Zocor

Vytorin, Zetia scrips drop 11% in April

Tracy Staton — Thu, 29 May 2008 10:21:48 -0400

Prescriptions for Vytorin and Zetia, Merck/Schering-Plough's co-marketed cholesterol meds, fell off by 11 percent just during the month of April, to less than 2.5 million from 2.8 million in March. Cumulatively, they're down by 22 percent since January.

You'll recall that in early January, the joint venture announced the results of the long-awaited Enhance study, which showed that the Vytorin combo of Zetia and Zocor didn't prevent artery-clogging any better than Zocor did alone. Predictably, scrip volume dropped by more than 13 percent month-over-month in February. But the numbers edged back upward in March as Merck and Schering-Plough did damage control with doctors.

Then, at the end of March, the Enhance data was presented at the American College of Cardiology meeting; doctors there recommended limiting use of Vytorin and Zetia to patients who'd tried a host of other alternatives. So it's not surprising that April scrips dropped so dramatically. Year over year, first-quarter sales of the meds rose about 6 percent to $1.2 billion, a big slowdown from the 30 percent growth in 2007.

- read the CNN Money article

U.K. aims to put 1.5M on preventive statins

Tracy Staton — Wed, 28 May 2008 10:03:15 -0400

New U.K. guidelines for heart-attack prevention could be a major windfall for statin-makers. The National Institute for Health and Clinical Excellence wants docs to search their patient rolls for people over 40 at risk of heart attack and stroke--and put them all on the cholesterol-fighting meds. According to agency estimates, 1.5 million more people would thus be added to the millions who already take statins, preventing 15,000 heart attacks, strokes, and angina cases per year.

The caveat: All the patients turned up during this hunt for heart risk will be put on simvastatin, which of course is a generic form of Zocor. So the intitiative is not likely to aid brand-name drugmakers. But if the idea spreads, the likes of Lipitor and Crestor may end up sharing the wealth.

- see the story in the Telegraph
- read the BBC coverage

McCain among patients switched off Vytorin

Tracy Staton — Tue, 27 May 2008 10:35:10 -0400

SPOTLIGHT: McCain among patients switched off Vytorin
Count Sen. John McCain's prescription for Vytorin among the Enhance study casualties. After the study was presented at the American College of Cardiology meeting--and the New England Journal of Medicine recommended that Vytorin only be used as a cholesterol fighter after trying several other alternatives--McCain's cardiologist switched him to simvastatin, a Zocor generic. (Zocor, remember, is one component of the Vytorin combo drug, which also includes Zetia.) His "bad" cholesterol went up then, to 123 from 83, but his docs appear to be satisfied with that. Other cardiologists say the presidential candidate should be on a higher dose of simvastatin or try another, more potent statin. Report

Should Hassan forfeit $13 million?

Tracy Staton — Mon, 19 May 2008 10:22:17 -0400

Should Fred Hassan (photo) give back his bonus? That's what Forbes is asking this week, saying that the Schering-Plough CEO's 2007 compensation package was probably artificially inflated by the fact that sales-damaging study results were held back until early January 2008. If the Enhance study--which pitted Merck/Schering-Plough's big moneymaker Vytorin against the now-off-patent Zocor--had been unveiled in November 2006 or March 2007 as cardiologists had long expected, Hassan might not have received $13 million of his cash compensation over those two years. The trial, you'll recall, showed that the Zocor-plus-Zetia combo Vytorin was no better than Zocor alone at preventing artery-clogging.

Here's how Forbes figures it: Hassan got $19 million in bonuses in 2006, including $9 million in cash, based largely on a Vytorin-fueled increase in Schering's market cap. The Enhance results probably would have eaten into that gain. But it's more likely that the study might have been ready for prime time in 2007, when Hassan got $4 million in cash bonus. If the study results simply stalled Vytorin and Zetia sales, Schering's EPS could have dropped to as low as $1.05 from 2007 actuals of $1.37. That would have wiped out $2 million of Hassan's cash bonus. If sales dropped, the hit would have been even bigger.

Schering protests, and rightly so, that this sort of hindsight isn't exactly 20/20. The company probably would have cut costs to minimize the EPS drop, for instance. And the company justifies the bonuses because it needs to hang onto its executive talent. But one corporate governance expert told Forbes that Hassan of all people might be one to give up a bonus under these circumstances. "[G]iven Hassan's reputation for open-mindedness in terms of compensation...if there were some doubts about whether he should receive a bonus, he would be more likely than others to voluntarily forfeit it. There are not many CEOs I'd say that about, but he would be one of them."

