By Turna Ray
In line with previously stated goals to grow its product portfolio and diversify its revenue base, Myriad Genetics this week said it is putting more marketing muscle behind Prolaris, its multi-gene prostate cancer assay.
Following positive data from several studies showing that Prolaris can distinguish whether a patient has a less aggressive form of prostate cancer or aggressive disease, the company has decided to double its urology sales team. These 20 reps will market Prolaris to physicians and payors.
During an earnings call with analysts this week, Myriad Genetics Laboratories President Marc Capone said that Prolaris has demonstrated strong predictive power in both biopsied and post-prostatectamy tissues. The company and collaborators are evaluating the test in four studies and three ongoing trials, comprising 3,000 patient samples.
At the American Society of Clinical Oncology's annual meeting last year, researchers from the Wolfson Institute of Preventative Medicine, St. Bartholomew's Hospital, Thames Cancer Registry, and Myriad investigated the utility of Prolaris's 46-gene cell cycle progression score in predicting outcomes in UK patients diagnosed with prostate cancer by needle biopsy who are monitoring their disease by watchful waiting (PGx Reporter 6/15/2011).
Based on the results of this study, the investigators concluded that "for patients managed by active surveillance, the Prolaris score is the strongest predictor of cancer death outcome yet described." Myriad's assay may provide independent prognostic information "valuable in the management of prostate cancer," they wrote in an abstract.
Capone noted in this week's call that this study, PRO-003, has been accepted for publication in the British Journal of Cancer and will be published in the next three months.
Another study, PRO-004, for which Myriad researchers collaborated with investigators from the University of California, San Francisco, investigated Prolaris's utility in analyzing patient samples in the post-prostatectomy setting. This study has been accepted by the ASCO Genitourinary Cancer Symposium, occurring this week.
PRO-006, meantime, is a Phase IV prospective study that Myriad is conducting with an organization that includes community urologists. The trial is investigating how the distribution of Prolaris scores impacts physician treatment decisions. The findings of this study "will be useful for reimbursement discussions," Capone noted.
In Myriad's estimation, three recent events suggest that its sales force may be able to successfully convince physicians to adopt Prolaris and payors to reimburse for the test. "The first [signal] is the recommendation to suspend [prostate-specific antigen-based] screening until a test can distinguish between the indolent and aggressive forms of prostate cancer," Capone said.
The US Preventative Services Task Force last year reviewed available evidence and concluded that PSA screening led to little or no reduction in mortality during a 10-year follow-up period. Furthermore, the USPSTF found that such screening can cause "harms related to false-positive test results, subsequent evaluation, and therapy, including overdiagnosis and overtreatment."
A second market opportunity for Prolaris is "the removal of a digital pathology test from the market that had similar indications" as Myriad's test, according to Capone. Although Capone didn't name the digital pathology test, he noted that it had an order run rate of more than 10,000 samples per year. "Those users are looking for another solution," he said.
Last year, Yonkers, NY-based Aureon Biosciences closed operations and laid off all 95 of its employees. Aureon marketed two laboratory-developed prognostic tests for prostate cancer: Post-Op Px, a test that gauges patients' likelihood of post-prostatectomy disease recurrence by assessing cellular, clinical, and molecular factors; and Prostate Px+, a tissue-based test that assesses whether a patient's disease is likely to metastasize and therefore should be treated aggressively.
With Aureon going out of business, these tests are likely no longer available. Technology review documents from one major payor suggests that the company may have had difficulty garnering reimbursement for these diagnostics (PGx Reporter 10/12/2011).
Third, recently published clinical and health economic analysis suggests that adjuvant radiation is "seriously underutilized" in the post-prostatectomy setting for patients with aggressive prostate cancer. As such, a test that can pick out which patients have an aggressive form of the disease and therefore should receive radiation treatment would likely be seen as clinically useful by payors and physicians alike.
In addition to accelerating commercialization for Prolaris, Myriad in the last quarter also signed an exclusive licensing agreement for RAD51C, a gene associated with increased risk of hereditary breast cancer and ovarian cancer. Myriad told PGx Reporter last month that this IP could very well lead to a new diagnostic, further strengthening the company's hereditary breast and ovarian cancer franchise (PGx Reporter 1/25/2012)
Given these advances, Myriad CEO Peter Meldrum said this week that the company is "making progress on a number of fronts toward the goal set forth in our strategic plan to diversify across multiple disease indications and grow revenues both domestically and abroad."
Myriad's second-quarter revenue increased 22 percent to $122.8 million from $100.4 million in the year-ago period. The company's molecular diagnostic revenues increased 17 percent to $117.6 million, while companion diagnostic services, which Myriad garnered through its acquisition of Rules-Based Medicine in 2011, contributed $5.2 million in revenues.
Although BRACAnalysis sales still comprise the bulk – around 83 percent -- of the company's revenues, Myriad's other tests are beginning to see more traction in the market.
Revenue from the BRACAnalysis test in the second quarter was $101.4 million, a 14 percent increase over the year-ago period. Myriad's Colaris and Colaris AP tests comprised nearly 9 percent of quarterly revenues, netting $10.9 million, a 56 percent increase over the same quarter last year.
Myriad's second-quarter R&D spending increased 67 percent to $10.2 million from $6.1 million, and its SG&A expenses increased 17 percent to $51 million from $43.7 million. The company finished the quarter with $428.3 million in cash, cash equivalents, and marketable investment securities.
During the earnings call, Myriad officials increased the company's revenue guidance for 2012 to a range of between $465 million and $475 million. Previously, the company had projected fiscal year revenues of between $445 million and $465 million.
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