Ariad Pharmaceuticals Inc. (ARIA) said the European Union’s drug regulator has granted its request for accelerated assessment of its new cancer medicine, which may lead to a faster approval.
Ariad submitted ponatinib to the European Medicines Agency yesterday for a cancer of the white blood cells known as chronic myeloid leukemia, the company said in a statement today. The accelerated assessment may shave off “several months” from the typical process that takes about a year, Chief Executive Officer Harvey Berger said. Ariad applied for approval from the U.S. Food and Drug Administration in July.
Chronic myeloid leukemia is characterized by an excessive production of white blood cells by the bone marrow resulting from a genetic abnormality. Ponatinib would compete with Bristol-Myers Squibb Co. (BMY)’s Sprycel, also known as dasatinib, and Novartis AG (NOVN)’s Tasigna.
“Patients fail those drugs quite routinely,” Berger said in a phone interview today. “There really is nothing available today for patients who fail one or the other of both of those agents. That’s where ponatinib comes in.”
A late-stage study presented at the American Society of Clinical Oncology’s annual meeting in June showed that 54 percent of chronic-phase leukemia patients achieved a response that reduced the number of cells with the abnormal gene associated with the disease to a normal level.
Peak sales of the drug for patients who failed to respond to or couldn’t tolerate previous treatment may reach $800 million globally, Berger said. That may rise to $1.5 billion if the drug is approved to treat newly diagnosed patients, he said. Ariad will conduct late-stage trials on ponatinib in that patient group and expects to complete enrolment of participants by the end of next year, he said.
Ariad stock has gained 67 percent this year, giving the company a makret value of $3.4 billion. A medicine developed by the company together with Merck & Co. failed to win the backing of a U.S. regulatory panel in March. The company, which has board members from Greece and Italy, will establish European headquarters near Lausanne, Switzerland, that will become fully operational by the end of this year.
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