· The first batches of localized Metalyse® (tenecteplase) for treatment of acute myocardial infarction are already available for Russian patients;
· Since 2019, it is planned to manufacture Actilyse, Boehringer Ingelheim’s thrombolytic agent, locally at Petrovax Pharm’s biopharmaceutical facility;
· Russia’s healthcare growing demand for thrombolytics will be completely met due to local manufacture.
September 2017: Boehringer Ingelheim and Petrovax Pharm successfully completed the first stage of technology transfer for Metalyse® (INN: tenecteplase) manufacturing in Russia. The drug is aimed for treatment of acute myocardial infarction. The first commercial batches of the localized drug have been already delivered to Russia’s healthcare centers, and are available for emergency medical care.
Commercial tenecteplase batches were manufactured at the site of Boehringer Ingelheim LLC strategic partner in Russia, i.e. Petrovax Pharm LLC, the Russian leading manufacturer of innovative pharmaceuticals and vaccines. Now the total demand for this agent will be met. Due to localization, the logistic cycle and supply timeframe will become shorter.
Pavol Dobrocky, Country Manager, Boehringer Ingelheim Russia: “The localization process is ongoing; it is on schedule, and we can see the first results already a year after the agreement with our Russian partner was signed. Presently, more than 30,000 Russian patients a year receive thrombolytic treatment. More than 30,000 people need this treatment. Our products that are really gold standard therapies will be the first thrombolytic agents to be localized in Russia.”
Elena Arkhangelskaya, President, Petrovax Pharm: “Our project is unique from the perspective of its significance for the Russian healthcare and in terms of its high-tech character as well as the implementation timeframe. In just a year, tremendous job has been done – from auditing and training specialists to updating the equipment, transferring manufacturing technologies and science-intensive quality control techniques. Out experts have received new knowledge and competencies from our partners, and have mastered thrombolytic manufacture. The first Metalyse® manufacture stage has been successfully completed on schedule. Russian patients will be timely provided with thrombolytic agents.”
Within the project framework, a full-cycle production technology for Actilyse® (alteplase), a thrombolytic agent well-known in clinical practice, indicated for treatment of acute ischemic stroke and myocardial infarction, is transferred to Petrovax Pharm LLC manufacturing facility. By the end of 2017, the first Actilyse® batches packaged in Russia will be available to patients. Since 2019, the agent will be manufactured in Russia based on a full-cycle technology in the amount sufficient to cover the Russian patients with the above severe diseases.
Within their partnership, both companies plan to gradually increase tenecteplase and alteplase production for further geographic expansion. Both companies rate high the project’s export potential, primarily for the EAEU member markets.
About the project
Boehringer Ingelheim LLC and Petrovax Pharm LLC’s joint project in Russia is the first project involving localization of innovative originator thrombolytic manufacture, and is an important step to the implementation of the national strategy of the pharmaceutical industry development, provision for accessibility of vital pharmaceuticals for all patient groups in need, reduction of mortality and disability associated with cardiovascular complications.
The agreement between Boehringer Ingelheim and Petrovax Pharm on localization of up-to-date cardiovascular medications was signed on 9 June 2016. By 2019, it is planned to complete localization of Metalyse® (tenecteplase) and Actilyse® (alteplase) that are gold standard anti-thrombotic therapies1 2 3 4 in acute myocardial infarction and ischemic stroke. Their efficacy and safety was studied in international and Russian clinical trials enrolling hundreds of thousands of patients as well as proven by many-year successful clinical use all over the world.
About Boehringer Ingelheim
Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. It is headquartered in Ingelheim, Germany, and has about 50,000 employees worldwide. R&D, manufacture, and marketing of innovative medicines for people and animals have since 1885 been what family-owned company Boehringer Ingelheim stands for. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.
Boehringer Ingelheim’s corporate culture hinges on social responsibility. That is why the company is involved in social projects such as the “Making More Health” initiative as well as focuses on its employees. Collaboration is based on mutual respect, equal opportunities, and harmonic career/family ratio. Furthermore, the focus is on environmental protection and sustainability in everything the company does.
1 Клинические рекомендации «Диагностика и лечение больных инфарктом миокарда с подъемом сегмента ST на ЭКГ». Кардиологический вестник 2014 № 4, с. 5-60
2 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. European Heart Journal (2017) 00, 1–66 doi:10.1093/eurheartj/ehx393
3 Гусев Е.И. и соавт. Клинические рекомендации по проведению тромболитической терапии при ишемическом инсульте. Всероссийское общество неврологов. Москва, 2015 г. - 34 с.
4 Стаховская Л.В. и соавт. Клинические рекомендации по ведению больных с ишемическим инсультом и транзиторными ишемическими атаками. М.: МЕДпресс-информ, 2017. - 196 с.