Biotech Values

[DewDiligence]

MRK Dumps MK-0524B

[MK-0524B, a combination of Zocor, niacin, and laropiprant (MRK’s proprietary anti-flushing agent), was once one of the most touted drugs in MRK’s pipeline. MRK says the drug is being dropped for business reasons, which makes sense insofar as niacin-based products have taken a major hit following the 2011 failure of the NIH’s AIM-HIGH study (#msg-63617748). MRK says that the 2-drug combo known as Cordaptive/Predaptive/MK-0524A, which consists of niacin + laropiprant, is still on target for an FDA re-submission in 2014; MK-0524A was rejected by the FDA in 2008 due to LT safety concerns (#msg-28864222, #msg-28896504), although it was approved in the EU and other countries.]

http://online.wsj.com/article/BT-CO-20120808-714718.html

›August 8, 2012, 3:57 p.m. ET
By Peter Loftus

Merck & Co. (MRK) said it has placed on hold its development of a combination cholesterol drug, citing "business reasons."

The Whitehouse Station, N.J., drug maker no longer plans to file for U.S. regulatory approval of the drug, code-named MK-0524B, in 2014 as it had previously planned. The combination drug was meant to help raise levels of good cholesterol while also lowering levels of bad cholesterol and a related substance implicated in heart disease.

Merck said in its quarterly report filed with the Securities and Exchange Commission that it placed the development program on hold in July for business reasons. A spokeswoman said the decision was part of Merck's "ongoing prioritization" of its drug research pipeline.

MK-0524B is a single-pill combination of three compounds: simvastatin, an widely used cholesterol-lowering drug that is now available as a generic drug; niacin, which lowers substances called triglycerides and raises good cholesterol; and laropiprant, a drug designed to alleviate reddening of the skin, which is a side effect of niacin.

Bernstein previously estimated MK-0524B would generate $248 million in sales for 2016.

Merck's single-pill combination of niacin and laropiprant is available in some countries outside the U.S. under the brand Tredaptive. Merck has said it plans to seek U.S. Food and Drug Administration approval of Tredaptive in 2013 [the NDA was rejected in 2008]. The company is awaiting results of a large clinical trial known as HPS2-Thrive, which is testing Tredaptive's ability to prevent heart attacks and other cardiovascular outcomes.

Merck said its decision to place MK-524B on hold doesn't affect its plans for Tredaptive, also known as MK-0524A, or the HPS2-Thrive study.

Investor expectations for Merck's niacin-based drugs were tempered by last year's halt to a government-funded study which found that adding niacin to cholesterol-lowering drugs known as statins didn't significantly improve cardiovascular outcomes versus statins alone.‹