Company news: Biogen Idec, MerckBiogen Idec cut its experimental amyotrophic lateral sclerosis treatment, dexpramipexole, from its pipeline. The company announced Thursday that the drug failed to hit not just its primary endpoints, but its secondary and tertiary goals as wells. The biotech said in a statement that the drug failed to demonstrate any efficacy and that it's pulling the plug but will present test details at a future conference. “We share the disappointment of members in the ALS community who had hoped that dexpramipexole would offer a meaningful treatment option,” EVP of R&D Douglas Williams said in a statement. Sanofi's Rilutek (rilusole) is the only approved treatment for the progressive nerve-destroying disease. ISI analyst Marc Schoenebaum wrote in a Thursday research note that the drug failure isn't going to dent support for the biotech's outlook. “We (and most of the Street) had characterized this trial as a high risk trial that carried more upside . . . than downside,” he wrote. Yet the analyst also noted that watchers still expected some sort of positive outcome, even with front-loaded pessimism, writing that a December ISI survey indicated that 46% of polled investors expected the trial to meet is targets and 90% expected it to show at least a small benefit.
Merck's cholesterol-fighting ezetimibe/atorvastatin combination is once again headed to the FDA for review. The company announced the resubmission Thursday, and noted that it had complied with the terms of a Complete Response Letter it received from the regulator last year. Merck expects the review to happen within the first half of this year. Approval would enable to company to pursue the equivalent of a brand extension, since it uses ezetimibe, also known by the brand name Zetia, which officially has four more years until its US patent expires, although the company noted in its Q3 report that an agreement could allow a generic as early as 2016.
Patients with consumer-driven health plans are high users of mobile digital health tools, according to a study by the Employee Benefit Research Institute, reported MobiHealth News. These plans place a greater financial responsibility on patients as a way to shape behavior. Researchers also said that the plan design has had a limited impact on patient behavior, in that CDHP members are more likely to ask about generics and find out if a treatment is covered prior to receiving it.
The American Journal of Pathology has a new editor in chief. The publication announced Thursday that neuropathologist Kevin A. Roth took the helm on New Year's Day. In addition to publishing his very first paper in AJP while a graduate student, Roth served as an Associate Editor for AJP since 2003 and as editor-in-chief of the Journal of Histochemistry and Cytochemistry from 2006 to 2010.