FDA's "Risky Business" for Pharma & Biotech

It's a big day for pipeline progress...or not. Late Friday, Merck (MRK) and Schering-Plough (SGP) announced that the Food and Drug Administration won't approve their combo Claritin-Singulair combo pill for allergies.

Analysts didn't have high hopes for the drug (especially after the agency recently revealed it's investigating a possible association between Singulair and suicidal behavior), so investors seem to be shrugging off the news.

In fact, MRK shares rallied Monday morning ahead of an anticipated FDA decision on its cholesterol drug called Cordaptive. It's a combo of Niacin and a special ingredient to reduce the facial flushing side effects of Niacin. Analyst estimates for peak sales of Cordaptive range from a few hundred million bucks a year to billion-dollar blockbuster status.

Abbott Labs (ABT) makes a Niacin drug called Niaspan which could possibly take a hit if/when Cordaptive gets approved. Monday was the date given as the PDUFA (Prescription Drug User Fee Act) or what, in plain English, I like to call the "action day" for an FDA Cordaptive decision in case you're wondering how people know when this kind of stuff is gonna happen.

Also late Friday, Bristol-Myers Squibb (BMY) and Medarex (MEDX) announced a regulatory delay for their skin cancer treatment. MEDX shares hit a new intra-day low Monday morning. The FDA wants the companies to test and see if the drug helps people live longer rather than just extending the amount of time that goes by before the cancer worsens.

Meantime, after dueling data presentations at a scientific conference in Milan over the weekend, analysts are declaring Vertex Pharmaceuticals (VRTX) the winner versus Schering-Plough in the latest round of the Hepatitis C drug battle. Vertex is partnered with Johnson & Johnson (JNJ) on telaprevir. Wachovia's George Farmer calls SGP's data "underwhelming" and says VRTX's data "positions telaprevir as the (Hepatitis C drug) of choice between these two candidates." Leerink Swann's Howard Liang says Schering's drug is "in the game" but adds, "Advantage goes to telaprevir."

Hep C doesn't get much mainstream media play, but in medical and investment circles it is considered to be a big area of unmet need and a potential goldmine for drug companies that can develop better treatments. The drugs on the market today don't work on many patients and can make them feel like they have the flu. VRTX and SGP have the most mature pipeline products, but other companies are also in various earlier stages of developing Hep C drugs.

Wachovia and Leerink Swann make a market in VRTX and LS trades in SGP.