Daiichi Sankyo is the winner in the latest antibody-drug conjugate patent battle against Seagen. Roche is buying a prostate cancer protein degrader from a Chinese company. AbbVie has pulled the plug on another CD47 clinical program in its potential $2 billion partnership with I-Mab. And more.
1. Seagen, after $42M victory, suffers loss in ADC patent feud with Daiichi
Daiichi Sankyo has come out victorious in an ongoing legal tussle with Seagen around an antibody-drug conjugate patent. An arbitrator ruled in favor of the Japanese pharma. The decision comes shortly after Seagen prevailed in a separate Texas lawsuit, in which the U.S. biotech was awarded $41.8 billion for Daiichi’s past infringement of the patent.
2. China's Jemincare nabs $650M biobucks pact with Roche's Genentech for prostate cancer hopeful
Roche’s Genentech put down $60 million upfront with an additional $590 million in biobucks to purchase Chinese company Jemincare’s androgen receptor degrader JMKX002992. Roche is angling the protein degrader for patients with treatment-resistant prostate cancer.
3. AbbVie stops 2nd CD47 study early, dropping out of AML race it joined in $2B biobuck deal
Back in 2020, AbbVie paid I-Mab $180 million upfront and dangled $1.74 billion in milestones for ex-China rights to the latter’s CD47 drug lemzoparlimab. Now, AbbVie has canned a second early-stage trial, which tested the drug in combination with Bristol Myers Squibb’s Vidaza, with or without AbbVie and Roche’s Venclexta, in acute myeloid leukemia or myelodysplastic syndrome.
4. After Trodelvy's approval in China, Gilead strikes $455M deal with Everest for Asian rights
Gilead Sciences is shelling out $280 million upfront to gain Trodelvy rights in certain Asian territories that Chinese company Everest Medicines had secured before Gilead’s 2020 acquisition of Immunomedics. The news comes just two months after Everest won Trodelvy its first nod in China for triple-negative breast cancer. The deal will help establish Gilead’s oncology presence in Asia, a company spokesperson said.
5. AZ, Daiichi Sankyo's Enhertu breaks more ground, nabbing fast FDA nod in HER2-mutant lung cancer
AstraZeneca and Daiichi Sankyo’s Enhertu is on a winning streak. After a groundbreaking FDA nod in HER2-low breast cancer, the antibody-drug conjugate has just become the first drug specifically approved for HER2-mutant non-small cell lung cancer. It also topped physician’s choice of HER2 therapy in a confirmatory trial in HER2-positive breast cancer patients who had previously got Roche’s Kadcyla.
6. Astellas' menopause therapy accepted for FDA review 5 months after late-phase study mars record
Astellas is using a priority review voucher to speed the FDA assessment of menopause candidate fezolinetant. The company now expects a regulatory decision by Feb. 22, 2023. A phase 3 trial showed fezolinetant topped placebo at reducing the frequency and severity of moderate to severe vasomotor symptoms. But the drug, at a lower dose, failed to hit its goal in a separate Asian trial.
7. Setback at Lundbeck: CGRP migraine drug Vyepti hits expansion snag, but sales still doubled
Lundbeck’s CGRP migraine infusion Vyepti failed to significantly outdo placebo at reducing monthly migraine days in a phase 3 trial called SUNLIGHT. The “aggressive” trial was meant to support an “accelerated path” in China, Lundbeck’s R&D chief said. The company now goes back to its “base strategy,” relying on a bigger trial in a different population to seek approvals across Asia, he said.
Other News of Note
8. Chinese CRO listed on Shenzhen exchange, raises $170M
9. Samsung, Organon’s high-concentration Humira biosimilar snags FDA nod