AstraZeneca gets EU backing for OA/RA drug Vimovo; Merck KGaA appeals EMEA decision on cladribine for MS

Anglo-Swedish drug major AstraZeneca (LSE: AZN) this morning said it has received a positive agreement for approval in 23 countries across the European Union for Vimovo naproxen/esomeprazole magnesium). It also results in a harmonized Summary of Product Characteristics (SmPC). EU member states will now pursue pricing and reimbursement and national approvals.

Vimovo is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.

The drug which is co-developed with US firm Pozen (Nasdaq: POZN), was approved by the US Food and Drug Administration in the spring, when it this triggered a $20 million milestone for the US partner, and the EU clearance – on approval of pricing and reimbursement - will make it eligible for a further $25 million (The Pharma Letter May 4). Analysts have predicted that Vimovo could generate between $500 million and $800 million in annual sales. Pozen could also receive sales milestones of up to $260 million.