Merck & Co announced yesterday that it is aiming for the approval of two cardiovascular drugs in the United States and the European Union for 2013. The two drugs are vorapaxar, an experimental drug for acute coronary syndrome chest pain caused by coronary artery disease, and K-524A (tredaptive), for the treatment of LDL (bad cholesterol) to reduce the incidence of vascular events.

The company made the announcement at the European Society for Cardiology 2012 Congress, in Munich, Germany.

Merck says it is in discussions with regulatory authorities on both sides of the Atlantic regarding vorapaxar.

Since January 2011, vorapaxar’s outlook has been hindered by bleeding concerns. An FDA Safety Committee which examined a comprehensive study said the anti-platelet medication was not suitable for patients who had had a stroke.

Merck intends to submit the anti-thrombotic drug in the USA and EU in 2013.

The aim is to seek approval for the prevention of cardiovascular events in individuals who have had at least one heart attack but no history of transient ischemic attacks (TIA) or strokes.

Merck says that the study – HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) – is progressing according to schedule and will be completed by the end of this year.

The company plans to submit the drug for approval in the USA and EU in 2013.

This drug is a combination of laropiprant and niacin to reduce blood cholesterol. Laropiprant has no active ingredient to lower cholesterol levels, but it reduces facial flushes which niacin induces.

Anacetrapib is an investigational CETP-inhibitor, which is being developed to treat high cholesterol levels (hypercholesterolemia) as well as preventing cardiovascular disease.

Merck has provided data regarding a different way to measure LDL cholesterol more accurately when patients are on anacetrapib. The new method, called beta-quantification, showed that those on 100 mg anacetrapib a day experienced a 25% to 35% drop in LDL cholesterol, compared to previously report from the DEFINE study, as well as some other studies.

According to Merck, the anacetrapib studies, which are taking place in Oxford, England, are progressing according to schedule and should be completed in 2017. The company says that DEFINE (Determining the EFficacy and Tolerability of CETP INhibiition with AnacEtrapib), which started in 2011, has already recruited about 20,000 participants; it adds that it is one of the largest cardiovascular trials every conducted.

Jeff Chodakewitz, M.D., senior vice president, Late Stage Development, Merck Research Laboratories, said:

“Merck remains committed to research to bring forward innovations in cardiovascular disease, which remains the leading cause of death worldwide.

The clinical outcomes studies for these three medicines have involved or will involve more than 90,000 patients around the world. All of these studies are designed to address the important question of whether, by adding these medicines to the current standard of care, we can further reduce the risk of cardiovascular events.”

Merck’s top-selling drug, Singulair for asthma and allergies, lost its patent exclusivity on August 3rd this year, meaning that it now faces fierce competition. In 2011, Singulair had sales of $5.5 billion dollars, the 11th highest selling drug in the world. Singulair, until its patent life expired, represented over 10% of the company’s total revenue.

Alongside several other pharmaceutical global giants, Merck is keenly seeking out new blockbuster drugs to make up for lost incomes from expired patients.

Written by Christian Nordqvist