Date: 2016-02-02
Type of information: Company acquisition
Acquired company: Acerta Pharma (USA - CA, The Netherlands)
Acquiring company: AstraZeneca (UK)
Amount: $ 4 billion
Terms:
- • On February 2, 2016, AstraZeneca announced that it has completed the transaction to acquire a majority equity stake in Acerta Pharma. The transaction, announced in December 2015, provides AstraZeneca with a potential best-in-class irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in Phase II/III development for B-cell blood cancers and in Phase I/II clinical trials in multiple solid tumours.
Upon completion of the agreement, AstraZeneca acquired 55% of the entire issued share capital of Acerta for an upfront payment of $2.5 billion and a further unconditional payment of $1.5 billion, to be paid either on receipt of the first regulatory approval for acalabrutinib for any indication in the US, or the end of 2018, depending on which is first.
- • On December 17, 2015, AstraZeneca announced that it has entered into an agreement to invest in a majority equity stake in Acerta Pharma, a privately-owned biopharmaceutical company based in the Netherlands and US. Under the terms of the agreement, AstraZeneca will acquire 55% of the entire issued share capital of Acerta for an upfront payment of $2.5 billion. A further unconditional payment of $1.5 billion will be paid either on receipt of the first regulatory approval for acalabrutinib for any indication in the US, or the end of 2018, depending on which is first. The agreement also includes options which, if exercised, provide the opportunity for Acerta shareholders to sell, and AstraZeneca to buy, the remaining 45% of shares in Acerta. The options can be exercised at various points in time, conditional on the first approval of acalabrutinib in both the US and Europe and when the extent of the commercial opportunity has been fully established, at a price of approximately $3 billion net of certain costs and payments incurred by AstraZeneca and net of agreed future adjusting items, using a pre-agreed pricing mechanism.
Details:
- The transaction provides AstraZeneca with a potential best-in-class irreversible oral Bruton\'s tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in Phase III development for B-cell blood cancers and in Phase I/II clinical trials in multiple solid tumours. Acalabrutinib is a highly selective, irreversible, second generation BTK inhibitor, with approximately 1,000 patients treated to date in clinical studies across the entire development programme. More than 600 patients have been treated with acalabrutinib monotherapy. Phase I/II data showing a favourable safety profile and strong efficacy in relapsed/refractory chronic lymphocytic leukaemia patients was presented at the American Society of Hematology Annual Meeting & Exposition in December 2015, with simultaneous publication in the New England Journal of Medicine. Potentially registrational studies in haematological malignancies are expected to be submitted for regulatory filings in second half 2016. In addition, a head-to-head study versus ibrutinib in high risk chronic lymphocytic leukaemia patients is currently ongoing. Acalabrutinib is also currently being tested in multiple Phase I/II studies in solid tumours, as monotherapy or in combination with immune checkpoint inhibitors or other standard of care regimens.
- The FDA has granted orphan drug designation for acalabrutinib for the treatment of Waldenstrom macroglobulinemia and for the treatment of mantle cell lymphoma.
- Acerta is also developing ACP-319, a novel isoform-selective inhibitor of phosphoinositide 3-kinase (PI3K) delta. The company has operations in Oss, the Netherlands and multiple U.S. sites. The U.S. headquarters is in Redwood City, CA.
Related: Cancer- Oncology
Is general: Yes
