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AstraZeneca has completed the acquisition of 55% stake in Acerta Pharma, a privately-owned biopharmaceutical firm, for $4bn.

Acerta Pharma has operations in Oss, the Netherlands and several US sites, while its US headquarters is located in Redwood City, California.

The deal gives AstraZeneca access to Acerta’s lead molecule, acalabrutinib (ACP-196), a selective and potent Bruton’s tyrosine kinase (BTK) inhibitor, which is claimed to be effective against relapsed / refractory chronic lymphocytic leukaemia.

Currently, acalabrutinib is in Phase III development for B-cell blood cancers and in Phase I/II clinical studies in multiple solid tumours.

As part of the deal, AstraZeneca paid $2.5bn upfront and the remaining $1.5bn will be paid either on receipt of the initial regulatory approval for acalabrutinib or at the end of 2018, depending on which occurs first.

The deal was announced in December and also noted that AstraZeneca has the option to acquire the remaining stake in Acerta for a further $3bn subject to achieving several milestones.

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In addition, the company can exercise its option to acquire the remaining 45% interest depending on the first approval of acalabrutinib in both the US and Europe and after the establishment of commercial opportunity.

Currently, acalabrutinib is in an extensive development programme with the opportunity for initial regulatory submissions in the second half of this year, for the treatment of patients with specific types of haematological malignancies.

"The company noted that potentially registrational studies in haematological malignancies would be submitted for regulatory filings in second half this year."

So far, around 1,000 patients were treated with acalabrutinib in clinical trials across the entire development programme, while more than 600 patients have been treated with acalabrutinib monotherapy.

In addition, data from a Phase I/II trial showed favourable safety profile and strong efficacy in relapsed / refractory chronic lymphocytic leukaemia patients.

The company noted that potentially registrational studies in haematological malignancies would be submitted for regulatory filings in second half this year.

Additionally, a head-to-head study versus ibrutinib in high risk chronic lymphocytic leukaemia patients is currently ongoing.


Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca.