Pharmaceutical Business review

AstraZeneca to acquire remaining stake in Caelum Biosciences

AstraZeneca Cambridge R&D Centre exterior view. Credit: AstraZeneca.

AstraZeneca’s subsidiary Alexion has announced plans to acquire all the remaining equity stake in Caelum Biosciences for up to $500m.

Alexion had entered into a partnership with Caelum in 2019, where it acquired a minority equity stake and also had an exclusive option to acquire the remaining equity in Caelum.

Now, the company has exercised its option to acquire  remaining equity stake in Caelum.

Upon on completion of the deal, which is expected to occur on 5 October, Alexion will pay the agreed option exercise price of about $150m to Caelum.

Additionally, Caelum will also receive up to $350m of additional payments from Alexion depending on certain regulatory and commercial milestones achieved.

Through the acquisition, AstraZeneca will gain control of Caelum’s potential fibril-reactive monoclonal antibody (mAb), CAEL-101, to treat light chain (AL) amyloidosis.

AL amyloidosis is a rare disease caused by abnormality of amyloid proteins in organs, which can lead to organ damage and failure, and may turn fatal.

CAEL-101 is a potentially first-in-class monoclonal antibody (mAb) that is intended to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis.

Alexion CEO Marc Dunoyer said: “With a median survival time of less than 18 months following diagnosis, there is an urgent need for new treatments for this devastating disease.

“CAEL-101 has the potential to be the first therapy to target and remove amyloid deposits from organ tissues, improve organ function, and, ultimately, lead to longer lives for these patients.”

The drug has received Orphan Drug Designation from the US Food and Drug Administration (FDA) and the European Commission as a potential therapy for AL amyloidosis patients.

In June this year, CAEL-101 was granted the US FDA Fast Track Designation.

Currently, the drug, in combination with standard-of-care (SoC) therapy, is being assessed in the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme in AL amyloidosis.

Additionally, it is being evaluated in two ongoing parallel Phase 3 trials in patients with Mayo stage IIIa disease and Mayo stage IIIb disease, respectively.