As a partner with Novartis on JAK inhibitor Jakafi, Incyte has pinned its future fortunes on the success of the blockbuster med, particularly with COVID-19 trials ongoing. But Incyte has been looking forward to a trio of late-stage candidates coming through, and now the first of those has scored an FDA nod.
The FDA on Friday approved Incyte's Pemazyre (pemigatinib) more than a month before its approval date to treat a particular type of advanced bile duct cancer that cannot be surgically removed, the drugmaker said in a release.
Incyte's drug targets the fibroblast growth factor receptor 2 (FGFR2), and bile duct cancers with FGFR2 rearrangements are believed to affect between 2,000 and 3,000 patients in the U.S., Europe and Japan, Incyte said. On Friday, the FDA also approved a Pemazyre companion diagnostic from Foundation Medicine.
Pemazyre will hit the market at a list price of $17,000 per treatment cycle, a price point that is "appropriate given the potential benefit it brings to this underserved population," Barry P. Flannelly, Incyte's executive VP and U.S. general manager, said on a Monday morning call with analysts.
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With an average treatment duration of around six months and eight or nine cycles, the cost per patient would be between $136,000 and $153,000. RBC Capital Markets analysts figure Pemazyre can bring in $50 million this year.
The drug will roll out immediately, Flannelly said, with "ample supply" that isn't expected to be affected by the novel coronavirus pandemic. Incyte holds exclusive rights to Pemazyre in the U.S. and markets outside China, Hong Kong, Macau and Taiwan, where Innovent Biologics will spearhead commercialization and development.
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Pemazyre's approval, granted on an accelerated basis, depended on overall response rate and duration of response in a single-arm, open-label phase 2 trial.
In the Fight-202 study, 107 patients received Pemazyre once a day for 14 days, followed by 7 days off. That 21-day cycle was repeated until the disease progressed or the patient experienced an "unreasonable level of side effects," Incyte said.
Thirty-eight patients, or 36%, responded to the drug, Incyte said, and the median duration of response was 9.1 months. For three patients—2.8% of the group—no evidence of their cancer remained at the end of the study.
Pemazyre will come with a warning label for dry or inflamed eyes, inflamed cornea, increased tears and a disorder of the retina; high levels of phosphate in the blood; and a risk of harm to the unborn baby or loss of pregnancy in pregnant women.
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Despite Pemazyre's approval, SVB Leerink analyst Andrew Berens said the drug's $140 million in peak sales won't move the needle much on investors' interest in the company––although future trial readouts could help.
"While the approval provides a source of revenue diversification to (Incyte), the opportunity represents minimal fundamental value, with worldwide revenue estimates of ~$140mn not a meaningful driver for (Incyte) shares, in our view," Berens wrote in a Monday note to investors.
Pemazyre is also being evaluated in bladder cancer, solid tumors and 8p11 myeloproliferative syndrome. The drug's bladder cancer trial is expected to read out in the first half of 2021, although the company said COVID-19 could affect that timeline, Berens noted.
Pemazyre's approval is the first of three FDA decisions Incyte is expecting this year, potentially beefing up its portfolio far beyond its best-selling JAK inhibitor Jakafi, which is also being evaluated as a therapy for cytokine storm in COVID-19 patients. Incyte in February picked up an FDA priority review for capmatinib, a non-small cell lung cancer med it licensed to Novartis, setting it up for a decision date in August.
Incyte is also in the process of closing a licensing deal with MorphoSys that’ll give the drugmaker certain rights to lymphoma med tafasitamab, also due for its FDA decision in August. The deal would allow the companies to co-promote the med in the U.S. and give Incyte full rights in the rest of the world.
Meanwhile, Novartis and Incyte on Friday rolled Jakafi into a phase 3 clinical trial to treat COVID-19 patients with cytokine storm, an immune system over-response that can lead to respiratory failure. The study, dubbed Ruxcovid, will evaluate a combination of Jakafi and standard of care against standard of care alone to reduce the proportion of patients who die, or require mechanical ventilation or intensive care, after 29 days, Incyte said in a release.
Incyte said it currently has enough Jakafi supply to meet patient needs and "is increasing manufacturing efforts to respond to anticipated supply needs related to COVID-19 studies and working closely with distribution partners to monitor the supply of (the drug)."