Ariad Pharmaceuticals ($ARIA) picked up an accelerated review for its promising leukemia drug ponatinib from the European Union's drug regulator as the Cambridge, MA-based biotech steams ahead with plans to commercialize the blockbuster hopeful over the next year.
Ariad CEO Harvey Berger has led a charge to ramp up commercial operations at the clinical-stage biotech in anticipation for the potential approvals and sales of ponatinib, and he told Bloomberg that the European Medicines Agency's accelerated review of his company's marketing application could trim several months from the standard process. The company aims the get a speedy review for the drug in the U.S., where it filed an application for approval of ponatinib in late July.
As Berger tells the news service, sales of ponatinib could hit $800 million for certain leukemia patients whose cancer fails to respond to previous treatments, and that revenue total could rise to $1.5 billion with an approval and marketing of the drug as an initial treatment for leukemia. With big plans for the European market, the company aims to set up this year a European beachhead in Lausanne, Switzerland.
Ponatinib, which FierceBiotech has highlighted for the past two years as a top-10 cancer drug in late-stage development, has yielded impressive results in clinical trials. Ariad has reported that 54% of patients with chronic myeloid leukemia (CML) who failed previous treatments showed a major cytogenetic response to treatment with ponatinib, a BCR-ABL inhibitor. The company is seeking EU approval of the drug for adults with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia.
Ariad has begun a late-stage study dubbed EPIC to compare ponatinib with Novartis' ($NVS) Gleevec as an initial treatment for patients diagnosed with chronic-phase CML.
- here's the release
- see Bloomberg's article
Special Report: Ponatinib – Top 10 Late-Stage Cancer Drugs – 2012
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