Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced that its partner Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a new drug application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for Iclusig® (ponatinib) for the treatment of resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL).

“The collaborative work to file this new drug application in Japan marks a significant milestone in expanding patient access to Iclusig in major geographies around the world,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. “If approved, Iclusig will provide an important new treatment option for Japanese patients with refractory Philadelphia-positive leukemia.”

ARIAD expects Otsuka to receive a decision on the new drug application in Japan in the second half of 2016.

The NDA for ponatinib is supported by the Phase 1/2 study in Japanese patients, as well as the global pivotal PACE and Phase 1 trials of ponatinib. The Japanese study included 35 Japanese patients with CML or Ph+ALL who experienced failure of prior tyrosine kinase inhibitor (TKI) therapy. With a median follow-up of 14.9 months at the time of analysis, the Phase 1/2 study results confirm that Iclusig demonstrates anti-leukemic activity in this patient population. Among chronic-phase patients, 65% achieved the primary efficacy endpoint of major cytogenetic response, and 35% had a major molecular response. Thirteen patients remained on therapy including 12 in chronic phase. The median duration of response had not been reached. The most common treatment-emergent adverse events in the trial of any grade were decreased platelet and neutrophil counts, pyrexia, hypertension, dry skin, rash and increased lipase. Treatment-emergent arterial thrombotic events were reported in four patients, or 11%.

According to a 2011 survey by the Ministry of Health Labor and Welfare in Japan, CML occurs in approximately 1 out of 100,000 people among all age groups and it is estimated that there are approximately 11,000 patients living with CML in Japan. (Original Source)

Shares of Ariad Pharmaceuticals closed yesterday at $5.26, down $0.48 or -8.36%. ARIA has a 1-year high of $10.07 and a 1-year low of $5.26. The stock’s 50-day moving average is $6.23 and its 200-day moving average is $7.17.

ARIAD Pharmaceuticals Inc is an oncology company. The Company is engaged in transforming the lives of cancer patients with breakthrough medicines. It commercializes & develops products and product candidates including Iclusig, Brigatinib, and AP32788.