Protocols

Astellas dumps a PhIII lung cancer drug; GSK gets one success, one failure in a pair of pivotal Crohn’s trials

→ Japan’s Astellas Pharma is punting its Phase III drug ASP8273, halting the late-stage SOLAR trial evaluating the efficacy and safety of ASP8273 versus erlotinib/gefitinib for the 1st line treatment metastatic or advanced unresectable non-small cell lung cancer harboring sensitizing epidermal growth factor receptor (EGFR) mutation. Astellas says that the decision to scrap the program was made on the recommendation of the independent monitoring board, but didn’t explain what went wrong.

Steve Yancey, GSK

→ GSK joined the parade of Big Pharma’s putting their late-stage failures on public view this week. The pharma giant says it ran the two Phase III studies needed for an approval of Nucala (mepolizumab) as a new therapy for COPD with an eosinophilic phenotype, and only one of them came in a success. The mixed data raises questions about the market reach of the IL-5 therapy, which is approved for severe asthma. GSK plans to press ahead, though. Steve Yancey, vice president and medicine development lead for mepolizumab, GSK $GSK said:  “We believe the reduction in moderate and severe exacerbations observed are of clinical relevance given the need for a new treatment approach in these difficult to treat patients. We will review the full data when available to determine our next steps.”

→ Adamas Pharmaceuticals $ADMS has struck a $100 million royalty-backed note agreement with HealthCare Royalty Partners. Adamas will receive $35 million at closing and an additional $65 million on FDA approval and receipt of orphan drug exclusivity for ADS-5102 (amantadine) extended-release capsules for the treatment of levodopa-induced dyskinesia in people with Parkinson’s disease.

→  J&J Innovation has added 24 new biotech companies to the roster on hand at the grand opening of its JLABS facility in Toronto a year ago. Check out the full list of biotech upstarts and what they are working on.


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