Dive Brief:
- Ariad Pharmaceutical's Iclusig (ponatinib), a drug whose pricing hikes are under evaluation by lawmakers, brought in $33.6 million of sales revenue in the U.S. and $34.3 million worldwide in the third quarter. This was a 66% increase year-on-year in the U.S. and a 25% increase worldwide.
- Brigatinib, Ariad's potent second commercial product, has priority review status from the FDA, with a PDUFA date of April 29, 2017 for non-small cell lung cancer. There are plans for a European submission early 2017, and Phase 3 clinical trials are ongoing.
- The first readout for AP32788, a precision therapy in Phase 1/2 for patients with a specifically-mutated form of NSCLC, is expected in 2017. This affects around 6,000 patients in the U.S. and there is no approved targeted treatment.
Dive Insight:
Ariad has been the subject of sharp criticism from lawmakers over the four price hikes for its chronic myeloid leukemia (CML) drug Iclusig, which almost doubled over four years, from $115,000 a year in 2012 to $199,000 a year in 2016.
"We believe the price of Iclusig is consistent with the unique innovation it represents in the marketplace and a meaningful clinical benefit it offers to patients with resistant CML, Philadelphia-positive ALL and T315I mutated disease," said COO Jennifer Herron, trying to justify the rise, but lawmakers asked for more information by November 4.
The company's earnings call touched on the topic, describing the drug as an ultra-orphan one, with around 1000-2000 patients. Newly appointed CEO Paris Panayiotopoulos said the company provided a response on Friday, as per the deadline. "We have been and will continue to be very respectful of the process and appreciate having had the opportunity to respond," he said on the call.
Switching gears, Panayiotopoulos highlighted the money the company is spending on R&D as it continues its restructuring. "Last year, we invested 143% of our revenues in R&D, one of the very highest in the industry. And since our founding, we've invested $1.3 billion in R&D, with more than 60% of our employees working in R&D. And we have never in-licensed therapy nor received government funding for Iclusig," he noted.