Protocols

Mallinckrodt to spin off generics business; BeyondSpring ready to submit approval for lead drug in China

→ Barely a month after Mallinckrodt $MNK reported a key drug failure, the company on Thursday said it was spinning off its specialty generics business — including Amitiza which it gained from its $1.2 billion acquisition of Sucampo — about two years after the UK-based company first said it was seeking options for the business. The generics business, which accounted for just over a quarter of net sales last year, will retain the Mallinckrodt name and be run by current CFO Matthew Harbaugh. The specialty branded drugs business, which includes the controversial drug Acthar, will be led by CEO Mark Trudeau, and will also be publicly listed under a so-far unannounced name.

→BeyondSpring $BYSI, a cancer-focused biotech with deep roots in China that completed an unusual IPO last year, claimed its lead drug plinabulin met the main goal of demonstrating non-inferiority to Neulasta in an interim PhIII analysis. Based on the company’s reading of the data, which they did not provide in the release, BeyondSpring plans to submit an application to market the drug in China for chemotherapy-induced neutropenia (CIN), and says it is on track for an NDA in the United States.

Novartis $NVS is expanding the scope of its cell therapy collaboration with CRISPR pioneer Intellia $NTLA, handing over $10 million in cash to add ocular stem cells to the menu. With expanded rights to the pharma giant’s lipid nanoparticle technology, Intellia will look into ex vivo development of therapies using these cells, in addition to hematopoietic stem cells included in the original pact.


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