December 15, 2009
This fast growth in the USA, UK, France, Germany, Italy, Spain and Japan will be driven by the launches of a number of new agents, including a strong pipeline of oral fixed-dose anticoagulants, most notably Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) and Bayer/Johnson & Johnson’s Xarelto (rivaroxaban), plus Sanofi-Aventis’s antiarrhythmic agent Multaq (dronedarone), according to the study, from Decision Resources.
In September, Boehringer Ingelheim presented data from the 18,000-patient RE-LY study showing Pradaxa “convincingly beating warfarin” in stroke prevention in AF. And earlier this month, another major trial, the RE-COVER study, showed the drug could be as good, if not better, than warfarin as a treatment for potentially life-threatening blood clots. “These impressive new data mean dabigatran has the potential to benefit even more patients and overtake warfarin as the treatment of choice,” said the firm.
In May, the US Food and Drug Administration voted 15-2 in favour of approving Xarelto for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery, but asked for additional data, including market surveillance studies from countries where the drug is already marketed. Earlier this month, Bayer and J&J said they would not be submitting their response to the FDA before 2010, because "postponing the complete response until these requirements are fully addressed provides the greatest opportunity for successfully bringing rivaroxaban through the regulatory process."
The Decision Resources report also forecasts that Multaq will take share from class IC and class III antiarrhythmics to capture 11% of the total AF patient share, and sales of $660 million, by 2018. In late November, Multaq became the first new anti-arrhythmic approved in the European Union for 10 years.
“Multaq is the first antiarrhythmic to demonstrate a reduction in the risk of hospitalization due to cardiovascular causes in patients with paroxysmal or persistent atrial fibrillation,” says Decision Resources analyst Ben Kong. “Physician enthusiasm for Multaq reflects the growing importance of clinically relevant outcomes in clinical trials involving antiarrhythmic therapies,” he adds.
The report also expects Cardiome/Astellas’s Kynapid (vernakalant) to provide an attractive alternative to electrical cardioversion, particularly in the US intravenous cardioversion market which is currently dominated by branded agents, and that, in the US alone, it will achieve sales of $130 million in 2018.
In May, in a deal potentially worth $600 million to Cardiome, Merck & Co secured global rights to the oral version of vernakalant for the maintenance of normal heart rhythm in AF patients, while its Merck Sharp & Dohme unit gained rights outside the USA, Canada and Mexico to the intravenous formulation for rapid conversion of acute AF to normal heart rhythm. In August, Merck said the European Medicines Agency had accepted its marketing authorisation application for the IV formulation for acute AF.
Return to In the News