"The unwarranted confusion in the U.S. about cholesterol management and about our product Vytorin/Zetia that started in January clearly had a big impact on this important franchise," said company Fred Hassan, Schering-Plough's CEO, during a conference call discussing the company's first-quarter earnings.
The drugs dominated talk during the call with analysts. The company's net income was $253 million, or 15 cents a share, down from $530 million, or 36 cents a share, from the same period a year ago. Company executives attributed the drop to charges related to the acquisition of Organon BioSciences last year. (Without the charges, the company said it would have had net income of $862 million, or 53 cents a share.)
Vytorin and Zetia sales were down 5% in the U.S. over the previous year. However, sales increased 46% in international markets, leading to an overall 6% gain for the drug, for a total of $1.2 billion in global sales for the first quarter. "You can expect us to continue our support of Vytorin and Zetia," said CFO Bob Bertolini. "They're strong global brands with continued safety, efficacy and tolerability profiles."
A study released earlier this year showed that Vytorin and Zetia are no more effective than better-known and older medications called statins (a category that includes drugs such as Lipitor and Zocor) at reducing LDL (or "bad" cholesterol). The study led the New England Journal of Medicine to editorialize that the two drugs should only be used after other options proved ineffective for patients.
Company executives countered those findings, saying press coverage of the results had been blown "out of proportion," according to Schering-Plough Research Institute president Tom Koestler, who noted efficacy and safety issues had not been raised from the study. "We stand behind our science and the science behind Vytorin and Zetia," he said.
"We are concerned the continued uproar undermines patient care," Hassan said. "Vytorin and Zetia continue to be valuable tools for cholesterol management. That is why we are committed to these treatments. And that is why we will continue to advocate their appropriate use."
Schering-Plough and Merck, which market the drugs under an equity arrangement, had pulled direct-to-consumer advertising for the drugs after preliminary results of the study were released. However, company executives would not say when DTC advertising for the drugs would resume.
"We are committed to continuing to provide full support [for the drugs] and continue to evaluate when is the right time to consider what to do next for DTC," said Carrie Cox, president of global pharmaceuticals. "We are very committed to patient education and to continue to provide substantial support to physicians for patient education materials."