After Roche Diagnostics last week released to Epigenomics the rights to develop a breast cancer recurrence test on which the two companies had been working jointly since 2002, Epigenomics finds itself on new and possibly more difficult footing in its bid to compete with Genomic Health's Oncotype Dx.
Epigenomics, based in Berlin, Germany, is among a small number of companies attempting to play in Oncotype's narrow market, which includes deducing the risk of disease recurrence in early stage, post-surgery breast cancer patients with node-negative, estrogen-receptor positive tumors, Oliver Schacht, Epigenomics CFO, told Pharmacogenomics Reporter this week.
"It's exactly the same medical question, and the question basically is, 'A woman following surgery is always going to get either tamoxifen or in the future aromatase inhibitors. Would [she] also require chemotherapy to prevent relapse, or could you do without the chemotherapy because the risk of relapse is really very small?'" he said.
Without Roche, Epigenomics may now have to compete with a very promising prime mover in breast cancer: Oncotype Dx. But the company appears to have absorbed the regulatory lesson that Genomic Health may now be learning with its test after receiving a letter from the FDA asking to talk about Oncotype Dx's place in the market as a diagnostic. [see 2/1/2006 PGx Reporter]
Our goal is to develop [methylated-DNA markers] into a kit."
Epigenomics said it definitely intends to achieve pre-market in vitro device clearance from the US Food and Drug Administration as well as Medicare reimbursement only the latter of which was obtained by Genomic Health for Oncotype Dx and it may choose to avoid first offering the test through a CLIA laboratory, as Genomic Health has done.
"Our goal is to develop [methylated-DNA markers] into a kit," Schacht said. "We believe this will require a class III medical device," which requires pre-market approval.
To be sure, the company is evaluating three options to initially launch its test: the CLIA route, in which the company would offer its test through a certified lab before attempting FDA clearance; an analyte-specific reagent route, in which Epigenomics would sell its reagents to a reference lab that would create its own diagnostic product; or directly through the PMA route with FDA clearance, said Schacht.
Approximately 200,000 women in the United States are diagnosed with early-stage estrogen-receptor positive, node-negative breast cancer every year, all of whom may benefit from Epigenomics' test, said Schacht.
The company will be watching the progress of Genomic Health as it responds to the FDA's recent request to discuss the regulatory status of Oncotype, Schacht added.
Genomic Health's experience may also embolden other diagnostic makers by illuminating a viable market. When a Medicare contractor last month agreed to reimburse the Oncotype Dx, it showed that "the medical need is clearly there, and insurance companies are willing to reimburse the cost for running those types of tests," said Schacht. [see 1/18/2006 PGx Reporter]
Still Allied With Roche
Epigenomics' association with Roche is not entirely at an end. The companies continue to work together on blood-based tests for early detection of colon, prostate, and breast cancers, said Schacht. Epigenomics has been handed the rights for the firm's other tissue-based project with Roche, which is a prostate-cancer profiling test, he said.
"We're going to be running full clinical trials on the prostate and the breast products here over the next 18 to 24 months," he added. "Our goal is to have FDA-approved in vitro diagnostic products on the market by 2008."
Duties for which Roche would have been responsible on the breast cancer test, including regulatory filings and clinical development, will now be absorbed by Epigenomics. The company, which employs 145 staffers, will look for partnerships for manufacturing and platform development, as well as for conducting clinical trials, said Schacht. Under the original agreement, tests emerging from the partnership with Roche were to be incorporated into PCR- and microarray-based assays, the companies said in a statement. "There are existing IVD devices that we can use," said Schacht.
Schacht declined to disclose any financial details involved in Roche's decision to surrender the rights to the companies' breast cancer test, including whether Epigenomics would no longer be receiving funding from the Swiss diagnostics giant.
Under the terms of the original agreement, penned in September 2002, Roche made an upfront payment of €4 million ($4.8 million) and provided R&D funding, milestone payments, and royalties on product sales. For Epigenomics, the total value of the original agreement could exceed €100 million, according to a March 2003 statement about the deal.
In an update of the agreement announced in February 2004, the companies expanded the number of samples to be studied for each diagnostic under development. Epigenomics was to receive additional R&D payments of up to €2 million, "the first tranche of which [had] already been committed with the initiation of transfer to Roche of the Breast Cancer Tamoxifen Response Test, which is the first one currently undergoing this expanded process," the companies added.
Chris Womack ([email protected])
As Genomic Health had with its breast cancer recurrence test Oncotype Dx, Epigenomics is initially describing its diagnostic as a test to predict patients' response to the drug tamoxifen.
"Tamoxifen response is what we originally set out to develop," according to Oliver Schacht, Epigenomics CFO. "There are two potential reasons for why a patient might relapse. One is that she doesn't respond to tamoxifen alone, and so you need additional chemo. The other [reason] could be simply because the cancer is more aggressive. It's virtually impossible to tell the two apart, so even under the Roche agreement, those two were merged into one. So it's a breast cancer classification/treatment-response test," he said.
Schacht said his company's focus on DNA-methylation markers is an advantage over Oncotype. Epigenomics' test uses "between one and three" DNA methylation markers, versus Oncotype's 21-gene expression profile, and should be less expensive, he said. Also, the DNA examined in Epigenomics' test is more stable in paraffin-embedded tissue than is the RNA that Oncotype measures.
Schacht said he could not yet estimate the cost of a single test with his company's diagnostic. The Oncotype Dx list price is $3,460, and a Genomic Health spokesperson declined to speculate whether the price would change over time.
In November, Genomic Health CEO Randy Scott told Pharmacogenomics Reporter: "There's one clear competitor that's in the market today, and that's Agendia." The Dutch company's MammaPrint assesses the risk of recurrence in node-negative patients whose breast cancer is either estrogen receptor positive or negative using a 70-gene profile. The Molecular Profiling Institute, the commercial arm of the Translational Genomic Institute, has an exclusive license to provide the MammaPrint breast cancer prognostic in the United States.
MammaPrint costs about $2,196 per test in Europe, and it will sell for approximately that amount when marketed in the US through MPI, according to Pharmacogenomics Reporter sister publication BioArray News.
In an interview this week, a Genomic Health spokesperson declined to designate any products as serious competitors of Oncotype. "There are others out there conducting studies," she said. But "we're not aware of any company that has clinically validated its work in multiple trials, and can provide the supporting data to compete with Oncotype Dx," she added.