Shire Pharmaceuticals Group plc has received a positive opinion from the CPMP for Xagrid (anagrelide hydrochloride) capsules to be used in the treatment of essential thrombocythaemia (ET). The CPMP is the scientific committee of the European Medicines Evaluation Agency (EMEA), and the CPMP opinion will be ratified by the European Commission as part of the granting of the pan-European marketing authorisation. Following the marketing approval, pricing reimbursement negotiations will commence with individual national authorities prior to launch.

Xagrid was granted European orphan drug status on 29 December 2000 for the treatment of ET, thereby providing the product with up to ten years market exclusivity in Europe from the date of marketing authorisation approval.

Essential thrombocythaemia is a chronic disorder of bone marrow, which is associated with the increased production of blood platelets. Excessive platelet production can result in abnormal blood clot formation and bleeding, thereby increasing the risk of stroke, heart attack and gastrointestinal bleeding.

It is estimated by Shire that 40,000 patients suffering from ET across the European Union member states would be eligible for treatment with Xagrid. There is currently no other platelet-reducing treatment approved for the treatment of ET across the whole EU.

The drug is already marketed by Shire in the US and a range of other territories under the trademark Agrylin. Sales of Agrylin in 2002 were $119.2 million, up 39% on 2001.