Russia through the prism of the world biopharmaceutical market

Biotechnology
Journal
a virtual industrial scale plant capable of producing 1810 kg
of API rHI annually, theoretical evaluations give operating
expenses $ 42.2/g and the selling price of $ 75/g [44]. This
demonstrates a potential of producing competitive biogenerics
in Russia.
Since 2004, ready-to-use Insuran formulations have
been successfully used for the treatment of diabetes mellitus.
Currently, ~6000 people (14% of the Moscow insulindependent
patients) regularly use different Insuran formulations.
With the launch of production of cartridge form
planned for the end of 2007, the Insuran share may reach
25% of the Moscow insulin market (45 000 patients with
an annual demand ca. 510 million IU insulin, i.e., ~20 kg
API or $ 16.7 million at complete saturation). Scaling up
the created pilot facility and the developed technologies
will allow manufacturing of effective, high-quality biopharmaceuticals
(although biogenerics at the initial
stage) that will have very competitive selling prices and
successfully compete with multinational biopharmaceutical
players for the fast-growing pharmaceutical market of
the Russian Federation [45].
5 The future of biotech innovations lies with
academia
In the long list of tasks that have to be solved by national
pharmaceutical biotechnology, production of highly competitive
biogenerics and follow-on biologicsls is only the
first step. The continued development of modern bioindustry
and particularly its newest branches such as genetic
and cell engineering, postgenomic technologies and
nanobiotechnologies strongly depends on breakthroughs
in basic research. Therefore, the next steps should include
revival of the potential of Russian fundamental science,
which has lost ~200 000 researchers of the most creative
age since 1992. It would be wrong to conclude that
basic research was not supported by Russian Government
at all. In the past 15 years leading Russian research
institutes have been involved in the Federal programs
“Human genome”, “Gene diagnostics and gene therapy”,
“Vaccine prophylaxis” and others. However, governmental
funding spread over 57 research centers did not exceed
3–5% of that spent, for example, in China
(http://www.bioinfo.ru). This has partially restored the intellectual
potential accumulated in the scientific schools
of RAS, Russian Academy of Medical Sciences (RAMS)
and their leading biotechnology institutes, including
IBCH, Engelhard Institute of Molecular Biology, Pushchino
Scientific Center, Institute of Gene Biology, Institute of
Medico-Biological Problems, Institute of General Genetics,
Institute of Molecular Genetics, Institute of Develop-
mental Biology, Center of Bioengineering, Institute of
Chemical Biology and Fundamental Medicine (Novosibirsk),
Orekhovich NII of Biomedical Chemistry, Institute
of Immunology, National Cardiology Research Center, Na-
12 © 2007 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim
BTJ 07/07 | TD | DOI 10.1002/biot.200700091
Biotechnol. J. 2007, 2
tional Oncology Research Center, as well as leading Russian
high schools Lomonosov Moscow State University, St.
Petersburg State University, Novosibirsk State University,
Khazan State University, Sechenov Moscow Medical University,
etc. However, the world ranking of the Russian
fundamental science has diminished year after year due,
in part, to poor compensations offered to Russian PhD scientists
(monthly salaries do not exceed $ 200–300). This
has also been a major obstacle for recruiting a new generations
of scientists.
In spite of the insufficient state support, some hot topics
were successfully developed by domestic fundamental
science mostly based on the knowledge and skills accumulated
earlier. It is not possible to overview in one
article all the spectrum of biopharmaceutical and related
research carried out in Russia. Below only a few achievements
of the national science supported by corresponding
Russian references are given:
– Innovative non-injected insulin delivery technology
(insulin pills) developed as early as in the end of 90s in
Topchiev Institute of Petrochemicals in collaboration
with Moscow State University and Bach Institute of
Biochemistry [46, 47], which can promote development
and marketing of non-injecting ready-to-use formulations
of domestic rHI;
– Laboratory trials of a new anti-tuberculosis vaccine
against Mycobacterium tuberculosis cytokine [48, 49],
which is of special importance because of wide spread
of tuberculosis in Russia;
– Development of vaccines against the most dangerous
infective diseases such as EBO by the GNC of Virology
and Biotechnology “Vector” to protect the population
from bioterrorism [50];
– Construction by NII of the Flu (St. Petersburg) of vaccine
bank targeting H5N1 virus by means of reverse
genetics to protect the population from a bird flu pandemic
[51];
– Development of new rIL-based drugs [52, 53];
– Novel medical applications of catalytic antibodies developed
by IBCH [54];
– Construction of a representative national collection of
hybridomas [55] and development of pharmaceutical
mAbs by Russian Oncology Research Center [56, 57];
– Stem cell therapy approaches [58, 59];
– Gene therapy approaches in the therapy of muscular
dystrophy and other diseases [60–62];
– Novel delivery systems for gene therapy agents
[63–65];
– New generation of polymer-conjugated vaccines by
the Institute of Immunology in collaboration with
Moscow State University [66];
– Computer design of vaccines by the Orekhovich NII of
Biomedical Chemistry [67];
– New antitumor peptide drugs based on α-fetoprotein
fragment by the Institute of Molecular Diagnostics
[68].
GALLEY PROOF