The global oncology company ARIAD Pharmaceuticals Inc. (ARIA) will participate in the 32nd annual J.P. Morgan Healthcare Conference in San Francisco, on Jan 14, 2014. The presentation will focus on the company’s overall business.
We expect the company to provide an update on its sole marketed product, Iclusig. ARIAD will resume selling Iclusig from mid-Jan 2014 under a modified prescribing and risk management plan approved by the U.S. Food and Drug Administration (:FDA). We remind investors that in Oct 2013, ARIAD announced the temporary suspension of the marketing and commercial distribution of Iclusig in the U.S. following instruction from the FDA due to a higher-than-expected incidence of blood clotting and narrowing of blood vessels.
In the EU, the regulators had recommended that Iclusig could remain on the market though tough restrictions would be imposed for continued marketing of the product. European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is conducting a further in-depth review of the risk/benefit profile of Iclusig. We expect the company to provide an update on the PRAC’s analysis of the drug.
ARIAD also discontinued the phase III EPIC study, in which Iclusig was being compared to Novartis’ (NVS) Gleevec in patients with newly diagnosed chronic myeloid leukemia (:CML).
Given the challenges faced by the company, we expect ARIAD to take some prompt actions to overcome the current impasse. We expect ARIAD to provide its 2014 guidance at this conference.