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Jaguar Health Inc (JAGX) RSS Feed

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Jaguar Health, Inc.  $JAGX

Bringing Plant-based Medicines to Life™

Pharmaceutical Manufacturing 

San Francisco, California

 

Jaguar Health’s organizational framework is designed to enable our product pipeline to reach the world’s interconnected marketplace, allowing for development and commercialization opportunities worldwide.

Products:

Mytesi Crofelemer 125mg delayed release tablets

Mytesi is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy

Market size of the FDA HIV Mytesi Crofelemer could be $25-$30 Million in the USA

Mytesi has a novel mechanism of action that modulates chloride secretion in the gastrointestinal tract, reducing excessive chloride and accompanying water flow and relieving watery diarrhea.

Mytesi is not indicated for the treatment of infectious diarrhea.  In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (6%), bronchitis (4%), cough (4%), flatulence (3%), and increased bilirubin (3%).

 

Canalevia-CA1 Crofelemer delayed release tablets

CANALEVIA-CA1 is conditionally approved for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal Law to use this product other than as directed in the labeling.

 

Lytham Partners Investor Select Conference February 1st, 2024

https://wsw.com/webcast/lytham10/jagx/2084640

 

Pipeline: https://jaguar.health/pipeline/

 
How to calculate the value of drugs and biotech companies

https://www.baybridgebio.com/drug_valuation.html



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, a 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 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 , a 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 is focused on developing novel prescription medicines derived from plants for mental health indications.

A Case Report: Improved Control of Tyrosine Kinase Inhibitor-Induced Diarrhea

Despite the efficacy of tyrosine kinase inhibitors (TKIs) across multiple cancers, side effects including treatment-related diarrhea can impede a patient’s ability to reach therapeutic doses or stay on therapy.
Below, we present the case of a 72-year-old patient with metastatic papillary renal cell carcinoma recurrent despite nephrectomy.
Over the course of treatment, the patient received multiple different tyrosine kinase inhibitors with varying efficacy.
Treatment with the TKI cabozantinib after failure of two prior TKIs resulted in a clinical response with shrinkage of his nodal metastatic disease.
However, the severe treatment-related diarrhea refractory to conventional management required both dose holds and dose reductions of cabozantinib.
Off-label administration of crofelemer, a novel FDA-approved antidiarrheal agent, successfully controlled the treatment-related diarrhea and allowed resumption and partial dose increase of cabozantinib.
This case suggests that crofelemer could be a viable therapeutic strategy to address TKI-induced diarrhea.
 







a Chloride ion channels in the intestinal lumen (CFTR and CACC) help to regulate the fluid and electrolyte balance in the GI tract. 
b Tyrosine kinase inhibitors can inhibit EGFR, and activate both basolateral membrane potassium (K+) channels and apical membrane CFTR channels in intestinal epithelia, leading to an imbalance of fluid and electrolytes in the GI tract and causing diarrhea. 
c Crofelemer regulates CFTR and CACC channels to normalize the balance of fluid and electrolytes, resolving symptoms of TKI-induced diarrhea




Crofelemer in Cancer

Cancer Therapy–related Diarrhea

Cancer related Chemo Diarrhea $3 Billion Market 50% Generic Valuation

 

9.8 million people
receive chemotherapy worldwide per year

Wilson B, Jacob S, Yap M, et al. Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040: a population-based study. Lancet Oncol. 2019;20(6):769-780. doi:10.1016/S1470-2045(19)30163-9

 

Chemotherapy-induced
diarrhea occurs in
50%-80%
of treated patients

Stein A, Voigt W, Jordan K. Chemotherapy-induced diarrhea: pathophysiology, frequency and guideline-based management. Ther Adv Med Oncol. 2010;2(1):51-63. doi:10.1177/1758834009355164 

 

Patients with cancer therapy–
related diarrhea (CTD) were
40% more likely to
discontinue chemotherapy or
targeted cancer therapy than
patients without CTD

Okhuysen PC, Schwartzberg LS, Roeland E, et al. The impact of cancer-related diarrhea on changes in cancer therapy patterns. J Clin Oncol. 2021;39(15):12111. doi:10.1200/JCO.2021.39.15_suppl.12111

Research & Development

In October 2020, Napo Pharmaceuticals initiated a pivotal Phase 3 clinical trial

 

This Phase 3 study is evaluating crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy

 

The principal investigator and co-investigators identified are from MD Anderson Cancer Center

 

Here are the cities and the hospitals that are conducting the Phase III trials in each of those countries. 

