Ponatinib to earn gold-standard status for refractory chronic myeloid leukemia in 2015

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Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed U.S. hematologist-oncologists and managed care organization (MCO) pharmacy directors agree that survival effect is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in patients with chronic myeloid leukemia who have failed first-line tyrosine kinase inhibitor therapy. Surveyed hematologist-oncologists also identify the importance of molecular effect on shaping their prescribing decisions, based on the fact that a good molecular response at 12 to 18 months predicts good long term outcomes for patients. Clinical data and the opinions of interviewed thought leaders indicate that Ariad's ponatinib has advantages on these attributes over Bristol-Myers Squibb/Otsuka's Sprycel, the sales leading agent for the indication in the United States.

“Owing to its competitive advantages in efficacy and safety and tolerability, we expect ponatinib to displace Sprycel and ponatinib will earn our proprietary gold-standard status for refractory chronic myeloid leukemia in 2015, following its launch for the indication in 2014”

The DecisionBase 2012 report entitled Chronic Myeloid Leukemia: Tyrosine Kinase Inhibitors Have Transformed the Landscape. What Will Emerging Therapies Need to Compete? also finds that, based on clinical data and the opinions of interviewed thought leaders, Sprycel has earned Decision Resources' proprietary clinical gold standard status for the treatment of refractory chronic myeloid leukemia. Sprycel has the strongest clinical profile among key marketed products that treat the disease. Novartis's Tasigna earns a similar score to Sprycel with an equivalent efficacy profile, slightly superior safety and tolerability but inferior delivery.

"Owing to its competitive advantages in efficacy and safety and tolerability, we expect ponatinib to displace Sprycel and ponatinib will earn our proprietary gold-standard status for refractory chronic myeloid leukemia in 2015, following its launch for the indication in 2014," said Decision Resources Therapeutic Area Director Joanne Graham, Ph.D.

Despite the significant survival gains made since the approval in 2001 of Novartis' Gleevec/Glivec for the treatment of chronic myeloid leukemia, surveyed U.S. hematological-oncologists and MCO pharmacy directors indicate that improving survival effects remains one of the greatest unmet needs in this indication. Interviewed experts also note that a minority of patients responds sub-optimally to current treatments and others ultimately become refractory as mutations arise. Clinical data and the opinions of interviewed thought leaders indicate that ponatinib has demonstrated the potential to partially fulfill this unmet need.

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