AbbVie and R-Pharm announce launch of full cycle production of Kaletra®

July 4
  • Localization of full cycle production of Kaletra® finished dosage form will help to improve access of Russian patients to antiretroviral therapy
  • There are 943,999 people living with HIV1 in Russia
  • The therapy coverage is increasing as stipulated by the government and public goals to combat the HIV/AIDS epidemic in Russia

Russia, Moscow, June 4, 2018 - AbbVie, a research-based global biopharmaceutical company, and R-Pharm Group announced that technology transfer for production of Kaletra® (lopinavir + ritonavir) drug for HIV/AIDS treatment in adults is completed. Kaletra® finished dosage form will be produced at the R-Pharm manufacturing complex in Yaroslavl. R-Pharm will use Kaletra® substance produced by AbbVie.

There are 943,999 people living with HIV in Russia now. About 346,000 people constantly receive antiretroviral therapy (ART)[1]. The therapy coverage is steadily increasing as stipulated by the government and public goals to combat the HIV/AIDS epidemic in Russia. The number of patients receiving ART has increased by 2.76 times compared to 2012[2].

"Completion of the technology transfer and organization of the full cycle production of the drug for HIV/AIDS treatment is an important stage in implementation of Pharma-2020 Strategy," said Vasily Ignatyev, General Director, R-Pharm Group. “Our partnership with AbbVie should increase efficiency of combat against diseases caused by the human immunodeficiency virus".

"At AbbVie, we are committed to make remarkable impact on patients' lives. Antiretroviral therapy helps patients to live normal live, control the disease, and restrains epidemic," said Anthony Wong, Regional Vice-President, Russia, Ukraine & CIS, AbbVie. "The full cycle production is a step forward to improve access to antiretroviral therapy for Russian patients".

AbbVie has been an active participant of the health care industry in our country for over 40 years now (as part of Abbott prior to 2013) and a strategic partner of the government in modernization of the medical assistance system and development of the Russian pharmaceutical market. Localization of AbbVie drugs is one of important company activities in Russia. Such projects help improve access to innovative therapy and correspond to the top priorities of the government health care policy.

The following steps have been successfully implemented under the Kaletra® localization project in Russia: additional installation of equipment at R-Pharm production facilities and laboratories, transfer of analytical methods of drug and pharmaceutical substance quality control, transfer of engineering technology, creation of experimental and LTSS batches, and process validation. Great attention was paid to training of R-Pharm quality and production control employees.

The Yaroslavl-based R-Pharm's manufacturing complex for production of finished dosage forms and biotechnological substances is fully certified to the GMP requirements and was approved by the Russian Ministry of Healthcare on March 19, 2018 for all process stages of the finished dosage form production.

R-Pharm is one of the key local partners of AbbVie in the implementation of the company's long-term strategy in Russia. Joint projects significantly contribute to the development of the Russian pharmaceutical industry and are implemented as part of the government strategic goals and initiatives.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook.

 

[1] - Excerpt from the speech of Olga Golodets, Deputy Chair of the Russian Government, at the 6th Eastern Europe and Central Asia HIV/AIDS Conference on April 18, 2018 http://government.ru/news/32325/

[2] - Action against HIV and other socially dangerous diseases: some figures for 6 years. http://government.ru/info/32200/

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