Protocols

AbbVie advances its two star pipeline therapies, filing BLA for risankizumab and posting promising data for upadacitinib

AbbVie racked up another round of promising data for its late-stage rheumatoid arthritis drug upadacitinib. All three doses — 7.5 mg, 15 mg and 30 mg — in their Phase IIb/III study in Japan met the primary endpoint of ACR20 versus placebo. And there were no major cardio events to speak investors this time, with no deaths, no events of pulmonary embolism or deep vein thrombosis reported. AbbVie has high hopes for this drug, which is competing against some major league rivals. The biopharma company has pegged peak potential sales at $6.5 billion.

→ While AbbVie was adding positive data to its RA drug, the company was also pushing its other star pipeline therapy toward a potential OK, filing a BLA for FDA approval. AbbVie paid Boehringer $595 million upfront to license rights to risankizumab in early 2016, and last fall the company displayed a late-stage dataset on psoriasis explaining why they wanted this drug so badly, staying on track to creating a new franchise player the pharma company believes can register $4 billion to $5 billion in peak annual sales.

→ Almost a year after launching out of X-Chem, X-Biotix Therapeutics has brought in a key exec, two board directors and $7 million in Series A funding. As chief scientific officer, Dominic Ryan — a former discovery director at Cubist Pharma — will steer the biotech’s research strategy as it pursues antibiotic scaffolds for multi-drug resistant Gram-negative pathogens. Waltham, MA-based X-Biotics is building a pipeline based upon X-Chem’s DNA encoding technology and a collaboration with several microbiology specialists at Harvard. Also joining the company are Aduro Biotech CEO Stephen Isaacs and private equity partner Christopher Ray, appointed to help grow the early-stage company.

→ Beefing up its infectious disease pipeline, Zai Lab $ZLAB has paid AstraZeneca spinoff Entasis $5 million upfront to license and partner on ETX2514, a broad-spectrum intravenous inhibitor of β-lactamases. In particular, Entasis is developing a combo of the drug with another β-lactamase inhibitor called sulbactam to treat a slate of multidrug-resistant infections caused by Acinetobacter baumannii, which is particularly prevalent in China. The deal, which gives Zai Lab rights to develop and commercialize the drug in the Asia Pacific region, also maps out a collaboration over a Phase III trial in China, where Shanghai-based Zai Lab will take charge of patient screening, enrollment and treatment. Entasis is in for a total of $7.6 million in near-term milestones and up to $91 million for meeting additional regulatory and sales goals.


With contribution by Amber Tong.


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