After investors blanched last month at a slower-than-expected launch timeline for Celcuity’s novel breast cancer med Revtorpyk, the company used much of its latest earnings call to address concerns over—and reaffirm confidence in—the pace of its expected rollout.
The holdup for now appears to center on FDA sign-off for a second manufacturing facility producing the drug.
“We want to have confidence that our review process with the FDA will proceed according to what we expect to occur,” Celcuity CEO Brian Sullivan told analysts on a conference call late last week. “That there are no surprises, and we’re very confident about being able to ship beginning the end of this [third] quarter.”
Celcuity’s share price initially jumped when the company shifted into commercial gear with its July green light for Revtorpyk (gedatolisib) in previously treated hormone receptor-positive, HER2-negative breast cancer without PIK3CA gene mutations.
But the revelation from the company that it wasn’t expecting to launch its drug commercially until the third quarter influenced a nearly 19% price drop on the morning of July 15, Reuters and other outlets reported at the time.
But from Sullivan’s comments, the few months’ wait for FDA manufacturing sign-off hasn’t shaken Celcuity’s confidence in the eventual debut of its small-molecule inhibitor, which targets various components of the cancer pathway PAM once believed to be undruggable.
Celcuity submitted validation data for this second manufacturing site “almost immediately after we got the approval,” Sullivan said. “So, that’s begun, and you can’t ship from that new site until you have received the go-ahead from the FDA. That’s the limitation on getting access to material from that second site.”
As for whether the FDA may need to inspect the second production plant Celcuity is using, Sullivan would not speculate on the regulator’s actions, though he explained that “if you are with a manufacturer that has met requirements, they don’t necessarily require that.”
“[W]e believe the validation data that we have is very consistent with the validation from our first site,” the CEO added, “and so we would anticipate that the review process will be straightforward.”
Once Revtorpyk does make it to market, Celcuity and other industry watchers expect the drug to leave a lasting impression.
With the drug priced at a wholesale acquisition cost of $10,000 per vial—which does not represent the end price patients pay after rebates and discounts through insurance and other programs—Sullivan estimated Revtorpyk sales could ultimately exceed $6 billion annually in a combined breast cancer population.
Around the time of approval, Leerink Partners analyst Andrew Berens, M.D., told Fierce that Revtorpyk indeed “could be a very big drug,” noting that the “efficacy is there, [and] the community docs, where a lot of these patients are treated, seem very receptive.”
Given the relative strength of blockbuster-in-waiting Revtorpyk compared to the rest of Celcuity’s pipeline, Berens speculated that the company would make a prime acquisition target rather than a standalone commercial force.
On the company’s second-quarter call, Sullivan said that Celcuity began laying the groundwork for Revtorpyk’s launch more than two years ago, connecting with key opinion leaders, breast cancer experts and more as an unbranded awareness campaign played out in parallel.
Launch infrastructure is in place and commercial activities kicked off “immediately” following Revtorpyk’s approval, Sullivan said, pointing to a field team of 88 sales specialists engaging with doctors, plus other teams working on the ground to secure access and reimbursement.
Shipments are, as the company communicated following its FDA nod, expected to begin in the third quarter, Sullivan reiterated. In the meantime, drug product has started to move out to doctors treating certain patients as part of an expanded access program, he said.
Aside from the first indication won by Revtorpyk, Celcuity still plans to submit a filing for the drug in breast cancer patients with PIK3CA mutations by the third quarter, the company said in an Aug. 13 release.
Celcuity is also running Revtorpyk through a phase 1/2 trial in prostate cancer.