Let's dive a bit deeper into FDA Botanical Drugs a
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Posted On: 01/06/2022 3:40:02 AM
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Let's dive a bit deeper into FDA Botanical Drugs and what that means
"To date, two botanical products have fulfilled the Botanical Guidance definition of a botanical drug product. Both botanical drug products have been approved for marketing as prescription drugs (sinecatechins, Veregen® and crofelemer, Mytesi™). There are some botanical drugs, including cascara, psyllium, and senna, that are included in the over-the-counter (OTC) drug review. For a botanical drug substance to be included in an OTC monograph, there must be published data establishing a general recognition of safety and effectiveness, including the results of adequate and well-controlled clinical studies."
https://www.fda.gov/media/93113/download
Veregen has 3 patents. And it got FDA approval off of In two Phase III randomized, double-blind, vehicle-controlled studies. It was licensed by all sorts of companies in differnet jurisdictions, Teva in Israel, Abbott in Germany, Fougera (now Sandoz) in the US. So those are companies that will look at botanicals acquisitions at least.
Mytesi is owned by Jaguar Health/Napo Therapeutics and has a couple patents. Dragon SPAC helped bring this to Europe for $10M upfront. This is a prime candidate to put on your radar, although not the biggest firm. This company shows a viable path forward and the importance of having precise well understood supply chain. I'm thinking we modeled our study after theirs since their Phase 2 was 80 persons. Their phase 3 took awhile but was ultimately 300 some odd persons
T Cell protect website has received a light renovation since I last looked in early December. Product is for sale now ay 95Euro. https://www.tcellprotect.com/
"To date, two botanical products have fulfilled the Botanical Guidance definition of a botanical drug product. Both botanical drug products have been approved for marketing as prescription drugs (sinecatechins, Veregen® and crofelemer, Mytesi™). There are some botanical drugs, including cascara, psyllium, and senna, that are included in the over-the-counter (OTC) drug review. For a botanical drug substance to be included in an OTC monograph, there must be published data establishing a general recognition of safety and effectiveness, including the results of adequate and well-controlled clinical studies."
https://www.fda.gov/media/93113/download
Veregen has 3 patents. And it got FDA approval off of In two Phase III randomized, double-blind, vehicle-controlled studies. It was licensed by all sorts of companies in differnet jurisdictions, Teva in Israel, Abbott in Germany, Fougera (now Sandoz) in the US. So those are companies that will look at botanicals acquisitions at least.
Mytesi is owned by Jaguar Health/Napo Therapeutics and has a couple patents. Dragon SPAC helped bring this to Europe for $10M upfront. This is a prime candidate to put on your radar, although not the biggest firm. This company shows a viable path forward and the importance of having precise well understood supply chain. I'm thinking we modeled our study after theirs since their Phase 2 was 80 persons. Their phase 3 took awhile but was ultimately 300 some odd persons
T Cell protect website has received a light renovation since I last looked in early December. Product is for sale now ay 95Euro. https://www.tcellprotect.com/
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