By David Wallace 28 Sep 2020
Sandoz sees key opportunities ahead in both the US and Canadian biosimilars markets, the firm’s US vice-president for marketing, market...
Dr Reddy’s has become the latest licensee of Gilead’s remdesivir after striking a non-exclusive deal with the originator to make and market a generic version of the potential COVID-19 treatment.
The agreement “will grant Dr Reddy’s the right to register, manufacture and sell Gilead’s investigational drug, remdesivir, a potential treatment for COVID-19, in 127 countries including India,” the firm announced.
A month ago, Gilead announced that it had agreed licenses with five firms – Cipla, Ferozsons, Hetero, Jubilant and Mylan – to manufacture remdesivir for distribution in 127 countries across the globe. (Also see "Gilead Licenses Remdesivir To Five Firms" - Generics Bulletin, 13 May, 2020.)
Under the terms of the agreements, Gilead said the licensees “have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly” and may also “set their own prices for the generic product they produce.”
The licenses will be royalty-free until the World Health Organization declares the end of the COVID-19 pandemic international public health emergency “or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier,” Gilead indicated.
Noting that it would receive technology transfer from Gilead to manufacture its generics, Dr Reddy’s said it “would need to do the manufacturing scale up and obtain regulatory approval for marketing of this drug in respective countries.”
The investigational antiviral therapy developed by Gilead has already received an Emergency Use Authorization from the US Food and Drug Administration to treat hospitalized COVID-19 patients. (Also see "After Remdesivir's Emergency Use Authorization, US Gov't Must Now Decide How To Distribute Limited Supply" - Scrip, 1 May, 2020.) It is also recommended for compassionate use in Europe and recently received regulatory approval in Japan.
Bangladesh’s Beximco recently became the first firm worldwide to launch a generic version of remdesivir, circumventing Gilead’s intellectual property via the World Trade Organization’s transitional period for least developed countries, which means that firms in Bangladesh can manufacture the product for local consumption without infringing the patent. (Also see "Beximco Launches First Remdesivir Generic" - Generics Bulletin, 21 May, 2020.)
Shortly after, The Searle Company announced a licensing deal with Beximco allowing it to market the firm’s generic remdesivir in Pakistan. (Also see "Searle Licenses Beximco’s Remdesivir For Pakistan" - Generics Bulletin, 29 May, 2020.)
28 Sep 2020
Sun Pharma and Bausch have decided to settle litigation over rifaximin, granting the generics company a non-exclusive license effective 1...
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