Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) recently announced a major milestone with marketing approval of Iclusig™ in Australia. The company is working closely with STA (Specialised Therapeutics Australia Pty Ltd) to make Iclusig available as quickly as possible in Australian markets. The company submitted its marketing application to TGA (Therapeutics Goods Administration), Australia in 3Q13 and following approval it is planning the launch early next year.
Why are analyst so optimistic about ARIA?
Iclusig is indicated for chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia. Iclusig therapy needs to be administered under strict supervision of an expert hematologist, having significant experience in managing adult leukemia.
The Iclusig Advantage
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA)’s Iclusig™ is specifically advised for blast phase, accelerated phase or chronic phase CML patients who are resistant/intolerant to prior tyrosine kinase inhibitors. It is also prescribed in cases where there is a T315I mutation. About 30% of CML patients are estimated to be resistant to current treatment options and Iclusig will provide valuable new option for these patients and treating physicians.
Carlo Montagner, CEO at STA, said that they are awaiting the Pharmaceutical Benefit Advisory Committee’s decision for reimbursing the cost of Iclusig treatment for difficult-to-treat CML or Ph+ALL patients.
Clinical Potential
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA)’s Phase II Pace trial demonstrated Iclusig’s anti-leukemic activity in 54% of chronic-phase CML patients with major cytogenetic response. Iclusig also demonstrated a major hematologic response in 57% and 34% of accelerated-phase and blast-phase CML patients, respectively.
Ariad is going to present key findings on Iclusig® at the upcoming Annual Meeting of the American Society of Hematology in San Francisco. The company will present a total of 17 abstracts in various oral and poster sessions at this event to be held from December 6 to 9, 2014.
Ariad will present Phase II PACE trial’s results in patients who were long followed-up to assess Iclusig efficacy and safety. The company is also going to present findings from a Phase III trial of Iclusig compared with Imatinib in Chronic Phase CP-CML patients.
