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ARIAD Pharmaceuticals Accelerates Ponatinib to Market

6 months ago2 min read
After a setback with its previous cancer drug, Ridaforolimus, ARIAD Pharmaceuticals Inc. is now focusing its efforts on bringing Ponatinib to market. Ponatinib is a targeted cancer drug intended for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
ARIAD has completed the rolling submission of the New Drug Application (NDA) for Ponatinib, seeking approval for its use in the aforementioned conditions. Clinical trials have shown promising results, with 54 percent of chronic-phase CML patients achieving a major cytogenetic response. Analysts predict that Ponatinib could reach peak sales of $800 million globally.
The company has requested accelerated approval and a priority review from the FDA, with hopes of launching Ponatinib in the U.S. by the first quarter of 2013. Similarly, the Marketing Authorization Application for Ponatinib is under review in Europe, where the Committee for Medicinal Products for Human Use has granted ARIAD's request for accelerated assessment.
In addition to seeking regulatory approval, ARIAD is conducting a phase III global clinical trial, known as the EPIC trial, to compare the efficacy of Ponatinib with Novartis' Gleevec in newly diagnosed chronic-phase CML patients. The trial is expected to be fully enrolled by the end of 2013. Furthermore, a multi-center phase I/II clinical trial has been initiated in Japan to evaluate Ponatinib's effectiveness in CML patients resistant or intolerant to prior therapy, aiming to support regulatory approval in Japan.
ARIAD's pipeline also includes AP26113, currently in a phase I/II trial for advanced non-small cell lung cancer, with the phase II portion expected to commence in the second half of 2012.
Despite its promising developments, ARIAD faces financial challenges, with no marketed drugs and an accumulated deficit of $664 million as of June 30, 2012. However, the company's progress in regulatory and clinical advancements could significantly impact its stock price and market position in the coming months.
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