Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced that its partner Otsuka Pharmaceutical Co., Ltd. (Otsuka) has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig®(ponatinib) for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to preceding drug treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
“Our collaboration with Otsuka has resulted in today’s approval of Iclusig in Japan, providing an important new treatment for patients with refractory CML and Ph+ ALL,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Japan represents a large market opportunity for Iclusig and its first approval in Asia. We are committed to expanding patient access and to continuing our successful partnership with Otsuka as evidenced by recent marketing applications for Iclusig submitted in Korea and Taiwan.”
This approval triggers a $10 million milestone payment to ARIAD from Otsuka under the parties’ collaboration agreement entered in December 2014.
”Treatment failure affects a substantial proportion of CML patients treated with tyrosine kinase inhibitors due to resistance or intolerance. For these patients living with CML in Japan, we are grateful to have Iclusig as a new approved treatment option,” said Arinobu Tojo, M.D., Ph.D, deputy director, Research Hospital, The Institute of Medical Science at the University of Tokyo.
The PMDA filing was supported by a Phase 1/2 study in Japanese patients as well as the international 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 confirmed that Iclusig demonstrated anti-leukemic activity in this patient population. Among the 17 chronic-phase patients, 65 percent achieved the primary efficacy endpoint of major cytogenetic response, and 35 percent 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 occlusive events were reported in four patients, or 11 percent. (Original Source)
Shares of Ariad Pharmaceuticals closed yesterday at $13.95, down $0.01 or -0.07%. ARIA has a 1-year high of $14.25 and a 1-year low of $4.37. The stock’s 50-day moving average is $10.97 and its 200-day moving average is $8.39.
On the ratings front, ARIA stock has been the subject of a number of recent research reports. In a report issued on September 26, Leerink Swann analyst Michael Schmidt reiterated a Buy rating on ARIA, with a price target of $20, which implies an upside of 43% from current levels. Separately, on August 22, Jefferies’ Brian Abrahams reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and Brian Abrahams have a total average return of 28% and 8.3% respectively. Schmidt has a success rate of 66% and is ranked #22 out of 4185 analysts, while Abrahams has a success rate of 55% and is ranked #314.
The street is mostly Bullish on ARIA stock. Out of 6 analysts who cover the stock, 4 suggest a Buy rating , one suggests a Sell and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $11.75, which represents a potential downside of 15.8% from where the stock is currently trading.
ARIAD Pharmaceuticals, Inc. operates as an oncology company which engages in the discovery, development, and commercialization of small-molecule drugs for the treatment of cancer. Its products include Iclusig and Caregivers.