Russian Prime-Minister Dmitri Medvedev visits Russia’s First Facility for Commercial Manufacturing of mAb-based Therapeutic Proteins

May 19, 2014


Head of the Russian Government Dmitri Medvedev visited today CJSC BIOCAD’s
[http://www.biocad.ru/en/we ] 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

http://photos.prnewswire.com/prnh/20140514/686712 )

BIOCAD’s [http://www.biocad.ru/en/we ] 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

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(R),
vastin(R) and MabThera(R). 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.


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
        Phone +7(812)3804933, ext. 632
        E-mail kenyukhova@biocad.ru




Source: PR Newswire

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