Big Year For UCB As Bimzelx Awaits US Green Light

The Brussels-based company's head of immunology has told Scrip that going into a crowded market against several highly effective biologics across different classes holds no fears for UCB despite some concerns that US prescribers will stick to what they know when it comes to psoriasis therapies.

Source: UCB

UCB S.A. has started the year strongly with the proposed $1.9bn acquisition of rare epilepsy drug developer Zogenix, Inc. but how successful 2022 is for the Belgian group will be measured by the launch of Bimzelx, potentially a mega-blockbuster for inflammatory diseases.

However, while Bimzelx (bimekizumab) comfortably secured approval for psoriasis in the EU and the UK in August last year, the regulatory pathway has been bumpier across the Atlantic. In October, the US Food and Drug Administration informed UCB it was unable to complete a review of the biologics license application for the IL-17A and IL-17F inhibitor until on-site inspections of the European manufacturing facilities for the drug were completed. (Also see "UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug" - Scrip, 18 Oct, 2021.)

In a recent interview with Scrip, UCB's immunology chief and head of US operations Emmanuel Caeymaex stressed that the agency cited only COVID-19-related travel restrictions as the reason for the deferral and had no safety or efficacy issues. The data submitted by the company are based on three Phase III studies – BE VIVID, BE READY and BE SURE – which all hit their co-primary and ranked secondary endpoints and showed that patients treated with Bimzelx achieved superior levels of skin clearance at week 16 compared with those who received AbbVie Inc.’s Humira (adalimumab), placebo and Johnson & Johnson's IL-12/23 inhibitor blockbuster Stelara (ustekinumab), respectively. The impressive rates of skin clearance seen in those trials were replicated in the BE RADIANT study which evaluated Bimzelx head-to-head with Novartis AG's blockbuster IL-17A inhibitor Cosentyx (secukinumab).  (Also see "Can UCB's Bimekizumab Go From Last To First In Psoriasis?" - Scrip, 15 Jun, 2020.) (Also see "UCB Is RADIANT As Bimekizumab Beats Cosentyx For Psoriasis" - Scrip, 24 Jul, 2020.) 

On the FDA inspection issue, Caeymaex said: "We hoped they would be able to do this in a manner that would be remote or even trust their European colleagues. Those plants supply Europe, so it's not like we're talking about something completely new here and they have a very good inspectional history."

However, the FDA insisted and UCB has supplied the agency with dates for the inspection. Caeymaex warned that "typically, those inspections take a number of weeks, and then there's several weeks of paperwork, so it can be very fast, or it can be a little longer, depending on whether there are any findings or not, however we're quite confident. It just needs to take place."

Assuming all goes well, UCB will be going into a crowded market with several highly effective biologics across different classes. Speaking to Scrip on a recent podcast, Datamonitor analyst Pamela Spicer noted that while Bimzelx performed better in the clinic compared with the IL-17A inhibitors such as Cosentyx and Eli Lilly and Company's Taltz (ixekizumab), US dermatologists told her that "while the PASI (skin clearance) numbers are higher, they don't really see this difference as meaningful enough to drive immediate switching from Cosentyx or Taltz or even putting new patients on the UCB drug." (Also see "A Deep Dive Into The Game-Changing Drugs For Skin Diseases" - Scrip, 17 Jan, 2022.)

She said: "They're going to stick with what they're already comfortable prescribing and though some of them say they're excited about the data, which looks great, they might be slower to adopt Bimzelx and it might take a bit of a longer time."

In response, Caeymaex said that the US presents a challenge, "especially when you don't have differentiation that speaks for itself, but we've had extensive discussions with virtually every payer in the country, whether at pharmacy benefit management level or the downstream health plans." He claimed that there was "a high expectation for Bimzelx and they're motivated to create a path for access. We recognize that it's a market that there's already a lot of good options, not one where there hasn't been any innovation for a long time, so probably the drug will initially be used in patients that have failed one or several biologics or other products first. I think we will be in a good position there, both from a payer and thought leader point of view."

EMMANUEL CAEYMAEX

Caeymaex insisted: "We've invested a lot over the last years to introduce UCB to the community and we're not starting from scratch." He noted that the company's field force is already selling the TNF-blocker Cimzia (certolizumab pegol) which is also approved for psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), as well as for Crohn's disease and rheumatoid arthritis.

On home turf, Caeymaex is pleased with how Bimzelx has started "as European regulators have really understood and are aligned with the progressive thought leaders that we want to give the patient not just what was possible but really ameliorate any impact on disease related quality of life." In England, Bimzelx became the first product to be cleared for use by NICE via a new approach to the fast-track cost-comparison review process before it had actually been approved, followed by another fast track approval from the Scottish Medicines Consortium.  (Also see "UCB’s Bimekizumab Gets Fast-Track Funding For Severe Psoriasis In England" - Pink Sheet, 2 Aug, 2021.)  (Also see "Scotland's HTA Body Says Fast-Track Yes To UCB’s Bimzelx" - Pink Sheet, 12 Nov, 2021.)

Noting that UCB had set a target of having 35% of the European population covered and funded by the end of 2021, which represents 45% in value due to slightly more advantageous pricing, Caeymaex said he was pleased with the level of uptake in Germany. He acknowledged that the lack of face-to-face engagement with physicians was a challenge, saying that "it doesn't matter so much for mature products but for a launch product, it does help to have frequent in-person contacts."

Promising In PsA And axSpA

UCB's ambitions for Bimzelx go beyond psoriasis and the company has been amassing impressive data in PsA and AS. In November, the company presented interim results from the 852-patient BE OPTIMAL study, the first of two Phase III trials studying Bimzelx in PsA, which showed that significantly more patients on treatment achieved at least 50% improvement in symptoms from baseline compared to those on placebo. On 21 January, UCB revealed that the second Phase III study, BE COMPLETE, was also positive and PsA filings are planned for the third quarter. (Also see "UCB’s Bimzelx Impresses In Psoriatic Arthritis Amid US Psoriasis Approval Delay" - Scrip, 19 Nov, 2021.)

Earlier this week, UCB presented positive topline results from the late-stage BE MOBILE 1 study where Bimzelx demonstrated significant improvement over placebo in the proportion of patients with nr-axSpA who achieved an ASAS40 (at least 40% improvement) response. ASAS40 measures improvements in disease across patient global assessment of disease activity, spinal pain, physical function and inflammation.

Caeymaex said the results, together with the recently reported top-line data from the BE MOBILE 2 study in AS, "support the clinical potential of bimekizumab to improve outcomes across the full spectrum of axial spondyloarthritis (axSpA)." Regulatory applications are planned in the US and the EU in the third quarter of this year. 

He concluded by saying that "we've established ourselves as a company that is prepared to take risks based on sound science and puts our money where our mouth is." Paying $1.9bn for Zogenix shows that, although it will seem a small sum if Bimzelx reaches its potential across skin and joint indications (the drug is also being evaluated for hidradenitis suppurativa) and tops $3-$4bn in sales.  (Also see "UCB Jumps Early Onto M&A Merry-Go-Round With Zogenix Buy" - Scrip, 19 Jan, 2022.)