Takeda detailed the phase 2b psoriasis data behind its $4 billion deal for Nimbus Therapeutics' TYK2 inhibitor. Biohaven reached out to a Chinese company for a TYK2/JAK1 inhibitor for development in neuroinflammatory diseases. Astellas and Pfizer's Xtandi showed it can work in non-metastatic hormone-sensitive prostate cancer, while the U.S. government denied a petition to grab the popular drug's patent.
Takeda has shared detailed plaque psoriasis data from a phase 2b trial for TAK-279, a TYK2 inhibitor it recently acquired in a $4 billion deal with Nimbus Therapeutics. On the trial’s primary endpoint, the drug, at the middle and high dose, helped 68% and 67% of moderate to severe patients achieve at least 75% of psoriasis resolution, respectively. The data look competitive against Bristol Myers Squibb’s in-class rival Sotyktu in a cross-trial comparison.
Biohaven is getting into TYK2, too. The company offered $10 million upfront, $10 million in equity and $950 million in milestones to acquire ex-China rights to a TYK2/JAK1 inhibitor developed by China’s Highlightll Pharmaceuticals. Biohaven is planning to test the drug in neuroinflammatory disorders, with a Parkinson’s disease clinical trial planned in 2023.
3. Astellas, Pfizer look to broaden Xtandi's patient base with new prostate cancer win after 8 years
US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi
Astellas and partner Pfizer achieved two wins for Xtandi. First, the androgen receptor inhibitor came out successful in a phase 3 trial in non-metastatic hormone-sensitive prostate cancer patients who had high-risk recurrence. Separately, the National Institutes of Health refused to initiate a “march-in” process on Xtandi, nixing a petition to grab the drug’s patent to potentially lower prices for consumers.
4. Astellas enjoys warm glow of success as antibody against hot cancer target hits again in phase 3
Astellas reported data from a second successful phase 3 trial of its potentially first-in-class anti-CLDN18.2 antibody, zolbetuximab. When used together with the CAPOX chemo combination, the drug cut the risk of disease progression or death by 31.3% over the chemo regimen alone in patients with CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction cancer in the phase 3 GLOW trial.
5. Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO
In a recent interview with Fierce Pharma, Eisai’s Alzheimer’s chief Ivan Cheung said the U.S. government’s recent decision to not revisit its Medicare coverage decision for Leqembi wouldn’t affect the drug’s chances for reimbursement when it gets a full FDA approval. For now, the company is focused on getting ready for the full launch, he said.
6. Novartis, Coherus PD-1 drugs finally set for FDA manufacturing inspections after COVID delays
Novartis and Coherus BioSciences have both said that the FDA has scheduled preapproval manufacturing inspections for their in-licensed PD-1 inhibitors. The agency has missed its target decision dates for Novartis and BeiGene’s tislelizumab and Coherus and Junshi Biosciences’ toripalimab by many months because of COVID-related travel restrictions in China.
7. Samsung Bio set to begin construction of new $1.5B plant, the start of Bio Campus II
Samsung Biologics, on an expansion spree, said it will start construction of Plant 5 in the first half of this year with a plan to start operations there in 2025. The $1.5 billion project will add 180,000 liters of capacity, bringing the Korean CDMO’s total capacity at the Incheon site to 784,000 liters.
Celltrion and Thermo Fisher Scientific were reportedly sizing up Baxter’s biopharma contract manufacturing business for a potential buyout. Celltrion confirmed in a securities filing that it’s indeed reviewed a potential acquisition of Baxter’s biopharma solutions business but said that “nothing has been confirmed.”
Other News of Note
9. Olympus hit with 3rd FDA warning letter in 5-month span over endoscope manufacturing
10. BeiGene pulls out of Leap of faith, letting option on immuno-oncology candidate lapse
11. Zymeworks, Daiichi end $293M bispecific collab after 6 unfruitful years
12. As approvals roll in, Takeda details pricing strategy for dengue vaccine launch
13. China approves its first mRNA shot, made by local firm CSPC (Reuters)