The Medicines Company said yesterday it will pursue marketing approvals for its anti-clotting drug candidate Cangrelor after it met its primary efficacy endpoint in a Phase III clinical trial of improvement compared with Plavix (clopidogrel).
The intravenous small molecule antiplatelet agent reduced by 22% the likelihood of patients experiencing death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis within 48 hours of taking it—to 4.7% from 5.9% of subjects randomized during CHAMPION PHOENIX. The Phase III trial compared Cangrelor to oral Plavix in 11,145 patients undergoing percutaneous coronary intervention.
Cangrelor also showed a 38% reduction (0.8% compared with 1.4%) over Plavix in the likelihood of patients experiencing the key secondary endpoint, incidence of stent thrombosis at 48 hours.
Cangrelor is designed to prevent platelet activation and aggregation that leads to thrombosis in acute care settings, including in patients undergoing percutaneous coronary intervention. During CHAMPION PHOENIX, Cangrelor made its best showing in patients with Q-wave myocardial infarction (QMI), lowering by 39% (to 0.2% compared with 0.3%) the incidence of QMI. Cangelor’s most disappoint showing was its inability to lower the odds of death compared with Clopidogrel; both drugs showed a likelihood of 0.3%.
"Our next step is to submit for market approvals in the U.S. and Europe. We anticipate submitting these data for a new drug application to the U.S. Food and Drug Administration in the second quarter with findings of prior trials, including the BRIDGE trial in patients awaiting open heart surgery,” Simona Skerjanec, PharmD, senior vp and innovation leader for antiplatelet therapies at The Medicines Company, said in a statement.
Medicines Company has said it expects Cangrelor to generate revenue of $450 million at its peak.
“Our model conservatively estimates that Cangrelor addresses a ~$200M U.S. market opportunity when Hatch-Waxman exclusivity expires in 2019. However, MDCO has filed a number of additional patent applications related to Cangrelor, which could provide an upside, in our view,” Leerink Swann analysts Joseph P. Schwartz and Michael Schmidt, Ph.D., wrote this morning in a note to investors.
Schwartz and Dr. Schmidt also said that specialists from MEDACorp, a health-care expert network launched by Leerink Swann, believed that an effect size of at least 20% in PHOENIX Phase III would be clinically meaningful: “They expected that, like most ACS/PCI trials, softer endpoints such as revascularization would contribute significantly but any trends on stent thrombosis, death, or myocardial infarction would be exciting.”
Plavix is marketed by Sanofi worldwide except in the U.S. and Puerto Rico, where the drug is marketed by co-developer Bristol-Myers Squibb (BMS). While patents for Plavix expired last year in May, Sanofi and BMS still managed to rack up $5.232 billion in combined 2012 sales for their branded version of the drug—but that was down 45% from $9.734 billion in combined 2011 sales.
Deepak L. Bhatt, M.D., the study’s co-principal investigator and director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital Cardiology, presented results of the CHAMPION PHOENIX trial yesterday at the American College of Cardiology's 62nd Annual Scientific Session and Expo. Results were concurrently published in The New England Journal of Medicine. Dr. Bhatt is also the chief of cardiology at VA Boston Healthcare System, and a professor of medicine at Harvard Medical School.
Joining Dr. Bhatt as CHAMPION PHOENIX’s other co-principal investigator was Robert A. Harrington, M.D., professor and chair of the department of medicine at Stanford School of Medicine.