Lowe makes FDA breakthrough

US regulator grants orphan-drug designation to anti-cancer product from cannabis

Thursday, July 13, 2017

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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).

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”.

The FDA explains on its website that the Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

“This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA's implementing regulations,” the agency states.

The FDA says that the OOPD “provides incentives for sponsors to develop products for rare diseases”, noting that the programme has successfully enabled the development and marketing of over 600 drugs and biologic products for rare diseases since 1983.

“In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983,” the FDA states.

Yesterday, Professor Errol Morrison, head of the National Commission on Science and Technology and who served as master of ceremonies at the function, told guests that the orphan drug designation will see the FDA providing US$250,000 annually for three years for continued development of the drug.

Dr Lowe, while outlining his vision and mission for scientific research in Jamaica, made an appeal for local funding which, he said, was critical to Jamaica reaping the full benefits of scientific work done here using indigenous plants.

Pointing out that Jamaica has 52 per cent of the globally recognised medicinal plants, Dr Lowe and Professor Morrison lamented the fact that the island has not benefited from vinblastine and vincristine — the two drugs processed from Periwinkle which are now used to treat childhood leukaemia.

Both scientists urged the Government to ensure that the country does not miss the potential opportunities for wealth creation from research and development using plants such as cannabis.

Prime Minister Andrew Holness, who gave the keynote address, commended Dr Lowe and his team for their remarkable achievement.

“This epitomises the type of innovation, hard work and tenacity that are necessary to improve Jamaica's growth projection,” Holness said.

Noting that research and development are at the core of innovation, and are responsible for knowledge acquisition, Holness said, “This achievement, through combining knowledge, technology and entrepreneurship leading to innovation by Dr Lowe, is a just reward for his hard work and dedication to science.

“It is important that we combine and continue to catalyse entrepreneurship and scientific research to stimulate job creation and economic growth,” Holness added. “We acknowledge and celebrate the many ways in which your entrepreneurship, Dr Lowe, is helping to stimulate economic growth in Jamaica and the Government applauds you.”

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