CV events halt Sanofi Multaq trial; Merck KGaA drops Idera cancer drug on safety concerns

In two clinical disappointments announced yesterday, French drug major Sanofi (Euronext: SAN) and Germany’s Merck KGaA (MRK: DE) each pulled the plug on studies due to safety concerns. Sanofi saw its shares dip 1.1% to 55.30 euros.

Sanofi has discontinued the PALLAS Phase IIIb trial in patients with permanent atrial fibrillation (AF), a population different from the population with non-permanent AF for which Multaq (dronedarone) is currently approved. The decision follows recommendations from the study’s Operations Committee and the Data Monitoring Committee (DMC) which observed a significant increase in cardiovascular events in the dronedarone arm. The decision to terminate the study was not related to any hepatic adverse event.

The benefit-risk of Multaq remains unchanged in its approved indication in non-permanent AF. Patients currently taking Multaq should not stop their therapy and should consult their treating physician should they have any questions. Multaq, which generated first-quarter 2011 sales of 63 million euros ($91 million), is currently approved in the EU in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. In the USA, Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted. Currently approximately 400,000 patients have been treated with Multaq worldwide.