Gilead Sciences Donates more than 25,000 vials of Remdesivir to Local Authorities across the Middle East
Ayman Elsayes, Director of Medical Affairs, Middle East, Gilead Sciences stressed that Saudi Vision 2030 includes strategic objectives for improving healthcare in the Kingdom and increasing the quality of life and life expectancy of citizens. Saudi Arabia is well positioned to become a leader in the pharmaceutical industry in the coming years.
As the largest and fastest-growing pharmaceutical market in the Middle East, Saudi Arabia has growing demand, robust regional integration, and strong governmental support to facilitate the country’s transformation into a center for the discovery and development of innovative medicines. To reach this potential, however, key regulatory developments are required including improving key IP protections, particularly in the areas of patent enforcement and regulatory data protection. By Effectively addressing these areas, Saudi Arabia will be better positioned to achieve the industrial development objectives of Vision 2030, including the pharmaceuticals sector.
About the usage of Remdesivir in the KSA and GCC, Elsayes said that Remdesivir is the first antiviral product approved for COVID-19, it’s fully registered/ licensed in 46 countries, receiving both European Medicines Agency’s conditional approval (granted on 3rd July 2020) and the United States Food and Drug Administration approval (granted on 22nd Oct 2020). In Saudi Arabia, the Marketing Authorization Application is currently under technical review by the Saudi Food and Drug Authority (SFDA). In the interim, to support patients, the SFDA has granted a Pre-License Import Authorization to accelerate access.
And he added that In other countries across the GCC, Emergency Medicine registration was granted by the Ministry of Health and Prevention in the UAE on 7th June 2020 and Emergency Use Authorization in Kuwait on 15th Jul 2020; similarly, the National Health Regulatory Authority in Bahrain issued on 13th July 2020 a temporary registration to ensure access.
Elsayes also mentioned that Since January, Gilead has been taking measures to ramp up production and to rapidly build supply of our investigational COVID-19 treatment remdesivir, preparing for potential global demand and in recognition of complex manufacturing processes associated with its production.
Elsayes also said that over the past few months, Gilead has donated the entire existing supply of remdesivir, totaling 1.5 million vials. During August and September, we have donated remdesivir vials to the Ministry of Health in Saudi Arabia and remain committed to supplying the demand for commercial remdesivir to support patients in the Kingdom.
About Gilead Science’s plans in the KSA, Elsayes said: “We work in areas of high unmet medical need and have been making our diverse portfolio available for patients in the Middle East through a robust network of local partners. Establishing our regional offices in Dubai in 2014, so far we have made available in the region over 10 medicines, mainly in four key therapeutic areas, HIV, Viral Hepatitis, Systemic Antifungals and now COVID-19 . The Middle East region continues to be a priority region for Gilead, with a commitment to expand our specialty portfolio, as well as growing our footprint.
Due to the pandemic, our priorities this year have been focused on securing approval and supply of our anti-viral medicine, remdesivir, as fast as we could. We are proud to have received regulatory approvals in seven countries in the Middle East so far, and the product was initially made available through clinical trials and a donation program. In the Middle East region more than 25,000 vials of remdesivir have been donated to local authorities, and now the product is widely available for COVID-19 hospitalized patients.
The next therapeutic areas we plan to launch in the region are Inflammation, mainly to support patients with Rheumatoid Arthritis, and in parallel new Oncology medicines, e.g. our breakthrough cell therapy treatments for refractory Cell B lymphoma.
From a footprint perspective, we are currently establishing a new legal entity in the Kingdom of Saudi Arabia, initiating a new chapter for us and reinforcing our local partnerships, in areas like manufacturing. Our plans are to continue to grow in a sustainable way- driven by our portfolio and people.”
Elsayes also said that the pandemic has slowed clinical trials and research initiatives across the industry, aggravated by logistical restrictions. To support patients, we remain committed to evidence-based medicine, working closely with the medical community and academia, including the Harvard School of Public Health, to build capacity among local healthcare professionals in the important area of clinical trials and medical research while exploring the patient epidemiology and care pathway for new therapeutic areas like Inflammation and Oncology. During the course of the pandemic, we continue to collaborate with our partner network and with organizations such as the National Institutes of Health and World Health Organization to ensure the widest access to COVID-19 treatment.