- see the Forbes article

Cholesterol drug market shifts

Mon, 12 May 2008 06:59:58 -0400

Big-name cholesterol meds are losing ground on two fronts. First, the Pfizer cholesterol drug Lipitor--its biggest seller--is falling victim to cost-cutting in the U.K. Primary Care Trusts are steering patients off the brand-name statin and onto simvastatin (generic Zocor). Lipitor scrips written by GPs dropped by 15 percent in 2007, or about $103 million. That's bad news for Pfizer--but also for other drugmakers, Pharmafocus notes, because it shows that the trusts are exercising their influence over prescribing habits.

Second, sales reps pushing Vytorin--the Merck/Schering-Plough combo pill that's attracted so much negative press lately--have been failing to get doctors' attention. Instead, Abbott's Simcor is turning heads. Twenty-three percent of primary care docs and cardiologists are listening to Simcor pitches, versus 20 percent for Vytorin. And despite the fact that Simcor was just launched, it's rapidly gaining ground on the popular Vytorin, nabbing one-third the number of scrips Vytorin did last month.

- see the Pharmafocus story
- check out the item at Pharmalot

ALSO: Back in 2003, when Abbott Laboratories raised the price of its Norvir AIDS drug, at least one company exec worried that the price hike might spur federal investigations, according to newly unsealed court documents. And of course, he was right. Report

U.S. Attys probe Schering over Vytorin

Wed, 07 May 2008 06:59:55 -0400

The ranks of investigators probing Schering-Plough and its Vytorin drug are broadening. In a recent SEC filing, Schering disclosed that U.S. Attorneys have been asking for info and documents related to the controversial Enhance trial, which pitted the combo cholesterol drug Vytorin against partner Merck's statin drug Zocor.

That trial, as you know, has been under scrutiny for months now as Merck/Schering-Plough dragged its feet in releasing the results, considering changing its primary endpoint, and then finally reported that Vytorin performed no better than Zocor alone at treating arterial clogging (though it did a better job of lowering bad cholesterol).

Details of the U.S. Attorneys' probes are scant; at this point, all we know is that another government official (or two or more, we don't know how many) has joined the investigatory fray. It's already well crowded with Senators, Congressional committees, state attorneys general and the like. We'll keep you posted.

- see the Pharmalot item
- check out the Shearlings Got Plowed dissection of the 10-Q filing
- read the filing itself at the SEC website

Office upholds Pfizer's Lipitor patent

Thu, 01 May 2008 06:59:54 -0400

Pfizer is breathing a big sigh of relief. The U.S. Patent & Trademark Office has said it will confirm the drugmaker's basic patent on the blockbuster Lipitor drug. The office had been re-examining the patent in response to a request by Indian generics maker Ranbaxy Laboratories.

It's been a long road for Pfizer, fighting Ranbaxy's patent challenges on Lipitor. The company has grappled with the generics maker in multiple U.S. court cases over Lipitor--and won. This patent confirmation finally appears to shut the book on Ranbaxy's challenges, in the U.S. at least. Until March 2010, when that patent actually will expire.

Ranbaxy has been more successful with its Lipitor challenges in other countries. It prevailed in Norway, and in Canada it and other generics makers defeated Pfizer at the lower court level (Pfizer appealed). But Pfizer's biggest Lipitor challenge actually isn't in any court--it's Zocor, the now-generic statin. Generic-switching has been eating into Lipitor's sales; they dropped by 13.6 percent year-over-year through April 18.

- see the brief in BusinessWeek
- check out Motley Fool's take
- read CNN Money's assessment of Lipitor sales

Fissures in Merck, Schering relationship?

Thu, 24 Apr 2008 06:59:58 -0400

Are fault lines in the Merck/Schering-Plough joint venture beginning to open up? Market-watchers are reading the earnings-call transcripts--and the tea leaves--and finding evidence of "the diverging interests of Merck... and its partner."

Part of the problem is that Merck depends less on Vytorin revenues than Schering does. Merck was perfectly willing to admit that it expects a $700 million hit on Vytorin this year, but Schering danced around that prospect like a fire-walker. "We really have no model" for figuring out how much Zetia and Vytorin sales might drop, Schering CEO Fred Hassan told analysts during his earnings call yesterday. A big company like Schering, with plenty of financial types at its disposal? Color the pundits skeptical

Plus, as Forbes points out, Merck is hoping to launch a new heart med this year, Cordaptive, a tweaked form of niacin that could be an add-on to statins--just as Schering's Zetia is. Imagine patients taking Merck's Zocor--one half of Vytorin--along with Cordaptive instead of Zocor-plus-Zetia, otherwise known as, yes, Vytorin. Why would Merck mind that? Schering, on the other hand, would mind it quite a bit.

