Napo specializes in the research, development, and production of natural, plant-derived therapeutic agents and has successfully developed and commercialized an extract from the sap of Amazonian tree bark known as dragon’s blood, or, in Spanish, sangre de drago.
The tree, known by its Latin name Croton Lechleri, grows in the Amazon basin in Peru and neighboring countries. The red sap has been used as a traditional medicine by indigenous peoples for hundreds, if not thousands, of years.
Napo Pharmaceuticals has isolated and developed a botanical drug called crofelemer that has been demonstrated as effective for treating several types of diarrhea.
The U.S. Food and Drug Administration (FDA) approved crofelemer, which is a naturally derived proanthocyanidin oligomer, for symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS who are undergoing anti-retroviral therapy. Crofelemer is one of only two drugs approved to date by FDA under its guidelines for chemically-complex botanical drugs.
The ABC Tyler Award was created to honor Professor Varro E. Tyler, PhD, a leading U.S. scientist in late-20th century herbal medicine and pharmacognosy. Pharmacognosy is the science that studies drugs of natural origin, usually from plants.
Tyler was an early ABC trustee, and vice-president of academic affairs and dean of the College of Pharmacy and Pharmaceutical Sciences at Purdue University. He was the senior author of six editions of the leading pharmacognosy textbook, Pharmacognosy, that was formerly used in every college of pharmacy in the United States, and numerous other professional and popular books and academic articles. Tyler advocated for scientific and product integrity, and envisioned a rational phytomedicinal health care sector that valued the proper evaluation of a phytomedicinal product’s quality, safety, and efficacy.
“During my 46-year career in the medicinal plant research and education community, Professor Varro Tyler was one of my prime mentors,” Mark Blumenthal, ABC founder and executive director, said. “He was strongly committed to the proposition that companies dealing with botanicals should invest some of their revenues into research on their phytomedicinal ingredients and products. I had the good fortune to accompany him on his two trips to the Peruvian Amazon in the 1990s for the ABC ‘Pharmacy from the Rainforest’ Ethnobotany Ecotours where we witnessed the traditional use of the red sangre de drago sap from the tree bark. With Napo Pharmaceuticals’ sustainable development of the trees for harvesting the sap and their development of an FDA-approved drug from it, I firmly believe that if he were here today, Prof. Tyler would fully support our choice of Napo Pharmaceuticals for this award in his name.”
ABC chief science officer Stefan Gafner commented, “Napo Pharmaceuticals has not only compelling science, but also an exceptional track record with regards to its sustainability practices,” Stefan Gafner, ABC chief science officer, said.
He said that Napo maintains sustainability in its harvesting process, initiatives to conserve the environment in which the Croton lechleri trees grow, and benefit-sharing strategy with the countries and cultural groups with which it collaborates.
“In my opinion, this company is a role model for the entire botanical drug and dietary supplement industry,” Gafner continued.
Research on crofelemer isolated from sangre de drago dates back to 1994, when it was investigated by the now-defunct Shaman Pharmaceuticals. The first report on crofelemer’s potential to treat diarrhea was in 1995 when the ingredient showed improvement of the symptoms of cholera toxin-induced diarrhea in mice.
The FDA approached Shaman to investigate crofelemer for the treatment of diarrhea, one of the most common adverse side effects in people living with HIV/AIDS on anti-retroviral therapy, which was becoming more commonly utilized at that time. Additionally, a significant portion of the HIV patient population, particularly the growing segment of patients afflicted with the virus for ten years or more, suffers from HIV enteropathy, which is chronic diarrhea due to the direct or indirect effects of HIV on the gastrointestinal tract.
Crofelemer’s anti-secretory mechanism of action and local activity in the gut provided a therapeutic benefit that is independent of the cause of the diarrhea, according to ABC. After studies on HIV/AIDS patients demonstrated proof of concept, crofelemer was fast-tracked by the FDA, and received drug approval from the FDA on Dec. 31, 2012.
Crofelemer was initially launched under the brand name Fulyzaq®. It was renamed Mytesi® in 2016. Each Mytesi tablet contains 125 mg of the NME, crofelemer, in a delayed release formulation.
In addition to HIV-associated diarrhea, crofelemer has been studied in human clinical trials for the treatment of traveler’s diarrhea, diarrhea related to irritable bowel syndrome (IBS), and in acute infectious diarrhea. Today, crofelemer has been used in 34 human trials.
Additionally, there have been three clinical trials with crofelemer in dogs for chemotherapy-induced diarrhea. Two clinical trials have been conducted on dairy calves for scours, a form of diarrhea that usually occurs in young calves. Two trials were conducted on horses for ulcers, and one on foals for diarrhea.
“We are very grateful to the American Botanical Council for this recognition,” Steven King, PhD, Jaguar Health’s executive vice president of sustainable supply, ethnobotanical research, and intellectual property, said. “We in turn would like to specifically acknowledge the intellectual contribution of local and indigenous peoples of the Northwest Amazon Basin for identifying the healing properties of traditional plant medicines. We would like to be sure that the international medical and patient community know that indigenous science and ethnomedical expertise continues to provide solutions to medical challenges for humans and animals.”
Lisa Conte, Jaguar Health’s president and CEO, commented, "We are delighted to receive this award that recognizes our focus on developing and commercializing novel, sustainably-derived therapeutics to enhance gastrointestinal health around the globe,” Lisa Conte, Jaguar Health’s president and CEO, said. “We are also pleased to be among the distinguished group of past recipients that includes our esteemed partner, Indena.”
Indena SpA, which received the ABC Tyler award in 2008, is one of the world’s largest producers of clinically-tested botanical extracts for the food, dietary supplement, cosmetic, and pharmaceutical markets.