Abbott and AstraZeneca have entered into an agreement under which the two companies will co-promote Abbott's cholesterol drug Trilipix (fenofibric acid) in the U.S. Financial terms were not disclosed.
"Abbott's portfolio of lipid therapies is designed to help physicians manage a patient's total lipid profile," said Jeffrey Stewart, divisional vice president, Primary Care, Abbott. "With AstraZeneca's established presence in the cardiovascular space, this agreement allows Abbott to expand visibility and education of Trilipix among physicians whose patients may benefit from this medication."
"Part of AstraZeneca's corporate strategy is to establish successful external collaborations. AstraZeneca has a long-standing commitment to cardiovascular health and has an established presence in the cholesterol market. This agreement allows us to further strengthen our presence with physicians by including Trilipix as an offering to physicians for patients with dyslipidemia," said Jim Helm, vice president, cardiovascular, AstraZeneca U.S. "With clinical data to support its use in helping certain patients with mixed dyslipidemia to manage all three key lipids, Trilipix is another important therapeutic option we can now offer physicians."
The two companies have also submitted a NDA to the FDA for an investigational compound for the treatment of mixed dyslipidemia—a combination of two or more lipid abnormalities including high LDL-cholesterol, high triglycerides and low HDL-cholesterol. The drug contains the active ingredients of Crestor (rosuvastatin calcium) and Trilipix (fenofibric acid). The NDA submission is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of the combined drug. Pending approval, the drug will be marketed as Certriad.
"The NDA submission is an important milestone in the development of CERTRIAD and demonstrates our commitment to developing treatments for dyslipidemia," said Howard Hutchinson, chief medical officer, AstraZeneca. "We look forward to continued discussions with the FDA about this potential new medicine."
"Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "If approved, Certriad could become an important treatment option for physicians looking to provide comprehensive management of mixed dyslipidemia to their patients."