AstraZeneca, Alexion close massive $39B merger; bluebird bio earns EU nod for Lenti-D as big split approaches
With the final hurdle recently cleared, AstraZeneca and Alexion can finally celebrate their $39 billion merger.
The drugmakers closed their major M&A pact Wednesday, with Alexion formally taking its place as the British drug giant’s rare disease unit. The UK’s Competition & Markets Authority last week gave its stamp of approval to the deal, marking the last significant regulator to sign off.
Alexion will bring aboard blockbuster drug Soliris as well as its successor drug Ultomiris, the focus of a major patient switching campaign as the older bestseller approaches the first of its patent cliffs in the coming years.
It’s not all gravy for either drug, though. Upstart competitors like Apellis are hunting for both drugs’ biggest patient populations and have reason to think their data could be better.
Bluebird bio earns approval for Lenti-D in Europe
With a big split between its rare disease and oncology units coming, bluebird bio has earned an approval in Europe for gene therapy Lenti-D for children with early cerebral adrenoleukodystrophy (CALD) and an ABCD1 genetic mutation without a matched sibling donor, the company said Wednesday.
The therapy will be marketed as Skysona in the EU and become the only drug approved there for CALD, an ultra-rare neurological disorder that causes a breakdown in myelin, which functions as a protective sheath around nerve cells, and is often fatal.
Available standard of care for CALD is a stem cell transplant, which comes with a risk of severe complications, and roughly 80% of patients do not have a matched donor available.
Lenti-D’s approval comes as a breath of fresh air for bluebird as it looks to split in two after years of turmoil around its gene therapy business, once the darling of biotech’s rare disease space.
Earlier this month, the drugmaker lifted a voluntary EU marketing hold on another gene therapy, Zynteglo for beta thalassemia, after a patient death in one of the drugmaker’s other products, LentiGlobin, halted clinical studies. Bluebird determined that death was highly unlikely to have been caused by the delivery virus used in both Zynteglo and LentiGlobin, easing investors’ concerns somewhat.
Biogen snags neurology R&D pact with RNAi specialist
With a controversial Aduhelm approval in hand, Biogen has found its next foray into neurology.
Biogen and New York-based Mirimus have signed a development deal for a slate of RNAi-based therapies targeting undisclosed neurology targets, the partners said Wednesday. Terms of the deal weren’t disclosed.
Mirimus, an 11-year-old biotech looking to develop RNAi and CRISPR-based therapeutics, said the pact would help the company advance its preclinical work into human tests.
“This collaboration marks an important advance for Mirimus as we seek to extend our expertise in RNAi animal models to the development of RNAi-based biotherapeutics,” CEO Prem Premsrirut said in a statement.
AI startup Exscientia kicks off CDK-focused JV with Chinese biotech
Shanghai-based oncology upstart GT Apeiron and AI wunderkind Exscientia have been hard at work on a CDK7 discovery project that has recently been bearing fruit. Now, the partners are taking the next step and launching a joint venture to seek out molecules across the entire CDK space.
The JV will leverage Exscientia’s AI and machine learning discovery platform to help infuse GT’s early pipeline with new candidates. Financial terms of the deal were not disclosed, but the partners said they would split ownership of any ensuing molecules with Exscientia taking an equity stake in GT.
“Based on what they have already achieved, Exscientia is clearly the leader in AI-driven drug discovery, and we have witnessed this first-hand in our collaboration so far,” GT Apeiron president Mingxi Li said in a statement.
Exscientia, one of a group of drugmakers who have claimed the first “AI-discovered” drug, is coming off a massive, $500 million mega-round in April and a discovery collaboration with drug pricing disruptor EQRx that the pair hopes will prove to be a destabilizing force on high-list prices for branded drugs.