Five things for Pharma Marketers to know: Tuesday, August 26
Merck's experimental PD-1 cancer therapy pembrolizumab is attracting more potential allies: Pfizer and Merck announced Tuesday that they will be testing Merck's PD-1 with Pfizer's lung-cancer drug Xalkori (crizotinib) starting next year. The clinical trial will focus on the Xalkori patient cohort—ALK-positive or metastatic non-small cell lung cancer patients. Reuters explains that the combination could deliver a two-prong attack, because they use different mechanisms of action. Tuesday's news is not the first Pfizer-Merck pembrolizumab collaboration: the companies had previously agreed to test Merck's experimental drug with Pfizer's Inlyta (axitinib) among renal cell carcinoma patients, as well as with Pfizer's investigational PF-05082566 across multiple cancer types.
Drugmakers should not dread black box warnings. The IndyStar reports that adding the risk information to Eli Lilly's antidepressants Paxil and Cymbalta have quieted lawsuits and have not dampened sales, which hit around $8 billion in 2012. This is despite initial concern by some mental health professionals that the black box warnings, which can include cautions such as being associated with suicidal thoughts, would scare patients away from the drugs.
The National Institutes of Health has released a list of drugs it wants tested in children. Regulatory Focus reports that the wish list of 88 therapeutic areas includes the drugs Viagra (sildenafil), Miralax (propylene glycol), Diflucan (fluconazole) and Epogen (epoetin alpha). RF explains that Congress has tried to encourage drugmakers to test drugs in children using incentives such as extended patents, but drugmakers don't always jump at the opportunity for greater exclusivity, in which case the NIH adds drugs it would like tested to a list it issues every three years. This list is then used to prod drugmakers to pursue pediatric testing, and if manufacturers refuse, the NIH will go ahead and do its own research.
The World Health Organization says it will take $430 million to control the Ebola outbreak which has now killed more than 1,400 patients. Bloomberg reports this number is tied to an effort to halt the number of new cases in two months and halting the spread of the virus within six to nine months. Bloomberg also notes Tuesday's figure is now six times greater than the $71 million the WHO thought it needed to contain the disease just last month. The deadly virus has no cure, and although two Ebola patients treated with the experimental Zmapp treatment left Emory University last week free of the disease, the death of Liberian physician Abraham Borber—who also received Zmapp—supported physician wariness about linking recovery to the vaccine. A new strain of the virus has also been reported in the Democratic Republic of Congo that differs from the one that has coursed through Liberia, Nigeria, Guinea and Sierra Leone.
Former FDA Commissioner Andrew von Eschenbach tells the Boston Business Journal that his former employer's clinical trial demands are cramping medical innovation. Now head of an FDA reform effort at the Manhattan Institute, von Eschenbach says the regulator has become too risk averse in a time when “the scientific possibilities are endless.”