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UCB (EBR:UCB) UCB Media Room: Update on U.S. FDA Review of Biologics License Application (BLA) for bimekizumab

Directive transparence : information réglementée

13/05/2022 08:01
https://mb.cision.com/Public/18595/3566508/89b97e0d45c65d3c_800x800ar.png ** Update on U.S. FDA Review of Biologics License Application (BLA) for bim= ekizumab ------------------------------------------------------------ Brussels (Belgium), 13th May 2022 =E2=80=93 08:00 CEST =E2=80=93 Regulated = Information =E2=80=93 Inside Information =E2=80=93 UCB, a global biopharmac= eutical company, announced today that the U.S. Food and Drug Administration= (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics = License Application (BLA) for bimekizumab for the treatment of adults with = moderate to severe plaque psoriasis.=C2=A0 The letter indicates that the FDA cannot approve the application in its cur= rent form. The CRL states that certain pre-approval inspection observations= must be resolved before approval of the application. We are cooperating wi= th the FDA and are working to address these observations as expeditiously a= s possible.=C2=A0 UCB is committed to bringing bimekizumab to patients worldwide. In August 2= 021, bimekizumab received marketing authorization in countries of the Europ= ean Union (EU)/European Economic Area (EEA) and Great Britain, for the trea= tment of moderate to severe plaque psoriasis in adults who are candidates f= or systemic therapy.^1,2=C2=A0In January 2022, bimekizumab received marketi= ng authorization in Japan for the treatment of plaque psoriasis, generalize= d pustular psoriasis and psoriatic erythroderma in patients who are not suf= ficiently responding to existing treatments.^3 In February and March 2022, = bimekizumab received marketing authorization in Canada and Australia, respe= ctively, for the treatment of moderate to severe plaque psoriasis in adults= who are candidates for systemic therapy or phototherapy.^4,5 In context of the CRL, UCB is reviewing its financial guidance for 2022. About Psoriasis Psoriasis is a common, chronic inflammatory disease with primary involvemen= t of the skin.^6 This skin condition affects men and women of all ages and = ethnicities.^6 Psoriasis signs and symptoms can vary but may include red pa= tches of skin covered with silvery scales; dry, cracked skin that may bleed= ; and thickened, pitted or ridged nails.^7 Psoriasis also has a considerabl= e psychological and quality-of-life impact, potentially affecting work, rec= reation, relationships, sexual functioning, family and social life.^8=C2=A0= =C2=A0 =C2=A0 =C2=A0=C2=A0 About bimekizumab=C2=A0 Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel= ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)= , two key cytokines driving inflammatory processes.^9=C2=A0 For further information, contact UCB:=C2=A0 Corporate Communications Laurent Schots T +32.2.559.92.64=C2=A0 email laurent.schots@ucb.com Investor Relations Antje Witte T +32.2.559.94.14=C2=A0 email antje.witte@ucb.com=C2=A0 Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 Email eimear.obrien@ucb.com About UCB=C2=A0 UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 8,600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. Forward looking statements=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. These forward-looking statements are= based on current plans, estimates and beliefs of management. All statement= s, other than statements of historical facts, are statements that could be = deemed forward-looking statements, including estimates of revenues, operati= ng margins, capital expenditures, cash, other financial information, expect= ed legal, arbitration, political, regulatory or clinical results or practic= es and other such estimates and results. By their nature, such forward-look= ing statements are not guarantees of future performance and are subject to = known and unknown risks, uncertainties and assumptions which might cause th= e 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 relea= se. Important factors that could result in such differences include: the gl= obal spread and impact of COVID-19, changes in general economic, business a= nd competitive conditions, the inability to obtain necessary regulatory app= rovals or to obtain them on acceptable terms or within expected timing, cos= ts associated with research and development, changes in the prospects for p= roducts in the pipeline or under development by UCB, effects of future judi= cial decisions or governmental investigations, safety, quality, data integr= ity or manufacturing issues; potential or actual data security and data pri= vacy breaches, or disruptions of our information technology systems, produc= t 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 uncertainti= es 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 b= e discovered or identified in the pipeline, will progress to product approv= al or that new indications for existing products will be developed and appr= oved. Movement from concept to commercial product is uncertain; preclinical= results do not guarantee safety and efficacy of product candidates in huma= ns. So far, the complexity of the human body cannot be reproduced in comput= er models, cell culture systems or animal models. The length of the timing = to complete clinical trials and to get regulatory approval for product mark= eting has varied in the past and UCB expects similar unpredictability going= forward. Products or potential products, which are the subject of partners= hips, joint ventures or licensing collaborations may be subject to differen= ces 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 p= artnership. UCB=E2=80=99s efforts to acquire other products or companies an= d to integrate the operations of such acquired companies may not be as succ= essful as UCB may have believed at the moment of acquisition. Also, UCB or = others could discover safety, side effects or manufacturing problems with i= ts products and/or devices after they are marketed. The discovery of signif= icant problems with a product similar to one of UCB=E2=80=99s products that= implicate an entire class of products may have a material adverse effect o= n sales of the entire class of affected products. Moreover, sales may be im= pacted by international and domestic trends toward managed care and health = care cost containment, including pricing pressure, political and public scr= utiny, customer and prescriber patterns or practices, and the reimbursement= policies imposed by third-party payers as well as legislation affecting bi= opharmaceutical pricing and reimbursement activities and outcomes. Finally,= a breakdown, cyberattack or information security breach could compromise t= he confidentiality, integrity and availability of UCB=E2=80=99s data and sy= stems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and it does not reflect any potenti= al impact from the evolving COVID-19 pandemic, unless indicated otherwise. = UCB is following the worldwide developments diligently to assess the financ= ial significance of this pandemic to UCB. UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances on which any such statement is based, unless such statement is= required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n 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 jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction.=C2=A0 References 1. BIMZELX (bimekizumab) EU Summary of Product Characteristics https://www.= ema.europa.eu/en/documents/product-information/bimzelx-epar-product-informa= tion_en.pdf. Last accessed May 2022. 2. BIMZELX (bimekizumab) GB Summary of Product Characteristics https://www.= medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/produc= t/12833. Last accessed May 2022. 3. Pharmaceuticals and Medical Devices Agency https://www.pmda.go.jp/englis= h/review-services/reviews/approved-information/drugs/0001.html. Last access= ed May 2022. 4. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pd= f.hres.ca/dpd_pm/00064702.PDF. Last accessed: May 2022.=C2=A0 5. https://www.tga.gov.au/apm-summary/bimzelx (https://www.tga.gov.au/apm-s= ummary/bimzelx. Last accessed May 2022) . Last accessed May 2022.=C2=A0 6. National Psoriasis Foundation. About Psoriasis. Available at: https://ww= w.psoriasis.org/about-psoriasis/. Last accessed: May 2022. 7. Mayo Clinic. Psoriasis: Symptoms & Causes. Available at: =C2=A0 https://= www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-203558= 40. Last accessed: May 2022. 8. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermato= l Ther (Heidelb). 2013;3(2):117-130. 9. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi= mekizumab, a humanized monoclonal antibody and selective dual inhibitor of = IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1= 001. GenericFile UCB PR Bimzelx Update FDA ENG (https://mb.cision.com/Public/18595/3566508/9= aea90ef0959d8ea.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x105084x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium

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