Myriad Genetics (MYGN) has entered into an agreement with BioMarin Pharmaceuticals (BMRN) to conduct BRCA1 and BRCA2 mutation testing on patients to be enrolled in the latter’s phase I/II clinical study of BMN 673. BMN 673 is a PARP-inhibitor drug candidate for treatment of genetically defined cancers.
Bracanalysisis Myriad’s flagship product, contributing 89% of total revenue. This test provides a comprehensive analysis of BRCA1 and BRCA2 genes for assessing woman’s risk of hereditary breast and ovarian cancers. Under the agreement, the company will carry out Bracanalysis test to identify the presence of germline mutations in the patients prior to enrollment in the study. Accordingly, it will provide standard test reports to the clinicians.
Myriad is aiming at establishing itself as a strong player in the companion diagnostic market. To establish Bracanalysis as a companion diagnostic for PARP inhibitors, Myriad has got into agreements with Abbott Laboratories (ABT) and AstraZeneca (AZN). PARP inhibitor is a promising oncology drug candidate under development and these drugs could be on the market in the 2012-2013 timeframe.
At present, Bracanalysis targets about a third of newly diagnosed and recurrent cases of breast cancer. However, Myriad believes that any woman being considered for a PARP inhibitor would be tested for the presence of BRCA mutations to check if she would respond to the drug. As a result, the targeted population would increase to include all women who would be appropriate for chemotherapy, bloating up the oncology market.
In January 2011, Sanofi-Aventis (SNY) announced disappointing results for iniparib from a phase III study conducted with 519 women suffering from metastatic triple-negative breast cancer (mTNBC). Results showed that iniparib failed to prolong overall survival and progression-free survival in these patients. While this comes as a setback for PARP inhibitors, AstraZeneca is progressing with a phase III clinical study in ovarian cancer where the enrollment criteria will be based on BRCA status.
We are currently Neutral on Myriad, which also corresponds to the Zacks #3 Rank (Hold) in the short term.
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