Pfizer can fully explain its slowdown in Xtandi sales, executives told investors Tuesday. It just didn’t anticipate the hurdles when it shelled out $14 billion to gain access to the cancer fighter.
Net sales of the prostate cancer med sank 11% in Q1, thanks to “significant increase in the utilization of our patient assistance programs,” company Innovative Health President Albert Bourla said on Pfizer’s earnings conference call. In a note to clients, Goldman Sachs analyst Jami Rubin quantified the enrollment increase at 25% to 30% quarter over quarter.
Why the mad rush? As Pfizer chief exec Ian Read explained on the call, last year, a government investigation into donations made by drugmakers to third-party foundations that help patients pay for meds “had a chilling effect on the amount of assistance” the foundations doled out.
Now that there’s a bit more clarity around the matter, though—the government is “not looking to shut down these foundations, or stop contributions to them. They just want to provide appropriate safeguards,” Read said, noting that Pfizer is continuing to donate—patients are coming back in droves.
Pfizer, in particular, has taken a hit, Read noted, as metastatic prostate cancer drugs boast a typically older, Medicare-eligible population. Two-thirds of Xtandi patients are on Medicare Part D, Rubin added, pointing out that Johnson & Johnson competitor Zytiga “faced similar dynamics.”
Still, “we remain skeptical and continue to explore these dynamics, particularly why other oncology drugs with high Medicare exposure haven’t faced the same pressure,” she wrote.
Meanwhile, the toll on Xtandi revenue prompted more than one analyst to question the hefty $14 billion sum Pfizer forked over for access to the med, and Bourla admitted the company didn’t anticipate the reimbursement hurdles when it struck its buyout deal.
“Today, Xtandi is performing below our expectations in the U.S.,” he acknowledged.
On the bright side, though, Pfizer expects that the “demand for patient assistance as a percentage of total demand will stabilize, moderate gradually through 2017, and over time be resolved,” Bourla said. At that point, Xtandi’s top-line haul will reflect demand for the med itself, which actually grew by 13% during the quarter.
And besides, “as we’ve said all along, the real critical pivot point for that deal is the non-metastatic, the earlier stage prostate cancer,” CFO Frank D’Amelio added.
“We remain confident in our ability to get approval for those indications,” he said.
By Carly Helfand
Source: Fierce Pharma
The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
US biopharma AbbVie has agreed to acquire ImmunoGen in a deal which values the company at about $10.1 billion and gives AbbVie access to flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC), as well as a pipeline of promising next-generation ADCs.
EUROAPI today announced the appointment of David Seignolle as Chief Operating Officer, succeeding Eric Berger, and Marion Santin as Chief Legal, Compliance, and IP Officer, both joining the company’s Executive Committee. In his new role, David Seignolle will lead the transformation of the Industrial Operations organization.
