ARIAD and MolecularMD Collaborate on Companion Diagnostic Test

ARIAD Pharmaceuticals (Cambridge, MA, USA) and MolecularMD Corp. (Portland, OR, USA) have entered into an exclusive collaboration agreement to develop a diagnostic test for leukemia patients.

MolecularMD will develop and commercialize a companion diagnostic test to identify the T315I mutation of the BCR-ABL gene in patients with chronic myeloid leukemia (CML) and Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL).

Under terms of the collaboration agreement, ARIAD will reimburse MolecularMD for predefined expenses for the development of the T315I diagnostic test. ARIAD will also pay MolecularMD milestones for achievement of key development and regulatory activities.

ARIAD is continuing its investigational pan-BCR-ABL inhibitor, ponatinib, in the PACE trial of patients with resistant or intolerant CML and Ph+ ALL, or those with the T315I mutation. MolecularMD performed BCR-ABL mutation testing with its standardized and validated sequencing test in patients enrolled in ARIAD's earlier Phase 1 trial of ponatinib, and now is conducting similar testing prior to patient treatment in the PACE trial.

As part of the collaboration agreement, MolecularMD will further optimize its currently available sequencing test and will file a Premarket Approval Application (PMA) with the US Food and Drug Administration (FDA; Silver Springs, MD, USA) to support commercialization of the diagnostic test.

The companies expect MolecularMD to submit the PMA at approximately the same time as ARIAD files its New Drug Application (NDA) for ponatinib in 2012. MolecularMD will also seek a CE Mark for a companion diagnostic test kit in Europe. Once approved, MolecularMD will have responsibility for commercializing the T315I diagnostic test.

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ARIAD Pharmaceuticals
MolecularMD Corp.
US Food and Drug Administration