Investor Presentaiton
CASE STUDIES: INVESTMENT PROJECTS IN 2018-2019
Servier,
GSK/ViiV Healthcare
V
SERVIER
AEB
Association
of European
Businesses
CEO
Jérôme GAVET,
Managing Director of Servier Group for Russia and EAEU
Xavier MORELON,
General Manager of pharmaceutical plant "Servier RUS"
Oleg DUBYANSKIY, General Director, GlaxoSmithKline
Date of the investment project
25 April 2019
Location
Moscow
Brief information about the investment project
On 25 April 2019 local manufacturing of the innovative anti-
HIV drug was launched in Moscow at Servier RUS produc-
tion site in partnership with GSK/ViiV Healthcare. This part-
nership for contract manufacturing is significant for the local
market - it will improve access of the drug to people.
Project progress
The decision on the need to manufacture the drug locally in
Russia was made in 2015, less than a year after the regis-
tration. The agreement between the drug's developer ViiV
Healthcare and Servier, which has its own pharmaceutical
plant in Russia (Servier RUS plant), was signed in May 2016.
The design of the localization project involves the one-stage
start of production of a full cycle (production of a finished
dosage form) without intermediate steps, such as secondary
packaging.
In September 2016, the first pilot and registration series of
the drug were produced at Servier RUS production complex
located in New Moscow.
During 2017, ViiV Healthcare and GSK (Great Britain) and Sh-
ionogi (Japan) production sites, which were included in the
technology transfer process, were inspected and received
Russian GMP certificates.
In 2018, a pharmaceutical substance was registered in Rus-
sia, and Servier pharmaceutical plant was approved (regis-
tered) by the Ministry of Health of the Russian Federation as
the Russian production site for the drug. In the same year,
within the framework of the St. Petersburg International Eco-
nomic Forum, GSK and Servier signed a final agreement on
the launch of full-scale manufacturing in Russia.
The agreement on production is for a period of 5 years with
plans to extend. The flexible scope of the production plan
provided by the agreement will satisfy the demand for this
drug in Russia.
In 2019, a high-tech line for the drug's production, which
has no analogues in Russia, was installed at the Servier RUS
plant. Servier is one of the active participants in the current
state pilot labeling project for drugs, and the new equipment
fully complies with Russian regulatory requirements.
The official opening ceremony of the production line took
place on April 25, 2019.
The implementation of the agreement will ensure the avail-
ability of a key innovative drug for the treatment of HIV infec-
tion produced in Russia, which will contribute to achieving
the goals of combating the spread of HIV infection, as well as
contribute to the development of the Russian pharmaceutical
industry and the innovative potential of Moscow.
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