Marketing applications for the test, which identifies the T315I mutation of the BCR-ABL gene, will be filed next year.
MolecularMD will develop and commercialize a companion diagnostic test for Ariad Pharmaceuticals’ Phase II candidate for chronic myeloid leukemia (CML) and Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL), ponatinib. The drug is a pan-BCR-ABL inhibitor, and the test will identify the T315I mutation of the BCR-ABL gene in patients.
Under their exclusive agreement, the test will be conducted prior to patient treatment in the mid-stage PACE trial, which includes patients with resistant or intolerant CML and Ph+ ALL. MolecularMD performed BCR-ABL mutation testing in patients enrolled in Ariad’s Phase I study of ponatinib.
The agreement calls for Ariad to 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.
MolecularMD will file a PMA to support commercialization, and submission is expected in 2012 at about the same time as Ariad files its NDA. MolecularMD will also seek a CE Mark for the companion diagnostic test kit.
Ponatinib is Ariad’s second internally discovered product candidate. The first, ridaforolimus, is an investigational mTOR inhibitor being developed by Merck & Co. It has successfully completed a Phase III trial in patients with soft-tissue and bone sarcomas and is also being studied in other cancer indications.