhea1.

Launched by Napo in October 2016, Mytesi® is the only antidiarrheal studied in and U.S. FDA-approved for the symptomatic relief of noninfectious diarrhea in adults living with HIV/AIDS on antiretroviral therapy (ART). 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.

As announced last month, Napo significantly expanded its national salesforce for Mytesi® through the recent hire in key U.S. markets of six sales representatives experienced in the sale of drugs to HIV physicians and gastroenterologists. With the equivalent of seven dedicated, full-time sales representatives now reporting to a newly hired national sales manager, supported by concomitant marketing, promotional and medical education initiatives, Jaguar and Napo expect a proportional response in the number of patients treated with Mytesi®. Jaguar and Napo estimate the potential U.S. market for Mytesi® to be approximately $100 million in gross annual sales and anticipate that Mytesi® will generate approximately $7.0 million in revenue by April 2018 for its current FDA-approved specialty indication.

To learn more about what you can do about HIV-related diarrhea, visit Mytesi.com.

For more information on the U=U campaign and to view a full list of partners click here.

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%).

More information and complete Prescribing Information are available 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 natural-products pharmaceuticals company focused on developing and commercializing novel, sustainably derived gastrointestinal products for both human prescription use and animals 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® is in development for multiple possible follow-on indications, including chemotherapy-induced diarrhea; orphan-drug indications for infants and children with congenital diarrheal disorders and short bowel syndrome; supportive care for inflammatory bowel disease (IBD); irritable bowel syndrome (IBS); and as a second-generation anti-secretory agent for use in cholera patients. Canalevia is our lead animal prescription drug candidate, intended for treatment of various forms of diarrhea in dogs. Equilevia is Jaguar’s non-prescription product for total gut health in equine athletes. Canalevia and Equilevia contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm Calf and Neonorm Foal are Jaguar’s lead non-prescription animal products. Mytesi®, Canalevia, Equilevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals.

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.” These include statements regarding Jaguar’s and Napo’s belief that, with the equivalent of seven dedicated, full-time sales representatives now reporting to a newly hired national sales manager, supported by concomitant marketing, promotional and medical education initiatives, there will be a proportional response in the number of patients treated with Mytesi®, Jaguar’s and Napo’s estimate that the potential U.S. market for Mytesi® is approximately $100 million in gross annual sales, the expectation that Mytesi® will generate approximately $7.0 million in revenue by April 2018 for its current FDA-approved specialty indication, and possible follow-on indications for Mytesi®. 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.

1Brenchley JM1, Douek DC. HIV infection and the gastrointestinal immune system. Mucosal Immunol. 2008 Jan;1(1):23-30. doi: 10.1038/mi.2007.1.


Source: Jaguar Health, Inc.

KCSA Strategic Communications
Kate Tumino, 212-896-1252
Lisa Lipson, 508-843-6428