Oxford Immunotec Announces New Initiative to Bring the Benefit of
Modern Tuberculosis Testing to the Russian Federation
Oxford Immunotec Global PLC (Nasdaq:OXFD) (the "Company"), a
global, high-growth diagnostics company, today announced a new
local production initiative to bring the benefits of the T-SPOT®.TB
test to the Russian Federation.
Since the T-SPOT.TB test received approval in the Russian
Federation in 2013, Oxford Immunotec has been working with a local
distribution partner, PharmLine LLC (“PharmLine”) and has seen
expanding uptake of the T-SPOT.TB test. In collaboration with
PharmLine, Oxford Immunotec will now also be working with Generium
Joint Stock Company (“Generium”), who will be manufacturing the
T-SPOT.TB test locally at their factory in the Vladimir region of
the Russian Federation. This is expected to reduce the cost of, and
expand access to, the T-SPOT.TB test for patients in the Russian
Federation. Additionally, Generium will be working with PharmLine
on marketing and distribution of the T-SPOT.TB test, including
applying for national TB control tenders.
The Russian Federation is among the 20 countries worldwide with
the highest estimated numbers of incident TB cases, with a reported
incidence rate of 60 cases per 100,000 population and a high rate
of HIV/TB coinfection.1 The Russian Federation has the 3rd highest
rate of multi-drug resistant TB in the world,2 which adds urgency
to the need to reduce TB rates before drug resistance undermines
the ability to successfully treat those diagnosed. With a strong
commitment to new actions to end TB, the WHO and the Government of
the Russian Federation convened the First WHO Global Ministerial
Conference, Ending TB in the Sustainable Development Era: A
Multisectoral Response, which was a fundamental milestone towards
the United Nations General Assembly (UNGA) High-Level Meeting on TB
in 2018. The development and implementation of more ambitious,
fully-funded national TB policies and strategic plans is also one
of many commitments included in the Moscow Declaration to End
TB.3
The WHO and the UN have both recognized that a critical
component in the fight to end TB is the rapid scaling up of access
to and testing for TB infection in high-burden countries,
particularly focusing on those most at risk of falling ill, such as
children and those with HIV.4 They have also called on stakeholders
to develop new models to increase access to the tools, such as
interferon gamma release assays (IGRA) tests,5 which are now
included in the WHO’s List of Essential In Vitro Diagnostics.6
“This new development allows Generium to bring into Russia a
high-precision laboratory test for the diagnosis of tuberculosis
infection, with the economic benefits of local production,” said
Dmitriy Kudlay, CEO of Generium. “Together with PharmLine and
Oxford Immunotec we are excited to expand the use of the T-SPOT.TB
test in Russia in order to support the state’s aims in ending TB in
the country.”
“We are very pleased to enter into this exciting new approach
with Generium, who as the skin test providers in Russia, have
unparalleled reach and relationships within Russia and Kazakhstan,”
said Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec. “We believe
working with PharmLine and Generium expands the reach of the
T-SPOT.TB test and we are proud to take another step forward in
helping the clinical community in Russia in their fight against
TB.”
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, high-growth diagnostics
company focused on developing and commercializing proprietary
assays for immunology and infectious disease. The Company's
T-SPOT.TB test has been approved for sale in over 50 countries,
including the United States, where it has received pre-market
approval from the Food and Drug Administration, Europe, where it
has obtained a CE mark, as well as Japan and China. The Company is
headquartered near Oxford, U.K. and in Marlborough, MA.
Additional information can be found at www.oxfordimmunotec.com.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford
Immunotec Ltd.
About Generium
Generium is the leading Russian biopharmaceutical company,
focused on developing and commercializing diagnostic systems and
pharmaceutical products for the treatment of orphan diseases,
infection diseases, cancer, multiple sclerosis, myocardial
infarction and strokes as well as tuberculosis diagnostic test -
Diaskintest®. Generium consists of a high-end R&D center and a
fully integrated manufacturing plant. Generium has more than 30
innovative products in the pipeline, including enzymes, monoclonal
antibodies and ATMPs. Generium is headquartered in Moscow, Russia.
Additional information can be found at www.generium.ru/en.
Diaskintest is a trademark of Generium Joint Stock Company.
About PharmLine
PharmLine was founded in 1993 and is a leading healthcare
product distributor. PharmLine specializes in the marketing and
sales of pharmaceuticals, diagnostic products and technologies for
hospital and laboratory use in the Russian Federation and the
Confederation of Independent States. PharmLine is located in
Moscow, Russia.
Forward-Looking Statements
This release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this release are
forward-looking statements. This includes statements about Oxford
Immunotec's anticipated plans and objectives, future performance
and revenues, financial condition, prospects for sales of its
products, growth, strategies, expectations and objectives of
management. Forward-looking statements can be identified by the
fact that they do not relate strictly to historical or current
facts. Forward-looking statements contained in this release reflect
Oxford Immunotec's current expectations and are subject to risks
and uncertainties. Actual results may differ materially from those
projected or implied by forward-looking statements. Other factors
that could adversely affect Oxford Immunotec's business and
prospects are described under the "Risk Factors" section in its
filings with the Securities and Exchange Commission ("SEC"). Oxford
Immunotec's SEC filings are available for free by visiting the
investor section of its website, www.oxfordimmunotec.com, or the
SEC's website, www.sec.gov.
Investors should give careful consideration to these risks and
uncertainties. Forward-looking statements contained herein are
based on current expectations and assumptions and currently
available data and are neither predictions nor guarantees of future
events or performance. Investors should not place undue reliance on
forward-looking statements contained herein, which speak only as of
the date of this release. Oxford Immunotec does not undertake to
update or revise any forward-looking statements after they are
made, whether as a result of new information, future events, or
otherwise, except as required by applicable law.
CONTACTS:
Karen KoskiVP, Strategy & Investor RelationsOxford
ImmunotecTel: +1 (508) 556-1377kkoski@oxfordimmunotec.com
Dmitriy MamykinThe Head of International DepartmentGeneriumTel:
+7 (495) 988-47-94 ext. 7073bd@generium.ru
Vsevolod LetskoPR ManagerGeneriumTel: +7 (495) 988-47-94 ext.
7020pr@generium.ru
Mikhail BokshteinGeneral DirectorPharmLine
LLCm.bokshtein@pharmline.ru
____________________________________________
1 Global tuberculosis report 2018 (35). WHO; 20182 Global
tuberculosis report 2018 (49). WHO; 20183 Moscow Declaration to End
TB; First WHO Global Ministerial Conference on Ending TB in the
Sustainable Development Era: A Multisectoral Response, November
2017. WHO and the Ministry of Health of the Russian Federation;
20174 Resolution adopted by the General Assembly on 10 October
2018: 73/3 Political declaration of the high-level meeting of the
General Assembly on the fight against tuberculosis (5 – 6). United
Nations General Assembly; 20185 Resolution adopted by the General
Assembly on 10 October 2018: 73/3 Political declaration of the
high-level meeting of the General Assembly on the fight against
tuberculosis (10). United Nations General Assembly; 20186 World
Health Organization Model List of Essential In Vitro Diagnostics –
First Edition (2018). WHO; November 2018
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