Merck expects FDA action on its NDA for Cordaptive , a combination of extended-release niacin and the novel flushing pathway inhibitor laropiprant, in the second quarter of 2008. The company announced it had submitted the NDA Aug. 29, indicating the drug will receive a standard 10-month review.

The addition of laropiprant in Cordaptive is supposed to reduce flushing associated with niacin treatment. Merck is seeking an indication for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels either alone or with a statin, as an adjunct to diet and exercise.

Merck has been highlighting the development of Cordaptive, previously known as MK-0524A, as one of its core pipeline projects. The NDA is supported by Phase III data that Merck said it plans to present in September at the Scientific Meeting of the European Society of Cardiology.

The firm has also been working on a related combo project, MK-0524B, which would combine Cordaptive with simvastatin ( Zocor ). However, last year Merck announced a setback in the development of MK-0524B due to formulation issues and said the drug would not be ready for filing in 2007 as previously anticipated (¹ Also see "Merck’s Simvastatin/Niacin Combination Delayed By Formulation Issues" - Pink Sheet, 29 September, 2006.).

The company is currently planning to file MK-0524B in 2008.

Niacin is recognized as an effective lipid-modifying agent, but treatment of cholesterol with the drug is limited due to its flushing side effect profile. Abbott recently launched a new coated-tablet formula of Niaspan (niacin extended release), which in a study indicated a reduction in flushing compared to the original version of Niaspan. However, FDA said Abbott would need to conduct a trial with predefined measurements for reduced flushing before the agency would consider adding such a claim to labeling (² Also see "FDA: For Niaspan Reduced Flushing Claim, Pre-Defined Criteria Necessary" - Pink Sheet, 13 April, 2007.).

Abbott also has a fixed-dose combination of Niaspan and simvastatin, Simcor , pending at FDA with a user fee date in February (³ Also see "Abbott Files Simcor With FDA" - Pink Sheet, 20 April, 2007.).

AG Edwards & Sons analyst Joseph Tooley said in an Aug. 28 research note, "While we expect Cordaptive to siphon some sales from Niaspan in the near term after its launch, we expect the market for HDL-raising therapies will grow significantly post-launch due to the relative convenience of Cordaptive (i.e. lower flushing) over existing niacin therapies." He modeled sales of $70 million in 2008, ramping up to $250 million, $550 million and $825 million in 2009, 2010 and 2011.

One day earlier, Merck and partner Schering-Plough announced that they anticipated FDA action on another NDA for a combination drug, this one mixing Merck's Singulair (montelukast) with Schering's Claritin (loratadine).

- Jessica Merrill (j.merrill@elsevier.com)

Merck’s Lipid-Lowering Combo Cordaptive Could Clear FDA In Mid-2008

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