ARIAD Pharmaceuticals, Inc.’s (ARIA) share prices rose 35.5% on the positive opinion by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (:EMA) for the continued availability of the company’s marketed drug Iclusig in the EU.
ARIAD gained EU approval for Iclusig for a couple of indications in Jul 2013. The first indication was the treatment of chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (:CML) in adults who do not respond to or cannot tolerate Sprycel or Tasigna. It is also approved for patients in whom Gleevec is not appropriate as a subsequent treatment. The second indication covers the treatment of Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults unresponsive to Sprycel. It also includes patients for whom Gleevec is not clinically appropriate. Iclusig is also approved for patients who have the T315I mutation.
The EMA has recommended on measures to help minimize the risk of occlusive vascular events in patients taking Iclusig. These include:
(i) Patients with a history of heart attack should not use Iclusig, unless the potential benefits of treatment are more than the risks. (ii) Before starting Iclusig treatment, an assessment of cardiovascular status of patients should be done. (iii) In the treatment process hypertension should be controlled and doctors should consider interrupting treatment if hypertension is not controlled. (iv) Patients should be monitored for evidence of vascular occlusion or thromboembolism, and treatment should be interrupted immediately in the event of its occurance. (v) The EMA plans to further review the risks/benefits associated with Iclusig and may make additional recommendations on its usage.
On Oct 31, 2013, there was a temporary suspension of the marketing and commercial distribution of Iclusig in the U.S due to higher-than-expected incidence of blood clotting. The share price fell more than 44% immediately after the news.
ARIAD carries a Zacks Rank #3 (Hold). Some better ranked stocks include Enanta Pharmaceuticals, Inc. (ENTA), Jazz Pharmaceuticals Plc (JAZZ) and Lannett Company, Inc. (LCI). All these stocks carry a Zacks Rank #1 (Strong Buy).