Merck & Co. highlighted the key developments in its late-stage pipeline and its near-term plans for regulatory filings. The company has 19 candidates in Phase III clinical trials and plans to submit eight new US regulatory filings in 2012–2013, including five new drug candidates.
The five new drugs targeted by Merck for US regulatory submission are Tredaptive (extended-release niacin and laropiprant) for treating atherosclerosis, suvorexant for treating insomnia, odanacatib for treating osteoporosis, V503 (a cervical-cancer vaccine), and Bridion (sugammadex) for reversing neuromuscular blockade. Overall, the company’s late-stage pipeline consists of 32 Phase II and Phase III candidates, which include new molecular entities and combination drugs.
The company also described six other promising candidates. Anacetrapib is a reversible and selective cholesterol ester transfer protein inhibitor in Phase III development. MK-3102 is a once-weekly oral dipeptidyl peptidase-4 inhibitor candidate for treating Type II diabetes that is expected to enter Phase III clinical trials in 2012. V212 is an inactivated varicella-zoster virus vaccine in Phase III development for preventing herpes zoster. MK-3222 is an anti-interleukin-23 monoclonal antibody candidate for treating psoriasis that is expected to enter Phase III clinical trials in 2012. MK-5172 is an oral pan-genotypic NS3/4a protease inhibitor for treating hepatitis C, and MK-8931 is a β-site amyloid precursor protein-cleaving enzyme for treating Alzheimer's disease that is expected to enter Phase II development in 2012.
In addition to its innovator drug program, Merck will continue to advance its biosimilars portfolio for “specific opportunities where the company can be a first mover upon patent expiry of the originator product,” according to a Nov. 10, 2011, press release.