Javelin slumps 35% as European partner Therabel withdraws batches of Dyloject

USA-based Javelin Pharmaceuticals, the subject of a $145 million takeover bid from Hospira, saw its shares plummet 25% to $1.35 in morning trading yesterday after it revealed that Therabel Pharma UK, a subsidiary of Netherlands-headquartered Therabel Pharma NV and Javelin's licensee for commercial rights to the non-steroidal anti-inflammatory drug (NSAID) Dyloject (diclofenac sodium) in injectable form in the European Union, publicly announced that it is voluntarily withdrawing all batches of the drug from the UK market with a Drug Alert Class 2 Medicines Recall.

Therabel reported that it became aware of the presence of a white particulate matter in some vials of Dyloject in its supply chain. These findings were promptly reported to The Defective Medicines Reporting Centre (DMRC) of The Medicines and Healthcare Products Regulatory Agency (MHRA) in accordance with standard procedures.

Additionally, Therabel further noted that its review of pharmacovigilance information does not appear to indicate any detected patient safety concerns linked to the particulate matter found in some vials. Dyloject has been marketed in the UK since December of 2007.