The history of the company is closely connected with the discovery of E. Lederer in 1974, a fundamentally new class of compounds – muramylpeptides.
Also in the seventies, independent research by a group of scientists led by Ph.D. T. Andronova, carried out in the laboratory of peptide chemistry of the Institute of Bioorganic chemistry of the USSR Academy of Sciences resulted in the production of an analogue of muramylpeptid – glucosaminylmuramyldipeptide (GMDP).
The synthesis of GMDP gave rise to many years of research into the biological activity of this compound, which formed the basis for the creation of a new immunotropic drug Lycopid (GMDP), and led to the creation of Peptech UK Ltd in 1985. (from the English. peptide technology peptide technologies).
Peptech UK Ltd. it had structural units in the UK and in Russia and was engaged in further development, preclinical research (based on Huntingdon Research Centre Ltd., Toxicol Laboratories Ltd., SSC Institute of immunology FMBA RF, research Institute of Pharmacology RAMS, Latvian Institute of Bioorganic synthesis) and clinical studies I-III phase (based on Charterhouse Clinical Research Unit Limited, the Royal Masonic Hospital, London, UK; UNSW Department of Surgery and Department of Oncology, Cancer Care Centre, The St. George Hospital, Australia; SSC Institute of immunology FMBA) in the UK, Australia and Russia.
In 1996 on the basis of the Russian division Peptech UK Ltd. it was created by JSC «Peptek» with 100% Russian capital.
In the same year, the work on the creation of the drug Lycopid® – a new immunomodulatory drug – was awarded the Prize of the Government of Russian Federation.
JSC «Peptek» is the owner of trademarks Likopid® and Glycopin® in Russia and CIS countries.
Lycopid® is registered in 10 countries: Russia, Ukraine, Kazakhstan, Belarus, Moldova, Uzbekistan, Mongolia, Georgia, Armenia and Azerbaijan.
Medicinal product for veterinary use Glycopin® was registered in Russia. It is registered in the CIS countries.
The company is developing dynamically. To date, the staff is about 50 people. Since 1996, the company has its own full-cycle production, including the production of GMDP substance and ready dosage form (uncoated tablets) of Lycopid® 1 mg and 10 mg and Glycopin® 1 mg. The Production has been reconstructed twice to bring the production sites in accordance with GMP standards. Reconstruction 2005 brought production in accordance with the requirements of GOST R 52249-2004, and reconstruction 2010-2011 –in accordance with GOST R 52249-2009, which is confirmed by licenses for production, respectively, 2006 and 2011. Since 2006 the quality assurance system has been functioning at the enterprise, since 2011 the status of the authorized person for the release of drugs into civil circulation has been introduced. Since 2009, the company has established a PHARMACOVIGILANCE service.
In 2010, a regional unit was established in Tver, the potential of which in the future allows to develop additional production facilities. In 2012, two production buildings of the Tver site were put into operation.
Milestones:
1975 — synthesis of GMDP — active substance of the drug Licopid® and Glycopin®.
1975–1981 — preclinical and experimental studies of the biological activity of GMDP and its synthetic analogues on the basis of the IBC of the USSR Academy of Sciences.
1981–1990 — development of a medicinal product on the basis of GMDP, preclinical and experimental studies.
1984–1989 — development of industrial technology production of GMDP.
1990–1994 — phase I-III clinical trials with Peptech (UK) in Accordance with GCP standards.
1995-1996 — obtaining a registration certificate for the drug Licopid® tablets 1 mg and 10 mg and a license for its production.
1996 — the RF government prize in science and technology «Development and creation of the drug Likopid® – new immunocorrecting drug».
1996 — establishment of JSC «Peptek» with 100% Russian capital.
1998 — permission of the Ministry of health of Russian Federation for the use of the drug for medical use Likopid® 1 mg in Pediatrics.
2000 — permission of the Ministry of health of Russian Federation for the use of the drug for medical use Likopid® 1 mg in neonatology.
2000 — obtaining a registration certificate for a medicinal product for veterinary use Glycopin® tablets 1 mg.
2001 — Licopid® 1 mg and Licopid® 10 mg were registered in the Republic of Belarus and the Republic of Kazakhstan.
2006 — modernization of production was carried out. The license for compliance of production with GMP requirements was received.
2007 — Licopid® 1 mg and Licopid® 10 mg were registered in the Republic of Moldova, the Republic of Armenia and the Republic of Azerbaijan.
2009 — registered products Licopid® 1 mg and Likopid® 10 mg in Ukraine.
2010 — a regional unit was established in Tver.
2012 — further modernization of production and opening of the second production site in Tver.
New registration certificates of drugs Lycopid® 1 mg and Lycopid® 10 mg for medical use in the territories of the Republic of Moldova, the Republic of Kazakhstan were obtained. New packaging has been put into circulation.
2013 — a new registration certificate of drugs Lycopid® 1 mg and Lycopid® 10 mg for medical use in the territory of the Republic of Armenia was obtained. New packaging has been put into circulation.
A perpetual license of the ROSSELKHOZNADZOR No. 00-13-1-001611 dated April 30, 2013 for the production of medicinal products for veterinary use was obtained. Permitted activities as part of the licensed activity – production, storage and sale of non-sterile medicines in the form of tablets.
2015 — in order to participate in the implementation of the Federal target program «Development of the pharmaceutical and medical industry of the Russian Federation for the period up to 2020 and beyond», JSC «Peptek» in cooperation with relevant leading scientific institutions and with the support of the Ministry of industry and trade of Russia has developed an innovative drug for antitumor therapy. The pharmaceutical development of a new drug was carried out and a full cycle of its preclinical studies was carried out. The high efficiency and safety of the new potential drug has been established. There is a conclusion of an expert organization on the need for clinical trials.
Licopid® was registered in Mongolia.
2016 — the company «Peptek» celebrated its 20th anniversary!
2017 — JSC «Peptek» has got Good Manufacture Practice certificate (GMP).
2018 — company has got a permission to carry out research of Licopid Fast®. The main goal was to study the safety profile, pharmacokinetic studies of the drug.
In December 2018 the absence of carcinogenity of the drug Likopid® was proven. The study was conducted on 200 mice and 200 rats, using three doses of the drug. It was shown that intragastric administration of GMDP to male and female mice for 18 months and rats in 21 months in these doses did not lead to the formation of tumors in the experimental animals. The frequency and depth of respiratory movements, the intensity of motor activity, the tactile reaction, the response to pain, sound and light stimulus, the color and humidity of the visible mucous membranes, the condition of the hair and skin, as well as internal organs and tissues (oral cavity, stomach, pancreas, liver, mucous membranes of the larynx, trachea, main bronchi, heart, aorta, kidneys, adrenal glands, spleen, brain, lungs, thymus, thyroid gland, ovaries and uterus) were evaluated. Results were published in «Research Results in Pharmacology». Research Results in Pharmacology 4(4): 97–106 UDC: 615.37:616-006:636.028 DOI 10.3897/rrpharmacology.4.32191.
2019 — August 19, President of JSC «Peptek» Tatyana Andronova was awarded the Certificate of Merit of the Ministry of Industry and Trade of the Russian Federation «For a great contribution to the development of industry».
2020 — JSC «Peptek» has re-registrated its drugs Licopid® 1 mg and Lycopid® 10 mg in Republic of Uzbekistan.