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Fierce Pharma Asia—Takeda's cancer drug withdrawal; Kyowa Kirin's gene therapy buy; Biogen's biosim nod
AcquisitionDrug ApprovalPhase 3IPOGene Therapy
Takeda's Exkivity market withdrawal, Kyowa Kirin's acquisition of Orchard Therapeutics and Biogen's Actemra biosimilar approval made our news this week.
Takeda will withdraw lung cancer drugKyowa Kirinfter a confirmatorOrchard Therapeuticswa KiBiogen 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.
Takedaeda to pull lunlung cancerd Exkivity around the world after confirmatory triaKyowa KirinOrchard TherapeuticsBiogenRocheBio-Thera SolutionsFDA
Takeda will pull Elung cancerm 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.
Takedahard lands $387M Kyowa buyout, reaping harvest of US gene therapy progressnon-small cell lung cancerEGFRExkivityJohnson & JohnsonRybrevant
Kyowa Kirin is paying $Kyowa 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.
Kyowa Kirinabs FDA nod for biosimilar version of Roche's Orchard Therapeuticsmetachromatic leukodystrophyFDAFDAKyowa
TheBiogenas appFDAed the first biosimilar to RochRochelockbuster 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.
4. AFDAi, building on the ashes of Novartis' Rochere, raises $57.5M IPO to run phase 3 cancer trialBiogenBio-Thera SolutionsBiogen
ChiAdlaiAmerican biotech Adlai NortNovartisaised $97.5 million through a Nasdaq IPO andcancerte 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.
5. In selling 3 businesseAdlai Nortyeids adieu to 10 manufacturing plants, 6,000 employeesNovartisPI3Kbuparlisibhead and neck cancerNovartisbreast cancer
Viatris is shedding some oveViatrisounter, 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.
6. Flooding halts manufacturing at Alembic Pharmaceuticals plant in India
7. Lokavant snares $8M investment tAlembic Pharmaceuticalsn Asia-Pacific region
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