Merck submits modified niacin to FDA

Share this article:
Merck's Cordaptive, an extended-release niacin combined with a flushing inhibitor, has been filed for approval with the FDA, the firm said.

Cordaptive could represent Merck's latest entrée into the $18-billion market for cholesterol drugs. Its statin Zocor (simvastatin) went off patent last year, but another cholesterol-lowering drug Vytorin, which Merck co-markets with Schering-Plough, has sold well.

Drugs that raise HDL, or “good,” cholesterol are considered a new direction for treatment. Flushing is the only known side effect of niacin, and analysts believe a more tolerable form could be a significant advance.

Back in March, Lehman Bros. analyst Tony Butler told MM&M that Cordaptive, then known as MK-524A, could earn between $800 million and $1 billion “or substantially more, if the clinical outcomes suggests a mortality benefit.”

Merck expects to present Phase III data at next month's European Society of Cardiology meeting and in November at a gathering of the American Heart Association.

The drug is designed to be used alone or in combination with a statin. MK-524B, Merck's combination of Cordaptive plus simvastatin (Zocor), is in Phase III trials.

An FDA decision for Cordaptive is anticipated in the second quarter of 2008, Merck said in a statement yesterday. It also plans to file for approval outside the US.

Niaspan, a branded, extended-release form of niacin sold by Kos, had US sales of $473.8 million last year, a 24% increase over 2005. Kos was bought by Abbott Labs in 2006.

Share this article:

Email Newsletters

More in News

AstraZenca beefs up respiratory portfolio

AstraZenca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.

Amgen Q2 sales rise, company to lay off up to 2,900

Amgen Q2 sales rise, company to lay off ...

The majority of the layoffs will be in the US.

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to ...

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like ...