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Waterfall news

             WATERFALL-bAsED



             cipLA TO bRinG cOviD-19


             TREATmEnT TO sA




             Antiviral medicine, remdesivir, approved as a treatment for cOviD-19.
            c       ipla, through a landmark agreement with Gilead


                    Sciences Inc. , has been granted a license to
                              1
                    manufacture and distribute the antiviral medicine,
                    remdesivir, in 127 countries, including South
             Africa , to support treatment measures of the Coronavirus
                 2
             (COVID-19) pandemic. Cipla will include several sub-Saharan
             African countries within the distribution of remdesivir, as
             many of these states are low-income countries and emerging
             markets that face obstacles in accessing healthcare.

             The Emergency Use Authorization (EUA) for remdesivir was

             first issued by the United States Food and Drug Administration
             (FDA) on 1 May 2020 , mainly based upon a study funded by
                             3
             the National Institute of Allergy and Infectious Diseases (NIAID)
             in the USA. This study showed that remdesivir shortened the
             time to recovery in patients hospitalised with COVID-19 .
                                                         3
                                                                  CEO of Cipla South Africa, Paul Miller
             This authorisation for emergency use was granted by the
             FDA on the basis that SARS-CoV-2 can cause a serious or life-  access to life-saving medication. In much the same way that

             threatening disease or condition; their view that the known   Cipla pioneered affordable medication during the height of the
             and potential benefits of remdesivir outweigh the known and   HIV crisis about two decades ago and helped to save the lives


             potential risks; and the fact that there is currently no adequate,   of millions of people, we’re committed to help find a solution

             approved alternative treatment available for COVID-19 .  in the fight against this unprecedented global pandemic.”
                                                         3
             Remdesivir is also approved for emergency and        Cipla will, therefore, ensure that the price of its remdesivir
             compassionate use in India, Japan and Singapore on similar   will be less than or similar to prices offered in other emerging   Experience the Spirit of SUCCESS

             grounds . More recently, in June 2020, remdesivir was   markets, thereby facilitating access to this medicine.
                   4
             recommended for a conditional marketing authorisation by
             the European Medicines Agency, a regulatory mechanism to   Cipla commenced manufacturing remdesivir in                                                www.kyalamischools.org
             facilitate early access to medicines that fulfil an unmet medical   June 2020 on a dedicated line at one of its FDA-,

             need, including in emergency situations in response to public   WHO- and SAHPRA-approved production facilities.
             health threats such as the current COVID-19 pandemic .
                                                         5
                                                                  Additionally, Cipla will continue to engage with
             cARinG FOR LiFE                                      the South African Health Products Regulatory
             CEO of Cipla South Africa, Paul Miller, says: “As part of our ethos   Authority (SAHPRA) to explore avenues of
             of Caring for Life, Cipla always aims to ensure that everyone has   accelerated access to remdesivir in the country.

                                                                                                                                                                                                        Beaulieu
             References:                                                                                                                                  Beaulieu               Kyalami               Beaulieu
             1.   Gilead website: Voluntary Licensing Agreements for Remdesivir. Available at  https://www.gilead.com/purpose/advancing-global-health/covid-19/  College         Preparatory and       Preparatory School
                                                                                                                                                                                                        Preparatory and
               voluntary-licensing-agreements-for-remdesivir
             2.   Cipla website: Cipla enters into a licensing agreement With Gilead to expand access to COVID-19 treatment. Available at: https://www.cipla.com/press-           Nursery School         Nursery School
               releases-statements/cipla-enters-licensing-agreement-gilead-expand-access-covid-19-treatment                                                Grade 8 - 12          Grade 000 - 7          Grade 000 - 7
             3.   Coronavirus (COVID-19) Update: FDA issues Emergency Use Authorisation for Potential COVID-19 Treatment: Available at https://www.fda.gov/news-
               events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment
             4.   Reuters. Singapore approves remdesivir drug for emergency COVID-19 treatment. Available at: https://www.reuters.com/article/us-health-coronavirus-  A community of schools developing global achievers
               singapore-remdesiv/singapore-approves-remdesivir-drug-for-emergency-covid-19-treatment-idUSKBN23H17F

             5.   European Medicines Agency: First COVID-19 treatment recommended for EU authorisation. Available at: https://www.ema.europa.eu/en/news/first-
               covid-19-treatment-recommended-eu-authorisation                                                                    admissions@kyalamishools.org  |  010 591 5004        Follow us @KyalamiSchoolsGroup
             16  Waterfall Issue 8   2020


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