ARIAD Pharmaceuticals, Inc.’s share price was up 2.37% after the company announced that Iclusig was once again available in the U.S.
We remind investors that the marketing and commercial distribution of Iclusig in the U.S. was temporarily suspended in Oct 2013 following instructions from the FDA due to a higher-than-expected incidence of blood clots and narrowing of blood vessels.
The product now carries a revised label (indication) as well as a boxed warning along with updated safety information and recommendations regarding dosing. The label indicates that Iclusig is approved for the treatment of T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, or chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia in patients for whom no other tyrosine-kinase inhibitor therapy is indicated.
Meanwhile, the starting dose remains unchanged at 45mg daily.
The resumption of marketing of Iclusig in the U.S. is a positive development for ARIAD. ARIAD’s shares have been on a rollercoaster ride ever since news regarding safety issues surrounding Iclusig first emerged. Now that Iclusig is back in the market, we expect investor focus to remain on the product’s performance. Iclusig sales for the quarter ended Sep 30, 2013 were $16.7 million.
ARIAD carries a Zacks Rank #2 (Buy). Other players which look attractive at current levels include Endocyte, Inc. (ECYT - Free Report) , Grifols, S.A. (GRFS - Free Report) and Biodel Inc. . While Endocyte and Grifols are Zacks Rank #1 (Strong Buy) stocks, Biodel is a Zacks Rank #2 stock.