Get ready for the next breakthrough cancer drug. Merck & Co. is developing pembrolizumab, an investigational anti-PD-1 immunotherapy also known as MK-3475. What makes this treatment so revolutionary is its use of the body’s own natural defenses to fight malignant tumors.
Since March, the Food and Drug Administration has allowed Merck to initiate an expanded access program in which a number of eligible patients with advanced melanoma have been able to receive treatment before final federal approval or outside of the clinical trial process. Merck has received a priority review for this drug prospect as the Octo. 28 FDA deadline nears for the agency to make a decision on a new wave of such immuno-oncology treatments. Moreover, the European Medicines Agency is in the process of reviewing a marketing authorization application for the drug that could be available throughout the continent by the end of the year.
Merck Chairman and CEO Kenneth Frazier views MK-3475 as a game changer with the potential to save millions of lives worldwide. Will Merck win the cancer drug race by beating its Big Pharma competitors Bristol-Myers Squibb and Roche to market? His response: “Let me start by saying that Merck is a company committed to saving and improving lives. With this new immunotherapy for cancer, we have a whole new way of treating people who have different kinds of cancers. We’re investigating it in more than 30 tumor types right now. Of course, we would like to get to market first. We like to be leaders. But the reality of the world is that all of these companies have an opportunity to contribute to the health of cancer patients. If we’re able to do that as an industry, that’s actually great for mankind.”
Frazier further makes his case, citing that Merck’s “raison d’Ãªtre is coming forward with transformational medicines.” And there are plenty of such offerings in the pipeline, including the next generation of drugs to treat HIV as well as a novel treatment for the hepatitis C virus, or HCV, a leading cause of liver damage that has infected around 150 million globally.
Frazier has authorized his team to make significant investments. Since taking the helm, he has given the green light to pumping billions into research and development to attack a host of pernicious diseases. And this fall Merck expects to complete the $3.85 billion acquisition of Cambridge, Massachusetts-based Idenix Pharmaceuticals, which focuses on HCV treatment, to add a third component of a “triple therapy,” combining it with two existing drugs in Merck’s portfolio.
Find out more about Frazier’s path to success on the next page …