Merck diabetes drug Januvia meets heart safety target

(Adds analyst comment)

By Bill Berkrot

April 27 (Reuters) - Merck (Other OTC: MKGAF - news) and Co's diabetes drug Januvia achieved the main goal of a long-awaited heart safety study, according to preliminary results released by the drugmaker on Monday, likely removing a cloud of uncertainty from its biggest product.

Merck shares rose nearly 4 percent in after-hours trading following the announcement. Januvia had sales of about $4 billion in 2014, plus another $1.8 billion for the related combination product Janumet.

The Tecos study involved 14,724 patients with type 2 diabetes and a history of heart disease. Januvia plus regular care led to no significant difference in a composite of time to the first cardiovascular-related death, non-fatal heart attack, non-fatal stroke, or unstable angina requiring hospitalization compared with usual care alone, Merck said.

Significantly, among the secondary goals of the study, there was no increase in hospitalization for heart failure in the Januvia group versus placebo, Merck said. That could give Januvia a leg up on rival drugs that have shown a potential heart failure connection.

Full details of the study are expected to be presented at a major diabetes meeting in Boston in June, the company said.

Sanford Bernstein analyst Tim Anderson said uncertainty over the Tecos study had been an overhang on Merck shares.

With Monday's initial results, "a psychological overhang has been removed and the threat of major downside has been eliminated," Anderson said in a research note.

Earlier this month, a panel of expert advisers to the U.S. Food and Drug Administration voted that two similar diabetes drugs, AstraZeneca Plc (NYSE: AZN - news) 's Onglyza and Nesina from Takeda Pharmaceutical Co Ltd, had acceptable cardiovascular risk profiles. However, they recommended that product information labels warn about the risk of heart failure.

The two rival medicines and Januvia belong to a class of diabetes treatments known as DPP-4 inhibitors.

The Tecos heart safety study was conducted by an independent academic research collaboration between the University of Oxford Diabetes Trials Unit and the Duke University Clinical Research Institute. It was undertaken after heart safety concerns were raised over other diabetes medicines.

Merck shares rose as much as 3.8 percent to $59.25 in extended trading from their New York Stock Exchange close at $57.10. (Reporting by Bill Berkrot, additional reporting by Ransdell Pierson; Editing by G Crosse, Alan Crosby and Andre Grenon)