AstraZeneca buoyed by Oprhan recommendations for Acerta cancer drug

AstraZeneca has been buoyed by news that its acalabrutinib cancer treatment has been recommended for orphan drug status by the European Medicines Agency (EMA) for three forms of lymphoma.

The EMA gave positive opinions for the acalabrutinib in the treatment of chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL) and lymphoplasmacytic lymphoma (Waldenström's macroglobulinaemia, or MG).

Acalabrutinib is being developed by Acerta Pharma, in which AstraZeneca bought a 55% stake in December for an initial $2.5bn upfront plus another $1.5bn to be paid when acalabrutinib wins full approval by a regulator.

The FTSE 100 company said the three positive opinions from the EMA's Committee for Orphan Medicinal Products (COMP) were "important milestones" for the drug, for which it has previously projected peak sales of more than $5bn.

"They reinforce the strategic rationale for our investment in Acerta, demonstrating clear progress in developing a potential best-in-class medicine that could transform treatment for patients across a range of blood cancers," said Sean Bohen, AstraZeneca's chief medical officer.

Granting orphan drug status for a drug is designed to allow company to benefit from incentives such as reduced fees and protection from competition once the medicine is placed on the market.

After the COMP's opinion is submitted to the European Commission for endorsement.

To be granted orphan status by the EC, a medicine must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence of up to five in 10,000 in the European Union.

Analysts at Barclays project revenues of $1.6bn in 2025 ahead of key head-to-head data versus Imbruvica in relapsed refractory chronic lymphocytic leukemia (RR-CLL) 2018.

Barclays said efficacy appeared to be at least in-line, with potentially a lower risk of major bleeding and atrial fibrillation. Combination data with Keytruda in solid tumours is due in the second half of 2016.