HIV Enteropathy

Quadri Pharma will cover 50% of the costs of development activity up to a capped dollar contribution Jaguar to host virtual educational webinar on intestinal failure with leading gastroenterologists and nutrition experts November 8th from 1:00 PM to 2:30 PM EST; Click here to register for the webinar SAN FRANCISCO, CA / ACCESSWIRE / November 2, 2023 / Napo Pharmaceuticals, Inc. (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that it has entered a revenue sharing license and commercialization agreement (the "Agreement") with Quadri Pharmaceuticals Store LLC (Quadri Pharma) that grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for the rare disease indications of microvillus inclusion disease (MVID), other congenital diarrheal disorders, and short bowel syndrome (SBS) with intestinal failure for a powder formulation of crofelemer for oral solution in multiple Middle East countries, following regulatory approval to market crofelemer for these indications. In addition, the Agreement grants Quadri Pharma exclusive rights to distribute the powder formulation of crofelemer for the specified indications through Named Patient Programs in the specified Middle East countries following regulatory guidelines. SBS can result from surgical resection of a portion of the small intestine, or from disease or injury, or be congenital. MVID is an ultra-rare congenital diarrheal disorder. An estimate of congenital birth defect rates shows a higher incidence of anomalies among live births in Arab countries compared to those in Europe, North America and Australia.1 Many Arab countries display some of the highest rates of consanguineous marriages in the world ranging around 20-50% of all marriages, contributing to a higher-than-normal rate of congenital abnormalities. "We are very happy to have entered this new collaboration with Quadri Pharma, which is distinct from the revenue sharing distribution and license agreement Napo and Quadri Pharma entered in early 2022 that granted Quadri Pharma exclusive promotional, commercialization, and distribution rights to the tablet formulation of crofelemer in certain Middle East countries for specified human indications including HIV-related diarrhea and cancer therapy-related diarrhea (CTD), following regulatory approval," said Karen Brunke, PhD, Jaguar Health's Executive Vice President of Corporate and Business Development. "Under the terms of this new Agreement, Quadri Pharma will cover 50% of the costs of development activity in the specified territory for the powder formulation of crofelemer for the specified rare disease indications for three years, up to a certain total dollar amount. We look forward to continuing our close relationship with Quadri Pharma and their team of experienced professionals as we work together to expand access to crofelemer to intestinal failure patients in need in this region." "We are very happy to enter into this new strategic relationship with Napo," said Dr. Hesham Elbakr, Chief Executive Officer of Quadri Pharma. "We expect crofelemer to be an important treatment option for patients suffering from the devastating rare diseases of SBS with intestinal failure and MVID in the Middle East countries specified in the Agreement. We have expertise in the distribution and marketing of prescription drugs throughout the Middle East, including the introduction and management of early access programs where that medicine does not have marketing approval and critically ill patients have very limited therapy options - such as requests related to Named Patient Programs, which provide access to individual patients ("named" patients) through physician requests." Napo to Host Virtual Educational Webinar on Intestinal Failure with Leading Gastroenterologists and Nutrition Experts November 8, 2023 from 1:00 PM to 2:30 PM Eastern Standard Time Participants in this virtual event, which will be moderated by Pravin Chaturvedi, PhD, Jaguar Health's Chief Scientific Officer and Chair of the Jaguar/Napo Scientific Advisory Board, will define intestinal failure, which is classified as a malabsorptive syndrome, discuss the current standards of care for SBS and MVID patients, including parenteral support, and address the major unmet need for treatment options for the debilitating, chronic, severe watery diarrhea that is associated with intestinal failure. Participants include these distinguished gastroenterologists and nutrition experts from the US, the Middle East and Europe: Professor Mohamad Miqdady, MD, Division Chief, Pediatric Gastroenterology, Hepatology & Nutrition Division, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates Professor Antonella Diamanti, MD, Head of Artificial Nutrition Unit, Bambino Gesù Pediatric Hospital, Rome, Italy Christos Tzivinikos, MD, DCH, FRCPCH, MSc, CEBP, Consultant Pediatric Gastroenterologist, Head of Pediatric Gastroenterology, Hepatology and Nutrition Department, Al Jalila Children's Specialty Hospital, Dubai, United Arab Emirates Lindsey Russell, MD, MSc, FRCPC, Department of Gastroenterology, Hepatology and Nutrition and the Digestive Diseases & Surgery Institute, Cleveland Clinic, Ohio Fabrizio Pasanisi, MD, PhD, Director of the Interuniversity Center for Studies and Research on Obesity (CISROD) and Professor of Internal Medicine, University of Naples Federico II, Naples, Italy Carol Wolin, MA, RDN, LD, Public Health Dietitian, Legacy Community Health, Houston, Texas Webinar registration required via Zoom. To register, please click here or email Jaguar@TogoRun.com for more information. MVID is a severe infantile disease characterized by diarrhea, malabsorption, and acid/base instability, requiring intensive parenteral support for nutritional and fluid management, and there are currently no approved drug treatments. MVID patients commonly face intestinal failure - a catastrophic health situation that also often afflicts patients with SBS, a rare and complex condition characterized by diarrhea and/or severe malabsorption of fluids and nutrients. Crofelemer has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for both MVID and SBS. Jaguar is supporting investigator-initiated and investigator IND proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure in the US, EU, and Middle East/North Africa (MENA) regions, with results expected before the end of 2023 and in 2024. In accordance with the guidelines of specific European Union countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for SBS or MVID for these debilitating conditions. Napo's Investigational New Drug application for crofelemer for the treatment of MVID was activated by the FDA August 7, 2023. Based in Abu Dhabi and Dubai in the UAE, Quadri Pharma provides services related to the registration, marketing, and distribution of pharmaceutical products in the MENA region in compliance with local and international regulatory standards. About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit Jaguar on LinkedIn: Visit Jaguar on X: Visit Jaguar on Instagram: Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Jaguar Health will host a virtual educational webinar on intestinal failure on November 8, 2023, the expectation that crofelemer may be an important treatment option for patients suffering from SBS with intestinal failure and MVID in the Middle East countries specified in the Agreement, the expectation that results from proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure may be available before the end of 2023 and in 2024, and the expectation that, in accordance with the guidelines of specific European Union countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for SBS or MVID. 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 several 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. 1 Call for improved genetic services in Arab countries, Nature Middle East, Published online May 21, 2014 CONTACT: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View source version on accesswire.com:

