Project: LONG ACTING AVERSIVE MEDICATION FOR ALCOHOLISM
The product descriptions
The technology of a new long-acting drug system for the treatment of alcohol dependence was developed and patented (three patents have been received).
The drug system has aversive properties (product includes new for pharmaceutical market acetaldehydedehydrogenase inhibitor.·
The system should provide relatively long release period – approximately one month.
The system should be intramuscularly injectable.
Alcohol consumption against the background of this medication brings about an increase of ethyl alcohol metabolite (acetaldehyde) concentration which makes further alcohol consumption unpleasant and impossible.
Competitive advantages of the developed medicine.
At present there are no similar medication in the world pharmaceutical market!
Project development stages of the long-acting formulation of aversive agent.
Stage I : Pre-Clinical (in vitro and in laboratory animals)
Phase 1 (in vitro): The delivery system will be developed, optimized with medical and technical issues in mind, and patented.
Phase 2 (in laboratory animals): The studies to be carried out at this stage are regarding toxicology, pharmacology, and pharmacokinetics.
Once Stage I is successfully completed the Stage II human clinical trial will be initiated (Phase I, II, and III).
Stage II. Clinical Trial
Phase I: To study subjective effects, pharmacokinetics, and tolerability in healthy human subjects. Anticipated duration is 12 months.
Phase II: Double blind randomized placebo controlled clinical trial in 150 patients with alcohol dependence. Objective: To evaluate efficacy in relapse prevention and safety of the long-acting formulation of aversive agent.
Phase III: Larger double blind placebo controlled randomized clinical trial in 200 patients with alcohol dependence with a longer follow-up. Objective: to study the long-term treatment effects, side effects, and interaction with other medications.
Costs and advantage of the project
Short period of product development 7 years!
Low cost of the project: The cost of development new medication is significantly many times less that of the US!
Low price of the medicine!
Much higher efficacy in relapse prevention (2-3 times higher) due to the direct effect of the product on alcohol metabolism (acetaldehydedehydrogenase inhibition) which makes alcohol consumption virtually impossible while product is active!
Sales of the product at the market
Given the lack of long-acting aversive medication for the treatment of alcoholism in Russia one can predict that the potential market for such a product is equal to the number of alcoholics seeking treatment (approximately 4 million people) and who abuse alcohol (another 5 million people). Thus, the estimated number of those who can be treated in Russia is about ~9 million people. If this product seizes 10% of market share for alcoholism treatment options (~800 000 alcohol dependent subjects) the sales will reach ~ EU 1 B. currently looking for an investment partner.
The potential market for this treatment within the countries of the Former Soviet Union is about 10-15 million people with alcohol abuse or dependence.
Sales of the product in Europe and other markets: the population of the European Union is approximately 372 million people. Аbout 41 million adults are estimated to abuse or be dependent on alcohol, yet 66% receive no treatment.
NOVOERG is currently looking for an investment partner.
Other potential uses of the delivery system:
The delivery system to be developed in this project might be used for sustained release formulations of other drugs:
Therapy for heroin and alcohol dependence.The Russian Federation patent entitled “Medication for the treatment of alcohol and opioid dependence” was received in 2010.