Merck & Co has given an update about its future hopes for the new combination cholesterol treatment MK-0524A which was rejected by US regulators at the end of April.

Then, the US Food and Drug Administration issued a not approvable letter for MK-0524A (extended-release niacin/laropiprant) and demanded additional efficacy and safety data. The agency suggested that the company wait for the results of the HPS2-THRIVE cardiovascular outcomes study, which is expected to be completed in January 2013.

Merck now says that it hopes to be able to address the FDA's concerns before the end of that trial, but believes that 2010 is the earliest it will be able to respond to the action letter. Peter Kim, the firm's executive vice president, said “we are disappointed, but continue to have confidence in the potential of MK-0524A”. European regulators would seem to concur having recommended approval for the drug just days before the FDA voiced its objections.

The HPS2-THRIVE study, conducted by Oxford University and funded through a grant from Merck, has already enrolled 12,000 patients and 8,000 more will join it, the firm said. It also noted that it will not seek US regulatory approval for MK-0524B (ER niacin/laropiprant/simvastatin) until it completes its response to the FDA regarding MK-0524A.

$300 million vaccine plant expansion
Meantime, Merck is planning to create 150-180 jobs by expanding its vaccine manufacturing facility in Durham, North Carolina.

The deal was announced by Governor Michael Easley who said that the drugmaker will invest about $300 million in the project, which is contingent upon approval of a grant by the Durham County Commission. Assuming that comes, construction should be completed in 2011.