Takeda will withdraw lung cancer drug Exkivity after a confirmatory trial failure. Kyowa Kirin is buying gene therapy biotech Orchard Therapeutics. Biogen's biosimilar version of Roche's Actemra, bought from Bio-Thera Solutions, won an FDA nod. And more.
Takeda will pull Exkivity from the market in the U.S. and beyond. The drug won an accelerated approval in 2021 for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. But the phase 3 EXCLAIM-2 confirmatory trial in the first-line setting was a blunder. Exkivity failed as a monotherapy, just as Johnson & Johnson’s rival therapy Rybrevant succeeded in a combination with chemotherapy.
Kyowa Kirin is paying $387.4 million upfront to purchase Orchard Therapeutics, which has a gene therapy for early-onset metachromatic leukodystrophy approved in Europe and under review at the FDA. Orchard investors will get an additional $1 per share if the FDA approves the med. After some clinical setbacks, Kyowa CEO Masashi Miyamoto recently said the company was working on acquisitions.
The FDA has approved the first biosimilar to Roche’s blockbuster autoimmune drug Actemra. The copycat, now branded as Tofidence, will be marketed by Biogen. The company got the drug in 2021 from Chinese company Bio-Thera Solutions by paying $30 million upfront. The approval comes as Biogen conducts a strategic review of its biosimilar franchise.
Chinese-American biotech Adlai Nortye has raised $97.5 million through a Nasdaq IPO and private placement, and traded down 33% on its first day. The company has a Novartis castoff, a PI3K inhibitor called buparlisib, serving as its lead candidate. The drug is in pivotal testing in head and neck cancer. Novartis sold the drug for just $9.5 million upfront after seeing safety issues in a phase 3 breast cancer study.
Viatris is shedding some over-the-counter, women’s health and active pharmaceutical ingredient assets for more than $3 billion. In one deal, Viatris has agreed to sell its API business in India to IQuest Enterprises. The deal features six manufacturing sites and an R&D lab.