Kadmon eyes $15.5K price tag and August debut for new transplant rejection med Rezurock

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Kadmon plans to launch its chronic GVHD med Rezurock in August at a price of $15,500. (NASA)

Blessed with its first-ever FDA approval, little-known Kadmon is revving up the commercial engine to debut its new graft-versus-host disease drug by summer’s end.

Kadmon plans to launch Rezurock, also known as belumosudil, in late August at a price of $15,500 per 30-count bottle, executives said Monday on a call with analysts. To see the mission through, the company has primed its sales team, started talks with payers and rolled out an access program dubbed Kadmon Assist, chief commercial officer Haya Taitel said.

Rezurock scored FDA approval on Friday to treat chronic graft-versus-host disease (GVHD) in patients who’ve failed on two prior systemic therapies. GVHD is a complication of transplant procedures that can cause serious health problems and even death. With its first-ever green light in the books, Kadmon is now gearing up to make its commercial debut.

The drug could gin up $500 million at peak, Cantor Fitzgerald analysts have predicted. Far from the only agent in the GVHD field, Rezurock will have to contend with Incyte’s Jakafi and Johnson & Johnson and AbbVie’s Imbruvica, which generated $1.94 billion and $5.31 billion in global 2020 sales, respectively.

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To make a splash in the “highly-concentrated” GVHD market, Kadmon is going it alone with an in-house U.S. sales team, CEO Harlan Waksal, M.D., said on the call. The company has 15 sales reps, plus a four-person market access team and four “medical-scientific liaisons” to update the medical community about the new treatment option, Taitel said.

More than 90% of GVHD patients are treated at just 100 U.S. transplant centers, Taitel said, so Kadmon expects to be able to deploy its sales force “efficiently."

The sales team will talk up the usual points to raise Rezurock’s profile, plus discuss recent pivotal trial results published in the journal Blood. In that study, the drug triggered complete responses in all organs involved, including those that are difficult to treat with fibrosis, such as the skin, eyes, lung, liver, joints and GI tract, Waksal said.

RELATED: Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD

There are about 14,000 patients with GVHD in the U.S. each year, and between 7,000 and 10,000 of them need systemic therapy, Taitel said. Roughly 60% of those patients have already tried and failed on two or more prior therapies. It’s those patients Kadmon will be targeting with its Rezurock launch.

On the access side, Kadmon has already started hashing things out with payers and formulary decision-makers, Taitel said. The company has also set up a “hub services” platform called Kadmon Assist, which will offer reimbursement assistance and savings programs to patients. The program will also provide nurse practitioners on-call for patient education and counseling, she said.

Meanwhile, Kadmon isn’t stopping at chronic GVHD: The company is also testing belumosudil in systemic sclerosis and boasts an immuno-oncology prospect dubbed KD033. The company expects to have data on KD033 in the fourth quarter, CEO Waksal said on the call.