Gilead signs agreements with generics firms to manufacture and market remdesivir
Voluntary licensing deals allow firms to distribute drug recently granted FDA EUA to treat patients with COVID-19 in 127 countries
Gilead Sciences has signed agreements with five generic pharmaceutical manufacturers based in India and Pakistan allowing them to manufacture its antiviral drug remdesivir for distribution in 127 developing countries, the biotech company said on Tuesday.
Earlier this month, 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.
Under the voluntary non-exclusive licensing agreements, the companies -- Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan -- have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly.
Gilead said the licensees can also set their own prices for the generic product they produce.
"The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier," the company said in a statement.
The 127 countries, which include India, Pakistan, South Africa and Nigeria, consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.
Commenting on the deal, Mylan said it was confident it could develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient (API) and the finished dosage form (FDF) in sterile powder lyophilized vials for administration of the medicine by intravenous (IV) infusion.
"We will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the WHO," Mylan said in a statement.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
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