20 YEARS SUCCESSFUL BUSINESS DEVELOPMENT AND PRODUCTION OF MEDICAL PRODUCTS BASED ON PEPTIDE TECHNOLOGIES AboutВ us Products Commercial Magazine Contacts About us Планируемые мероприятия Планируемые мероприятия “PEPTEK. History of business development” Business history of the company is closely related to discovery of fundamentally new class of formulation named muramyl peptides by E.Lederer in 1974. Moreover, in 70-s independent studies of scientific group headed by Andronova, T.M., Candidate of Chemical Sciences, pursued in laboratory of peptide chemistry of the Institute of Biochemistry of the Academy of Sciences of the USSR succeeded in production of muramyl peptide equivalent, i.e. glucosaminyl-muramyl dipeptide (GMDP). GMDP synthesis gave a push to various longitudinal bioactivity studies of such formulation, thus, succeeding in creation of new immunotropic medical product Licopid® (GMDP), and had resulted in foundation of Peptech UK Ltd. (peptide technology) in 1985. Peptech UK Ltd. had structural subdivisions in Great Britain and Russia and engaged in further development and preclinical studies (based on Huntingdon Research Centre Ltd., Toxicol Laboratories Ltd., State Scientific Center of Immunology Institute of the Federal Medical and Biological Agency of the Russian Federation, Pharmacology Research Institute of the Russian Academy of Medical Sciences, Latvian Institute of Bioorganic Synthesis), and clinical studies of 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; State Scientific Center of Immunology Institute of the Federal Medical and Biological Agency of the Russian Federation) in Great Britain, Australia, and Russia. CJSC “PEPTEK” with 100% of Russian capital was founded in 1996 on the basis of Russian subdivision Peptech UK Ltd. In the same year, the company had won the Award of the Government of the Russian Federation for working on creation of Licopid®, new immunomodulary medical product. CJSC PEPTEK is the owner of such trademarks as Licopid ® and Glicopin® in Russia and CIS states. Licopid ®was registered in 7 countries: Russia, Ukraine, Kazakhstan Republic, Belarus, Moldova, Armenia, and Azerbaijan. Glicopin® a.u.v. was registered in Russia. Recently, it is in process of registration in CIS states. The Company dynamically evolves. Recently, its staff numbers nearly 50 people. Since 1996, the company has obtained its own complete cycle production, involving production of GMDP formulation and finished dosage form (uncoated drugs) of medical products Licopid® 1 mg and 10 mg, and Glicopin® 1 mg. Production site was subjected to reconstruction two times in order to bring thereof to conformity with GMP. Due to reconstruction in 2005, production site was brought to conformity with GOST R 52249-2004, and due to reconstruction during 2010-2011 production site was brought to conformity with GOST R 52249 -2009, as evidenced by production licenses of 2006 and 2011 accordingly. Since 2006, the company applies quality assurance system, and since 2011 the company has introduced office of authorized person in charge for putting medical products into civil circulation. Since 2009, the company runs PHARMACOVIGILANCE Service. In 2010 regional branch was founded in Tver city, which potential would allow mastering complementary production capacity. In 2012 two production blocks of production site in Tver city had been accepted and put into operation. 1975 — synthesis of GMDP, active substance of Licopid® and Glicopin® products. 1975-1981 — preclinical and trial studies of GMDP bioactivity and its synthetic equivalents in the Institute of Biochemistry of the Academy of Sciences of the USSR; 1981-1990 — development of GMDP-based medical product; preclinical and trial studies; 1984-1989 — development of industrial technology for production of GMDP; 1990-1994 — clinical studies of Licopid® I-III phases jointly with Peptech (UK) subject to GCP standards; 1995-1996 — obtainment of Marketing Authorization for medical product Licopid®, 1 mg and 10 mg tablets, and production license. 1996 — award granted by the Government of the Russian Federation in scientific and technology domains “Development and creation of Licopid product- new immunocorrecting drug” 1996 — opening of CJSC “PEPTEK” with 100% of Russian capital; 1998 — sanction of the Ministry of Health of the Russian Federation for application of medical product Licopid ® 1 mg in pediatry; 2000 — sanction of the Ministry of Health of the Russian Federation for application of medical product Licopid ® 1 mg in neonatology; 2000 — obtainment of Marketing Authorization for medical product Glicopin® 1 mg tablets, a.u.v. ProductsCommercialContacts ZAO <Peptek>. All right reserved. Contacts: Moscow, Mikluho-Maklaja street, 16/10 (ИБХ РАН) phone./fax: (495) 330-7456, 429-8010, 429-7740