Healthy Skepticism Library item: 12419
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Publication type: news
Krauskopf L, Caney D.
Schering, Merck cholesterol drug misses goal
Reuters 2008 Jan 14
http://www.reuters.com/article/rbssHealthcareNews/idUSN1457434220080114
Full text:
Merck & Co and Schering-Plough Corp said on Monday their shared Vytorin cholesterol treatment failed to significantly halt clogging of arteries better than an older generic drug.
Schering-Plough, which depends more on the widely used Vytorin, fell more than 6 percent, while Merck shares dropped 2 percent.
Vytorin’s failure to prove greater effectiveness in this measure over Zocor — which is available in cheaper generic forms — could hurt its standing in the hotly competitive market for cholesterol treatments.
“In an era where there are cost-control pressures, if you can’t prove better efficacy, the value proposition gets questioned,” Miller Tabak analyst Les Funtleyder said.
The closely-watched trial examined Vytorin — which combines the companies’ Zetia drug with Merck’s older Zocor drug — against Zocor alone in demonstrating plaque regression and cholesterol lowering. Patients in both groups received a high dose of Zocor.
The 720-patient Enhance trial tested the drugs in patients with a rare genetic predisposition to dangerously high cholesterol levels.
There was no statistically significant difference between treatment groups for the main goal, which was the change in thickness in the carotid arteries that feed blood to the brain, the companies said.
“It is disappointing, but it was a high hurdle testing patients that started out with such high levels” of “bad” LDL cholesterol, Schering-Plough spokeswoman Mary-Fran Faraji said.
Patients in the trial began with LDL levels of at least 318 milligrams per deciliter, several times higher than target cholesterol guidelines.
The trial has garnered intense investor interest because Vytorin and Zetia have annual sales of about $5 billion, and are important to future earnings growth of the companies.
The results could make it tougher for the companies to make the case for spending more on Vytorin over generic cholesterol drugs, Edward Jones analyst Linda Bannister said.
“People are concerned about near-term prescription growth for Zetia and Vytorin,” Bannister said. “People will wonder if (they are) getting any bang for the buck here.”
Vytorin did show it was significantly better at reducing “bad” LDL cholesterol, cutting it by 58 percent, compared with 41 percent for just Zocor. And overall rates of serious side effects were similar, the companies said.
The companies plan to release complete results from the trial at a medical meeting in March.
Despite the sell off, several analysts predicted the results would eventually benefit Merck and Schering-Plough because no major safety problems emerged in the trial, lessening concerns hanging over Vytorin and Zetia.
Natixis Bleichroeder analyst Jon LeCroy also said in a research note that other big-selling cholesterol drugs have continued to fare well despite having failed to reduce plaque in arteries.
However, Pfizer Inc’s Lipitor cholesterol drug in a smaller trial unveiled in 2001 did slow build-up of plaque in the carotid arteries, Schering-Plough’s Faraji said, although the type of patients and the study design were somewhat different.
Schering-Plough shares were off $1.82, or 6.6 percent, at $25.91, while Merck’s shares were down $1.24 at $59.31, both on the New York Stock Exchange.
Schering-Plough shares had been one of the industry’s highest fliers in 2007, but retreated toward the end of the year amid investor concern about disclosures that the companies changed the Enhance study’s primary goal even as the study was under way.
U.S. lawmakers in December said they would investigate allegations that Schering-Plough and Merck withheld data from the trial, which was completed in April 2006.
