MedImmune To Release Phase III Data By Year-End For Synagis Follow-On
This article was originally published in The Pink Sheet Daily
Executive Summary
MedImmune is on track to launch the newest member of its respiratory syncytial virus therapy franchise for the 2008–2009 respiratory virus season.
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MedImmune expects to report top-line data from a Phase III study of its Synagis (palivizumab) follow-on in the fourth quarter, President-R&D James Young said during a second quarter earnings call July 20. The pivotal Phase III study compares Synagis to its follow-on respiratory syncytial virus therapy Numax (motavizumab). The primary endpoint is reduction in RSV hospitalization of high-risk infants; 6,600 children were enrolled. Three additional studies of Numax have completed dosing: a 620-patient study of Numax in children with congenital heart disease; a study of whether Numax reduces instance of hospitalization in Native American infants with RSV, with an enrollment goal of 1,100 patients; and a 260-patient mixed-dosing study of the safety of giving both Synagis and Numax to the same child during the same RSV season. MedImmune is also planning to start another study in the fall to evaluate the effectiveness of Numax in infants infected with RSV and to measure clinical outcomes, Young said. Pending approval, the company plans to launch Numax "sometime during the 2008-2009 [RSV] season," CFO Lota Zoth added. MedImmune has completed a revamp of its sales and marketing arm that increased the number of dedicated pediatric-focused reps from 300 to 425 in preparation for the 2006-2007 flu and RSV season as well as for the Numax launch, CEO David Mott said. The new hires are "leading the charge, now that we have taken back full responsibility for sales of Synagis in the U.S. from Abbott," the CEO said. On July 1, Abbott relinquished full promotional responsibility for Synagis (1 (Also see "MedImmune Plans To Expand Sales Force As It Reacquires Synagis Promotion Rights" - Pink Sheet, 31 Aug, 2005.)). In the second quarter of 2006, MedImmune reported revenues of $73 mil., down from $88.5 mil. for the year-ago quarter. Worldwide sales of Synagis dropped from $51 mil. to $33 mil. for the same period. The company also is on track to begin production on the refrigerator-stable formulation of its FluMist intranasal flu vaccine, despite receiving a "complete response" letter from FDA July 18 (2 (Also see "FluMist Refrigerator-Stable Formula On Track For 2007/2008 After FDA “Complete Response”" - Pink Sheet, 18 Jul, 2006.)). "We expect to be very far along, if not through the approval process for [the new formulation] in time for the manufacturing cycle," Mott said. The company also is proceeding in coming weeks with an sBLA to expand the vaccine's label to include "children down to one year of age who do not have a history of wheezing," Young said. - Shirley Haley |