Russia to see the launch of innovative thrombolytic drug production

Boehringer Ingelheim and Petrovax Pharm to localise the production of biotechnological medicines to treat infarctions and cerebrovascular accidents

Boehringer Ingelheim, a global pharmaceutical leader, and Petrovax Pharm, Russia’s top pharmaceutical manufacturer, have signed an agreement to localise full-cycle production of the most advanced medicines to treat cardiovascular diseases. The signing ceremony took place on 9 June in the Chamber of Commerce and Industry of the Russian Federation during the meeting to discuss the development of high-tech medical care for the prevention of cardiovascular diseases in Russia. The agreement effected as part of Russia's 2020 Pharmaceutical Industry Development Strategy (Pharma 2020) will be another step towards making life essential medicines more affordable and help to save lives of tens of thousands of patients.

Petrovax Pharm will be the world’s second site to manufacture Boehringer Ingelheim’s innovative thrombolytic drugs

For Boehringer Ingelheim, this is the first localisation project of its kind: by the end of 2019, the company intends to complete the transfer of technologies and quality controls, and launch full-cycle production of its innovative thrombolytic drugs at Petrovax Pharm’s production facility in the Moscow Region. The facility’s capacity will be enough to fully meet the need for these drugs in Russia.

Cardiovascular diseases (CVD), especially infarctions and cerebrovascular accidents, remain a major threat to life and health of the nation. Despite the upgrade of the healthcare system, which helped to bring down the CVD death rate to 12%, as reported by the Ministry of Health, over 30,000 Russians are still in need of effective thrombolytic therapy, annually.

Therefore, localised production of these drugs and their greater affordability will contribute to lower mortality fr om these diseases and better quality of life for the patients. The partnership of the two companies will also be a milestone in implementing the Pharma 2020 strategy.

“By launching the high-tech production of innovative thrombolytic drugs in Russia, we help to save dozens of thousands of patients with cardiovascular pathologies. This is our first experience in transferring the unique technologies outside of Germany, the only country wh ere they were previously available. Local manufacturing of thrombolytic drugs will increase their affordability and boost the patients’ health, while also contributing to the pharmaceutical industry development,” said Pavol Dobrocky, Managing Director of Boehringer Ingelheim Russia. 

CVD is a systemic risk factor

Based on the data provided by the Healthcare Committee of the Russian State Duma, non-communicable diseases, including cardiovascular pathologies, make up 68.5% of total mortality rate in Russia. Last year, for instance, 420,000 Russians had an ischemic stroke according to the National Registry, and an effective thrombolytic therapy could save their lives, as well as prevent the associated negative effects.

In 2014, CVD accounted for nearly half of all death cases in the country and around one third of deaths among working age adults. Experts believe that cerebrovascular accidents are the second most common cause of mortality after infarctions, which top the list. However, every year sees a drop in mortality from these diseases. As compared to five or seven years ago, when Russia had one of the highest death rates from cerebrovascular accidents in Europe, we have made a huge leap forward.

Our success in combating CVD is largely due to Boehringer Ingelheim's original biotechnological medicines that have made a sizeable contribution to reducing the number of deaths from infarctions and strokes. Over 140,000 patients, including Russian ones, took part in clinical trials of the company's thrombolytic drugs.

These drugs are prescribed to over 30,000 people annually – a figure that stands for the saved lives of patients who have been given a chance to recover thanks to the innovative solution. Thrombolytic therapy helps to halve the death rates from acute myocardial infarction and minimise the risk of incapacitation for patients who suffered from an ischemic stroke.

At the same time, one should take into account country specifics as crucial factor in treating CVD, especially in Russia. In Europe, it takes much less time to bring a CVD patient to a hospital in order to perform percutaneous coronary intervention, while in Russia, people often call for the ambulance far too late, and at times it has to travel up to 60 km to reach the nearest in-patient facility. Hence, pre-hospital (thrombolytic) therapy takes centre stage in cases of myocardial infarction. Boehringer Ingelheim's thrombolytic drugs are administered as a single bolus injection in emergency treatment of acute myocardial infarction, and their optimal properties make them the drug of choice for emergency doctors. Prompt medical aid is crucial in cases of cerebrovascular accidents, as well. Boehringer Ingelheim's biotech thrombolytic drug is the only medicine that can be given to patients with an ischemic stroke within four and a half hours after the onset of symptoms.

“Launch of thrombolytic drug production is of great importance for Petrovax Pharm as these drugs are in great demand in Russia. Last year, post-stroke therapy was provided to 8,280 patients out of some 21,000 of those who needed it. Our partnership with Boehringer Ingelheim will make the life-saving thrombolytic drugs more affordable to Russian patients,” said Elena Arkhangelskaya, CEO of Petrovax Pharm.

Large-scale preparations and ample development opportunities

The signing of the agreement was preceded by an in-depth research and monitoring of the Russian market. A complex product containing living organisms, biotech medicines require special conditions to be maintained throughout the production cycle, from the production proper to quality control. “We were looking for a high-tech site with a proven track record of producing innovative medicines. When it comes to life and health of patients, we cannot afford to take on risks and make mistakes. This is why we were particularly scrupulous in selecting the partner for this project. We are happy to localise the production of our unmatched medicines in cooperation with Petrovax Pharm, whose facilities are fully compliant with international and local standards, as well as our own high requirements,” commented Pavol Dobrocky.

“We are confident that the project will be successful and carried out on schedule as Petrovax Pharm has great expertise in the production and localisation of innovative medicines,” added Elena Arkhangelskaya.

The partners have an extensive work programme to deliver by the time the transfer of technologies is fully completed in 2019. It includes the installation and validation of high-tech equipment, transfer of production technologies and quality controls, and most importantly, trainings for Petrovax Pharm's employees provided in Russia and Germany. The project will be jointly executed by a team of Russian and German experts working in close cooperation with each other. A key stage will be the transfer of quality control practices for finished products. Once the target capacity is reached, Petrovax Pharm’s plant will produce the amount of medicines sufficient to treat at least 30,000 patients per year, with the potential to expand further to serve every patient in Russia.

“Petrovax Pharm has enough capacities to fully meet the need for thrombolytic therapy in Russia. In addition, we have reserve capacity, which allows us to increase the production several times and opens new prospects for further development,” said Elena Arkhangelskaya.

“For years Boehringer Ingelheim has been working for the sake of every patient, seeking not only to provide effective treatment, but also to ensure availability of advanced medicines. Our joint project with Petrovax Pharm will bring us one step closer to this goal,” commented Pavol Dobrocky.