KDTB Research LLC is a company established to complete pre-clinical and clinical studies, and to launch CINARIF®– a new molecule for the treatment of tuberculosis.
Many years of research on hundreds of molecules led to the development and testing of CINARIF®.
We believe it is the right moment to finalize the trials on CINARIF®. Our team consists of some of the scientists that discovered the molecules, as well as experienced specialists in the fields of R&D, pharmaceutical business and patent law, among others. Our assessment shows that aside from the humanitarian benefits for the millions of affected patients, there is huge market potential for a drug with the characteristics of CINARIF®, which makes the remaining clinical trials economically viable.
We have already done a lot of work
- Two in vitro studies with strains Mycobacterium tuberculosis (Mtb) including H37Rv, wild strains of Mtb, atypical mycobacteria, MRSA, etc.
- In vivo acute oral toxicology and intraperitoneal toxicology studies.
- Patents already granted for 71 countries including USA, India, China, Indonesia, EPO, EAPO, ARIPO, Vietnam, Japan.
- The production technology is available - the product is a semi-synthetic antibiotic.
- The production site is already identified – a chemical synthesis pilot plant specifically designed for the production of CINARIF®.
- We have developed a detailed business plan, including sales forecast, respective market shares, forecasted cash flow, headcount, balance sheet, P&L as well as an investment plan and detailed Cost of goods with all ingredients, Price policy by country and market access approaches.
- Forecast of cost-effectiveness by countries is also available.
Dr. Kiril Ditchev, M.D., MBA – KDTB Research Founder, Medical doctor with specialties of Internal diseases and Respiratory diseases, 11 years of clinical practice, 2,5 years in Bulgarian Ministry of Health – National TB program lead, Lung Diseases’ Expert Council’s secretary, monitor of 14 hospitals for treatment of tuberculosis and other respiratory diseases, over 17 years of experience in pharmaceutical business.
Assoc. prof. Kiril Ninov, PhD – Chemist, inventor of CINARIF®, former head of Chemical Pharmaceutical Research Institute, Sofia, author and co-author of 40 scientific publications on the synthesis of new active compounds, author of 26 patents for the preparation of medicines, Bulgaria
Assoc. prof. Velichka Dimova, M.D., PhD – Medical doctor, pre-clinical and clinical design developer, co-inventor of CINARIF®, 5 years of clinical experience, 26 years pharmaceutical R&D in Chemical Pharmaceutical Research Institute, Sofia – Senior Research Officer (Medico-biological Department, Pharmacology, Chemotherapy), 20 years of product management and medical advisory in a pharmaceutical business. Fields of Research : Experimental and Clinical Chemotherapy, Bioavailability Studies, Experimental Animals Models, Healthy Volunteers, Experimental and Clinical (Comparative) Studies on bioavailability and therapeutic efficacy of new pharmaceutical products (Generic and original) , Drug Master Files, Dossiers, Registration, Expert Reports. Author and co-author of 120 scientific publications, including all the publications regarding T9 and T11 compounds, Bulgaria
Prof. Petko Minchev, M.D., D.Scs. - Scientific consultant of the project , Medical doctor with specialties of Pediatric diseases, Respiratory diseases and Pediatric respiratory diseases, National consultant of pediatric respiratory diseases and tuberculosis, Head of Bulgarian Association of pediatric respiratory diseases, author of 228 scientific publications, author of four books (including "Clinical tuberculosis") and one patent , Member of European respiratory society, Bulgaria
Mr. Kevin Smith – Financial consultant, over 25 years of financial experience in pharma business including as CFO, GM for the companies Actavis, Wellcome & Merck, UK
Prof. Evtimia Ivanova Velikova – Stefanova, Master of Pharmacy, former Head of Division for Drug Dosage Forms in Chemical Pharmaceutical Research Institute, Sofia, Bulgaria. Fields of Research: hard drug dosage forms, studies on the physical-chemicals and rheological characteristic of the drug substances, granules and tableting mixtures, studies of the biopharmaceutical characteristics of drug release and development of sustained and modified release dosage forms. Author of more than 75 scientific publications, 52 patents, 46 scientific reports and more than 163 technologies for different dosage forms all of them produced currently in the Bulgarian pharmaceutical plants.
Mr. Martin Paev, CFA, Investment consultant - a Founder and Chairman of SORTIS GROUP with 20+ years of investment banking, M&A, private equity and asset management experience. Holds a Master’s degree in Banking and Finance and a Bachelor’s degree in Business Administration. He is a CFA® Charterholder, a member of CFA Institute (USA) and a licensed appraiser of companies, receivables and real estate. Previously worked at ING Barings (Frankfurt-am-Main, Germany) and then for ETEBA (investment bank of National Bank of Greece) and Balkan Advisory Company (investment banking boutique). Mr. Paev structured and managed the first Real Estate Investment Trust in Bulgaria (TBI-BAC REIT) and then was Executive Director of Address Invest, the investment arm of AG Capital, the largest Bulgarian real estate advisory firm. He also is a chairman of the Board of Directors of Cremio, a leading European manufacturer of vegetable cream and milk. He is a regular speaker at private equity and investment conferences for Central and Eastern Europe.
Dr. Petko Ditchev, MD – graduate of the Medical University of Sofia, software developer and AI researcher
Mrs. Valentina Nesheva – Chemist and Lawyer, Intellectual property consultant, Bulgaria