Moscow, 30 June 2015
The global biopharmaceutical company AbbVie and the largest pharmaceutical manufacturer in Russia [1] Pharmstandard JSC announce the start of manufacture of Synagis® in Russia, with secondary packaging to be manufactured at one of the Pharmstandard plants. The medicine is used for the prevention of respiratory syncytial virus (RSV) infection (type of ARVI) in children at risk: premature infants born before 35 weeks of pregnancy, children with bronchopulmonary dysplasia and congenital heart disease.
About 100,000 premature babies are born in Russia every year, and the infant mortality rate in our country is twice as high as in European countries 1. Monitoring of the incidence and structure of the ARVI infectious agents among children under two years of age conducted in 2013 by the Research Institute of Influenza of the Ministry of Health of the Russian Federation has confirmed that the RSV is the main cause of morbidity and hospitalization of children of this age for severe respiratory infections. With timely prevention of the RSV infection, the risk of fatal bronchopulmonary complications can be significantly reduced.
Synagis® (palivizumab) has been used successfully for more than 17 years in more than 60 countries and is included in the relevant national guidelines of Europe, the United States and Japan to prevent the development of lower respiratory tract infections due to RSV, reduce the frequency and duration of hospitalizations, and also alleviate the disease course and reduce the incidence of complications.
‘According to experts, mortality from respiratory diseases is one of the main factors influencing overall infant mortality [2],[3]’, said Anthony Wong, General Manager, AbbVie in Russia, Ukraine and CIS. — ‘Improving children's health is one of the priorities of public health policy, and we also strive to contribute to improving the situation in this field. Synagis® (palivizumab) is a complex bio-product with the efficacy and safety proven by seventeen years of global experience and research [4]. The localization of this product is another confirmation of AbbVie's commitment to the development of the healthcare industry in the country. We hope that the implementation of this joint project with Pharmstandard will contribute to the further development of the treatment and care standard in neonatology and help more premature babies and children from other risk groups to grow up healthy’.
‘We are a partner of AbbVie in the localization of this drug and believe that with Synagis® the standards for nursing children at risk will be qualitatively improved, the incidence of complications and disability, as well as mortality and hospitalization in newborns will be reduced’, adds Grigory Potapov, CEO, Pharmstandard JSC.
AbbVie has been an active participant in the Russian healthcare industry for more than 37 years (as part of Abbott until 2013) and seeks to become a strategic partner of the state in modernizing the healthcare system and creating the strong local pharmaceutical market. Localization of the key medicinal product portfolio is one of the main areas of AbbVie's work in Russia, as such projects help improve access to innovative locally manufactured medicinal products [5] and are in line with the public health policy priorities, particularly improving children's health and reducing mortality.
As part of a long-term strategy in Russia, AbbVie has been implementing partnership projects jointly with the largest local pharmaceutical manufacturers since 2012. AbbVie and Pharmstandard signed a Cooperation Agreement in December 2013; on the 9th of April, 2014, the Ministry of Health of the Russian Federation approved the Pharmstandard production site in Ufa for the secondary packaging and release of Synagis® (palivizumab). Locally packaged Synagis® (palivizumab) 50 mg and 100 mg lyophilisate for solution for intramuscular injections is already available in Russia since the end of 2014.
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About AbbVie
AbbVie is a global biopharmaceutical research company founded in 2013 through a demerger from Abbott. The company's mission is to use the expertise, experience of dedicated employees and a unique approach to innovations to develop and market the advanced treatment methods designed to address some of the world's most complex and serious diseases. AbbVie and Pharmacyclics, a wholly owned subsidiary of AbbVie, employ over 28,000 people and market medicinal products in more than 170 countries. For more information about the company and its employees, product portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter and explore AbbVie's career opportunities on the company's Facebook or LinkedIn pages.
About Pharmstandard
Pharmstandard JSC is a leading pharmaceutical company in Russia that develops and manufactures advanced, high-quality and affordable medicinal products that meet healthcare requirements and patient expectations.
Pharmstandard Group manufactures more than 250 medicinal products, including for the treatment of cardiovascular diseases, diabetes mellitus, growth hormone deficiency, gastroenterological, neurological, infectious diseases, metabolic disorders, oncology and other diseases. Over 120 medicinal products (including all forms and dosages) are included in the Vital and Essential Drugs List.
Pharmstandard is one of the leading Russian companies in localizing the manufacture of medicinal products from leading global manufacturers.
Company information: http://pharmstd.ru/
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For more information, please contact:
Anna Samokhvalova
AbbVie's Public Relations Director for Russia, Ukraine and CIS
8 (965) 115-88-61
Alexey Chernushkin
Chief Investment Officer, Pharmstandard JSC
8 (495) 970-00-30
[1] In terms of production output in 2014 in physical terms, according to IMS Health
[2] According to WHO http://apps.who.int/gho/data/view.main.200
[3] According to the Federal State Statistics Service http://www.gks.ru/wps/wcm/connect/rosstat_main/rosstat/ru/statistics/population/demography/#
[4] Impact-RSV Study Group. Pediatrics. 1998; 102: 531-537. 3. Feltes T. F., Cabalka A. K., Meissner H. C., et al. J. Pediatr. 2003; 143: 532-40.
Feltes TF, Cabalka AK, Meissner HC, et al. Palivizumab prophylaxis reduces hospitalisation due to respiratory syncytial virus in young children with haemodynamically significant congenital heart disease. Journal of Pediatrics. 2003;143(4): 532-540.
Checchia et all Pediatr Crit Care Med 2011 Vol. 12, No 5
Turti T. V., Baibarina E. N., Degtiareva E. A., et al. BMC Research Notes 2012, 5:484.
[5] In December 2014, the product for the prevention of RSV infection was included in the list of vital and essential medicinal products.
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