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Dr. HENRY LOWE, Jamaican scientist makes FDA breakthrough. US regulator grants orphan-drug designation to anti-cancer product from cannabis

 Thursday, July 13, 2017

A drug developed from cannabis by Jamaican scientist Dr Henry Lowe and his team of researchers to treat acute myeloid leukaemia has been granted orphan-drug designation by the United States Food and Drug Administration (FDA).
Prime Minister Andrew Holness (right) greets scientist
 Dr Henry Lowe at yesterday function at the Eden Gardens
Wellness Resort and Spa in Kingston. (Photo: Naphtali Junior
)
Dr Lowe, who described the development as historic, pointed out that the FDA designation could see the drug, which has the trade name Cresorol, being placed on the market within three years, with estimated annual minimum sales of more than US$250 million in the US market alone. Globally, the figure would multiply significantly.
“As far as I am aware, this is the first time that anyone from a developing country like Jamaica has been able to achieve this feat of starting from the isolation of a bioactive molecule and working it up to provide a new drug from scratch, which is recognised by the FDA, which is the world-leading food and drug regulator and approval agency,” Lowe said in a prepared text for a function announcing the development at his Eden Gardens Wellness Resort and Spa in Kingston yesterday afternoon.
Lowe, known globally for using the properties of Jamaican plants, particularly ball moss and cannabis, in his cancer research, was notified of the approval late last month.
The FDA, in a letter to Flavocure Biotech, a company formed by Dr Lowe, stated that it was granting the company's request for the orphan drug status pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act.
Significantly, the FDA stated that the designation granted is broader then the indication proposed in the company's request.
The agency advised Lowe that he must submit to the Office of Orphan Products Development (OOPD) a brief progress report of the drug's development within 14 months after the date of the notice “and annually thereafter until marketing approval”. more