ARIAD Pharmaceuticals, Inc. and its diagnostic collaborator, the privately held MolecularMD Corporation recently announced that the latter has withdrawn its Premarketing Approval (PMA) application with the US Food and Drug Administration (FDA) for the BCR-ABL T315I mutation test. The application was withdrawn on a voluntary basis.
The test was designed to identify the presence of T315I mutation of BCR-ABL in patients suffering from chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). MolecularMD was looking to get the test approved as a companion diagnostic test, in combination with ARIAD’s BCR-ABL inhibitor, ponatinib.
MolecularMD’s voluntary withdrawal was preceded by a notification from the FDA. The US regulatory body’s Center for Devices and Radiological Health informed MolecularMD that BCR-ABL T315I mutation test was no more considered as a combination diagnostic test for ponatinib. The FDA stated in its guidance that a companion diagnostic test, to gain PMA, requires information that is essential for the safe and effective use of a therapeutic product.
In July this year, MolecularMD submitted the PMA application to the US regulatory body for the BCR-ABL T315I mutation test as a companion diagnostic to ponatinib.
We remind investors that last month, ARIAD announced the submission of a Marketing Authorization Application (MAA) for ponatinib, to the European Medicines Agency (EMA). ARIAD is looking to get the candidate approved in the EU for treating adults suffering from resistant or intolerant CML and Ph+ ALL.
ARIAD had requested accelerated assessment of the MAA for its investigational candidate, which was granted by the Committee for Medicinal Products for Human Use (CHMP).
ARIAD is also seeking US approval of ponatinib for the same indication. The company expects to launch ponatinib in the US in the first quarter of 2013 following the FDA approval.
ARIAD also intends to commercialize ponatinib beyond Europe and the US. Last month the company initiated a multi-center phase I/II clinical trial with ponatinib in Japan. Japan is one of the largest CML markets in the world.
We currently have a Neutral recommendation on ARIAD. The stock carries a Zacks #3 Rank (Hold rating) in the short run.