United States: 

Arizona Locations 
Prescott, Arizona, United States, 86314 
Arizona Oncology Associates PC - HAL 

California Locations 
Anaheim, California, United States, 92801 
Pacific Cancer Medical Center Inc 
Corona, California, United States, 92882 
The Oncology Institute of Hope and Innovation 
Glendale, California, United States, 91204 
The Oncology Institute of Hope and Innovation 
Whittier, California, United States, 90602 
PIH Health Whittier Hospital 

Colorado Locations 
Lafayette, Colorado, United States, 80218 
SCL Health Research Institute 

Florida Locations 
Aventura, Florida, United States, 33180 
GenesisCare USA 
Palm Bay, Florida, United States, 32909 
Cancer Care Centers of Brevard, Inc. 
Plantation, Florida, United States, 33322 
BRCR Global 
Saint Petersburg, Florida, United States, 33710 
Advanced Research Institute 

Maryland Locations 
Bethesda, Maryland, United States, 20817 
American Oncology Partners of Maryland 

Minnesota Locations 
Minneapolis, Minnesota, United States, 55404 
Minnesota Oncology Hematology, P.A. 

Nebraska Locations 
Omaha, Nebraska, United States, 68114 
Nebraska Methodist Hospital 

New York Locations 
Bronx, New York, United States, 10461 
Jacobi Medical Center 
Port Jefferson Station, New York, United States, 11776 
North Shore Hematology Oncology Associates dba New York Cancer and Blood Specialists 

Ohio Locations 
Canton, Ohio, United States, 44718 
Gabrail Cancer Research 

Oregon Locations 
Portland, Oregon, United States, 97239 
Oregon Health & Science University (OHSU) Knight Cancer Institute 

Tennessee Locations 
Germantown, Tennessee, United States, 38138 
The West Clinic Research 

Texas Locations 
Denison, Texas, United States, 75020 
Texas Oncology - Denison 
Flower Mound, Texas, United States, 75028 
Texas Oncology, P.A. - Flower Mound 
Houston, Texas, United States, 77030 
MD Anderson Cancer Center 
New Braunfels, Texas, United States, 78130 
Texas Oncology - New Braunfels 
Plano, Texas, United States, 75075-7787 
Texas Oncology - Plano East 
Webster, Texas, United States, 77598 
Texas Oncology - Gulf Coast 

Virginia Locations 
Fairfax, Virginia, United States, 22031 
Inova Schar Cancer Institute 
Winchester, Virginia, United States, 22601 
Shenandoah Oncology Associates 

Washington Locations 
Tacoma, Washington, United States, 98405 
MultiCare Institute for Research and Innovation 

Argentina 
Buenos Aires, Argentina, 1414 
Fleischer Medical Center 
Buenos Aires, Argentina, C1019ABS 
Medical Center Austral 
Buenos Aires, Argentina 
Buenos Aires British Hospital 
Córdoba, Argentina 
Cordoba Oncology Institute (IONC) 
Paraná, Argentina, 3100 
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER) 
Salta, Argentina 
CEDIT Diagnostic and Treatment Center 
Santa Fe, Argentina, S3000FFV 
Isis Specialized Clinic 
Tucuman, Argentina, 4000 
9 of July Sanatorium 

Georgian RUSSIA 
Tbilisi, Georgia, 0112 
LLC "Todua Clinic" 
Tbilisi, Georgia, 0159 
Archangel St. Michael Multiprofile Clinical Hospital LTD 
Tbilisi, Georgia, 0159 
JSC K. Eristavi National Center of Experimental and Clinical Surgery 
Tbilisi, Georgia, 0172 
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC 
Tbilisi, Georgia, 0186 
LTD Caucasus Medical Centre 

Serbia RUSSIA 
Belgrade, Serbia, 11 080 
Clinical Hospital Center Bezanijska Kosa 
Belgrade, Serbia, 11000 
National Cancer Research Center 
Kragujevac, Serbia, 34 000 
University Clinical Center Kragujevac 
Nis, Serbia, 18 000 
University Clinical Center Nis 
Sremska Kamenica, Serbia, 21204 
Institute of Pulmonary Diseases of Vojvodina 
Sremska Kamenica, Serbia, 21204 
Oncology Institute of Vojvodina (IOV) 

Taiwan 
Changhua, Taiwan, 500 
Changhua Christian Hospital 
Kaohsiung, Taiwan 
Kaohsiung Chang Gung Memorial Hospital 
Taichung, Taiwan, 404332 
China Medical University Hospital 
Tainan, Taiwan, 736402 
Chi Mei Medical Center - LiouYing Branch 
Taipei, Taiwan, 100226 
National Taiwan University Hospital 
Taipei, Taiwan, 112201
 

 

Jaguar Health https://jaguar.health/

 

Napo Pharmaceuticals  https://napopharma.com/

 

Napo Therapeutics  https://napotherapeutics.com/en/

 

Magdalena Biosciences  

https://www.magdalenabiosciences.com/

Developing novel, natural prescription medicines derived from plants for mental health indications including attention-deficit/hyperactivity disorder (ADHD) in adults

Magdalena is a joint venture formed by Jaguar Health and Filament Health. The company holds an exclusive license to Jaguar's proprietary library of approximately 2,300 highly characterized medicinal plants and 3,500 plant extracts for designated therapeutic indications.

