R-Pharm Group of Companies completed study of a new antihypertensive drug

November 24

Analysis of the findings of a Russian clinical trial of fimasartan, angiotensin II (AT1) receptor blocker, has been completed. The trial has demonstrated a high efficacy and a good safety profile of the drug in Russian patients with arterial hypertension. R-Pharm plans to launch the drug in the Russian market in 2016.

Early in 2013, R-Pharm made a contract with Boryung, a pharmaceutical company based in Republic of Korea, for assignment of rights to develop and manufacture the original antihypertensive drug fimasartan in Russia.

The drug has been successfully used in South Korea since 2010, where it was registered after all necessary non-clinical trials, detailed evaluation of drug pharmacokinetics and pharmacodynamics in clinical trials, and a comparative randomized double-blind phase III clinical study to confirm drug efficacy and safety including long-term administration. 

For the purpose of registration in the Russian Federation, a Russian multi-center, open-label, randomized, comparative, phase III, parallel-arm study in adult outpatients with stage I-II hypertension was completed in 2014-2015. The study enrolled 179 patients in 13 major Russian centers, including Almazov North-Western Federal Medical Research Center; People's Friendship University of Russia; Pavlov First Saint Petersburg State Medical University; North-Western State Medical University named after I.I.Mechnikov; and National Research Center for Preventive Medicine.  

The change of systolic blood pressure from baseline was used as a primary variable of efficacy. The study results showed that fimasartan causes blood pressure reduction in hypertensive patients which is comparable to used comparator. Upon that, the investigational drug had a favorable safety and tolerability profile. >In addition to efficacy and safety assessment, the study also included the assessment of pharmacokinetics of fimasartan. The pharmacokinetics of fimasartan in Russian patient population was similar to the pharmacokinetic data previously obtained in a population of Korean patients with hypertension.

Complete study results will be published in trade journals. The findings of the pharmacokinetic part of the study were presented at the 25th European Meeting on Hypertension and Cardiovascular Protection (Milan, 12-15 June 2015). 

Professor Z.D. Kobalava, a leading Russian expert in hypertension and chair of the department of internal diseases, cardiology and clinical pharmacology at the People's Friendship University of Russia, believes that this project is a good example of a well-planned and well-implemented Russian randomized controlled study that meets the international guidelines on Good Clinical Practice, as well as the current guidelines on clinical study of antihypertensive drugs. It is expected that the  full cycle of manufacture from an active pharmaceutical substance of the  drug will be performed in Russia at R-Pharm’s finished dosage form manufacturing site in Yaroslavl. Before this the finished dosage form of the original drug will be imported from the original developer, Boryung Pharm. in Republic of Korea, for a certain period of time.

About Boryung

Founded in 1963, it is a major pharmaceutical company in Republic of Korea engaged in the development, manufacture and commercialization of medicinal products, medical devices and parapharmaceutical products. Its product portfolio comprises a whole range of generic and original drugs, including biotechnology-derived products. 

About arterial hypertension

Arterial hypertension is widely spread in the world. Russia is the regions with high prevalence of hypertension. Hypertension is a main risk factor for other cardiovascular diseases, including myocardial infarction and stroke. According to the National Research Center for Preventive Medicine, systolic blood pressure above 160 mm hg increases the risk of death from coronary heart disease in 4 times, and the risk of stroke - almost in 9 times. Currently, drugs of 5 major classes are recommended for hypertension treatment. Among them, angiotensin II (AT1) receptor blockers are the most promising and rapidly developing class.  

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