Merck on Track to Seek Approval for Two Heart Drugs in ’13
Whitehouse Station, NJ-based pharmaceutical giant Merck (NYSE: MRK) provided an update Sunday on three of its experimental drugs to treat cardiovascular conditions during the European Society of Cardiology meeting in Munich.
In a statement the company said it plans to file for approval next year in the United States and Europe for the anti-clotting drug vorapaxar. The experimental compound was a key driver of Merck’s 2009 $41 billion acquisition of Schering Plough, which developed it, but trials of the drug revealed concerns about bleeding risk in patients who had suffered strokes. Merck says it will seek approval for use of the drug to prevent cardiovascular events in patients with a history of heart attack—but no history of stroke.
Merck says it expects this year to complete its trials of its extended release form of niacin and laropiprant (Tredaptive), which it is developing to treat patients with cholesterol problems. The company intends to file for approval in the U.S. and Europe next year.
Merck also provided an update on anacetrapib, a drug designed to raise levels of HDL, otherwise known as the “good” cholesterol. Merck says it is currently recruiting patients for a pivotal trial, which it expects to complete in 2017. Anacetrapib is in an emerging class of drugs that are designed to inhibit a protein called CETP (cholesterylester transfer protein). CETP inhibitors have had mixed success so far—Pfizer (NYSE: PFE) had to stop trials of its experimental compound several years ago due to side effects and Roche recently ended its trials of a CETP inhibitor.
Merck said yesterday it had improved its method for measuring levels of the “bad” cholesterol, LDL, and had determined that in earlier trials, anacetrapib produced 25 percent to 35 percent reductions in LDL-C, compared to the 40 percent previously reported.
Shares of Merck closed at $43.12 on Friday and were unchanged in after-hours trading.