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European Biopharmaceutical Review
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Over the last decade, Russia has made a significant leap in
biopharmaceutical R&D. After the fall of the Soviet Union in 1991,
the country was virtually excluded from innovative drug development. The
Russian market at that time was dominated by locally and Eastern Bloc
produced generics, with only a limited number of patented medicines
available. But the situation now is very different.
Total
healthcare expenditure per capita has shown a significant and steady
growth, from $480.2 in 2002 to $1,316.3 in 2011 (1). The market is
flooded with pharmaceutical products, the clinical trial industry is
rapidly expanding, and the regulatory landscape is becoming more akin to
European Medicines Agency and US Food and Drug Administration
standards.
Yet Russia still lags substantially behind most
developed countries in terms of healthcare spending. There is, however,
an obvious natural demand for more investment and quality in the
healthcare sector. The country’s large ageing population and the
prominence of cardiovascular and oncological conditions, combined with
growing prosperity and medical awareness, make the situation similar to
Europe and the US.
Pharma 2020
To address these
needs, the Russian government has launched the Pharma 2020 programme,
which specifies goals, spending and investment for the healthcare
sector. In a bid to reverse the country’s reliance on imported
pharmaceutical products, the initiative aims to facilitate the domestic
development and manufacturing of innovative drugs.
Among the
programme’s goals are to reach 60 per cent share of patented drugs in
the portfolios of domestic manufactures by 2020, and to increase the
total sales share of locally produced drugs to 50 per cent (from 20 per
cent in 2007) (2). Although many sceptics question the feasibility of
these targets, the initiative is a tangible effort to tackle Russia's
healthcare problems and boost biopharma and medical device development.
Moreover, the expectations of further growth in healthcare spending have
prompted many leading multinational companies, such as Pfizer,
Novartis, AstraZeneca, Teva Pharmaceuticals and GlaxoSmithKline, to
start investing in Russian manufacturing and R&D facilities.
Investment Funds
Amid
its efforts to diversify the economy, the Russian government has
initiated a number of state-backed investment funds which operate in the
biopharma space. The RVC Biopharmaceutical Investment Fund, Maxwell
Biotech Venture Fund, Rusnano and Skolkovo Foundation are funds with a
defined strategy to help start-up companies transform promising
scientific ideas with commercial potential into fullyfledged businesses.
These funds actively look domestically and abroad for
attractive co-investment opportunities. There are, of course, some
conditions attached: foreign companies must be willing to establish
their R&D or manufacturing facilities in Russia and bring
substantial economic potential or social benefit (3).
At the same
time, many companies entering investment agreements have expressed
their hopes for shorter study enrolment time, more flexible regulations,
and other factors which can accelerate drug research and registration
in the country.
Cooperation Examples
There are a
number of interesting examples of investment cooperation in biopharma.
Selecta (RUS) LLC – the Russian subsidiary of US-based Selecta
Biosciences – along with its biopharma partner, BIND Biosciences, became
Rusnano’s first portfolio companies in the pharma sector to open a
research centre in Russia (4). At the new facility, Russian and US
scientists will develop immunotherapies and vaccines for the treatment
and prevention of cancer, as well as respiratory, infectious, autoimmune
and allergic diseases. The President and Chief Executive Officer of
Selecta will move to Moscow to become the General Director of the
Russian subsidiary.
Furthermore, in February 2014, BIND (RUS) –
established in 2011 as a result of an investment agreement between
Rusnano and BIND Therapeutics – announced the launch of a new R&D
centre in Moscow. A key objective of the centre is to develop a new
class of highly selectively targeted therapeutics (accurins) for the
treatment of cancers and other diseases.
Another announcement
from early this year concerns Hepatera, a Skolkovo resident company
funded by Maxwell Biotech Venture Fund, which has recently completed
enrolment of a Phase 2 clinical trial of Myrcludex B. This innovative
drug for the treatment of chronic viral hepatitis B and D originated
from research at the University Hospital Heidelberg, Germany, and is
being developed with the German biotechnology company MYR GmbH (5).
Routes to Success
The
joint venture SynBio LLC – whose stakeholders include the Human Stem
Cells Institute, Pharmsynthez, Cryonix, FDS Pharma LLP and Rusnano – is
an example of Russian collaboration with British and German firms in
innovative pharmaceuticals. SynBio has headquarters in Moscow and a
controlling interest in research laboratories in the UK and Germany. The
company develops nine medicines based on three biotech platforms –
Histone, PolyXen and Gemacell – for the treatment of liver disease,
cardiovascular disease, acute leukemia, growth hormone deficiency and
diabetes milletus (6).
Meanwhile, one of the most successful
infrastructural investments Rusnano has made is BiOptix Diagnostics, a
USheadquartered producer of biodetectors for drug tests whose technology
was developed by 2005 Nobel Prize Laureate in Physics, John Hall.
