GSK shells out $700 million to co-develop two Alector immuno-neurology candidates

GlaxoSmithKline agreed to pay Alector $700 million upfront to jointly develop two monoclonal antibodies for a range of neurodegenerative disorders, including Alzheimer's and Parkinson's disease. As part of the deal announced Friday, Alector is also eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.

The transaction covers Alector's investigational compounds AL001 and AL101, which target the progranulin (PGRN) pathway. The company hypotheses that the immune system plays a critical part in the development of all neurodegenerative diseases, and that decreased levels of PGRN, known for its role in immune response, lysosomal function and neuronal survival in the brain, are genetically linked to many of these disorders.

The collaboration follows a recent GlaxoSmithKline investor event during which the UK drugmaker said it would be looking to maximise opportunities rooted in immune science and genetics, with chief scientific officer Hal Barron suggesting its research focus in these two fields "gives us unique insights into the potential of targets such as PGRN."

Mid- and late-stage studies under way

Enrolment in the Phase III INFRONT-3 trial of AL001 is currently under way in pre-symptomatic and symptomatic individuals with frontotemporal dementia (FTD) due to a PGRN gene mutation. The drug is also being investigated in a Phase II study in symptomatic FTD patients who have a mutation in the C9orf72 gene, and is expected to enter mid-stage testing for amyotrophic lateral sclerosis (ALS) in the second half.

Meanwhile, AL101 is currently being evaluated in a Phase I trial with healthy volunteers, and is intended to be developed for the treatment of Parkinson's and Alzheimer's disease, according to the companies. The FDA has granted both AL001 and AL101 orphan drug designations for FTD.

Under the agreement, Alector will lead the global clinical development of AL001 and AL101 through Phase II proof-of-concept, after which the companies will share development responsibilities for all late-stage studies, with related costs divvied up between them. Upon approval, the partners will be jointly responsible for commercialisation in the US and will split profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and GlaxoSmithKline will handle those for AL101 in Alzheimer's and Parkinson's disease. Outside the US, commercialisation for both compounds will fall under GlaxoSmithKline's responsibility, while Alector would be eligible to pocket tiered royalties.

Turbulent times at GSK

The partnership announcement comes at a time when GlaxoSmithKline has been trying to persuade shareholders and industry observers that it is well-positioned for growth as it prepares to spinout its consumer business and stave off pressure from hedge fund Elliott Management, which wants to shake-up the UK drugmaker's leadership. On Friday, GlaxoSmithKline CEO Emma Walmsley secured the backing of its board to continue leading the drugmaker once it splits off its consumer healthcare division around the middle of next year.

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