MolecularMD and ARIAD collaborate to develop and commercialize CML, ALL diagnostic test

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and MolecularMD Corporation today announced an exclusive collaboration agreement in which 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).

ARIAD is advancing its investigational, pan-BCR-ABL inhibitor, ponatinib, in the pivotal PACE trial of patients with resistant or intolerant CML and Ph+ ALL, or those with the T315I mutation. MolecularMD has 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 this collaboration agreement, MolecularMD will further optimize its currently available sequencing test and will file a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration 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.

MolecularMD's expertise in BCR-ABL mutation testing stems, in part, from the pioneering research and intellectual property of its scientific founder, Dr. Brian Druker, director of the Oregon Health & Science University (OHSU) Knight Cancer Institute, Howard Hughes Medical Institute Investigator, and JELD-WEN Chair of Leukemia Research at OHSU. Dr. Druker also has been a long-standing scientific and medical collaborator of ARIAD in the development of ponatinib.

"We believe that MolecularMD has more experience with T315I mutation assays than any other laboratory in the world," stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. "We are pleased to extend our highly productive collaboration with MolecularMD and look forward to working together on the development of a commercial test for the detection of the T315I mutation."

"MolecularMD was founded with the goal of offering clinically relevant molecular testing in the age of targeted cancer therapies," commented Stephane Wong, Ph.D., M.B.A., chief scientific officer of MolecularMD. "We have been working with ARIAD throughout ponatinib's clinical development and share in the excitement over the drug's activity in resistant and intolerant CML patients and those with the T315I mutation for whom current therapies are ineffective. We are pleased to be advancing our partnership with ARIAD, and we look forward to commercializing our T315I test as a companion diagnostic to ponatinib."

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. The MolecularMD companion diagnostic test is being developed to identify CML and Ph+ ALL patients who have the T315I mutation. A companion diagnostic test is not necessary to support the broader potential use of ponatinib in patients who are resistant or intolerant to the current second-generation BCR-ABL inhibitors, as being studied in the PACE trial. Many mutations in addition to T315I account for resistance to currently marketed BCR-ABL inhibitors.