Flavocure LLC, a drug company founded by Jamaican scientist Dr Henry Lowe, received its second orphan drug approval from the United States Food and Drug Administration (FDA) in late September for Caflanone, which treats pancreatic cancer.
The process towards commercialisation of the drug requires years of clinical trials, which Lowe, the executive chairman of Flavocure, estimates will cost up to $2 billion.
The cannabis researcher says he is looking to various sources for financing, including plans to float Flavocure on the stock market in the United States either in the “first or second quarter of next year”.
“Listing would be in the US market to fund in excess of US$100 million. Other stock markets will follow,” he told the Financial Gleaner.
Last November, Flavocure received an injection of capital from Canadian firm Atlas Biotechnologies Inc in exchange for a 20 per cent stake in the cannabis research firm.
Atlas paid US$5.75 million for the stake in US-based Flavocure, valuing Lowe’s outfit at US$29 million ($3.7 billion).
Flavocure is a member of Lowe’s Eden Gardens Group of Companies. The company was founded in 2015 by Lowe and the company’s CEO, Dr Ngeh Toyang. The lab is one of three science-based institutions developed by Lowe for the purpose of cannabis research.
The cannabis plant from which Caflanone is made has been given the designation code, FBL-03G.
“The drug was subsequently synthesized through a proprietary methodology and is now available in commercial quantities for clinical trials,” Lowe said.
He said the cannabis plant was a rare strain and difficult to locate outside Jamaica.
The FDA’s orphan drug approval indicates that there are upwards of 200,000 patients with the condition that the drug is intended to treat. Lowe called the approval significant in that it underscores the company’s successful innovations and drug development programme.
Flavocure is optimistic about the commercial possibilities for Caflanone, saying although fewer than 200,000 persons are diagnosed annually with pancreatic cancer, it remains the third most common cause of death among cancer patients in the United States.
To develop a drug, especially coming from a plant source, is “extremely difficult” and involves a number of steps, including pre-clinical trials, and then clinical trials, prior to going to market, Lowe said.
“This process could take anywhere from 10 to 15 years and could cost anywhere from $1 billion to $2 billion. The cost for developing this particular drug requires a lot of support from colleagues, friends, investors and associates, as well as university based institutions,” the scientist added.
The company expects to start clinical trials on humans in the coming months.
Flavocure has also developed other therapeutic molecules, which use cannabis flavonoid derivatives in the treatment of aggressive forms of cancer, such as pancreatic and brain cancer.
In 2017 Lowe received FDA orphan drug status for his development of Cresorol, another drug developed from cannabis.