Jaguar Health Engages Former FDA Gastroenterology Division Deputy Director Andrew Mulberg, M.D. to Bolster Company's Regulatory Expertise
Jaguar Health, Inc. (NASDAQ:JAGX) has appointed Andrew Mulberg, M.D., former FDA Deputy Director, as a regulatory consultant to enhance its regulatory strategy. Dr. Mulberg, noted for his role in approving Jaguar's crofelemer, will support the company’s focus on ongoing clinical trials, including a Phase 3 study for cancer therapy-related diarrhea. This appointment aims to leverage Dr. Mulberg's extensive regulatory expertise to facilitate future access to crofelemer, a plant-based treatment for various gastrointestinal disorders. Jaguar Health continues to develop non-opioid medicines for serious gastrointestinal conditions while ensuring sustainability in its production processes.
- Appointment of Andrew Mulberg as a regulatory consultant enhances Jaguar's regulatory expertise.
- Dr. Mulberg's experience includes leadership roles at the FDA and relevant pharmaceutical companies.
- Focus on continuing Phase 3 trials for crofelemer supports potential for future market access.
- None.
SAN FRANCISCO, CA / ACCESSWIRE / January 30, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that it has entered into a consulting agreement with Andrew Mulberg, M.D. to enhance the company's regulatory expertise. Dr. Mulberg was formerly Deputy Director for six years in the Division of Gastroenterology and Inborn Errors Products at the U.S. Food and Drug Administration (FDA).
"We are thrilled that Dr. Mulberg, the world-renowned gastroenterologist who led the regulatory review team at the FDA that granted approval of our first-in-class plant-based drug crofelemer for HIV-associated diarrhea, has joined our team as a regulatory advisor," said Pravin Chaturvedi, PhD, Jaguar's Chair of the Scientific Advisory Board and Chief Scientific Officer. "He brings invaluable drug regulatory experience for our pipeline as we continue to focus on our core development activities for crofelemer: our Phase 3 pivotal OnTarget trial for the prophylaxis of cancer therapy-related diarrhea, and our clinical development efforts for short bowel syndrome and congenital diarrheal disorders."
"Given my extensive experience with crofelemer, I am very happy to be supporting Jaguar's regulatory activities and look forward to helping the company expand access to crofelemer," said Dr. Mulberg.
A pediatric gastroenterologist with nearly 30 years of experience and a strong passion for helping bring important new medicines to market for patients with devastating rare diseases, Dr. Mulberg currently serves as Senior Vice President, Regulatory Affairs and Quality Assurance at Neurogene Inc. Prior to joining Neurogene, Dr. Mulberg's industry experience included leading global regulatory affairs for Amicus Therapeutics, and various roles of increasing responsibility within global drug development and medical affairs at Johnson & Johnson. In addition to Dr. Mulberg's biotechnology and pharmaceutical experience, he served as Division Deputy Director for six years in the Division of Gastroenterology and Inborn Errors Products at the U.S. FDA. He received his B.A. from Columbia University and his M.D. from Mount Sinai School of Medicine and served as Attending Physician and Fellowship Director of Gastroenterology and Hepatology at Children's Hospital of Philadelphia. Dr. Mulberg is currently an adjunct Professor of Pediatrics at the University of Maryland Medical Center and Chairman of the Medical Advisory Board Go4 the Goal foundation, a pediatric cancer advocacy 501c3 organization.
About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health
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, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.
For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo Therapeutics, visit napotherapeutics.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 (
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 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.
Contact:
Peter Hodge
phodge@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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