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.
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.
By: Angus Liu
Source: Fierce Pharma
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy. The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older.
Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm could create a new closed-loop system for largely hands-off diabetes management.
Apnimed started the year by bagging nearly $80 million in extended series C funds and the momentum has kept up, with the sleep-apnea-focused biotech nailing its goals in a phase 2 study. “For those who cannot tolerate current treatments, AD109 has the potential to be a convenient, oral pill that could improve people’s quality of life both at night and during the day.”