The oncology research space has become rather crowded these days, with numerous clinical-level companies cropping up with novel technologies. While these offer a lot of scope for speculative trading, finding promising companies in the oncology space has become rather cumbersome.
A key criterion while choosing from these biopharma companies should be picking the ones that already have a commercial line-up, which in turn, offers a steady revenue stream. Karyopharm Therapeutics (NASDAQ: KPTI) falls into this segment. The company’s XPOVIO (selinexor) is the only FDA approved drug for both Multiple Myeloma and Diffuse large B-cell lymphoma (DLBCL), the latter approval coming as recently as in June.
Sales trend and profitability
The highly sought commercial product-line drove the company’s topline to $33.5 million in the second quarter, compared to $9.5 million a year ago. In an interview with AlphaStreet, Karyopharm Therapeutics CEO Michael Kauffman said the high demand for oral therapies during the pandemic period is likely to have played a key role in XPOVIO sales remaining strong, even as the overall market for multiple myeloma drugs witnessed a weakness.
The CEO also expressed confidence in receiving approval in second-line myeloma early next year, which would open up the market further for Karyopharm. He said:
Once this opens up, we’re going from approximately 6,000 target myeloma patients to around 30,000 myeloma patients. Ultimately, we believe this is a drug that will garner somewhere between $700 million and $1 billion in myeloma alone.
Kauffman sidestepped from providing specifics on a timeline to profitability but stated that the company could see some “real progress” in this regard by around 2022, given the current sales trends and on the condition that next year’s approval goes through without any hiccups.
Karyopharm has also been conducting trials to study the efficacy of low dose selinexor as an anti-viral agent in COVID-19 patients. As the Phase 2 trials showed clinical benefit only among patients who were 75 years or younger and without other severe medical conditions, the company will continue to focus on this subpopulation going forward.
The Newton, Massachusetts-based pharmaceutical company now expects to partner with non-profit organizations like The National Institutes of Health or World Health Organization to go ahead with the trials. Kauffman stated:
We accomplished what we set out to do, which was to prove the antiviral activity of XPOVIO low doses. We don’t have the wherewithal to do a randomized phase 3 study broadly along with our oncology program. So we’re talking to the NIH, to the World Health Organization and other potential partners, and if they find the data compelling, we hope that they’ll agree to take the drug ahead and include it in their trials.
The road ahead
Karyopharm clearly has some plans laid out into later this year and next year. Among them, of foremost importance would be to clear the regulatory barriers in Europe for selinexor combination to treat multiple myeloma. Certain monitoring activities and the global pandemic had delayed the process and the company now expects to receive a response from EMA before the end of this year, the company had said during the post-earnings conference call.
Apart from myeloma and lymphoma, Karyopharm is expanding its study into selected solid tumors and uterine cancer. In the words of the CEO:
We are going to be focusing our efforts now in selected solid tumors. We’ll have data coming up in dedifferentiated liposarcoma. This is a relatively small indication but a huge unmet medical need. So much that both the FDA and the EMA have allowed us to do a phase three randomized trial towards an approval against placebo. If approved, it would become the only oral drug approved in liposarcoma.
Kauffman also expressed confidence in funding the future R&D requirements through the revenues generated from the commercial products, hinting that the company is pretty self-sufficient.
For more insights into Karyapharm Therapeutics, read the latest earnings call transcript here
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