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Petrovax Pharm: winning dynamics

 Petrovax1

Petrovax Pharm is the leading Russian R&D and manufacturing company focusing on innovative pharmaceutical products and vaccines. 

The company was founded in 1996 by a Russian scientific team to develop, manufacture, and practically implement innovative pharmaceuticals and vaccines. Presently, Petrovax Pharm is among the TOP5 immunobiological manufacturers in Russia, with 20+ patented molecules and technologies and a product portfolio solely of originator pharmaceuticals and vaccines. This portfolio includes both in-house R&D products and medications that are a result of cooperation with leading Russian and foreign companies. The pharmaceuticals manufactured at state-of-the-art facilities are widely used in Russia and the CIS, EAEU, Iran, and Eastern Europe. In January 2018, the company won the All-Russia Contest of the Russian Union of Industrialists and Entrepreneurs “Russian Business Leaders: Performance and Commitment’2017” in the category “For the Dynamic Development of Business”.

Facts and Figures
In 2017, Petrovax Pharm recorded 9.6B RUB in revenues. Over the past three years, an average growth rate in terms of annual revenues was 155%, with net earnings picking up 34%, and exports in real terms posting a 81% growth. The company has shown a high innovative development index and successful import substitution projects. Its products have marketing authorizations in 11 countries.

Milestones
The Petrovax Pharm history is a continuous breakthrough record. Over the 20+ years of operation, Petrovax Pharm has come a long way from the discovery of a unique molecule to its practical implementation in Russia and abroad. As a result of the company’s R&D efforts, the following innovative products have been launched to the market: Polyoxidonium®, a combined-effect immunomodulating agent; Grippol®, an adjuvanted influenza vaccine; and Longidaza, an enzyme for the treatment of connective tissue hyperplasia-induced diseases. In 2008, Petrovax Pharm was the first Russian immunobiological company to launch a GMP-compliant manufacturing complex in the Moscow Region, which marked a breakthrough for the Russian pharmaceutical industry. The newly-launched facility has manufactured the first batches of state-of-the-art preservative-free flu vaccine Grippol® plus in disposable syringes that has been for many years used for mass immunization of the Russian population as well as exported.

All these achievements would have been impossible without a fundamental scientific background the foundation for which has been laid at the time of being established and which has ramped up its potential over the past 20+ years. Significant investment being made by Petrovax Pharm in R&D on an annual basis provides for launching in-demand, efficacious, and safe medicinal products. Thus, in 2016, the company launched Imoferaza®, an innovative skin scar revision product to specifically address scarred and adhesion sites; the product contains hyaluronidase, a unique enzyme.

In 2018, the company is launching the first Russian quadrivalent flu vaccine. This is the most advanced influenza vaccine currently available on the market; it boasts a high preventive effect and safety profile and provides for protection against four flu virus strains. Since 2012, the WHO has recommended influenza immunization using quadrivalent vaccines. Just five countries have quadrivalent vaccine manufacturing facilities, i.e. Australia, the USA, Canada, Germany, and France. In Russia, Petrovax will be the first company to organize manufacturing of a quadrivalent vaccine. The company is confident that the new flu vaccine will be in-demand not only in Russia but also in other countries.

High-tech manufacture to international standards
One of the company’s key success factors is state-of-the-art, well-equipped manufacturing facilities that are fully compliant with the Russian and international GMP standards.

The state-of-the-art manufacturing and warehousing complex in the Moscow Region is one of the most sophisticated biopharmaceutical enterprises in Russia. This is a full-cycle manufacturing facility for active pharmaceutical ingredients (APIs) and finished dosage forms in disposable syringes, ampoules, and vials. Its manufacturing capacity exceeds 160 million shots of immunobiological products per year, including 40 million shots of the flu vaccine and 20 million shots of the pneumococcal vaccine. The facility operates two production lines for Grippol® plus and Prevenar® 13 vaccines in prefilled syringes as well as for Polyoxidonium® and Longidaza® in ampoules and vials.

In 2018, Petrovax’s manufacturing complex marks its 10th anniversary. The company celebrates this anniversary together with another key event, i.e. the launch of the third manufacturing line for APIs and finished dosage forms (tablets and suppositories) of originator local pharmaceuticals. The investment in production capacity expansion is 907M RUB, of which 300M RUB come from the Industry Development Fund as a low-interest loan. When implemented, this project will provide for a 2.5-fold boost of the API production, a 7-fold increase in tablet manufacture, and a 4-fold growth of suppository manufacture by 2019 as well as for extension of partnership projects associated with production localization and drug exports overall. The company plans to expand production facilities to accommodate four lines, extend the warehousing facilities, and erect an office building.

Technology transfer: a two-way road
Petrovax Pharm aims at developing international partnerships, and has significant expertise in the implementation of international technology transfer projects for a full-cycle product manufacture, quality control, and quality assurance. Localization of manufacture of high-tech socially significant imported products is both key and promising for Petrovax Pharm in Russia. The company believes that it is important to adopt international technology transfer experience, develop joint R&D projects with top ranking international and domestic companies as well as create a modern innovative infrastructure.

