ARIAD Announces Continuation of Iclusig Review Related to Article 20 Procedure in Europe

ARIAD Pharmaceuticals, Inc.

today announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has provided the Company with a request for limited additional information regarding Iclusig^® (ponatinib) as part of its ongoing review under the Article 20 referral procedure. The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following ARIAD's response and input from the agency's Scientific Advisory Group, the Company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use (CHMP) at its meeting in October 2014. “As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. In March 2014 ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June. The authorized indications of Iclusig in Europe, as approved in July 2013, remain as follows: * The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or * The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. To view the Iclusig Summary of Medicinal Product Characteristics, click here. The PRAC is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. The PRAC's recommendations are considered by the CHMP when it adopts opinions for centrally authorized medicines and referral procedures. About CML and Ph+ ALL CML is a cancer of the white blood cells that is diagnosed in approximately 7,000 patients each year in Europe^[1]. CML is characterized by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. After a chronic phase of production of too many white blood cells, CML typically evolves to the more aggressive phases referred to as accelerated phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic leukaemia that carries the Ph+ chromosome that produces BCR-ABL. It has a more aggressive course than CML and is often treated with a combination of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein is expressed in both of these diseases.