January 12, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Drug giant Merck & Co. said early Monday that it will speed up its application process for cancer drug Keytruda and will implement a new business model it says will save the company $2.5 billion in annual net cost by the end of 2015.
Merck made the announcement ahead of the opening of the J.P. Morgan Healthcare Conference in San Francisco, the oldest and largest conference of its type, which begins Monday and will include 300 of the largest biotech, healthcare and biopharma companies presenting their top-line data and estimates to a sea of eager bankers, analysts, institutional investors, hedge funds and journalists.
Merck said that pushing Keytruda to achieve certification to treat more types of cancer is part of its effort to prioritize what has been criticized as an aging pipeline and lack of focus for the company’s pharmaceutical division. Keytruda is a PD-1 protein inhibitor that uses the body’s own immune system to help target and destroy tumors. It was the first anti-PD drug approved by the U.S. Food and Drug Administration, which green lit it last September. Merck said Monday it is on track to ask the FDA for a biologics license for Keytruda to treat additional types of small lung cancer.
As part of that effort, Merck said it will also file a new drug application for its hepatitis C treatment, grazoprevir/elbasvir, which is a chance to get a bite out of a billion dollar market currently involved in a price war between Gilead Sciences and its closest competitor AbbVie . Merck has also started its first Phase III trial of experimental HIV drug doravirine.
Merck’s two year restructuring will involve the continued overhaul of its research and development unit, as well as establish new global research hubs in the science-heavy communities of Boston and Shanghai.
“Over the past 15 months, we’ve seen the results of our transformation strategy, including advancing major pipeline candidates, completing multiple business development actions and securing first-in-class product approvals,” said Kenneth Frazier, chairman and chief executive officer of Merck in a statement. “As a result of our strong and continued commitment to the pursuit of science and R&D, our labs are focused on many of the most innovative areas in biomedical research today, which we believe is the best way to create intrinsic value for both society and for our shareholders.”
Prior to today’s announcement, Merck has been making sure Wall Street is well aware of its efforts to revive is flagging drug pipeline, with its efforts so far concentrated on sprucing up its immuno-oncology drugs, as well as prioritizing its candidates for treating Alzheimer’s disease, hepatitis C, antimicrobial resistance and cardiometabolic disease. The company has also signaled it is open to going shopping soon, though it has said it is mostly interested in smaller “bolt on” deals that will allow it to flesh out lacking areas in its business model.
