For investors

Investment proposal:

The signing of a license agreement with the provision of the part of rights to produce and sell the drug.

The market of antiepileptic drugs shows steady growth. From July 2013 till June 2014 the share of this group of drugs on the Russian pharmaceutical market increased by 25%, exceeding, 7 billion rubles according to the latest IMS Health. In real terms, analysts also observe stable dynamics of this market sector: + 6% (from 6.6 million to 7.0 million packages) in 2013, + 5% (from 7.0 to 7.3 million packages) in 2014. On the international market, the sales of this group of drugs is 12 billion dollars with an annual growth up to 7%.

The long-term market share for the drug "Galodif" is 3-4% (0, 25 billion rubles).

Major competitors and substitutes:

Depakine chrono, Depakine enteric 300 (Sanofi-Winthrop Industrie, France)
Finlepsin(AWD.pharma, Germany)
Lamictal (GlaxoSmithKline Pharmaceuticals SA, Poland)
Carbamazepinum (Sintez, PFK Obnovlenie, Russia)
Clonazepamum (Polfa, Poland)
Dipheninum («Luganskij HFZ», Ukraine)
Benzonal (Asfarma, Tatchimfarmpreparaty, Russia)

The existing antiepileptic drugs are not able to reduce the incidence of attacks for approximately 20-30% of patients. Furthermore, medication is accompanied by serious side effects. Therefore, an urgent task is the development and introduction of new drugs that have significant clinical effect, low toxicity and low cost.

Features and benefits of business

Activity owner: "Sintegal" LLC (Tomsk, Russia). Creation date - 2010

Head: Vladimir Nikolayevich Khudoley

An innovative company that develops a new drug, "Galodif" for its application in several indications: 1) the treatment of epilepsy, 2) the treatment alcohol addiction.

Qualitative and quantitative operating results:

The main part of the necessary pre-clinical studies was carried out: the study of mutagenicity and carcinogenicity, the study of allergenic effect; studies on toxicity (acute, chronic, reproductive) and specific activity (indication: epilepsy, alcohol addiction);
Galodif substance is included in the State Register of Medicinal Remedies of the Russian Federation (FS-000860 dated 17.06.2014). Manufacturer: SDTB "Technolog" (St. Petersburg);
mature technology of production of finished dosage form "Galodif", 100 mg tablets. Producer: "Tomskaya farmacevticheskaya fabrika" LLC (Tomsk);
рThe technology of the new forms of the pharmaceutical substance "Galodif" of prolonged action was developed;
The technology of the enantiomeric forms of the drug was developed

Intellectual property:

The trademark "Galodif";
The invention patent of the Russian Federation No.2537361 dated 18.07.2013 - "Optical isomers (+) and (-)-benzhydryl urea and (+) and (-)-1-[3-chlorophenyl) -phenyl-methyl] urea, pharmaceutical composition based on them and their method of preparation".
The invention patent of the Russian Federation No.2561592 of 03.07.2013, “Immobilization method of drugs on a surface of detonation nanodiamonds”.
International Application No. RST/RU2014/000147 dated 05.03.2014 – “Optical isomers (+) and (-)-benzhydryl urea and (+) and (-)-1-[3-chlorophenyl) -phenyl-methyl] urea, pharmaceutical composition based on them and their method of preparation". It takes the international phase.

The strategic goal is

the introduction of a new innovative anticonvulsant for treatment of epilepsy into the Russian and international markets. Epilepsy is one of the most common chronic neurological human diseases. We focus on the prospect of further enlargement of indications on the use (treatment of alcohol addiction).

Planned stages of the project:

Clinical studies 1-3 phases;
Registration of the drug in the Ministry of Health of the Russian Federation;
Manufacture and promotion on the Russian market.

For more information, please use tel. (3822) 42-72-02 or e-mail info@halodif.ru