Five things for pharma marketers to know: Friday, January 23
George Paz, CEO, Express Scripts
Drugmakers who do not manufacture hepatitis C drugs may want to take note of the PBM pushback that's roiled the marketplace of late: Express Scripts — the same folks who refused to cover Gilead's Harvoni — has made oncology costs its next target. Bloomberg reports that the company is focused on the new PD-1 cancer drugs, which can cost about $150,000. Action may be swift. The company's chief medical officer told Bloomberg, “we want to be able to start influencing the market by 2016.”
Sen. Elizabeth Warren (D-MA) has a plan that will convert illegal marketing into a research funding tool. The Wall Street Journal reports that Warren is proposing that companies that pay government settlements for kickbacks, illegal marketing or other activities put 1% of their profits into the public research sector. The Journal explains that the senator's thinking is that pharma used publicly funded research for blockbuster medications and many small and large manufacturers have paid settlements “but have otherwise not been penalized.” The WSJ says Warren says her proposal would have netted $6 billion in research grant funding if it had been in effect over the last five years. Interest group PhRMA told the Journal the proposal was a misguided policy.
An FDA panel voted 8 to 2 Thursday that the regulator should approve Astellas's anti-fungal infection treatment Cresemba (isavuconazonium). Reuters reports that the orphan drug is meant to treat a rare infection that targets blood-cancer patients. BioCentury noted in a Tuesday preview that the panel's posted comments did not hew positive or negative, although they did note “evidence of exposure-related QT shortening . . . the clinical significance of which is uncertain.” Reuters said panels backed Astellas's drug in part because patients need more treatment options—Pfizer's Vfend is the current standard treatment.
The European Medicines Agency has recommended marketing authorization of Novo Nordisk's Saxenda (liraglutide) for obesity, BioCentury reported Thursday. The drugmaker stated that it plans to receive marketing authorization from the European commission within two to three months and expects to launch the drug later this year. An FDA committee voted 14-1 recommending liraglutide be used as an obesity treatment in September. Last month FDA approved Saxenda as a treatment for chronic weight management.
GlaxoSmithKline's investigational Ebola vaccine could be put to use in Liberia as early as next week, The Guardian reported Friday. The NIH-conducted trial will look to evaluate whether the drug can ward off the infection for health workers and burial teams. 30,000 people will be vaccinated, of whom one-third will get the Ebola vaccine while others will get a routine vaccine for another disease. Investigators hope this will help evaluate the drug's efficacy. Trials of healthy volunteers have already demonstrated the drug to be safe, according to the newspaper.