In 2008, the first in Russia state-of-the-art complex to develop and manufacture immunobiological products facility to the international GMP standards was built in partnership with Abbott.

In 2015, a joint project with Pfizer was implemented in Russia that involved a technology for a full-cycle manufacturing, quality control, and quality assurance of Prevenar® 13, the most sophisticated 13-valent conjugated pneumococcal vaccine. The project includes the formulation of a finished dosage form, primary packaging (filling into disposable syringes), secondary packaging, and release quality control. Under the partnership agreement, a full-cycle manufacturing technology has been transferred that is compliant with the applicable Russian and international GMP standards, and a large-scale vaccine production has been launched. To date, only three countries, besides Russia, are running full-cycle productions of a finished dosage form of this 13-valent vaccine.

Since 2014, pneumococcal vaccination has been on the National Immunization Schedule, which is a priority for Russia’s healthcare as a local production of the vaccine is a key patient access factor. Over the past five years, the company manufactured and shipped to Russia’s regions more than 18.5 million shots of the pneumococcal vaccine.

In 2016, Petrovax started cooperation with Boehringer Ingelheim on localization of full-cycle manufacturing of advanced thrombolytics for cardiovascular diseases. August 2017 saw the first commercial Metalyse® batches going to the market, and in February 2018, the first batches of localized Actilyse® to treat acute ischemic stroke were launched. The technology transfer is to be completed, and a full-cycle Actilyse® production is to become smoothly running at Petrovax Pharm’s facility by 2019. The implementation of this project will be yet another step to providing access to vital drugs and will help save the lives of dozens of thousands of Russian patients.

Due to cooperation with pharma industry leaders, Petrovax Pharm has been able to appreciably upgrade its expertise as well as technological and professional level. The company has acquired unique manufacturing competencies, special expertise, and a comprehensive background as well as has re-trained its staff. The Russian pharma has received access to the most sophisticated pharmaceutical manufacturing technologies, which is a major contribution to the local pharma development. Through localized manufacturing projects, foreign partners access the Russian pharma market, whereas Russian patients access innovative medications.

Export: geographic footprint
and portfolio extension
From year to year, Petrovax Pharm has kept extending its geographic footprint both in Russia and abroad. As of 2017, exports accounted for 11.2% of the company’s total sales.

The company has a significant competitive edge for operating in the world market, i.e. an in-demand innovative originator product portfolio and state-of-the-art high-tech manufacturing facilities compliant with the international GMP standards. Petrovax Pharm has been heavily investing in the existing products (including clinical trials, epidemiology, and post-approval studies abroad) as well as in R&D for new medications.

With each foreign country, the company cooperates productively to provide for all-round development. These are mainly EAEU member-states as well as Slovakia and Iran. Importantly, Petrovax Pharm furnishes Grippol® plus vaccine to four countries (Belarus, Kazakhstan, Iran, and Kyrgyzstan) within the framework of the government-funded free population vaccination programs. Thus, in 2017, the company shipped 6.9 million shots of the flu vaccine abroad.

Not only does the company develop pharmaceutical exports but also has a unique expertise in localization of Russian immunobiologicals abroad. In 2016, a Grippol® plus production technology transfer project was implemented in Belarus at Belmedpreparaty facility. It was the first immunobiological manufacturing experience for that country. In 2016, a Grippol® plus localization project also started in Iran where production of state-of-the-art flu vaccines had been nonexistent. To date, Grippol® plus is the first Russian vaccine to be issued marketing authorization in Iran.

While developing its export business, the company initiates post-approval clinical trials in other countries. In 2017, Petrovax Pharm successfully completed a post-authorization safety study (PASS) on Polyoxidonium® in Europe. This was an international evaluation of a high safety profile of a Russian drug, and the first post-approval study experience for a Russian drug in Europe that confirmed a high safety profile of an originator pharmaceutical product developed by Russian scientists.

The company’s strategic objectives include emerging in the new export marketplaces, further development in the Middle East, and further expansion in the North Africa and Southeast Asia. Petrovax also plans tapping into Egypt and Latin America’s markets. In 2017, the company launched several projects in these regions and initiated the approval process for its pharmaceutical products.

Human resources policies: stability
and professional development
The company’s successful development would have been impossible without the formation of its major asset, i.e. human resources. Presently, Petrovax Pharm has 650 employees, of them more than 300 employees working directly at the pharmaceutical facilities, and 10 % of the staff representing the R&D unit.
Petrovax Pharm has been heavily investing in setting up and developing its professional team as they are sure that people are the most valuable company’s asset. Most employees have higher professional education, a hands-on experience in a mass-scale immunobiological manufacture, and a relevant international experience. The company runs a mandatory GMP training system. Due to additional training and re-training courses, the employees have good self-fulfillment and career advancement prospects.

Experts participate in a variety of educational programs as well as do courses at the international partners’ facilities abroad on a regular basis. A diverse organizational chart and multiplicity subdivisions provide opportunities to develop not only vertically but also horizontally to new businesses, make different applications of one’s expertise or develop and master new skills.

Petrovax’s success is driven by people thinking big, honesty and enthusiasm for work as well as a focus on achieving leadership in the development and manufacture of competitive innovative pharmaceuticals. 

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