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Seeking blockbuster status, UCB eyes 4 new indications for psoriasis med Bimzelx in 2024

March 2, 2024
Life sciences

After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels.

This year, the company is focused on growing its blockbuster hopeful Bimzelx and tacking on four extra indications for the psoriasis med, alongside other launches.

After 14 regulatory approvals on three continents last year, UCB is positioned to grow for “a decade-plus,” CEO Jean-Christophe Tellier said in the company’s full-year earnings press release. Meanwhile, eight regulatory reviews are ongoing.

UCB’s recent approvals span Europe, Japan and the U.S. and include UCB’s generalized myasthenia gravis meds Rystiggo and Zilbrysq, plus epileptic seizure med Keppra. Last but not least, the psoriasis drug Bimzelx has a “best-in-disease” profile, Tellier has said.

Bimzelx’s initial psoriasis approval in the U.S. came later than expected after a few setbacks, including a manufacturing-related complete response letter in May 2022. Still, UCB maintains that the delay helped it to collect the necessary data for other indications, allowing follow-on filings to be “accelerated,” Tellier said in an interview at the time.

Now, the FDA has accepted the company’s bids to expand Bimzelx’s label to treat psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). UCB also submitted an application for an approval in hidradenitis suppurativa (HS). All four indications are expected to see “FDA action and potential approvals” before the end of 2024, the company said.

So far, the drug has pulled 148 million euros ($160 million) in sales, including 9 million euros ($9.7 million) in the U.S. following its mid-November launch. UCB expects peak sales to reach at least 4 billion euros.

Riding this momentum, the company will “accelerate our investments launching three products across the globe,” including by starting a direct-to-consumer campaign for Bimzelx that was originally slated for 2023, chief financial officer Sandrine Dufour noted in the release.

UCB expects 2024 revenue to land between 5.5 billion euros ($5.96 billion) and 5.7 billion euros ($6.17 billion), while the company projects its 2025 revenue to reach at least 6 billion euros ($6.49 billion).

The year-over-year growth will be driven by “intense ongoing global launches” of Bimzelx, Rystiggo, Zilbrysq, as well as its Amgen-partnered osteoporosis med and its Fintepla for seizures associated with Dravet syndrome and Lennox–Gastaut syndrome, UCB said.

As for 2023, UCB raked in a total of 5.25 billion euros ($5.68 billion).

By Zoey Becker

Source: fiercepharma.com

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