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Pharmstandard And Johnson & Johnson Signed A Memorandum Of Intent On The Production And Supply Of A Drug For The Treatment Of Tuberculosis

Today, JSC "Pharmstandard" and "Janssen Pharmaceutica NV" (part of the group of companies "Janssen Pharmaceutical Companies" holding "Johnson & Johnson"), signed a memorandum of intent on the production and supply of the drug "Sirturo". One of the largest manufacturers of pharmaceuticals in Russia, the Ufa Vitamin Plant, JSC "Pharmstandard" is given the status of the manufacturer of the preparation "Sirturo" (Bedakvilin) โ€‹โ€‹of the company "Janssen". The drug is used to treat multidrug resistant tuberculosis (MDR-TB) in adults . The proposed cooperation will allow to provide additional production facilities for the production of Bedakville.

According to the World Health Organization (WHO), tuberculosis is one of the main socially significant diseases, and Russia continues to be among the countries with a high incidence of tuberculosis. According to WHO, globally, the incidence of tuberculosis declines by about 2% per year. To achieve the goals by 2020, within the framework of the Strategy for the Elimination of Tuberculosis, the rate of decline in the incidence rate should be accelerated to 4-5% per year.

"The market of anti-tuberculosis drugs of the Russian Federation shows a high level of localization of production - production of only 3 international non-patented drugs from 38 products on the Russian market is not localized in the Russian Federation, " said Russian Industry and Trade Minister Denis Manturov. " At the end of 2017, total sales of anti-tuberculosis drugs amounted to 5.8 million packs worth 4.5 billion rubles. There is a stable dynamics of increasing the share of antituberculous drugs of domestic production: in 2015 - 77.1%, in 2016 - 83.7%, in 2017 - 86.1%. So, in 2017 the volume of production of medicines for the treatment of tuberculosis increased by 38% and amounted to 4.19 billion rubles. "

The new format of cooperation will expand the current partnership between JSC "Pharmstandard" and Janssen. Under the terms of the licensing agreement signed in 2012, Pharmstandard JSC received from Janssen commercial rights for Bedakvilin, used to treat MDR-TB, in the territory of the Russian Federation and a number of countries of the Commonwealth of Independent States (CIS), Eastern Europe and Asia.

"We are proud of the expansion of partnership with JSC" Pharmstandard ", which will help to provide patients with MDR-TB patients with Bedakvil in the world. Cooperation between the public and private sectors, and within each of them, is crucial to achieving an ambitious but realistic goal - to defeat TB worldwide by 2030, " said Dr. Paul Stoffels , director of research at Johnson & Johnson.

In addition, Janssen transferred a number of technologies and know-how to the production of Bedakvilin to JSC Pharmstandard. In 2013, JSC "Pharmstandard" became the holder of the registration certificate for the drug Bedakvilin in Russia.

Also in 2015, Pharmstandard and Janssen began cooperation under the Bedakvilin donation program, which provides up to 6,000 courses of therapy in Russia and some CIS countries for four years. These commitments were made with the aim of strengthening cooperation with the International Stichting International Dispensary Association, the Drug Purchase Agency of the Global Stop TB Partnership Foundation and the United States Agency for International Development (USAID). Under the terms of the Program, the company promised to donate up to 30,000 treatment courses for use in more than 100 countries of the world selected by the Global Fund.

"Russia demonstrates strong leadership in the fight against tuberculosis. Last November, the first ever WHO World Ministerial Conference on Tuberculosis took place in the Russian Federation. Expansion of cooperation with JSC "Pharmstandard" is another important step for Russia on the way to the final victory over this life-threatening disease, " said Ekaterina Pogodina , Managing Director of Janssen Russia and CIS.

The basis for the signing of the Memorandum was the research into the treatment of tuberculosis, which Johnson & Johnson has been conducting for almost 20 years. In 2012, Bedakwinin was approved in an accelerated manner by the United States regulatory authorities in combination therapy for adults (> 18 years old) suffering from pulmonary MDR-TB, a new mechanism of action that became the first antituberculous drug approved in the US for more than 40. Now it is included in the list of essential medicines of the World Health Organization (WHO) .At the moment of obtaining permission, patients in 95 countries of the world were supplied with more than 43,000 bedakwinil courses .  

It is important to note that according to the World Health Organization, in 2016, there were 490,000 new cases of MDR-TB and 240,000 deaths caused by complications associated with MDR-TB.

This year, world leaders will gather in New York for the first-ever United Nations High-Level Meeting on Tuberculosis to discuss a strategy to intensify the fight against the deadly disease and achieve one of the goals of the United Nations Sustainable Development Agenda and the World Health Organization's strategic goal of eliminating tuberculosis until 2030 of the year.

 

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