Jaguar Health Subsidiary Napo Pharmaceuticals Enters ex-U.S. Distribution Agreement for Mytesi (Crofelemer) with TannerGAP, Inc.
SAN FRANCISCO, CA / ACCESSWIRE / October 30, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”), today announced that the Company’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (“Napo”), has entered into a two-year distribution agreement (“the Agreement”) with TannerGAP, Inc. (“Tanner”), a division of Tanner Pharma Group, a global provider of integrated specialty access solutions. The Agreement names Tanner as a distributor of Mytesi® (crofelemer) on a named patient supply basis outside of the United States, Canada and Israel in regions where the product is not yet registered.
“Our ongoing commitment is to enhance Mytesi (crofelemer) access for people living with HIV - across all populations, all countries, and we believe this agreement will help accelerate that access to Mytesi on a named patient access basis in underserved international markets,” Lisa Conte, Jaguar’s president and CEO commented. “Tanner possesses extensive knowledge and experience in the distribution of pharmaceutical products on a global basis, including the servicing of requests for a particular medicine in markets where that medicine is not licensed.”
Maryori Alvarenga, Managing Director of US of Tanner Pharma Group, commented, “We are pleased to be working with Napo to expand the distribution of Mytesi (crofelemer) to patients in need around the world. TannerGAP has a strong track record of success in working with physicians, hospitals and ministries of health to provide medicine that is not currently available in their country.”
Jaguar’s Mytesi (crofelemer) product is approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. There have been requests outside the US for named patients in need outside the US.
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 Tanner Pharma Group
For over 17 years, Tanner Pharma Group has pursued its core purpose of Improving Lives by providing highly specialized pharmaceutical services to its biopharmaceutical and healthcare partners. Companies partner with Tanner Pharma to solve complicated distribution and procurement problems via licensing products for commercialization in challenging international markets, managing Managed Access Programs and Global Access Programs, and sourcing comparator drugs for clinical trials and bioanalysis. For more information, visit www.tannerpharma.com.
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.
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the belief that the Agreement will help accelerate access to Mytesi on a named patient access basis in underserved international markets. 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. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. 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.
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