Vytorin

Drop in Vytorin scrips slows

Tracy Staton — Mon, 23 Jun 2008 09:40:33 -0400

Has the Vytorin prescription drop leveled off? The most recent data shows that scrips for the Merck/Schering-Plough cholesterol med only dropped 1.1 percent in May, month-over-month, to 2.5 million. By contrast, the decline was 11 percent from March to April and 23 percent since January. That's when the ill-fated Enhance trial data was released, showing the combo Vytorin--a mix of simvastatin and Zetia--was no better than simvastatin alone at slowing artery-hardening.

The numbers took a big initial hit--13 percent in February, month-over-month--but rebounded a bit in March until the American College of Cardiology meeting, where an expert panel recommended using Vytorin only after a host of other cholesterol meds proved ineffective. That led to the drop in April, and to an aggressive cost-cutting program at Schering-Plough, whose revenue depends heavily on Vytorin and Zetia.

- find the Schering-Plough FAQ for investors
- read the Wall Street Journal story

Hassan's advice for hard times

Tracy Staton — Fri, 20 Jun 2008 09:48:49 -0400

When the interview subject is adversity, who better to question than Schering-Plough's Fred Hassan, who's seen his share this year? BusinessWeek chatted with the Schering CEO about dealing with hard times, and he delivered some familiar words about tough times making people stronger. One key, Hassan says, is facing up to problems instead of ignoring them or submitting to "a downward spiral of complaining and commiserating." Another: seeking help from colleagues.

For anyone who's followed the whole Vytorin-Zetia-Enhance series of unfortunate events, the advice is familiar. When the American College of Cardiology meeting yielded advice against Vytorin--one of Schering Plough's biggest moneymakers, in partnership with Merck--Hassan didn't waste time. He asked Schering's key execs for their input and came up with a cost-cutting plan to help make up the revenues Schering was sure to lose to falling Vytorin sales. We suppose that qualifies as facing up to a problem. Maybe Hassan wishes he'd faced up to the original problem--releasing the not-too-flattering data on Vytorin from the Enhance study--a little sooner than he did.

- read the Business Week interview

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

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

AMA calls for tighter DTC regulation

Fri, 09 May 2008 06:59:57 -0400

We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. We expected Chairman Bart Stupak to call for tighter controls on the ads. What we didn't expect was for the American Medical Association to join the fray. President-elect Nancy Nielsen told lawmakers that the FDA should be given more authority to pre-approve DTC ads. Striking directly at drugmakers' usual defense of the ads as "educational," Nielsen said, "It is frankly clear that the majority of what's happening has a marketing effect and not an educational effect."

Nor did we know that the feds' own watchdog, the Government Accountability Office, would say the FDA isn't completely effective at regulating those ads; the agency takes more than six months to issue warnings about ads that violate the rules.

During the hearing, ads such as those for Merck/Schering-Plough's Vytorin and Johnson & Johnson's Procrit were called misleading and not completely truthful. Pharma officials struck back, saying that the claims made in those ads were "supported by research" (M/S-P) and "true, responsible, and substantiated by scientific studies" (J&J). And Republicans on the committee said the (unfunded) standards Congress set last year for drug commercials should be paid for and given a chance to work.

- read the AMA's press release
- see the story from ABC News
- check out the USA Today piece
- read the Star-Ledger article

ALSO: The feds need to add rules governing drug product placements, too, according to a report from University of California-Los Angeles researchers. Report

Will DTC hearing lead to new regulation?

Thu, 08 May 2008 06:59:56 -0400

Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak (photo) hopes. The chairman of the House Energy and Commerce's subcommittee on oversight says he'd like to tighten controls on drug marketing to consumers. For one thing, he'd give the FDA power to force changes in TV ads before they're aired.

Of course, Congress has tried before to stiffen DTC rules, but the TV industry--which reaps billions from the ads--and pharma lobby have fended off those changes. But several recent controversies may aid the reform cause this time. Merck and Schering-Plough have drawn fire for heavily promoting their Vytorin cholesterol drug while dragging their feet on data that questioned its effectiveness. Pfizer pulled its Lipitor campaign when critics assailed its use of artificial-heart inventor Robert Jarvik. And then, says Stupak, there's Johnson & Johnson, which advertised its anemia med Procrit as an anti-fatigue drug, a use for which it was not approved. The FDA repeatedly asked J&J to revise those commercials, but the company didn't. Stupak told the Wall Street Journal: "They advertised this for seven years."

J&J disputes that assertion, saying that the commercials were accurate and consistent with their FDA-approved labeling at the time. But expect to hear more argument of these points during today's hearing, which you can watch on the committee's website, among other places.

- see the Wall Street Journal article
- find the video link at the committee website

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

Merck to cut 1,200 sales reps

Tue, 06 May 2008 06:59:58 -0400

The axeman cometh to Merck's sales force. The drugmaker plans to lop off about 15 percent in the sales ranks, or 1,200 jobs. The fact that it's not alone in trimming back on reps--Wyeth just announced it would slash its sales force by 1,200--likely isn't much comfort to Merck's rank-and-file.

The reasons for the cuts probably aren't comforting either, though they're as obvious as the signature on a letter from the FDA. The agency just refused to approve Cordaptive, a cholesterol med Merck was hoping might grow to blockbuster status. And then there are the lingering Vytorin woes: Since the Enhance study results were first announced in January, sales have fallen off significantly, though they did manage a 1.6 percent year-over-year increase in the first quarter. Plus, the company says that it's completed the launch of eight meds and vaccines since 2006, and is scaling back the sales forces for those products. Which means, in essence, that there's a lull in new launches.

The cuts are part of an ongoing cost-control program, the company said in announcing them. But "with an unexpected delay in a new product approval," the company decided to accelerate their pace. Reps will be notified by the end of the month whether they're to stay or go.

- see Merck's release
- check out the item in the Wall Street Journal Health Blog
- read the the WSJ article