Ariad Pharmaceuticals, Inc. (ARIA - Analyst Report) recently provided an update on its pipeline and the commercialization of Iclusig in the US.
We remind investors that in Dec 2012, Iclusig gained the US Food and Drug Administration (FDA) approval for the treatment of CML and Ph+ALL in patients resistant or intolerant to the prior tyrosine kinase inhibitor therapy.
Ariad said that during the first 12 weeks of Iclusig’s launch in the US, there were more than 225 unique prescribers of Iclusig and nearly 200 unique accounts using the product. Iclusig is being used to treat more than 325 patients.
About 65% of the prescribers are community based physicians with the balance representing the academic setting. As the launch progresses, usage by community based physicians is expected to increase.
Meanwhile, Iclusig should gain approval in the EU in the second quarter of 2013. In Mar 2013, the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) had voted in favor of approving Iclusig for two indications namely, chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL).
Once approved, Iclusig will be used for the second-line treatment of patients who are resistant to Bristol-Myers Squibb Company’s (BMY - Analyst Report) Sprycel (dasatinib) or Novartis AG’s (NVS - Analyst Report) Tasigna (nilotinib) or who have the T3151 mutation of BCR-ABL.
Ariad intends to submit regulatory applications for Iclusig in Canada, Switzerland and Australia in the third quarter of 2013.
We note that Ariad is evaluating Iclusig in additional studies. Iclusig is currently in the phase III EPIC study (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia), with interim results due in mid-2014.
The development process for AP26113 is also underway. The company is developing AP26113 for anaplastic lymphoma kinase (ALK) positive NSCLC patients with brain metastases.
Ariad currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on the commercialization of Iclusig. Other biopharma stocks that look better positioned than Ariad include Array BioPharma, Inc. (ARRY - Snapshot Report), which carries a Zacks Rank #2 (Buy).