Protocols

Amgen offers cash and milestones for Provention to take the lead on a celiac drug; Aveo’s PhIII fails to impress, shares slide

→ Little Provention Bio has struck a deal to continue the development work on Amgen’s celiac drug, AMG 714. In exchange for taking over the mid-stage work, along with members of the Amgen team, the big biotech will pay Provention $20 million in an upcoming financing while offering a $150 million milestone on the Phase IIb. “Data presented at Digestive Disease Week 2018 from two Phase 2a clinical trials of AMG 714 demonstrated the drug’s potential in celiac disease and refractory celiac disease type II (RCD-II), an in situ gastrointestinal T cell lymphoma, and confirmed that IL-15 plays a central role in non-responsive celiac disease and RCD-II,” said Francisco Leon, co-founder and chief scientific officer of Provention.

Aveo Oncology $AVEO reported its top-line data from the Phase III study comparing tivo with sorafenib for renal cell carcinoma. Researchers reported a 44% improvement in median PFS and 26% reduction in risk of progression or death. The median PFS was 5.6 months for tiro compared to 3.9 months for sorafenib. Overall survival, the key secondary, hadn’t matured to the point needed for a thorough understanding of its impact, but at the preliminary point there was no clear OS benefit. The topline readout was positive but failed to inspire much enthusiasm for Aveo, which saw its shares plunge 15% in Tuesday morning trading.

→ With generic competition for Restasis looming, Allergan has dropped plans for a $200 million expansion of a manufacturing site in Texas.


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