Karyopharm lines up $150 million cash injection to back controversial drug launch
Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.
The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.
Xpovio raised eyebrows across the industry in July when it nabbed FDA approval over the objections of 8 out of 13 of the experts on an outside panel, a sign either of the agency’s increasingly laissez-faire attitude or of its commitment to getting out-of-options patients access to experimental treatments. The drug raised numerous concerns, many of which were included by FDA representatives in the internal review. These included a 94% grade 3 or grade 4 adverse effect rate with 10 fatal adverse effects in the main arm of the study used for accelerated approval, no evidence of single-agent effectiveness, a preponderance of partial responses and missing data from dropouts. One study found worse survival rates from those taking selinexor.
The FDA did get a look at some additional data, though, which may have won the day for Karyopharm.
Treatments are limited for multiple myeloma and the drug is only approved for patients who have gone through other options and are left with few, if any, choices. At the time of the internal review, one of the FDA’s outside experts, Dana Farber’s David Harrington, said the data didn’t point either way but “I think we do patients some potential benefit if this is used constructively.”
The drug is priced at $22,000 per month wholesale. HealthCare Royalty Partners also has agreements with Adamas Pharmaceuticals, Agenus and La Jolla.