BiOptix
instrumentation allows researchers to study label-free proteinprotein
and protein-small molecule interactions, the measurements of which are
essential for the development of promising molecular candidates for
innovative drugs. In the latest move, the company is to open a Russian
subsidiary, BiOptix Nanoprom, to produce its disposable bionanosensors
and create an R&D presence in the Moscow region. It says that
Rusnano’s participation will hasten the process of building a successful
business and enable it to tap into new, previously inaccessible markets
and resources (7).
Major Force
Joseph Damond,
Senior Vice President of International Affairs at the Biotechnology
Industry Organization, has commented: “Creating a more open trade
atmosphere will encourage cross-border partnerships that will ultimately
help to grow the industry in Russia, and will enable other countries
and companies to benefit from the important work being conducted in the
country” (8).
Assured of solid funding, the success of biotech
investments in Russia lies mostly with effective management in order to
minimise bureaucracy, maximise transparency in public spending and
guarantee the protection of intellectual property.
The extent of
recent developments in Russia indicates that the country is taking big
steps to gain influence within the scientific community and establish
itself as a major force in biopharma innovation.
Box Out; Biopharma to Benefit from Planned Innovation City
In
terms of investment and expectations, the proposed Skolkovo Innovation
Center is one of the most fascinating projects currently unfolding in
Russia. The project will see the construction of a 400-hectare site – a
so-called ‘innocity’ – that is a hub of modern technological, including
biopharma, development. The scheme, which is still in the planning
stages, is being led by the Skolkovo Foundation, launched in 2010 with
substantial governmental support.
Located near Moscow, the city
will accommodate about 22,000 inhabitants and be an easy commute for a
further 20,000 workers. Infrastructurally advanced, environmentally
friendly and creatively designed, it will be based around two main
features: the University and Technopark. Alongside laboratories, office
buildings and a conference centre, there will be residential,
recreational, fitness and store areas (9).
Start-Up Involvement
More
than 1,000 start-ups are lined up to participate, of which about one
quarter – or more than 250 registered companies – operate within
biomedical clusters. The idea is not only to foster promising scientific
ideas, but to facilitate the ultimate goal of bringing them to market.
Whereas scientific advancement in Russia is historically highly esteemed
– and primarily supported by the academic world – marketing and
investment remain a weak link, which hampers successful
commercialisation of products.
The project is governed by
special legislation that will offer beneficial economic conditions for
residents and employees at the site. Project participants will be
relieved from paying value-added, profit and corporate property taxes,
and will benefit from a reduced rate on insurance premiums (10). In
addition, they may be eligible for grants to fund their projects. There
is also a simplified procedure to hire foreign employees, and virtually
no visa and work permit requirements for foreign residents and their
families based on-site.
Funding Needs
The project is
expected to receive a total of $15.2 billion of funding through 2020,
from which $4.1 billion is pledged from the state budget, with the rest
coming from the private sector (11). Some $1.2 billion will go to the
development of the Skolkovo Institute of Science and Technology
(Skoltech), which was established in collaboration with the
Massachusetts Institute of Technology and has already welcomed about 70
students this year.
One of the criteria for the project’s
effectiveness is the high proportion of private investment, compared to
public funding. Skolkovo Foundation president Viktor Vekselberg has
expressed hopes that it will not need government financing after 2025
(12).
However, with the project largely a stateled initiative,
critics fear that the old Soviet tradition of governmental supervision
could limit its success, and that it could fall foul to burdensome
bureaucracy and funds embezzlement. Some recent events seem to confirm
these concerns – for example, last year the project became entangled in a
number of corruption scandals (13). High-level commitment is required
to ensure the project achieves its ambitious aims.
References
1. Visit: http://apps.who.int/gho/data/view.country.16600
2. Visit: www.pharma2020.ru/strategy.html
3. Visit: http://en.rusnano.com/investment
4. Visit: http://en.rusnano.com/presscentre/news/20121128-selecta-rusopen-a-research-center-in-russia
5.
Visit: http://community.sk.ru/foundation/biomed/b/weblog3/
archive/2014/02/10/hepateraa-skolkovo-resident-companycompletes-enrollment-of-phase-iiaclinical-
trial-of-myrcludex-b-a-novelentry-inhibitor-for-treatment-ofchronic-hbv-infection.aspx
6. Visit: http://en.rusnano.com/portfolio/companies/synbio
7. Visit: http://en.rusnano.com/presscentre/news/88539
8. Visit: www.bioworld.com/content/russia-ready-build-permanentbiopharma-market-0
9. Visit: http://community.sk.ru/innograd/p/main_objects.aspx#build_ partnerships
10. Visit: http://community.sk.ru/net/ participants/p/benefits.aspx
11. Visit: www.themoscowtimes.com/business/article/skolkovo-foundationto-get-15bln-in-2013-2020/483982.html
12.
Visit:
http://community.sk.ru/press/b/pressabout/archive/2013/08/01/_2200_skolkovo_2200_-do-2020-g-mozhetpoluchit-367-mlrd-rub-chastnyhinvesticiy.aspx
13. Visit: www.themoscowtimes.com/news/article/ponomaryovs-skolkovofine-appeal-rejected/490108.html
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