Ariad Pharmaceuticals, Inc. recently presented pre-clinical data on Iclusig (ponatinib). The company presented data which showed that Iclusig has the potential to inhibit RET and FGFR. While it has been clinically proved that RET is an oncogenic driver of medullary thyroid cancer (MTC) and non-small cell lung cancer (NSCLC), FGFR is mutated in endometrial, lung and other cancers.
The encouraging pre-clinical results support the investigation of Iclusig in RET and FGFR-driven cancers. Ariad said that a phase II investigator-sponsored study is scheduled to commence in the second quarter of 2013 evaluating Iclusig in patients with RET-driven cancer.
Meanwhile, Iclusig is already being evaluated in a phase II investigator-sponsored study in patients with FGFR-driven squamous cell carcinomas (SCCs). The study is currently enrolling patients.
We note that Iclusig is already approved in the US for the treatment of chronic, accelerated or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in patients resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Ariad recently provided an update on the commercialization of Iclusig in the US. The company said that during the first 12 weeks of Iclusig’s launch in the US, there were more than 225 unique prescribers and nearly 200 unique accounts using the product.
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.
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.
Ariad currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on the commercialization of Iclusig. Currently, companies like QLT Inc. , UCB Pharma and Biodel Inc. look more attractive. While QLT Inc. and UCB are Zacks Rank #1 (Strong Buy) stocks, Biodel is a Zacks Rank #2 (Buy) stock.