ARIAD Pharmaceuticals Inc. ARIA announced that its partner Otsuka Pharmaceutical Co., Ltd. has filed a new drug application (NDA) with the Japanese Pharmaceuticals and Medical Devices Agency for leukemia drug, Iclusig (ponatinib). Otsuka is looking to get Iclusig approved in Japan for the treatment of patients suffering from resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL).
The NDA was based on data from a phase I/II study in Japanese patients as well as the global pivotal PACE study and other phase I studies on Iclusig. Through a median follow-up of 14.9 months at the time of analysis, the results from the Japanese study confirmed that Iclusig demonstrated anti-leukemic activity in patients with CML or Ph+ALL who experienced failure of prior tyrosine kinase inhibitor (TKI) therapy.
ARIAD expects Otsuka to receive a response on the NDA in the second half of 2016. We note that ARIAD had entered into a collaboration agreement with Otsuka for the commercialization and further development of Iclusig in Japan and nine other Asian countries in Dec 2014.
Iclusig is currently approved both in the U.S. and EU for the treatment of adults suffering from T315I-positive CML (chronic, accelerated or blast phase) or Ph+ALL or for whom no other TKI therapy is approved.
We remind investors that last month, ARIAD lowered the 2015 revenue guidance for Iclusig in view of its continuing negotiations with the Economic Committee on Health Care Products in France regarding the drug’s pricing and reimbursement. The company had previously expected to reach an agreement by the end of 2015. However, with discussions now ongoing in 2016, ARIAD expects Iclusig global sales (excluding France) in the range of $110 million to $115 million in 2015, lower than the previous guidance of $130 million to $140 million.
In a separate press release, ARIAD announced the appointment of Alexander J. Denner as chairman of the board of directors of the company, effective Jan 8, 2016.
ARIAD is a Zacks Rank #2 (Buy) stock. Some of the other favorably ranked stocks in the health care sector include Baxalta Incorporated BXLT, Anika Therapeutics Inc. ANIK and Aerie Pharmaceuticals, Inc. AERI. All three stocks carry a Zacks Rank #1 (Strong Buy).
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