The "trouble in Merck/Schering-Plough land" chatter must have some traction, because Merck CEO Richard Clark (photo) addressed it in a Star-Ledger interview published today. The fallout from the controversial Enhance study "won't result in any changes" to the partnership, the Star-Ledger reports. "The joint venture is well-managed," Clark said. "This was an unfortunate outcome."

- see the Forbes article
- check out the item at BNET's pharma blog
- read the Star-Ledger piece

Vytorin news buried in Merck report

Tue, 22 Apr 2008 06:59:57 -0400

Read deep into Merck's first-quarter earnings report and you'll find some Vytorin secrets spilled. First off, the company expects to lose some $700 million in revenues off the blockbuster cholesterol drug, which has been dropping off, scrips-wise, since the big Enhance announcement in January (you remember all that news). This is the first time we've seen a real number applied to the potential sales slide. That figure might help a savvy prognosticator ballpark lost sales at Schering-Plough, which reports its earnings tomorrow; Schering is Merck's partner on Vytorin, a combo of Merck's Zocor statin and Schering's cholesterol-lowering Zetia pill.

Second, New Jersey's attorney general has issued subpoenas to Merck and Schering-Plough, probing the Enhance study, which found that Vytorin did no better at treating artery-clogging than Zocor did alone. The study results, remember, were delayed for some two years while the companies and their researchers wrangled with the data. New Jersey joins a queue of states and feds looking into that delay and the marketing of the expensive drug in the meantime. New York and Connecticut are investigating, as are two Congressional committees.

Meanwhile, another Enhance-related lawsuit has hit the courts--and this one is a civil suit filed under RICO, alleging racketeering-type fraud. Interestingly, this suit uses the e-mailed comments of Dr. James Stein, who hit the news last week when his criticism of some "meeting minutes" was released by one of the Congressional committees investigating the whole affair. The suit also includes letters and statements by Sen. Chuck Grassley, who's leading the charge for that committee.

- check out Pharmalot's New Jersey AG news
- see the RICO lawsuit
- view the CNBC video of CEO Richard Clark on Merck's Vytorin numbers

ALSO: Merck CEO Richard Clark says he's "aggressively looking" for the right biotech deal, but declined to identify any targets. He's said the same before, however, so there's no indication that anything is imminent. Report

Vytorin records created after the fact

Mon, 14 Apr 2008 06:59:58 -0400

Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Merck and Schering-Plough face new questions about their controversial Enhance trial as a Congressional committee releases documents that raise "serious concerns" about the companies' delay in reporting the results of that study, which showed that their high-priced combo drug Vytorin did no better at preventing artery-clogging than Zocor alone. The documents--unearthed by the committee in an ongoing probe of Enhance--show friction between Merck and Schering-Plough and questions about why the results weren't reported sooner. At one point, the tensions ran so high, a top Schering exec resorted to, shall we say, colorful language in an email.

But the most obvious question raised by the document dump is this: Why did the companies create minutes for a key meeting--in which experts and company execs discussed changing the study's primary endpoint--a month after the fact? Are those minutes inaccurate, as one participant in that meeting alleges? The minutes suggested that outside consultants recommended changing the endpoint--but James Stein, an imaging expert at the University of Wisconsin, said Merck and Schering-Plough made that choice. "We did not vote on this," Stein said in an email.

Meanwhile, some FDA documents have surfaced, showing just why Merck and Schering-Plough elected to pull Vytorin ads back in January. Apparently, the agency had been asking the joint venture to tone down the ads--which claimed superiority for Vytorin over statin therapy alone--at least since January 23. DTC promotions needed to be revised to show that "Vytorin has not been shown to provide any additional cardiovascular outcome benefits compared to using Zocor alone," the FDA letter said. Reps. John Dingell and Bart Stupak want to know what the company has done to comply--especially given that their deadline is April 24.

- see the M/S-P documents released by Congress (.pdf)
- read the story in Forbes
- see the Wall Street Journal article about the minutes
- check out the DTC item and FDA letters at Pharmalot

Related Articles:
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Congress: M/S-P sat on bad news. Report from Congress
Companies saw Vytorin threat in 2005. Vytorin report
Congress: Were Enhance results secret? Enhance report
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