EuroBiotech Report: AstraZeneca rejection, Novartis phase 3 fail, $30M round, BioLineRx and Pierre Fabre

europeGOOD

Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with setbacks at two of the big beasts of European pharma. AstraZeneca began the week’s woes by revealing FDA has once again rejected the hyperkalemia drug it acquired in its $2.7 billion (€2.5 billion) takeover of ZS Pharma. And Novartis continued the theme by revealing its serelaxin failed a phase 3. The setback follows an FDA rejection of the heart failure candidate in 2014. A team of researchers who left Big Pharma years ago enjoyed a better week. The group leading Pulmocide—who worked at GlaxoSmithKline before leading RespiVert to a takeover by Johnson & Johnson—raised $30.4 million to take inhaled treatments for respiratory syncytial virus and pulmonary aspergillosis through early clinical tests. BioLineRx bought Agalimmune to expand its cancer pipeline. Pierre Fabre joined up with a spinout from the French Alternative Energies and Atomic Energy Commission to access monoclonal antibody technology. And more.—Nick Taylor

1. AstraZeneca’s $2.7B ZS-9 rejected again by FDA

The FDA has rejected AstraZeneca’s hyperkalemia drug ZS-9 for the second time in 12 months. The news marks a further blow for an AstraZeneca program that gave it a sizable share of a $6 billion (€5.5 billion) market when it acquired the asset in its $2.7 billion buyout of ZS Pharma.

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2. Novartis' serelaxin misses endpoint in heart failure phase 3

Novartis’ phase 3 trial of serelaxin in acute heart failure has missed its primary endpoint. The Swiss pharma saw the 6,600-patient trial as a way to bounce back from FDA’s 2014 rejection, but instead the study cast further doubts over the efficacy and future of a drug previously tipped to rack up blockbuster sales.

3. Ex-GSK team raises $30M for respiratory infection trials

Researchers who worked at GlaxoSmithKline before leading RespiVert to a takeover by Johnson & Johnson have raised $30.4 million (£24.5 million) for their latest venture, Pulmocide. The Series B will allow Pulmocide to take inhaled treatments for respiratory syncytial virus (RSV) and pulmonary aspergillosis through early clinical trials.

4. BioLineRx buys Agalimmune to expand cancer pipeline

BioLineRx has bought Agalimmune to expand its immuno-oncology pipeline. The takeover adds the synthetic alpha-gal immunotherapy AGI-134 to BioLineRx’s pipeline as the drug nears the start of a first-in-human trial in solid tumors.

5. Pierre Fabre pens oncology pact with atomic energy spinout

Pierre Fabre has teamed with an immuno-oncology spinout from the French Alternative Energies and Atomic Energy Commission (CEA) to run drug discovery projects. The deal with H-Immune gives Pierre Fabre access to technology for generating fully human monoclonal antibodies.

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