November 11, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Merck & Co. announced this week that the results of a large clinical study examining the efficacy of cholesterol medications Vytorin and Zetia would not cause the company to write down the value of the two drugs. Although the outcomes of the studies have not been disclosed, the third-quarter SEC filing suggests the company was happy with the results and they would not damage the market value of the drugs.
The study results, dubbed “Improve-It,” will be presented at a medical meeting in Chicago on Nov. 17.
In the first nine months of 2014 Zetia sales were $1.99 billion. In the same period, sales of Vytorin were $1.15 billion. In the third quarter of 2014, combined global sales of Zetia and Vytorin were $1 billion, a decrease of 3 percent compared with the same period in 2013. For the first nine of 2014 combined sales were $3.1 billion, basically the same as for 2013.
“The company has been unblinded to the results from the IMPROVE-IT trial, an approximately 18,000 patient event-driven cardiovascular outcomes study evaluating ezetimibe/simvastin alone in patients presenting with acute coronary syndrome, which will be presented at the American Heart Association Scientific Sessions on November 17, 2014,” Merck wrote in the SEC filing. “The company has determined that the Zetia and Vytorin assets have not been impaired.”
In other news, Merck presented positive results today today at the 65th American Association for the Study of Liver Diseases Annual meeting regarding a multi-arm Phase 2 clinical trial of grazoprevir/elbasvir. Several papers were also published in The Lancet.
The trial evaluated grazoprevir/elbasvir (MK-5172/MK-8742), protease inhibitor NS3/4A and NS5A inhibitor, respectively, with or without ribavirin to treat chronic hepatitis C virus (HCV) genotype 1 infections. It involved 18,000 patients.
“Merck is committed to developing an efficacious, well-tolerated therapy suitable for a broad spectrum of patients with HCV,” said Eliav Barr, vice president of infectious disease for Merck Research Laboratories in a statement. “We are encouraged by the findings for grazoprevir/elbasvir in the C-WORTHy trial and look forward to advancing our broad Phase 3 program, which includes hard-to-cure patients that are of the highest need and least studied to date.”
Interim results from these studies, specifically the C-WORTHy study, were presented in April 2014 at the 49th Annual Meeting of the European Association for the Study of the Liver. The C-WORTHy study is a randomized, dose response, parallel-group, multi-site, double-blind clinical trial that compares diverse patient populations that have been exposed to different treatment durations of grazoprevir/elbasvir with or without RBV in patients that have chronic HCV infection.
