MedImmune completes recruitment in Ph III Numax vs Synagis trial

USA-based drugmaker MedImmune has completed enrolling approximately 6,600 infants at high risk of respiratory syncytial virus in a pivotal Phase III study comparing the safety and efficacy of its investigational humanized monoclonal antibody Numax to its approved drug Synagis (palivizumab).

The Gaithersburg, Maryland-headquartered firm has completed enrollment of more than 620 patients in a separate, late-stage clinical study with Numax in children with hemodynamically significant congenital heart disease. The company is developing Numax as a potential improvement to Synagis, which was introduced to the market in 1998 and has become the standard of care for the prevention of serious RSV disease in these infants, it noted.

The 2005 impact of incremental recruiting and enrollment costs for both trials is anticipated to be approximately $10.0 million, which was not included in MedImmune's previously-stated financial guidance for 2005, issued on October 20.