Jaguar Health Announces Import of Coca Leaf From Peru by Joint Venture Magdalena Biosciences for Research in Treating ADHD

Magdalena Biosciences is focused on developing novel, natural prescription medicines derived from plants for mental health indications

Import of coca leaves was authorized by the Peruvian Health Authority

SAN FRANCISCO, CA / ACCESSWIRE / September 21, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Magdalena Biosciences, Inc. ("Magdalena"), the joint venture recently formed by Jaguar and Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) ("Filament" or "Filament Health"), successfully completed an import of coca leaf to a Filament facility (Psilo Scientific) in Canada.

Magdalena was founded on a mission to develop novel, natural prescription medicines derived from plants for mental health indications including attention-deficit/hyperactivity disorder (ADHD), depression, and anxiety in adults. The coca leaf imported from Peru will be used for initial research purposes to look at these and other neuropsychiatric indications.

The import of coca leaves was authorized by the Peruvian Health Authority - Dirección General de Medicamentos Insumos y Drogas (DIGEMID) - and acquired from the Empresa Nacional de la Coca (ENACO), which is the only company in Peru authorized to collect, distribute, and export coca leaves and their derived products.

"We are grateful to the Peruvian government for their cooperation, and look forward to Magdalena initiating its pioneering research into the potential benefits of coca for ADHD, depression, and anxiety," said Steven King, PhD, Jaguar's Chief Sustainable Supply, Ethnobotanical Research, and IP Officer and an Advisor to Magdalena, who facilitated the relationship with ENACO on behalf of Magdalena and Psilo Scientific. "In traditional medicine, coca leaves are utilized as a remedy for a wide variety of conditions, ranging from alleviating oral pain, digestive maladies, hunger, altitude sickness, as well as muscular and skeletal aches. Many commonly used neuropsychiatric medications have side effects such as personality changes or sedation. With centuries of use by Indigenous healers and traditional psychiatrists, plant-derived medicines offer potential new mechanisms of action for treating mental disorders while being potentially safer than the small molecule drugs that may have 'off target' effects."

"I am delighted that Magdalena Biosciences is proceeding with initial research on the therapeutic potential of coca leaf for ADHD, depression, and anxiety and I believe there will be benefits at multiple levels for Andean nations and for patients around the world if coca leaf products become available to help manage a diversity of medical conditions," said Wade Davis, Ph.D. Dr. Davis, an adviser to Magdalena and a member of the Scientific Strategy Team for Jaguar's Entheogen Therapeutics Initiative (ETI), is an ethnobotanist, anthropologist, bestselling author, and former National Geographic Explorer-in-Residence.

Once considered a childhood disorder, ADHD is now acknowledged to persist into adulthood in approximately 50-65% of individuals, and impacts an estimated 5.2% of U.S. adults aged 18-44. Treatment of ADHD remains challenging. An estimated 20-50% of adult patients either are non-responders to stimulants or cannot tolerate the adverse effects of current therapeutics. New therapeutics in development for the global ADHD market, which is projected to reach a value of US$18.69 billion by 2030 according to a report by Grand View Research, show promise but continue to have significant side effects.

Social anxiety and depression are common co-morbidities of ADHD. Social anxiety, typified as extreme fear in social settings and debilitating social withdrawal, often has an age of onset during late childhood. Common treatments include medication and psychotherapy. Unmet needs in the treatment of anxiety disorders include the need for more effective, rapidly acting, and better tolerated medications. Botanical drugs offer these potential advantages.

Current medications for treatment of depression are often ineffective as well as personality altering. Unmet needs in depression include medications with greater overall effectiveness as well as improvement in the patient's ability to function day to day. Botanical drugs have the potential to meet these needs while also offering an improved safety profile.

"We are pleased to partner with Filament Health (Psilo Scientific) and Magdalena to facilitate this landmark import," said Silveria Dongo Gonzales, Technical Director of ENACO. Richard Caballero, Director of Industrial Commercialization at ENACO, added, "We appreciate Filament's and Magdalena's efforts to ensure that they have fully followed all of the requirements of ENACO, and that they are working through the process to obtain full compliance with the Nagoya Protocol in Peru."

Magdalena and Psilo Scientific are in the process of seeking full Nagoya Protocol compliance at this time in Peru. The Nagoya Protocol is an international agreement that ensures sharing of benefits arising from the utilization of genetic and indigenous knowledge in a fair and equitable manner.

ABOUT MAGDALENA BIOSCIENCES
Jaguar Health, Inc. and Filament Health Corp. formed Magdalena Biosciences, Inc. as a joint venture in 2023 to develop novel, natural prescription medicines derived from plants for mental health indications including attention-deficit/hyperactivity disorder (ADHD), depression and anxiety in adults. Boulder, Colorado-based One Small Planet, founded by Will Peterffy, has committed to funding of US$1,000,000. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders.

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, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo Therapeutics, visit napotherapeutics.com. For more information about Magdalena Biosciences, visit magdalenabiosciences.com.

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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.

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SOURCE: Jaguar Health, Inc.