UCB starts European green light for psoriasis drug in autumn

The European green light for the psoriasis drug from the Belgian biopharma group UCB is the first step towards potential blockbuster status for bimekizumab in a few years’ time. “The approval in Europe is the first market approval worldwide for this new psoriasis treatment.”

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The listed biopharma group UCB

, headquartered in Anderlecht, announced on Tuesday that it may launch bimekizumab on the European market under the brand name Bimzelx as a drug for the treatment of moderate to severe psoriasis.

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The decision of the European Commission is not really a big surprise: in June there was already one favorable advice of the drug watchdog EMA.

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For UCB, the green light kicks off a busy autumn: The US drug watchdog FDA is expected to rule on bimekizumab as a psoriasis drug by Oct. 15.

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Analysts emphasize that in the hyper-competitive US psoriasis market, bimekizumab has to compete with treatments from giants such as Novartis and AbbVie. But UCB insists that bimekizumab was shown to be superior in comparative studies with existing treatments, including Novartis’ Cosentyx.

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Analysts emphasize that in the hyper-competitive US psoriasis market, bimekizumab has to compete with treatments from giants such as Novartis and AbbVie.

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“The approval of bimekizumab in Europe is the first global market approval for this new psoriasis treatment and marks a milestone for UCB,” said Emmanuel Caeymaex, executive vice president and head of the immunology department. “We believe that bimekizumab has the potential to raise expectations of what psoriasis treatment might mean.”

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At the end of 2021 and early 2022, important research results will follow for bimekizumab, in the treatment of joint disease AS and psoriatic arthritis (PsA).

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By the end of next year, six months faster than expected thanks to rapid recruitment, UCB also expects Phase 3 results for bimekizumab treatment of moderate to severe hidradenitis suppurativa, a chronic skin condition. In the short term, bimekizumab could therefore be used as a treatment for four indications.

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But UCB also has irons in the fire. For example, in the fourth quarter of this year and the first quarter of 2022, Phase 3 results are also expected for rozanolixizumab and zilucoplan, two complementary treatments for myasthenia gravis. That is the rare muscle disease for which the Ghent Argenx at the end of this year hopes to get a first effective treatment approved by the FDA.

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Cooking costs money

The many ongoing studies in the last (and most expensive) research phase temporarily weigh on the profit margin of UCB, but are crucial for the future of the pharmaceutical company, which achieved a turnover of 2.8 billion euros in the past six months, 7 percent more than in the same period last year, and a net profit of 571 million euros, well above the expected EUR 495 million.

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UCB did not raise its forecasts in the half year results announcement at the end of July because of high costs for studies and product launches this year.

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For example, UCB currently has seven phase 3 studies underway. That is the last and most expensive phase of clinical development before the commercialization application. These studies caused the costs for research and development to rise by 9 percent in the past six months, to 733 million euros. In addition, UCB is investing heavily in marketing for new product launches.

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Bimekizumab as the next blockbuster

Bimekizumab is being groomed as the first blockbuster in the line. The stock exchange house UBS figured the potential peak sales for bimekizumab/Bimzelx by 2028 at 2.5 billion euros.

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Bimekizumab and the other experimental agents in the pipeline should be as seamless as possible later this decade take over the baton of the current strongholds who will gradually lose their patent, such as the reumamiddel Cimzia.

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The patents of ‘old-timers’ such as Cimzia and the epilepsy drug Vimpat will expire between 2022 and 2024, which means that new blockbusters will come into play at UCB to avoid an excessive dip in revenues.

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Cimzia accounted for a third of the UCB group turnover for the 2020 financial year with EUR 1.8 billion. Over the past six months, UCB’s key products have also shown their resilience, despite the corona pandemic. Sales of the epilepsy drug Keppra (+16 percent) and Cimzia (+4 percent) were strong, among others.

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UCB starts European green light for psoriasis drug in autumn

Cooking costs money

Bimekizumab as the next blockbuster

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