Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with stories about two of Roche’s most closely-watched late-phase assets. One, hemophila drug emicizumab, ran into problems when the death of a patient raised more questions about its safety profile. The other, Alzheimer’s hopeful crenezumab, still has the tribulations of phase 3 data to come. History suggests the odds are stacked against crenezumab, but Roche nonetheless doubled down on the program this week by unveiling a second phase 3 trial. Away from Basel, Israel’s Pharma Two B raised $30 million from a Biogen-backed fund and added ex-Pfizer CEO Jeff Kindler to its board. EMA accepted an Alnylam RNAi drug onto its PRIME fast-track scheme. Arix Bioscience and Takeda Ventures teamed up to build oncology and gastrointestinal biotechs. And more.—Nick Taylor
1. Patient death in phase 3 raises doubts about safety of Roche’s emicizumab
Roche has revealed that a patient died in a phase 3 hemophilia trial of bispecific antibody emicizumab. The trial investigator ruled the death was unrelated to emicizumab, but, with the event following on from other reports of similar serious adverse reactions, it has added to questions about the safety of the experimental regimen.
2. Roche starts second Alzheimer’s phase 3 of anti-Abeta drug
Roche is doubling down on its anti-amyloid beta antibody crenezumab. The Swiss Big Pharma is starting a second phase 3 trial in patients with prodromal to mild Alzheimer’s disease after getting a look at binding, dose escalation and drug-disease progression model data late last year.
3. Pharma Two B raises $30M for Parkinson's phase 3
Pharma Two B has raised $30 million (€28 million) to complete a phase 3 trial of its Parkinson’s asset P2B001. The round provides a hint of the impact of the recently founded Israel Biotech Fund (IBF), which led the investment and is adding ex-Pfizer CEO Jeff Kindler to Pharma Two B’s board.
4. EMA adds Alnylam RNAi drug to PRIME fast-track scheme
The European Medicines Agency (EMA) has added Alnylam’s acute hepatic porphyria candidate to its priority medicine (PRIME) scheme. Securing the status positions Alnylam to benefit from a close relationship with the EMA as it works to move the drug prospect into phase 3 by the end of the year.
5. Arix, Takeda team up to build oncology, GI biotechs
Arix Bioscience has teamed up with Takeda Ventures to create and grow biotechs. The agreement gives Arix another outlet for turning promising research into biotech startups, and Takeda access to the deal flow provided by the network its new partner has put together.