Gilead outlines plans for global expansion of remdesivir production
Biotech in discussions with pharmaceutical and chemical manufacturers on how to broaden supply of antiviral that last week received an emergency use authorization for treatment of COVID-19 from the FDA
Gilead Sciences is in discussions with pharmaceutical and chemical manufacturers around the world about expanding global production and supply of its antiviral remdesivir, which has shown promise as a treatment for COVID-19, the biotech firm said on Tuesday.
Last week, the US Food and Drug Administration issued an emergency use authorization for remdesivir for the treatment of severe COVID-19 in hospitalized patients, saying a clinical trial had shown the investigational drug to shorten recovery in some participants.
“Close coordination of remdesivir manufacturing will be critical,” Gilead said in a statement, adding that it is working to build a consortium of manufacturing partners to pool efforts to help maximize global supply.
“Producing the drug requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity. Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so,” the company said.
Gilead said the discussions revolved around manufacturers’ ability to produce remdesivir for markets in Europe, Asia and the developing world on a voluntary license basis through at least 2022.
“The company is also negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries. Gilead will provide appropriate technology transfers to facilitate this production,” Gilead said.
Gilead said it is also in discussions with long-term partner, the Medicines Patent Pool, to license remdesivir for developing countries.
The FDA's emergency use authorization for remdesivir stated that distribution of the drug will be controlled by the US government.
Earlier this week, Gilead chairman and CEO Daniel O’Day told reporters the company has donated 1.5 million vials of the drug, amounting to between 100,000 and 200,000 treatment courses, depending on dosage.
He added that the US government would begin shipping tens of thousands of treatment courses out this week and would adjust distribution as the epidemic shifts and evolves in different parts of the country.
Last month, O’Day said the company had managed to reduce the end-to-end manufacturing timeline for remdesivir from one year to around six months.
“Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses,” he said, adding that Gilead was providing this existing supply at no cost to treat patients with the most severe symptoms of COVID-19.
In a preliminary modelling exercise, the US Institute for Clinical and Economic Review said remdesivir could be priced at USD 4,460 per patient and still be cost-effective when being used as a treatment for hospitalized patients with advanced COVID-19 and lung involvement.
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance