The botanical drug candidate NFL-101 is derived from an allergenic extract originally developed by France’s Institut Pasteur in the 1970s to desensitize tobacco factory workers who had developed skin allergies to tobacco leaves when handling them.

Marketed by Stallergenes until 2004, the allergenic extract had been converted over the past ten years into a smoking cessation aid by an anesthetiologist and mesotherapy practitioner Dr Jean-Pierre Nicolas at Clinique du Parc, Orange (France).

He subcutaneously injected one or two doses (7-10 days apart) of the product in high concentrations into smokers wishing to quit, after referral by their GP or by word of mouth. The feedback from smokers was so enthusiastic that Dr Nicolas ended up treating 10,000 patients over 10 years.

In 2006, the results of a retrospective study of smokers treated by Dr Nicolas in 2003 attested to the efficacy and high degree of tolerance of the extract used in smoking cessation.

Of the 1,750 patients who had received one or two injections that year, 290 were randomly chosen and successfully contacted: 44% of them reported continuous abstinence of at least one year after administration of the extract, and 32% abstinence of at least three years.

NFL Biosciences acquired the manufacturing expertise of the tobacco leaf allergen extract from Stallergènes and began pharmaceutical development with a view to obtaining a marketing authorization for the product.

Production is standardized to guarantee reproducibility between batches. To meet the requirements of the regulatory authorities for a botanical drug, quality control is conducting from tobacco seed to the final NFL-101 product.