New Jersey-based drug giant Merck & Co. announced last week it will not seek FDA approval this year for a heart-failure drug after preliminary results from a late-stage study showed the stuff didn’t meet efficacy targets.
In 2007, Merck acquired the drug, rolofylline as part of its $366 million buy-out of NovaCardia.
It was the latest in a series of hits to the company’s late-stage drug pipeline which was described by Sanford Bernstein analyst Timothy Anderson as “uninspiring” in a memo to investors after the announcement.
Three months ago, Merck said it was postponing near-term plans to seek approval for its migraine fix, telcagepant, after safety concerns surfaced in a mid-stage study. In 2008, the FDA asked Merck to wait until a large trial concluded in 2013 before seeking approval for Cordaptive, a cholesterol-buster.
In addition, Merck recently shelved its early-stage obesity drug, taranabant due to a lousy side effect profile.
Merck spokesperson Ronald Rogers scoffed at criticisms of his company’s pipeline.
In fact it has a “strong track record of bringing new products to market,” he told the Wall Street Journal, citing the diabetes drug Januvia, the HIV-fighter Isentress, and Gardasil and Zostavax, the vaccines for cervical cancer and shingles, respectively.
The recent setbacks have highlighted the importance of Merck’s plan to acquire the Plough for $41 billion, a deal that should close in Q4. Both companies are fired up about 2 potential blockbuster drugs in the Plough’s pipeline—the clot-buster TRA and the arthritis drug golimumab (aka Son of Remicade).
Merck’s asthma drug, Singulair, accounts for 18% of the company’s revenues. It loses patent protection 3 years from now.