Commercial batches of localized innovative thrombolytics to be launched to Russian market in June

On May 16, within the framework of the Russian Pharmaceutical Forum organized by Adam Smith Conferences, Boehringer Ingelheim and leading Russian immunobiological manufacturer NPO Petrovax Pharm announced that as soon as in this July, commercial batches of innovative thrombolytics will be launched to the market. An agreement on localization of full-cycle manufacture of up-to-date cardiovascular medications was signed on June 9, 2016, as another step to the implementation of the national pharmaceutical industry development strategy as well as the vital and essential drug (VED) access program for Russian patients. Localization has become part of an integrated approach to the reduction of cardiovascular mortality as a result of joint efforts by health officials, medical community, patient associations, and businesses.

«A partnership concept is an integrated approach to the reduction of cardiovascular mortality that meets the demands of all parties to the health system. The center of the concept is patient’s health that is the ultimate reason why we are striving to join the efforts of all parties concerned," says Pavol Dobrocky, Boehringer Ingelheim General Manager Russia. «We look at the idea of partnership as the basis of our company development, because only together we can achieve high results, and significantly contribute to saving patients’ lives. One of the essential elements is the long-term manufacture localization agreement for innovative thrombolytics between BI and Petrovax.»

Cardiovascular diseases, and primarily infarctions and strokes, remain one of major live and health threatening factors for Russian citizens. Despite the fact that due to the health system upgrade, mortality from vascular diseases decreased by 12%, according to the Russian Ministry of Health, every year, several dozen thousand Russians need an efficacious thrombolytic therapy. According to the Committee for Public Health of the Russian State Duma, mortality from major non-infectious diseases including cardiovascular disorders in Russia accounts for 68.5% of all-cause mortality. E.g. in 2015, according to the National Register, 420 thousand Russians were diagnosed with ischemic stroke, and approx. 63 thousand people died of infarction. An efficacious thrombolytic therapy could have not only saved their lives but could have also prevented adverse after-effects of the diseases.

«Russian patients badly need thrombolytic agents," says Elena Arkhangelskaya, NPO Petrovax Pharm President. «In Russia, this is the first manufacture localization project for original innovative biologics of this category, and our project is a contribution to the reduction of cardiovascular mortality, and implementation of the national pharmaceutical industry development strategy.»

The project provides for manufacturing two thrombolytic agents that are the «gold standard» in infarction and stroke treatment. Their efficacy and safety have been proved in numerous international clinical trials. Overall, more than 140 thousand patients, including the Russians, participated in clinical trials of two Boehringer Ingelheim products.
The state-of-the-art thrombolytic therapy is indicated in cardiovascular diseases. Advanced thrombolysis in myocardial infarction and ischemic stroke can not only save human lives but also prevent adverse after-effects of the diseases. Thrombolysis helps restore blood supply to the damaged areas, reduce the brain damage, or prevent brain injury progression. Clinical study data suggests that a substantial advantage of thrombolytic therapy is in a significant reduction of the percentage of patients with post-stroke disability signs, which makes thrombolytic therapy even more in-demand.

Biotech pharmaceuticals by Boehringer Ingelheim, a leader in cardiac pharmacology, are the only thrombolytics localized in Russia. Boehringer Ingelheim is for the first time involved in a project associated with transferring unique biotech manufacturing technologies to Russia, and not by coincidence the company has chosen a partner for this ambitious project. «Since foundation, Petrovax Pharm has manufactured original pharmaceuticals only," says Elena Arkhangelskaya. «The company aims at manufacturing advanced high-tech products in high demand by the Russian public health system. Therefore, we are interested in pursuing BI’s products localization project. The unique feature of our localization project is not only technologies but also the implementation rate. We will implement it in the shortest time possible, and plan to complete full-cycle localization by 2019.»

«We do this to provide a broad access to innovative thrombolytics for all those who need them in order to reduce disability and mortality rates associated with infarction and stroke in this country as well as increase life expectancy, and improve the patients’ quality of life," says Pavol Dobrocky. «Currently, more than 30 thousand Russian patients receive thrombolytic therapy every year, and several dozen thousand people more need this kind of treatment. Our objective is to meet this demand in full, and cover the Russians with state-of-the-art pharmaceuticals. And out localization project will provide for that.»

The project includes a transfer of technological processes while simultaneously upgrading Petrovax Pharm manufacturing capacities, implementing more than 20 special quality control techniques, performing hemolytic testing, training personnel, and purchasing new analytical instrumentation.

Having assessed all market prospects and opportunities, risks, and regulatory novelties, the partners made a joint resolution on marking already the very first pharmaceutical lots. Both companies are participants of the pilot drug marking project initiated by the Federal Service for Surveillance in Healthcare and Social Development.
The partnership concept is not limited to cardiovascular medications: to increase VED access, Boehringer Ingelheim is developing a drug export expansion plan for the EAEU as well as a general localization strategy for Russia in respect of the company’s entire portfolio of diabetes mellitus, cancer, and pulmonology medications.