Themis Medicare Ltd (NSE - Symbol: THEMISMED; BSE - Scrip code: 530199) a Pharmaceutical company headquartered in Mumbai with a legacy of over 50 years of making new treatment options available to patients has entered into a partnership to develop NFL-101 with NFL BIOSCIENCES (Euronext Growth Paris - FR0014003XT0 - ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, the company's drug candidate for smoking cessation, for the Indian market.
Themis Medicare Limited (Themis Medicare) submitted an IND (Investigational New Drug) application for a Phase II / III clinical trial to the Central Drugs Standard Control Organization (CDSCO), the National Regulatory Authority of India (NRA). India has approximately 267 Million smokers, and their options for smoking cessation are very limited.
Once the study is approved, the clinical trial will be conducted in India, targeting 334 smokers. The cost of the process, from submission to completion of the study, will be carried out by Themis Medicare. Themis Medicare will purchase from NFL Biosciences NFL-101 Active Pharmaceutical Ingredient (API). NFL will also receive double digit royalties on sales.
Addressable market for NFL-101 in India (Source: https://www.who.int/india/healthtopics/tobacco)
Tobacco use is a major risk factor for many chronic diseases, including cancer, lung disease, cardiovascular disease and stroke. It is one of the major causes of death and disease in India and accounts for nearly 1.35 million deaths every year. India is also the second largest consumer and producer of tobacco.
Nearly 267 million adults (15 years and above) in India (29% of all adults) were users of tobacco, according to the Global Adult Tobacco Survey India, 2016-17. The most prevalent form of tobacco use in India is smokeless tobacco and commonly used products are khaini, gutkha, betel quid with tobacco and zarda. Smoking forms of tobacco used are bidi, cigarette and hookah.
The total economic costs attributed to tobacco use from all diseases in India in the year 2017-18 for persons aged 35 years and above amounted to INR 177 341 crore (USD 27.5 billion).