The drug safety monitoring board overseeing Merck’s Improve-It Vytorin trial said the drug maker can continue to sound out what, if any, advantage its medication has over simvastatin, which Merck previously sold under the brand name Zocor. The test, which is looking to gather information on close to 5,300 endpoints across more than 18,000 patients, was kicked off by a 2008 finding that the cholesterol-lowering medication, which is a blend of simvastatin and ezetimibe (Zetia) really didn’t do much in terms of reducing cardiovascular death or stroke compared to standalone simvastatin. While Bloomberg noted market watchers took the board’s “go on” message as a reason to rally behind the company, Matthew Herper of Forbes said last week that the study is poised to have a major impact on the cardiovascular category for two reasons: it hold millions of dollars in the balance at Merck and can determine the fate of pipeline PCSK9 drugs which are being prepped for testing that focuses on their “cholesterol-lowering potency, not hard proof they prevent heart attacks.” He added that if the Improve-It test fails, clearing the PCSK9 drugs of Amgen, Sanofi and Pfizer “becomes less likely.”
Shire’s latest acquisition – privately-held Swedish firm Premacure AB – gives the company access to a Phase II treatment to prevent retinopathy of prematurity (ROP), a rare disorder that puts premature infants at risk for blindness. The company announced the purchase Tuesday, noting that a successful treatment would be a first for the condition, and that the purchase gives the company a foothold in a new field: neonatology. The company said ROP is a concern for infants born at 31 weeks and is one of the most common causes of vision loss in childhood.
