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Schering-Plough Hopes Duke Biomarker Finding will Yield Companion Dx for HCV Rxs

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By Ben Butkus

This article was originally published on Aug. 18.

Schering-Plough owns the intellectual property rights to a genetic marker discovered in collaboration with Duke University researchers that is designed to help predict how patients with hepatitis C respond to certain treatments, a Schering spokesperson said this week.

In addition, the company is contemplating how it might be able to further develop and market a diagnostic based on the biomarker to accompany its current marketed interferon-based HCV treatment, the spokesperson said.

"We are looking at all sorts of options for developing a test and making it available," the spokesperson told BTW this week. "We realize the importance of making such a test available for physicians and patients."

Schering Plough owns the rights to develop diagnostic products based on the biomarker because it funded the biomarker-discovery project through its Schering Plough Research Institute arm, the spokesperson said.

Schering-Plough has little experience in diagnostics or personalized medicine. However, the company's looming merger with Merck may provide an entrée into the market. Last week, Merck shareholders voted overwhelmingly to approve the estimated $41 billion merger between the companies, which is expected to close sometime in the fourth quarter.

As reported by BTW sister publication Pharmacogenomics Reporter, Merck has increased its personalized medicine play in the past two years, a company official told attendees of a diagnostics conference last week, adding that collaborations between drug and diagnostics companies are "a method for success during an economic crisis" (see PGx Reporter, 8/12/2009).

Still, the official also said that it is "early days" at Merck for developing drug/diagnostic combinations; and the only two Rx/Dx partnerships disclosed by the company in the past two years have been in the area of cancer.

Schering-Plough has more than a passing interest in the genetic marker, however. The company markets peginterferon alfa-2b, also called PegIntron, in combination with ribavirin as an approved therapy for HCV, which affects an estimated 170 million people worldwide.

However, the treatment, which has a 40-percent cure rate, is expensive, takes four months to administer, and can lead to serious side effects in some individuals.

"The side effects of hepatitis treatment can be brutal, and about half the time, the treatment fails to eradicate the virus," David Goldstein, director of the Center for Human Genome Variation in Duke's Institute for Genome Sciences and Policy, and senior author of the biomarker study, said in a statement.

"This discovery enables us to give patients valuable information that will help them and their doctors decide what's best for them," Goldstein added.

"Being able to identify people with a higher likelihood of having a favorable outcome is very important," John McHutchison, associate director of Duke University's Clinical Research Institute, and co-author on the biomarker study, told BTW sister publication GenomeWeb Daily News this week.

Goldstein, McHutchison and colleagues at Duke collaborated on the research with researchers from Schering-Plough and Johns Hopkins University as a follow-on to an earlier study that assessed the effectiveness of various HCV treatment regimens. The results of that work appeared earlier this month in the New England Journal of Medicine.

"Schering Plough has been involved in developing new treatment regimes for HCV, and we sought out the Duke investigators because of their genomic experience," the Schering-Plough spokesperson said. "From the beginning, we discussed with the two lead authors [at Duke] the potential of looking at the genetic underpinnings of treatment."

The HCV biomarker study, which appeared this week in the advance online version of Nature, was funded by the Schering-Plough Research Institute, Schering-Plough's human pharmaceutical research unit.

The researchers conducted a genome-wide association study on nearly 1,700 individuals with HCV genotype 1, which accounts for about 70 percent of HCV cases in the US, looking for differences in treatment outcomes with current interferon therapies. They found a strong association between a SNP near the interferon-lambda-3 gene IL28B and treatment response.

The scientists will now investigate whether the SNP is a marker for other important genetic changes or whether the change itself directly influences treatment outcomes; and whether a similar correlation exists in patients infected with genotypes other than the HCV genotype 1.

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