Biotechnological production of a drug for the treatment of cancer
1. Description of the product and the necessary funding for implementation
Production of a safe preparation from a strain of black Antarctic yeast "Nadsoniella nigra var. Hesuelica" for the treatment of various types of cancer.
Scientific rationale: we studied more than 30,000 pages of text documents on working with melanin by the Soviet biochemist, Ph.D. Svetlana Lyakh, who has devoted more than 30 years of her scientific career to the study and work with black Antarctic yeast nigra var. Hesuelica . The drug was given the name "AstroMelanin". Subsequently, Svetlana Lyakh received confirmation of the very high antioxidant activity and anticancer properties of this drug. In addition, as a result of research, a positive effect was obtained on a number of other diseases, such as type II diabetes mellitus, gastric ulcer, and bronchial asthma. With its very high antioxidant activity of 10-16 spin / mg, the drug can also be used to increase immunity.
The development received positive feedback and support from the heads of three leading oncological centers in Russia, who assessed the drug as promising and reflecting the latest methods in cancer treatment.
For 2 years of work, we have completely recreated the laboratory technology for the production of melanin from the strain of black Antarctic yeast Nadsoniella nigra var. Hesuelica.
2. Trouble in the world
According to WHO estimates, cancer is the leading cause of death in the world. According to GLOBOCAN, in 2020, 19.3 million new cases of cancer were registered worldwide and more than 11 million people died.
The annual increase is between 3 and 5%, and by 2040 it is expected to grow to 28.4 million new cases per year.
3 . Economic overview
Depending on the drug, treatment costs can range from $150,000 with Keytruda to $450,000 with Kimriah for a year of treatment. However, these drugs do not give guarantees for a complete cure, and new foci of the disease may appear after a while. All drugs have a large number of side effects on the body.
According to US National Library of Medicine National institutes of Health 2017:
the average cost of developing a single drug in 2017 was $793 million
average development time per drug is 7.3 years
average profit from the sale of one drug per year $330 million
Expenditure on medicines used to treat cancer patients has more than tripled in 10 years:
2011 total spending $56 billion
2021 total spending $187 billion
Over the next 5 years, the market is expected to grow to $280-$300 billion.
Cancer drug sales, according to S&P Global market Intelligence for 2020:
Keytruda - $14.38 billion
Eliquis - $14.12 billion
Revlimid - $12.1 billion
Eylea - $10.7 billion
Imbruvica - $9.4 billion
4. Potential buyer
At the initial stage of sale, the drug will be registered as a dietary supplement, and it will be sold through pharmacy chains and online platforms.
We already have an interested partner (a Russian manufacturing company with extensive experience in the production, sale and promotion of dietary supplements), ready to promote and sell our drug.
The next stage is clinical trials, as a result of which the drug will be of interest to medical institutions and clinics involved in the treatment of oncology, as well as individuals who need effective and safe treatment.
There is already a demand for the drug at this stage, since it has a rather long history and positive results of use.
5. Why people will buy from us
Our drug is non-toxic and completely safe for the body, unlike other oncological drugs used. Our drug is recommended for both treatment and prevention, due to the absence of any harmful side effects on the body.
We are the exclusive and sole manufacturer of this drug, with full rights to the full production technology.
Stage 1. Launch of small production with the involvement of a company for outsourcing the cultivation of yeast culture.
Start production and work out the technology for the industrial production of the drug
Register the drug as a dietary supplement
Start selling dietary supplement
Collect statistics and reviews on the use of the drug
Apply for a patent for drug development
Create market demand
Production capacity: 1 kg of finished products per month
1 kg of melanin = 500 monthly courses of the drug
Minimum initial selling price: preliminary $300 for a monthly course
Profit for 1 month: 500 x $300 = $150 000
Profit per year: $150 000 x 12 = $1 800 000
Production is planned to open in the special economic zone "Technopolis Moscow"
Purchase of equipment, launch of production, payroll, marketing: $280 000
Stage 2. Organization of the full production cycle
Start a full production cycle. Prepare for preclinical and clinical studies, collect data on the results of the use of the drug.
Production capacity: 4 kg of finished product per month
4 kg of finished products per month = 2000 monthly courses of the drug
Profit for 1 month: 2000 x $300 = $600 000
Profit per year: $600 000 x 12 = $7 200 000
Director, accountant, technical director, chief engineer, supply manager, biotechnologist, equipment operator, laboratory assistant on duty, mechanic on duty, electrician on duty (repair personnel), wastewater treatment plant operator, EPR spectrum operator.
Cost estimate for 2 years
Purchase, installation, launch of equipment: $4 800 000
Building construction: $1 600 000 - $1 900 000
Purchase of office equipment and software: $18 000
Purchase of raw materials for production: $200 000
Purchase of reagents and consumables: $60 000
Maintenance and service of equipment: $30 000
Overhead costs, wages, business expenses: $950 000
Promotion, marketing: $100 000
Total: $8 058 000
Starting from the second year of operation, production is fully paid off and we receive a net profit.
Stage 3. Conducting preclinical and clinical studies
The goal is to convert dietary supplement into drug.
Based on the production base and experience in the use of the drug, preclinical and clinical studies can be started. This will create an increased demand for products and recommendations from physicians for use by patients. A positive result of the research will give a huge potential for the application of products in the world market. Based on the positive results of studies, the price of the drug can be increased by 2 or more times, since the drug will receive the status of a drug with an effect confirmed by clinical studies.
Terms of testing: 3-4 years.
Cost: $2.5-$3 million
Stage 4. Scaling production
Based on the results of preclinical and clinical studies, with a positive outcome, a decision is made to increase the production capacity.
Since the global demand for drugs for the treatment of oncology is constantly growing, and our drug is also safe for the body, has no side and harmful effects, the demand for it will far exceed the supply.
Conducting an IPO to raise additional funds in order to increase production capacity.
In the future, the sale of the company or a merger with a large pharmaceutical company is possible.
2004 - Pfizer buys cancer drug from Aventis for $620 million
2016 - Pfizer bought out Medivation (manufacturer of cancer drugs ) $14 billion
2018 – GlaxSmithKline bought out TESARO (manufacturer of cancer drugs ) $5.1 billion
2019 - Pfizer bought out Array BioPharma (manufacturer of cancer drugs ) $11.4 billion