In a redemption of the amyloid beta theory in Alzheimer's disease, Eisai and Biogen's lecanemab clinched a phase 3 trial win in a potential prelude to blockbuster sales. Astellas got a less-than-ideal temporary injunction against a Pfizer generic to testing agent Lexiscan. Novartis is selling a Sandoz Chinese plant to a local CDMO. And more.
Eisai’s Biogen-partnered Alzheimer’s disease drug lecanemab surprisingly hit its phase 3 goals. After 18 months, the drug slowed cognitive decline by 27% compared with placebo. The drug delivered a 0.45-point absolute advantage on the 18-point CDR-SB score. While detailed data will be shared in November, the positive readout adds support to the amyloid beta theory and tees up mega blockbuster sales projections. But the drug still needs to overcome the bad precedent left by Aduhelm and win favorable Medicare reimbursement.
A federal court in Delaware has granted Astellas an interim injunction preventing Pfizer’s Hospira from launching a generic to Lexiscan, which is used for cardiac testing, until Oct. 5. But the judge also rejected Astellas’ bid for a preliminary injunction, which would have blocked the launch until the case works its way through the appeals court. A lower court had previously ruled in favor of Hospira.
Novartis’ Sandoz has reached a deal to sell a finished drugs plant in Zhongshan, China, to local CDMO Jiuzhou Pharmaceutical for $15.1 million. The Chinese firm will inherit the manufacturing assets and staffers, and it also plans to refurbish and expand the facility, altogether redirecting $18.5 million of capital to the Sandoz project.
Daiichi Sankyo has won Japanese approval for Ezharmia, or valemetostat, to treat relapsed or refractory adult T-cell leukemia/lymphoma (ATL). The go-ahead makes Ezharmia the first EZH1/2 dual inhibitor approved anywhere. Targeting U.S. and EU filings, the company is also running a global registrational phase 2 for previously treated peripheral T-cell lymphoma, including ATL.
Just after Asymchem’s proposed $57.9 million acquisition of Snapdragon Chemistry was effectively derailed by foreign investment regulators, the Chinese CDMO is plotting a big investment at home. The company plans to invest up to 5 billion Chinese yuan ($697 million) to build a new R&D and production site on the outskirts of Shanghai.
6. Almirall licenses Simcere’s IL-2 drug in potential $507M deal (press release)
China’s Simcere has out-licensed ex-China rights to its interleukin 2 mutant fusion protein, SIM0278, to Almirall for $15 million upfront. Simcere could get up to $492 million in milestone payments down the line, plus sales-based royalties. The drug is on track for a first-in-human study and is billed as a potential treatment for various autoimmune diseases.
Shionogi’s oral COVID-19 drug, ensitrelvir (S-217622), has hit its goal in the phase 3 part of a phase 2/3 study in Asia. In mild to moderate patients who had symptoms within 72 hours, the protease inhibitor, given once daily for five days, helped resolve symptoms by an average of 24 hours faster than placebo. Japanese authorities previously denied the drug an emergency approval, asking to see more data.
The FDA has slapped a warning letter on Zhejiang Tianyu Pharmaceutical after an inspection of the company’s plant in the Chinese province of Zhejiang. The regulator laid out multiple lapses in Tianyu’s active pharmaceutical ingredient production, including failure to properly investigation drug impurities. Some of the concerns were repeats of problems the FDA had flagged three years ago.
WuXi AppTec’s CDMO subsidiary WuXi STA has opened its first high-potency oral drug production plant. The facility, located in the city of Wuxi near Shanghai, features multiple formulation processes, plus filling capacity of 400 million tablets and 200 million capsules a year.