WHITEHOUSE STATION, N.J. (AP) — Merck & Co. said it will file for U.S. and European marketing approval of its experimental blood thinner vorapaxar and cholesterol drug Tredaptive in 2013.
Merck said it will complete a late-stage clinical trial of Tredaptive later in 2012 and will file for approval in 2013.
The company said it will ask regulators to approve vorapaxar for the prevention of cardiovascular events like heart attacks in patients with a history of heart attack and no history of transient ischemic attacks or strokes. The company originally hoped to get a broader approval of vorapaxar, but studies showed that while it lowered the risk of cardiovascular events it also raised the risk of major bleeding, including dangerous bleeding in the head.
BMO Capital Markets analyst Dave Shove said he has serious concerns about the demand for both drugs. He said Tredaptive may meet its goals in clinical testing, but if approved, the drug would face tough competition from generic versions of Abbott Laboratories Inc.’s Niaspan, and predicted sales will reach about $420 million in 2015.
He said vorapaxar’s side effects are a major concern. “We have low expectations based on modest reductions in cardiovascular events and significantly higher risk of serious bleeding,” he said.
The company also said it expects to complete a study of a third drug, anacetrapib, in 2017. Shove said anacetrapib is Merck’s most promising cardiovascular drug, although he had expected the company to complete its current study a year earlier, in 2016.
Date: August 27, 2012
Source: Associated Press
Filed Under: Drug Discovery
