July 1 Quick Takes: Amgen gains on court win; plus Hua, J&J, argenx, Seattle Genetics-Genmab, Interprotein

Appeals court upholds Enbrel patents
Amgen Inc. (NASDAQ:AMGN) shares rose 8% Wednesday, adding more than $11 billion to the company’s market cap, after the U.S. Court of Appeals for the Federal Circuit upheld a 2019 district court decision affirming the validity of two patents covering autoimmune drug Enbrel etanercept. The district court had held that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN), which had challenged the patents while developing a biosimilar version of the drug, failed to prove that they were invalid.
Hua meets again in diabetes Phase III
Hua Medicine Ltd. (HKEX:2552) announced Wednesday that oral dorzagliatin met the primary endpoint in HMM0302, its second Phase III trial of the first-in-class GCK activator to treat Type II diabetes. It expects to submit an NDA in early 2021. Dorzagliatin plus metformin reduced HbA1c levels by 1.02% vs. 0.36% for metformin alone (-0.66, CI: -0.79,-0.53, p<0.0001) -- changes on par with those in the Phase III SEED study of dorzagliatin monotherapy. EVP and CFO George Lin told BioCentury SEED’s patients could be characterized as early stage Type II diabetics, in whom it might be easier to control blood sugar compared with HMM0302’s patients who could be considered mid-stage diabetics; and the data show dorzagliatin has similar efficacy at different disease stages (see “Hua Shows Sustained Benefit in Diabetics”).

J&J win for Ebola, loss for lupus
The European Commission approved a two-component Ebola vaccine -- Zabdeno and Mvabea -- from Johnson & Johnson (NYSE:JNJ) Wednesday. The pharma also discontinued the Phase III LOTUS study in systemic lupus erythematosus after Stelara ustekinumab failed to show efficacy in a pre-planned interim efficacy analysis. ...