Company Strengthens its Regulatory and Quality Capabilities to Support Mytesi® Commercial Markets as Well as Ongoing Clinical Studies Including the Pivotal Phase 3 Trial for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Therapy
SAN FRANCISCO, CA / ACCESSWIRE / October 14, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) and the company's wholly-owned subsidiary, Napo Pharmaceuticals Inc. (Napo), announced today the appointment of Melissa Yeager, J.D., a successful executive leader with broad global regulatory affairs experience in the pharmaceutical, medical device and biotechnology fields, to the role of Senior Vice President, Regulatory Affairs & Quality Assurance for both Jaguar and Napo.
Ms. Yeager has held management positions in regulatory affairs, quality assurance and operations with Fortune 500 corporations such as Gilead Sciences and Becton Dickinson as well as specialized biotechnology ventures that include Alder BioPharmaceuticals, Breath Therapeutics, and Cardeas Pharma. Her major achievements include drug, device and combination product approvals in more than 40 countries. She has provided key leadership through all phases of product development and product approval efforts for multiple pharmaceutical products including Vyepti®, Cayston® and TOBI®, the first approved inhalation antibiotic product. Ms. Yeager additionally has extensive experience in directing company compliance in accordance with international standards for laboratory testing and human clinical trial and manufacturing activities. She received her B.A. degree in Human Biology from Stanford University and her J.D. degree from Santa Clara University.
'I am very pleased to join Jaguar and Napo and look forward to providing leadership for regulatory and quality functions as the company continues to commercialize Mytesi as well as pursue new indications and the expansion of the product's global markets,' Yeager commented.
'We're very happy to have appointed Melissa to this key role,' Pravin Chaturvedi, Napo Pharmaceuticals Chair of the Scientific Advisory Board and acting Chief Scientific Officer stated. 'With the ongoing commercialization of Mytesi as well as the recent initiation of Napo's pivotal Phase 3 clinical trial of crofelemer (Mytesi) for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy, it is important to continue to expand the regulatory and quality capabilities of our company. Melissa brings exceptional leadership and experience in these areas, and she is a great addition to our senior management team that supports our manufacturing, clinical and commercialization functions.'
Mytesi is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is FDA approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy. The only oral plant-based prescription medicine approved under FDA Botanical Guidance, Mytesi has a novel mechanism of action that works locally in the gut by gently and effectively modulating and normalizing the flow of water and electrolytes with minimal systemic absorption.
About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, specifically chronic, debilitating diarrhea. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from 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 and the only oral plant-based prescription medicine approved under FDA Botanical Guidance.
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.
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 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.
View source version on accesswire.com: