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NFL BIOSCIENCES PARTNERS WITH THEMIS MEDICARE FOR THE DEVELOPMENT OF NFL-101 IN INDIA

NFL BIOSCIENCES PARTNERS WITH THEMIS MEDICARE FOR THE DEVELOPMENT OF NFL-101 IN INDIA

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, is announcing that it has entered into a partnership to develop NFL-101, the company’s drug candidate for smoking cessation, for the Indian market with Themis Medicare Ltd (NSE Symbol: THEMISMED; BSE - Script code: 530199) a Pharmaceutical company headquartered in Mumbai with a legacy of over 50 years of making new treatment options available to patients.

Themis Medicare Limited (Themis) 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 will purchase from NFL Biosciences NFL-101 Active Pharmaceutical Ingredient (API). NFL will also receive double digit royalties on sales.

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Ignacio Faus, CEO of NFL Biosciences said: “We are very happy to partner NFL-101with Themis Medicare. The Indian market for smoking cessation is very large and unserved. We hope for a fast and expedited development in India so that NFL-101 can reach the market in timely way. This is our first partnership with respect to the NFL-101 international development and we intend to implement further ones in the future, in developed as well as low and medium income countries. For this transaction, our strategic advisors are Aagami Inc., USA.”.

Addressable market for NFL-101 in India (Source: https://www.who.int/india/health-topics/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).

About NFL Biosciences

NFL Biosciences is a biopharmaceutical company based in the Montpellier area which develops botanical drug candidates for the treatment of addictions. NFL Biosciences' ambition is to bring new, natural, safer and more effective therapeutic solutions to the entire world population, including low- and middle-income countries. Its most advanced product, called NFL-101, is a standardized, nicotine-free tobacco leaf extract protected by two patent families. NFL Biosciences intends to offer smokers who want to quit a natural, safe, easy-to-administer and personalized alternative. NFL Biosciences is also developing NFL-301, a natural drug candidate for the reduction of alcohol consumption and has a drug development project for the treatment of cannabis use disorders.

The shares of NFL Biosciences are listed on Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at www.nflbiosciences.com

Contacts

Bruno Lafont – info@nflbiosciences.com - +33 4 11 93 76 67         Agence Calyptus – nflbio@calyptus.net - +33 1 53 65 68 68

About Themis Medicare Ltd.
Themis Medicare Ltd (TML) incorporated in 1969 is a leader in hospital business in India. It is one of the fastest growing (NSE and BSE listed) pharmaceutical company specializing in manufacture, marketing and distribution of prescription pharmaceuticals. It has a fully integrated facility from pharmaceutical intermediates, API, and Finished dosage formulations (FDF) to cater all the markets it serves. The organization has four main verticals to service their internal and external customers worldwide.

  1. Finish Dosage Formulations: TML’s FDF facility is EU approved and equipped to produce tablets and topicals dosage forms. TML also have injectable facility with capabilities in vials, ampoules and PFS dosage.

  2. The FDF facility has a proven R&D expertise with capabilities for:

    1. Formulation & development of Novel Drugs Delivery Systems (N.D.D.S.),

    2. Contract Development & Manufacturing Services (CDMO),

  3. Synthetic API: Vertically backward integration of Synthetic API’s forms the backbone with independent R&D capabilities.

  4. Fermentation Biotech: One of the pioneering companies to setup fermentation chemistry based capabilities.

TML has a diversified business model with presence across the B2B model and strong presence in domestic B2C market. The Company has export presence in over 45 countries and had a strategy to grow its portfolio in Hospital segment focusing on stringent regulatory geographies.
TML has pursued the mission with patience, dedication, imagination and skill, for over 5 decades. Our vision is to develop targeted medicines that offer patients and physicians better, safer, more cost-effective healthcare for all.
For more details, please visit: www.themismedicare.com.

Contacts:

Mr. Nirav Patel – nirav.patel@themismedicare.com; +91 98250 50034;        Dr. Sachin Patel – sachin@themismedicare,com; +91 98202 88254

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