PRAC Decision On Leukemia Drug Good News For Ariad Pharmaceuticals, Inc., Says Analyst
October 10, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
News that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the use of Ariad Pharmaceuticals, Inc. 's leukemia drug Iclusig is not as conclusive as market watchers might like, an analyst from Citigroup said Friday.
Iclusig, also known as ponatinib, is used in the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML), as well as adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL).
PRAC had recommended that Iclusig continue to be used as indicated but did not necessarily rule out further actions from European regulators.
“Based on prior PRAC comments, we believed the drug’s EU label was at risk for a potential change in indication, or at least more restrictive to parallel what happened with the U.S. label,” wrote Jonathan Eckard in a note to investors. “The potential impact of this decision on the near-term EU ramp remains unclear and we will look for guidance on resumption of reimbursement discussions during the next quarterly earnings call.”
The new guidelines are not “particularly restrictive,” said Eckard. They suggest consideration of discontinuation of treatment if patients don’t achieve a complete response by three months, and dose-reductions in patients who continue treatment. “Given we primarily model EU sales for Iclusig in patients who have failed at least two prior TKIs, we do not see these recommendations” as difficulties,” he wrote.
The new ruling will be good news for Ariad on the reimbursement front, after discussions with several European countries appeared to have slowed or paused pending the resolution of this PRAC decision.
“We expect these discussions to pick back up by year end, while both the timing of these decisions and any impact on ultimate drug pricing remain unclear,” said Eckard. “We will look for management guidance during the next quarterly call.”
Once final labeling and reimbursement discussions are complete, the ultimate demand for the drug is difficult to foresee, said Citi.
“We view Iclusig as likely the only treatment option for patients who have either the T315I mutation or have failed all leading CML TKI agents,” concluded Eckard. “However, [we] have been surprised by the relatively modest uptake in the current markets where Iclusig is reimbursed relative to the potential number of patients who could potentially benefit from the drug. We expect it could take some time to gauge the full opportunity of the drug.”