On October 1, 2013 Myriad Genetics reported that BioMarin Pharmaceutical Inc. will use Myriad’s BRACAnalysis test in connection with its pivotal Phase 3 clinical studies for BMN 673. BMN 673 is a novel, orally-active PARP inhibitor designed to induce synthetic lethality in BRCA-deficient cells (Press release, Myriad Genetics, OCT 1, 2013, View Source [SID:1234502303]).
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Myriad will collaborate with BioMarin to deliver BRAC testing for its pivotal clinical studies. As required by the U.S. Food and Drug Administration, Myriad also submitted an Investigational Device Exemption (IDE) to the FDA that will allow for BRACAnalysis testing to be used as a companion diagnostic to stratify patients in the BMN 673 clinical program. Additional terms of the deal were not disclosed.
"Companion diagnostics are a major focus of our business and are increasingly being integrated into drug development programs," said Mark C. Capone, president of Myriad Genetics Laboratories. "BRACAnalysis has shown promise as a companion diagnostic, and we are actively collaborating with BioMarin to identify responders and non-responders to therapy with BioMarin’s novel PARP inhibitor."
"Through our experience working with the Myriad BRACAnalysis test in our Phase 1 trial for BMN 673 in solid tumors, we appreciate the investment that Myriad has made in developing this assay and understanding its use," said Len Post, vice president, Chief Scientific Officer Drug Discovery at BioMarin. "Identifying the right patients to enroll in our Phase 3 study for BMN 673 in BRCA breast cancer will be critical in answering important scientific questions about the safety and efficacy of the compound in this select population."