Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with upbeat late-phase updates from Big Pharma companies. AstraZeneca is lining up a 2020 filing for anifrolumab in lupus on the strength of data it thinks show the drug works, despite one of the phase 3 trials missing its primary endpoint. Meanwhile, Roche revealed a phase 3 trial of its challenger for the spinal muscular atrophy market has met its primary endpoint, setting the stage for a showdown with Biogen and Novartis. Elsewhere, Kiadis Pharma dumped its lead drug and laid off half its staff. Genfit CEO Pascal Prigent set out his vision for a nonalcoholic steatohepatitis diagnostic. Merck moved to cut 100 R&D jobs at a French site. And more. — Nick Taylor
1. AstraZeneca plans 2020 filing for anifrolumab in lupus
AstraZeneca is planning to file for approval of anifrolumab in systemic lupus erythematosus in the second half of next year. The Big Pharma is confident data generated across mid- and late-phase trials show the anti-IFNAR1 antibody works despite a pivotal study missing its primary goal.
2. Roche's challenger for SMA market hits goal in phase 3
A phase 3 trial of Roche’s risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA) has met its primary endpoint. The results tee Roche up to file for approval to compete with Biogen and Novartis in the increasingly crowded SMA market.
3. Kiadis dumps phase 3 drug, halves head count in pivot to NK cells
Kiadis has dropped its lead program midway through a phase 3 trial. The action will see Kiadis lay off half of its staff and switch its attention to earlier-stage natural killer cell therapies against solid tumors and hematological cancers.
4. Prigent on better NASH tests for R&D and the doctor's office
What the nonalcoholic steatohepatitis (NASH) field needs, says Genfit CEO Pascal Prigent, is something like Hb1Ac for diabetes: a test that’s easy to do and that’s “commonly regarded as the right way to monitor the disease that everybody can use.” To that end, Genfit is working on a blood test that could become the first diagnostic approved specifically for NASH.
5. Merck to slash more than 100 R&D jobs from French site
While Merck announced it was spending a few hundred million on an early-stage biotech this week, we have learned it is also shuttering an R&D site in Riom in the heart of France.
And more articles of note>>