NEUDORF SPECIAL ECONOMIC ZONE, ST. PETERSBURG, Russia, May 19, 2014 /PRNewswire/ --
Head of the Russian Government Dmitri Medvedev visited today CJSC BIOCAD's commercial manufacturing facility for mAb-based therapeutic proteins. This private facility is unique in Russia and Easter Europe. It produces monoclonal antibodies-based APIs for biological products that are widely used in treating oncological and autoimmune disorders. The visit occurred in the context of the Presidium's meeting of the Russian Presidential Council on Innovations and Modernization. The focus of this meeting was on innovative developments in medical equipment and pharmaceutical industry.
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BIOCAD's Therapeutic Proteins Facility, Neudorf, St. Petersburg Special Economic Zone
Up to now, Russia has experienced high levels of lethal outcomes among oncology patients. Dr. Andrei Kaprin, director of the Hertzen Oncology Research Institute in Moscow, says that the lethal outcome among Russia's oncology patients within one year of being diagnosed is reaching nearly twenty-six per cent. Belated diagnosis is only part of the problem, which is compounded by prohibitively high prices for medications, many of which are only available from foreign pharmaceutical companies.
For instance, one vial of imported rituximab, which is used against certain types of cancers and rheumatoid arthritis, can be close to $ 2 000, and usually at least ten vials are needed for a full course of therapy. The Russian government spends over $ 300 m dollars on this product annually.
In order to overcome dependency on this and similar imported high-value biopharmaceuticals, the Russian government has embarked on an ambitious program of supporting high-tech domestic manufactures. These companies are capable of setting up commercial production facilities for biological oncology and other products that are on par with the foreign competitors in terms of efficacy and quality, yet are by far more affordable. Russia's prime biotech firm BIOCAD, located in the Neudorf Special Economic Zone just outside St. Petersburg, is one such company. First in Russia, rituximab, trastuzumab and bevacizumab, oncology drugs based on monoclonal antibodies, will be produced here.
CJSC BIOCAD's commercial biopharmaceutical manufacturing facility at Neudorf, Saint-Petersburg Special Economic Zone.
"In our country today there is a tremendous shift in supplying patients with pharmaceuticals. Thanks to the support of the Ministry of Health, the Ministry of Industry and Trade, and the Ministry of Economic Development, Russia is seeing more high-value, high-tech biopharmaceutical products. Of course, most foreign competitors do not like what they see. But today we are absolutely confident that we can pose serious competition. Quality and technology at our facilities are on par with those at many Western companies," says Mr. Dmitri Morozov, founder and CEO of BIOCAD.
Bringing the new facility online was the final one in a series of steps of implementing a Private-Public partnership project of setting up mAb-based APIs and finished dosage forms production in the context of the partial import substitution strategy.
On May 16th, 2014, Neudorf Special Economic Zone, St. Petersburg, the facilty was visited by the members of the Russian Presidential Council on Economic Modernization and Innovative Development.
Among the visitors were Russia's Prime Minister Dmitri Medvedev, Minister of Economic Development A. Ulukayev, Minister of Industry and Trade A. Manturov, Minister of Health V. Skvorczova, Head of Russia's Customs Service A. Belyaninov, Governor of St. Petersburg G. Poltavchenko, and other federal and city officials.
CJSC BIOCAD's mAb facility at Neudorf, Saint-Petersburg Special Economic Zone.
Commercial production capacity of the mAb facility at Neudorf fully meets current Russia's demand in mAb-based biologics most commonly used for oncology and autoimmune disorders. It will allow to substitute such high-value imports as Herceptin®, Аvastin® and MabThera®. The price of the three biosimilars of these products in Russia will be lower than that of the originator's. This means better coverage alleviation of suffering for larger numbers patients.
Proposals to develop the three oncology biological drugs received approval from the Presidential Council on modernization and Innovation. From 2010 to 2012, BIOCAD received over $9 m from the Russian government for related research and development in the context of Strategy-2020 of developing domestic pharmaceutical industry.
CJSC BIOCAD's research laboratories at Neudorf, Saint-Petersburg Special Economic Zone
BIOCAD's drug researchers have successfully developed complex biosimilars rituximab, bevacizumab and trastuzumab, from gene to the finished drug product. All products undergo clinical trials that are conducted in compliance with EMA's recommendations. On April 4th, 2014, Russia's Health Ministry registered Russia's first mAb-based biosimilar rituximab based on the results of a multi-center international comparative clinical trial. Today, BIOCAD already has eight international supply agreements with known foreign companies. This in itself testifies to the fact that the development was timely, and that the product fully complies with the rigorous international regulatory requirements.
About CJSC BIOCAD
Headquartered in St, Petersburg, Russia, Joint-Stock Company BIOCAD is Russia's leading private, fully integrated biopharmaceutical company specializing in research, development and manufacturing of generic, biosimilar and innovative drug products. BIOACAD works to provide more affordable therapeutic proteins and small-molecule generics to patients who previously had limited access to high-value drugs in the areas of oncology, autoimmune and infectious diseases.
The company currently employs over 700 people, 150 of whom are researchers and investigators working at BIOCAD's labs. BIOCAD 2013 sales were close to $ 90 m. The company has subsidiaries and representation in Belarus, Brazil, China, India, Ukraine, and the U.S.
Irina Kenyukhova
PR-manager
Phone +7(812)3804933, ext. 632
E-mail kenyukhova@biocad.ru
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