Zelnorm

Novartis restricts Zelnorm to emergencies

Thu, 03 Apr 2008 07:59:55 -0400

Goodbye cruel world. Novartis is pulling the irritable bowel med Zelnorm off the market almost completely, saying it will supply the drug only for emergency use. And even in emergencies, Zelnorm will only be available to patients who don't smoke, and don't have high blood pressure or diabetes or eight other preexisting conditions. And docs who want it must ask the FDA for authorization.

Talk about going out with a whimper. Zelnorm racked up $560 million in sales in 2006, then was withdrawn in March 2007 after it was shown to boost the risk of heart attck, strokes, and chest pain. Novartis eventually made a deal with the FDA to supply Zelnorm to a limited number of patients because it was the only remedy approved for irritable bowel treatment. Eight months later, bye-bye. FDA says the withdrawal was voluntary; we'll have to wait and see whether Novartis offers an explanation.

- see the FDA's press release
- read the Pharmalot item

Related Articles:
Novartis CEO's pay drops with profits. Report
Novartis shares slide after Zelnorm gets yanked. Report
EMEA committee rejects Novartis' Zelnorm. Report

Novartis CEO's pay drops with profits

Fri, 18 Jan 2008 06:59:58 -0500

Novartis had a tough year in 2007: Its vaunted new diabetes drug Galvus got the stiff-arm treatment from the FDA, so much so that the company may not even try again to get it approved. Its painkiller Prexige ran into reports of liver problems; first withdrawn in Australia, it fell in other countries one after the other, domino-style. Zelnorm caught the FDA fisheye, and Novartis finally agreed to withdraw it for safety reasons. The company managed to report a fourth-quarter profit, but at a level 45 percent less than last year's numbers.

And profits aren't the only thing that fell. So did CEO Dan Vasella's (photo) pay. He took home 17 million Swiss francs ($15.6 million), which is no chump change, but it's 20 percent less than he made last year. It's the first time his pay has dropped since he took over at Novartis over ten years ago. Sometimes pay-for-performance packages really hurt. Other Novartis execs took bigger hits. Thomas Ebeling, former chief of the company's pharma unit (and now consumer health honcho), saw his pay fall by 65 percent to 3.7 million francs, or $3.36 million.

Three guesses which unit delivered its boss more pay this year than last. Hint: its sales grew by 20 percent to $7.2 billion and profits rose by a hefty 41 percent to $1 billion. That's right, generics. Andreas Rummelt, Sandoz's chief, made 5.6 million francs ($5 million), 16 percent more than last year.

- see the earnings news from Novartis
- read the compensation article in the Wall Street Journal Health Blog
- get more about Novartis' rosier outlook for the second half of 2008

ALSO: Take a look at Novartis' pipeline. Report

Related Articles:
CEO: Novartis plans big restructuring. Report
Lagging sales spur Novartis layoffs. Report
Novartis makes a $10B bet on generic drugs. Report

Novartis plots 2,500 more job cuts

Thu, 13 Dec 2007 06:59:57 -0500

CEO Daniel Vasella (photo) gave us the broad outline two days ago. Now here are the details: Novartis is slashing its payroll by 2,500 jobs, or 2.5 percent of its worldwide workforce. The cutbacks are designed to save $1.6 billion in annual costs by 2010; Novartis will take a $450 million charge to pay for the program. In October, the company announced it would cut 1,250 jobs, mostly in the U.S. These new cuts come on top of those, bringing the grand total to 3,750 jobs.

The litany of Novartis' woes is familiar to anyone in pharma these days. The company has new generic competition for three of its big drugs. It's been stymied in getting new drugs to market; witness Galvus, which has been delayed because of safety concerns. Another blow was the withdrawal of its bowel drug Zelnorm earlier this year.

This less-than-stellar news has depressed Novartis stock by 8.8 percent this year. But the market likes the cutback plan: Shares were up 1.6 percent this morning.

- check out the release on the layoffs
- read this BBC report
- take a look at the article from Dow Jones

Related Articles:
CEO: Novartis plans big restructuring. Report
Top 5 layoffs of 2007 (Updated). Report
Lagging sales spur Novartis layoffs. Report
Novartis makes the "Biggest Splash". Report
Novartis bankrolls a drug manufacturing revolution. Report

7. Zelnorm - Top 10 Warnings and Recalls

Maureen Martino — Thu, 29 Nov 2007 09:53:42 -0500

Drug: Zelnorm

2006 sales: $561 million

Manufacturer: Novartis

Safety concern: Recall; heart risks

Related Articles:
> FDA allows limited Zelnorm use. Report
> Novartis shares slide after Zelnorm gets yanked. Report
> EMEA committee rejects Novartis' Zelnorm. Report