Genomic Health and Almac Group Enter Exclusive In-Licensing Agreement to Develop and Commercialize Anthracycline Chemotherapy Benefit Test for High Risk Breast Cancer

Genomic Health, Inc. and ALMAC GROUP Ltd jointly announced today that Genomic Health will exclusively license Almac Group’s technology and intellectual property to further develop, validate and subsequently commercialize a multi-gene test to predict benefit from DNA damage-based chemotherapy drugs, such as the commonly used anthracycline-based regimens, in breast cancer. Such a test would be particularly useful for high-risk breast cancer patients who are eligible for chemotherapy based on their Oncotype DX® score.

Genomic Health will identify a study cohort for the validation of Almac’s previously identified and published genes. Genomic Health made an up-front payment of $9 million dollars, which the company expects to expense in the fourth quarter of 2013, and will pay additional milestones as certain clinical and commercial endpoints are achieved in the future. Upon successful commercialization of the test, Genomic Health will pay additional royalties to Almac Group.

“Working with Almac, we have the opportunity to gain further insight on the role of DNA repair in drug efficacy, which may provide clinical utility to help select which breast cancer patients benefit from specific chemotherapy drugs and regimens,” said Steven Shak, M.D., Executive Vice President of Research and Development of Genomic Health. “Over the past ten years Oncotype DX has played a critical role in predicting benefit of chemotherapy, in general, for more than 400,000 estrogen-receptor positive breast cancer patients. This new test may address another unmet need by providing additional information specific to the benefit from anthracycline-based regimens for high-risk patients and possibly those with triple negative breast cancer as well.”

Anthracycline-based chemotherapy regimens are commonly used to treat breast cancer, but have significant toxicities that can be debilitating and impact long-term quality of life. Currently, the decision to use these therapies is based on conventional clinical and pathologic factors including age, tumor grade, tumor size and patient comorbidities. However, none of these factors accurately determine which patients will benefit from anthracycline-containing regimens.

“As developers of novel prognostic and predictive tests, we are very pleased to partner with Genomic Health and look forward to leveraging their rigorous clinical validation approach and commercial expertise to advance our development work to reach patients,” said Paul Harkin, President and Managing Director of Almac Diagnostics. “We see tests such as this having a significant impact on accelerating personalized healthcare thereby improving the clinical management of cancer patients.”