• BIMZELX^® (bimekizumab-bkzx) is now commercially available by prescription in the United States 
• BIMZELX is the first and only IL-17A and IL-17F inhibitor approved for the treatment of adults with moderate-to-severe plaque psoriasis 
• BIMZELX Navigate™, a personalized patient support system, is available to eligible patients to provide support during treatment  

ATLANTA, November 14, 2023 – 7:00 (ET) – UCB, a global biopharmaceutical company, announced today that BIMZELX® (bimekizumab-bkzx) is commercially available for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. BIMZELX was approved by the U.S. Food and Drug Administration (FDA) on October 17, 2023. 

BIMZELX is available as an autoinjector and a pre-filled syringe.1 BIMZELX may be administered subcutaneously by a healthcare professional, or a patient may self-inject after proper training.¹ People living with moderate-to-severe plaque psoriasis should talk to their healthcare provider to see if BIMZELX may be right for them.

“While the treatment landscape for psoriasis has evolved in recent years, many unmet needs remain for the more than 7.5 million adults in the U.S. living with the disease,” said Dr. Jeffrey Stark, Head of Medical, U.S. Immunology, UCB. “With BIMZELX now available, patients and their healthcare providers have access to a treatment that has proven to consistently deliver rapid, complete, and maintained skin clearance from the first dose.” 

BIMZELX is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).¹ The approval of BIMZELX is supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of BIMZELX in 1,480 adults with moderate-to-severe plaque psoriasis.^2,3,4

“At UCB, we are committed to creating accessible treatments that empower people living with psoriasis to achieve their own goals and live their best possible lives,” said Camille Lee, Head of U.S. Immunology, UCB. “That’s why we developed BIMZELX Navigate™, a tailored patient support program designed to help patients with access, affordability, and treatment support throughout their treatment journeys with BIMZELX.” 

Through BIMZELX Navigate, UCB offers tailored patient support to all those with moderate-to-severe plaque psoriasis upon receiving their BIMZELX prescription. Upon enrollment, patients will be paired with a dedicated Nurse Navigator. This licensed Registered Nurse will be available to discuss treatment goals, train patients on how to administer BIMZELX, connect patients to Co-Pay support, and keep patients up-to-date about their BIMZELX shipment and insurance status. Eligible patients living in the U.S. may enroll in BIMZELX Navigate at https://www.bimzelx.com/patient-support. 

UCB is actively engaging in access conversations with payers, with a focus on our patient value strategy and keeping the patient at the center of these discussions. Based on these conversations, we are progressing well toward our goal to enable affordable access to our medicines for all people who need them, in a way that is sustainable for patients, society and UCB.  While we work toward securing access for patients with payer organizations, our BIMZELX Navigate program is in place and successfully operating to get patients started. Full affordability information can be found at ucb-usa.com/Sustainability/Affordability/Bimzelx-Pricing-Info and http://www.BIMZELX.com. For additional medical information, patient assistance or any other information, please call UCBCares^® at 1-844-599-CARE (2273) or visit askucbcares.com. 

Key Findings from the Phase 3 Clinical Development Program
The efficacy and safety of BIMZELX were evaluated in three Phase 3 studies, versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), and versus adalimumab (BE SURE).2,3,4 All studies met their co-primary endpoints and all ranked secondary endpoints.^2,3,4

Patients treated with BIMZELX achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (ranked secondary endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and BE VIVID; p<0.0001) and adalimumab (co-primary endpoint, BE SURE; p<0.001), as measured by at least a 90 percent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).^2,3,4 Ranked secondary endpoints included PASI 75 at week 4 and PASI 100 (complete skin clearance) at week 16.^2,3,4 Key findings across all studies include:

• Clear or Almost Clear Skin: More than eight out of 10 patients receiving BIMZELX (320 mg every four weeks [Q4W]) achieved PASI 90 and IGA 0/1 at week 16.^2,3,4 
• Complete Skin Clearance: Approximately six out of 10 patients receiving BIMZELX (320 mg Q4W) achieved PASI 100 at week 16.^2,3,4
• Speed of Response: Clinical responses achieved with BIMZELX were rapid, with more than seven out of 10 patients achieving PASI 75 at week 4 following one dose (320 mg).^2,3,4
• Maintenance of Response: Clinical responses achieved with BIMZELX at week 16 (PASI 90 and PASI 100) were maintained for up to one year.^2,3,4 Long-term data showed that clinical responses were maintained in the vast majority of patients through to three years of BIMZELX treatment.⁵

The most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.¹

About BIMZELX (bimekizumab-bkzx)
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.1 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.¹

Please see Important Safety Information below and full U.S. prescribing information at UCB-USA.com/Innovation/Products/BIMZELX and http://www.BIMZELX.com.                                                             

BIMZELX U.S. IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior 
BIMZELX® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.

Infections
BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.                                  
                                                                                                                         .
Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded.  Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.    

Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.        
                                                                                      
Most Common Adverse Reactions 
Most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.


For further information, contact UCB:                                                                                          

Investor Relations
Antje Witte
T +32.2.559.94.14 
email antje.witte@ucb.com 

U.S. Communications
Ally Funk
T +1.678.365.6321
email ally.funk@ucb.com 

About UCB 
UCB, Brussels, Belgium (www.ucb.com), is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements 
This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems. 

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. 

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 
 

References

1. BIMZELX (bimekizumab) U.S. Prescribing Information https://www.ucb-usa.com/Innovation/Products/Bimzelx. Last accessed: October 2023.
2. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE    VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487–498.
3. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475–486.
4. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–141.
5. Strober B, Tada Y, Mrowietz U et al. Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial. Br J Dermatol. 2023; 24;188(6):749-759.