Amateur Hour at Merck: FDA Refuses to Look at Zetia-Lipitor Combo Pill

Merck was sent back to the drawing board on its new Zetia-Lipitor combo drug when the FDA refused to accept its application. That’s an unheard of gaffe for a Big Pharma firm. Merck slipped the news into its 10-Q filing with the SEC:

The Company submitted for filing an NDA with the FDA for MK-0653C, ezetimibe combined with atorvastatin, which is an investigational medication for the treatment of dyslipidemia being developed by the MSP Partnership, and the FDA recently refused to file the application.

The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA’s response in order to determine a new timetable for filing.

Motley Fool points out that while such a flub happens occasionally to small companies with less experience, it’s “really embarrasing” to see it at a grownup operation like Merck.

Merck needs some good news on Zetia and Vytorin, its Zetia-Zocor combo. In addition to the still-unfolding Arbiter-6 horror — in which signs point to Vytorin missing yet another primary endpoint — both Merck’s cholesterol drugs have seen their market share collapse over the last year. Here’s a graph from Leerink Swann. Note that Merck’s drugs are the only ones at below 5 percent share.

And finally: What’s really going on in this graph is the triumph of generic Zocor (simvastatin), devastating the category. Even Pfizer’s mighty Lipitor can’t resist it.

• Previously:
• The New Merck, Day 1: a Catalog of Impending Doom
• Leerink Outlines Gloom Potential for Merck/Schering’s $2B Zetia Franchise
• Leerink Bets Abbott’s Niaspan Beat Merck/Schering’s Zetia in Mystery Trial
• Abbott Q2: Niaspan Sales Are a Bright Spot in a Lumpy Quarter
• UPDATED: Why Zetia Researchers’ Silence on Ending of Niaspan Trial Is Unfair to Merck