A week after winning FDA Emergency Use Authorization, Gilead Sciences' remdesivir has been cleared to treat the novel coronavirus in Japan in its first official global nod. The biotech is also in talks with drugmakers around the globe for potential licensing deals around the drug. Eli Lilly has paid $10 million upfront to license ex-China rights to Junshi Biosciences' coronavirus neutralizing antibodies, just as the U.S. pharma reported positive results for its Innovent-partnered PD-1 drug Tyvyt in front-line non-small cell lung cancer in China. And more.
In its first full global nod, Gilead Sciences’ remdesivir, now called Veklury, has been approved in Japan for SARS-CoV-2. The Japanese Ministry of Health, Labour and Welfare doled out the decision under the “exceptional approval pathway” just three days after the company filed an application. It’s based on data from a National Institutes of Health-run phase 3 and other compassionate use results Gilead presented.
Gilead can only make so much of remdesivir by itself, so the company is now in licensing talks with other companies to produce the med around the globe, until at least 2022. It’s also looking for long-term deals with generics makers in India and Pakistan to manufacture the drug for the developing world.
Less than two months after teaming up with AbCellera, Eli Lilly has penned another coronavirus neutralizing antibody deal. The U.S. pharma has agreed to pay $10 million upfront and committed up to $245 million for ex-China rights to Junshi Biosciences’ antibodies. It’s also taking a $75 million interest in the Chinese firm. The pair plans to file for a U.S. clinical trial for the lead candidate, JS016, in the second quarter.
GlaxoSmithKline sold its entire 5.7% stake in Unilever’s Indian business, known as Hindustan Unilever, for Rs. 254.8 billion ($3.35 billion). The British pharma got its hands on the shares in its divestment of Horlicks drinks and other consumer health nutrition brands to Unilever.
Astellas and Seattle Genetics’ new bladder cancer treatment Padcev easily beat analysts’ expectations in its first quarter on the market, even during the pandemic. The antibody-drug conjugate's sales of $34.5 million exceeded JPMorgan’s forecast by four- to fivefold and came in way ahead of SVB Leerink’s projection of $10 million. Given the strong performance, SVB Leerink’s Andrew Berens has dialed up his 2020 target to $221 million.
The alliance Takeda and CSL Behring helped form to create an unbranded plasma-based treatment for COVID-19 has partnered with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases to test the candidate’s safety and efficacy for regulatory approvals. Such treatments, known as hyperimmune immunoglobulins, work by concentrating antibodies from recovered patients’ blood.
Innovent Biologics and partner Eli Lilly said their PD-1 inhibitor Tyvyt, in combination with Lilly’s chemo Gemzar and platinum chemo, topped chemo alone at stalling tumor progression or death in a Chinese phase 3 study in newly diagnosed squamous non-small cell lung cancer (NSCLC) patients. In January, the pair said a combination of Tyvyt, Alimta and platinum chemo also hit the goal in first-line nonsquamous NSCLC.