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Sebelius on Vaccines

24 Nov 2009

Discussing whether a new $487M investment from the government will help speed up the production of the most important vaccines, with Kathy Sebelius, Health & Human Services secretary and CNBC's Mike Huckman.

The New Formula for Faster Vaccines

24 Nov 2009

Novartis is opening on Tuesday the country's first plant to produce flu vaccines using cell cultures. These vaccines are faster, better and cheaper to make than egg-based methods, reports CNBC's Mike Huckman.

Novartis Opens 1st US Plant for Flu Vaccine

24 Nov 2009

Cholesterol Drug Battle: Niaspan vs. Zetia 16 Nov 2009
Abbott Laboratories' Niaspan beat Merck's Zetia in a new study. CNBC's Mike Huckman has the details.

Cardiologist Grades Cholesterol Drug Study

16 Nov 2009

Abbott Laboratories' Niaspan beat Merck's Zetia in a new study. Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at The Cleveland Clinic, shares his reaction with CNBC's Mike Huckman.

Merck's Cholesterol Drugs Under Pressure

16 Nov 2009

A new study is putting Merck's cholesterol drugs under pressure today, reports CNBC's Mike Huckman, with Ken Frazier, Merck Global Human Health president.

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Apr.29

11:37 AM ET

Tuesday, 29 Apr 2008

Merck "Adapts" To Tredaptive Setback

Posted By:Mike Huckman

Sectors:Health Care Equipment and Services | Health Care | Pharmaceuticals

Companies:Biogen Idec Inc | Genentech, Inc. | Abbott Laboratories | Schering Plough Corp | Merck & Co Inc

AP
Investors are finding no solace in Merck's reaffirmation that it'll still hit its earnings numbers this year. Instead they're punishing the stock after the company announced what everyone is calling a surprise and a significant setback.

Yesterday I blogged about regulatory risk and late yesterday the Food and Drug Administration provided Merck [MRK Loading... () ] with another example of it. The agency rejected the drugmaker's cholesterol treatment formerly known as Cordaptive and now called Tredaptive (The FDA sometimes makes companies change proposed commercial drug names for any number of reasons.)

In a press release Merck didn't divulge the FDA's problem(s) with the drug, but analysts suspect it has something to do with safety issues. Tredaptive combines Niacin with a new drug to reduce the extremely bothersome facial flushing side effects of Niacin.

Anecdotally, two co-workers at CNBC told me separately in the days leading up to the FDA decision date that they'd both taken Niacin, but had to go off of it because the turned red, tingly and hot. Abbott Labs [ABT Loading... () ] markets A Niacin drug under the brand name Niaspan. ABT shares are rallying on the elimination of, at least, a near-term threat to the drug which brought in $660 million in revenue last year.

Just last week European regulatory authorities recommended approval of Tredaptive. That, perhaps, goes to the point. Schering-Plough [SGP Loading... () ] Chairman and CEO Fred Hassan made in my interview with him last week, that he believes the regulatory, political and media environment in the U.S. is putting the country at risk of ceding its drug innovation leadership position to overseas.

Indeed, Merck has suffered two FDA slapdowns in as many days. Last Friday, the agency said no to MRK and SGP's combo allergy drug and then late Monday came the Tredaptive decision.

Analysts are all over the story. Miller-Tabak healthcare analyst writes in a stinging research note to clients: "Two non-approvals in one week. Is this a record for MRK? It seems more like PFE. We had expected this drug to be a blockbuster in the middle of the next decade. Obviously this is called into question."

And Catherine Arnold at Credit Suisse says: "MRK's late stage pipeline is seen as mediocre absent Cordaptive...."

Merck has a diet and another cholesterol drug in development, but similar drugs at competitors have not fared well. CS has banked Merck and wants to do it again.

If investors didn't realize it before, this week's events (and the week is young) are a painful lesson (unless you're on the short side of the trade) that the pharma-biotech sectors are rife with risk. Not just regulatory, but also clinical. This morning before the opening bell Genentech[DNA Loading... () ] and Biogen Idec [BIIB Loading... () ] announced their late-stage test of Rituxan on lupus didn't meet its goal. Both stocks are getting hammered.