Shares of Merck & Co have shot up on the back of an earlier-than-expected filing its much-touted investigational melanoma drug, positive news on its heart drug vorapaxar and confirmation that it is exploring options for its animal health and consumer care businesses.
Firstly, the US drugs giant has started a rolling submission to the US Food and Drug Administration for MK-3475 (lambrolizumab), its anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with Bristol-Myers Squibb’s Yervoy (ipilimumab). A rolling submission allows completed portions of the application to be filed and reviewed by the FDA on an ongoing basis and the company expects to complete the application in the first half of 2014.
MK-3475 is currently being studied in three trials for advanced melanoma including a Phase III study versus Yervoy. The drug received breakthrough therapy designation from the FDA last April and Merck believes it could be a major growth-driver.
FDA staff back vorapaxar
Another key product in the pipeline is the bloodthinner vorapaxar. It looks as though the first-in-class thrombin receptor antagonist is well on the way to approval given that FDA staffers have recommended approval, ahead of a Cardiovascular and Renal Drugs Advisory Committee meeting later this week.
Merck is hoping that the drug, which will be called Zontivity, will get the green light as an adjunctive therapy for the reduction of atherothrombotic events in patients with a history of myocardial infarction.
Finally, Merck has presented at the JP Morgan Healthcare Conference in San Francisco and chief executive Kenneth Frazier noted that “we are quickly moving ahead to build on this momentum to make Merck a leaner, more agile company”. This includes “unlocking value in non-core areas”, says the firm which notes that since October it has been exploring strategic options for animal Health and consumer care businesses “to determine the most value-creating option for each”.
Merck adds that it “could reach different decisions about the two businesses” and “expects to complete the process and take action, if any, in 2014”. One option made by observers of late has been a possible swap of the consumer care unit for Novartis’ animal health division.