Mytesi® (crofelemer) is indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy Napo to host educational dinner for nurses about HIV-related diarrhea and Mytesi during conference SAN FRANCISCO, CA / ACCESSWIRE / October 18, 2023 /Napo Pharmaceuticals, Inc. (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that it will exhibit at the Annual Association of Nurses in AIDS Care (ANAC) Conference, which takes place October 25-28, 2023 at the New Orleans Marriott in New Orleans, Louisiana. Mytesi (crofelemer) is Napo's oral plant-based prescription drug that is FDA-approved and commercially available for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The company is also hosting an educational dinner for nurses about HIV-related diarrhea and Mytesi during the conference. The Annual ANAC Conference brings together nearly 500 nurses, nurse educators and other healthcare providers to network and learn more about important topics like pharmaceutical breakthroughs, racial disparities, The Plan to End HIV, and more. About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Jaguar family company Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit Jaguar on LinkedIn: Visit Jaguar on X: Visit Jaguar on Instagram: 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 Croton lechleri tree in the Amazon rainforest. Napo Pharmaceuticals, a Jaguar family company, 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 Napo will exhibit at the 2023 Annual ANAC Conference and host an educational dinner for nurses during the event. 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 several 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. CONTACT: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View source version on accesswire.com:

Jaguar aims to leverage digital technologies including AI enhancement to help connect with investor communities SAN FRANCISCO, CA / ACCESSWIRE / August 24, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX), a commercial-stage pharmaceuticals company developing first-in-class plant-based gastrointestinal (GI) prescription medicines, today announced it has engaged B2i Digital to execute an innovative digital investor engagement and awareness program. B2i will harness its investor platform and data-driven digital marketing expertise to highlight Jaguar's novel pipeline of prescription drugs sustainably derived from rainforest plants. "With major late-stage clinical catalysts approaching, we want to ensure our story reaches new audiences in the investment community," said Jaguar founder and CEO Lisa Conte. "B2i Digital's cutting-edge technologies will allow us to communicate our progress, competitive advantages, and long-term vision to stakeholders." "We are thrilled to partner with Jaguar as they pioneer novel plant-based prescription drugs that could transform how we treat GI diseases," said David Shapiro, B2i Digital CEO. "Once we evaluated Jaguar's promising pipeline assets like crofelemer for cancer therapy-related diarrhea and rare disorders, we realized our digital investor engagement platform is ideal for expanding their investor base and visibility within the financial markets. These digital efforts will be combined with traditional corporate access activities such as investor conferences, fireside chats, and Non-Deal Roadshows (NDRs)." "From Mytesi® for HIV-related diarrhea to the Canalevia®-CA1 FDA conditional approval in dogs, Jaguar is delivering on its mission to develop sustainably sourced GI prescription medicines that improve patient lives," Shapiro added. "We will leverage the full power of our digital toolset to showcase Jaguar's unique leadership position in the emerging field of novel pharmaceuticals approved under FDA Botanical Guidance to our 410,000+ social media community of investors." About B2i Digital, Inc. B2i Digital, Inc. leverages the latest digital marketing technologies to tell a company's story to retail investors, institutional investors, and research analysts. B2i Digital creates robust profiles for companies on its platform, b2idigital.com, and launches targeted digital marketing campaigns to bring the most relevant investors to each company based on its sector, stage in its capital markets evolution, and overall company story. The company was founded in 2021 by David Shapiro, previously the Chief Marketing Officer for Maxim Group LLC and its investor awareness platform, M-Vest.com. B2i Digital Contact Information: David Shapiro Chief Executive Officer B2i Digital, Inc. 212.579.4844 Office david@b2idigital.com About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted, and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Jaguar family company Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial-stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy, in 2021, focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp., is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about Jaguar Health, please visit . For more information about Napo Pharmaceuticals, visit . For more information about Napo Therapeutics, visit napotherapeutics.com. For more information about Magdalena Biosciences, visit magdalenabiosciences.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." 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 several 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. Contact: Jaguar Health, Inc., 200 Pine Street, Suite 400 San Francisco, CA 94104 Tel: 415-371-8300 hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View source version on accesswire.com: