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Biodesix Partnering with Pharma/Biotech to Accelerate VeriStrat Adoption

By Tony Fong

NEW YORK (GenomeWeb News) – Biodesix is progressing on its plans to partner with pharmaceutical and biotechnology firms to drive adoption of its VeriStrat test, a company official told GenomeWeb Daily News last week.

A year ago, the Broomfield, Colo.-based firm said that in order to increase commercial adoption of the proteomic test, it would seek to collaborate with biopharmas interested in using the test to identify non-small cell lung cancer patients likely to respond to EGFR inhibitors.

Last week, on the sidelines of the JP Morgan Healthcare Conference in San Francisco, Paul Beresford, vice president of business development and strategic marketing, told GWDN that Biodesix now has 14 deals with pharma/biotech and 26 other potential deals in various stages of proposal development and negotiations.

The deals, both some already forged as well as others being considered, include contracts to use VeriStrat's underlying mass spectrometry-based platform to develop new tests.

In one of the company's first collaborations with a drug firm, it conducted a study with GlaxoSmithKline that compared a regimen of GSK's Tykerb (lapatinib) plus Femara (letrozole) with a regimen of just Femara, which is marketed by Novartis.

The phase III study, which used serum samples from 1,041 patients, found that VeriStrat could predict differential treatment effect between patients who were classified as either VeriStrat Good or VeriStrat Poor.

The study was directed at breast cancer and the results were presented at the 2011 San Antonio Breast Cancer Symposium. It included Her2-positive and Her2-negative patients, and in the Femara/placebo treatment arm, VeriStrat Good patients had a median progression-free survival of 10.8 months, compared to VeriStrat Poor patients who had a PFS of 2.8 months.

In the Femara/Tykerb arm, VeriStrat Good patients had a PFS of 11.4 months, while VeriStrat Poor patients showed PFS of 11 months.

Biodesix and GSK are currently engaged in an "interesting dialogue," Beresford said. Tykerb is toward the "tail end" of its life cycle and a greater opportunity for Biodesix may be use of VeriStrat for Femara.

He added that the results of the study have "certainly borne out our pharma strategy to a certain extent."

As it concentrates on pharma/biotech partnerships, Biodesix has stopped doing fee-for-service work.

"We don't want to be seen as this … fee-for-service agnostic company. We want to be seen as a biotech that's focused on developing and commercializing diagnostic tests, so we're really working only in the collaborative model," Beresford said.

Biodesix has focused much of its work on developing VeriStrat as a diagnostic for NSCLC, though it also is developing tests for other indications such as head and neck cancer, breast cancer, and pancreatic cancer.

Companion diagnostics are gaining ground in the NSCLC market. During the summer, the US Food and Drug Administration cleared a companion diagnostic from Abbott for Pfizer's NSCLC drug Xalkori (crizotinib), which inhibits the anaplastic lymphoma kinase. Abbott's test detects rearrangements of the EML4-ALK gene to identify patients that are likely to respond to the drug.

The VeriStrat test targets a different pathway, EGFR, which Beresford said affects about 80 percent of patients in the US with NSCLC. Patients who are EML4-ALK wild type but have EGFR mutations may benefit from other drugs, such as Genentech's Tarceva, after they have already received chemotherapy.

"We've been able to work in that second- and third-line setting to have doctors use that as part of their clinical decision-making on how to delineate which therapies [target] the mutation," he said.

Biodesix has had discussions with FDA about VeriStrat and expects to file for clearance from the agency, Beresford said

He said that clinical adoption of VeriStrat, which was launched as a laboratory-developed test in the company's CLIA lab in May 2009, is still in its early stages, and he declined to provide revenues for the test. But during the past year, Biodesix saw "tremendous uptake" of the test and it expects to "double or triple" adoption in the coming year, contingent on the publication of data stemming from a prospective trial conducted by partners in Italy assessing VeriStrat's ability to predict response to EGFR-tyrosine kinase inhibitors.

Biodesix has a sales force of 20 and anticipates adding another 10 to 20 sales people if the ongoing studies have positive outcomes.

Discussions with private payors and with the Centers for Medicare and Medicaid Services are also ongoing, Beresford said. The firm has coverage decisions with two private payors and on average is reimbursed at full price 20 percent to 30 percent of the time. Biodesix expects a CMS reimbursement decision in 12 to 18 months.

In June the company raised $20 million in a Series D financing round and anticipates raising another round during this summer. While the exact amount is still to be determined, Beresford said that another $20 million may be targeted, the bulk of which will be directed toward continued commercialization efforts of VeriStrat.

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