Fujifilm pairs with Dr. Reddy's, Global Response Aid to make COVID-19 drug Avigan

Meeting global demand for a potential COVID-19 treatment is more than any one company can handle on its own. Acknowledging that reality, Japanese drugmaker Fujifilm has picked partners for its offering.

Fujifilm has struck a three-way deal with India’s Dr. Reddy’s Laboratories and Dubai-based Global Response Aid to manufacture and sell its flu drug Avigan (favipiravir) for potential treatment of COVID-19, the company said Wednesday.

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The drug is already approved for COVID-19 in India and Russia. The new agreement covers all countries other than Japan, China and Russia.

Specifically, for an unidentified lump-sum license fee and royalties on sales, Fujifilm is granting Dr. Reddy’s and GRA access to Avigan’s preclinical and clinical data to help run their own studies. Dr. Reddy’s gains exclusive rights to the drug in India.

In addition, Fujifilm will transfer its manufacturing method exclusively to Dr. Reddy’s, which will establish production of the drug and utilize GRA’s global sales network to supply the med.

Avigan was originally developed against influenza pandemics. It gained global attention when Japanese Prime Minister Shinzo Abe touted it as a potential COVID-19 treatment.

With that government support, a fast-track approval in Japan was initially expected in May. But clinical research on the drug suddenly slowed down as COVID-19 cases dropped in Japan. A month ago, Nikkei Asian Review reported that completion of the trial would instead come in July at the earliest, as it has only hit around 70% of the enrollment goal.

Back in April, amid speculation around Avigan’s potential in COVID-19 and its side effects, including birth defects, Fujifilm said it would increase monthly production of Avigan up to 100,000 treatment courses by July, about 2.5 times more than its level at the beginning of March.

On June 20, India’s Glenmark Pharmaceuticals won a local go-ahead to market a generic version of Avigan, which it’s selling under the brand FabiFlu, for the treatment of mild to moderate COVID-19 patients.

Meanwhile, Gilead Sciences has also signed on multiple partners for FDA-authorized COVID-19 drug remdesivir, including India's Cipla and Hetero Labs and Jubilant Life Sciences.

Jul 1, 2020

https://www.fiercepharma.com/

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