 

Visit Jaguar on LinkedIn:

https://www.linkedin.com/company/jaguar-health/

 

Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/

 

Visit Jaguar on X: https://twitter.com/Jaguar_Health

 

Phone: 415-371-8300

 

Contact: hello@jaguar.health

 

Press Releases: https://jaguarhealth.gcs-web.com/news-releases

 
Most if not all works by mechanism chloride ions into the gut then water comes and diarrhea out. Crofelemer normalizes abnormal ion flow targeting only locally in the gut. 
Jaguar has been putting the expense into making sure Crofelemer drug supply is ready to get into this opportunity to treat cancer related chemo patients since pharmacy’s already can get FDA approved, all ready in the in the supply chain in the pharmacy as Crofelemer for AIDs patients. 

Research has shown it costs 3x as much to treat a cancer patient with diarrhea. 
It would be better to treat the cancer patient for diarrhea with Crofelemer pending OnTarget Study and FDA approval. 

Since Crofelemer is FDA approved to treat dogs for Cancer Chemo related Diarrhea it has been said: 
If your going to have cancer and cancer related Diarrhea, it’s better to be a dog than a human right now. 

The companies that manufacture the cancer agents/drugs sort of point to the availability of Crofelemer because it allows them to keep their patients on their therapies thereby improving their penetration and their revenues opportunity. 

3rd party market research put Short Bowel Syndrome at $5-$12 Billion opportunity because these patience are so ill, high mortality, high morbidity (the state of being unhealth for a particular disease or situation), so high of expense to manage through life. 
That opportunity can be reached in small trials around the world to show benefits to be able to show global development. 

Product already approved, already fully in the supply chain in the pharmacy.

Potential Market of Mytesi (crofelemer) 

Jaguar and Napo $JAGX if the Phase 3 OnTarget Study has good results.

The Phase 3 OnTarget Study results are due to be out soon in this quarter.

FDA approval is a target for submission to the FDA 
Full Stage I and Stage II results to the Phase III results will be in this quarter.
They will submit them to the FDA around June... After the FDA gets the information, it will take another 3 to 4 months before they issue an approval or send it back for more study.

 

The Phase 3 OnTarget study is testing whether the company's plant-based prescription drug crofelemer can prevent or substantially reduce diarrhea and other symptoms of CIOB when any one of the selected 24 different targeted therapies that are associated with diarrhea in patients is initiated.
 

Each year, more than 1 million cancer patients in the United States receive chemotherapy or radiation.  Globally 9.8 million require chemotherapy.

Diarrhea is a common side effect of targeted therapies. Up to 95% of patients on tyrosine kinase inhibitors (TKIs) suffer from diarrhea, depending on the TKI used.

Any drug used to treat cancer (including tyrosine kinase inhibitors or TKIs) can be considered chemo, but here chemo is used to mean treatment with conventional cytotoxic (cell-killing) drugs that mainly kill cells that are growing and dividing rapidly. Chemo was once one of the main treatments for CML.

 

The cost for Mytesi oral delayed release tablet 125 mg is around $2,600 for a supply of 60 tablets.  This amount is the one month supply as testing in the OnTarget Study.

That is a 24 week study = 5.6 month supply needed = $14,560.00 for treatment.
 

Potential Market of Mytesi (crofelemer) 

100,000 patients a year = $1,456,000,000

250,000 patients a year = $3,640,000,000

500,000 patients a year = $7,280,000,000

1,000,000 patients a year = $14,560,000,000 (assuming worldwide)

5,000,000 patients a year = $72,800,000,000 (assuming worldwide)

 

The estimate of patients depends on how many quit taking chemo, the onTarget Study, FDA approval and or quit taking Mytesi (crofelemer).
 

JAGX SECURITY DETAILS

Share Structure

 
Market Cap Market Cap
16.6 Million
03/20/2024
Authorized Shares
Not Available
 
Outstanding Shares
206.76 Million
3/20/2024

 
 



 

 

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