UCB (EBR:UCB) UCB Media Room: Evenity CHMP Positive Opinion

Directive transparence : information réglementée

18/10/2019 07:00
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6HnxecXG1JIbC-2BRoqEGnn-2FZVhT-2Byjn1p44es9dOapUvbhZWpVXBT8mJFL= AGKyOBFJBWmCbF7L1-2FIkx0teFiOTGmF72F_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5B= wmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAZc= KVZHkpy-2BrGgPw85DKCCEpBMiHLdhR8y2MTyabI7sd4IwgSaFPLmjNUia-2BuNkLg-2FJq5stK= IX1gq9KYhi95J-2FtLOvfD6HX5N-2BtdnavXtKLlrJutzNuUnygadhmPXry0MA99IiwtqY4IcXd= khqCaeHZhBknXK8e2NbioNAB06oKt693mlfdEhHpecogBr7skt30NWzOM9y5RPsIEJokNEpvVGH= cug97MulSft2hLcvtr6aKo1c-2BRraaQhJ-2FXUzfWs-3D ** EVENITY=C2=AE (romosozumab) Receives Positive CHMP Opinion for the Treat= ment of Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture ------------------------------------------------------------ Brussels, Belgium and Thousand Oaks, Calif. (October 18, 2019 - 07:00) =E2= =80=93 UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced= that following a re-examination procedure, the Committee for Medicinal Pro= ducts for Human Use (CHMP) of the European Medicines Agency (EMA), has adop= ted a positive opinion recommending Marketing Authorization for EVENITY^=C2= =AE (romosozumab) for the treatment of severe osteoporosis in postmenopausa= l women at high risk of fracture and with no history of myocardial infarcti= on or stroke. Romosozumab is a novel bone-builder with a dual effect that i= ncreases bone formation and, to a lesser extent, reduces bone resorption (o= r bone loss). =E2=80=9CPost-menopausal osteoporosis and fragility fractures are a signifi= cant women=E2=80=99s health issue that=E2=80=99s far too often overlooked, = with evidence showing that an estimated 77 percent of women aged 67 or olde= r remain undiagnosed and untreated following a fracture^1. This is why new = treatment options are so important,=E2=80=9D said Dr. Pascale Richetta, hea= d of bone and executive vice president, UCB. =E2=80=9CWe believe that the C= ommittee=E2=80=99s positive opinion is an important step forward to help im= prove the lives of post-menopausal women with severe osteoporosis who are a= t high risk of fragility fractures.=E2=80=9D The CHMP=E2=80=99s recommendation will now be reviewed by the European Comm= ission (EC), which has the authority to approve medicines for use throughou= t the European Union. A European Commission decision is expected by year-en= d 2019. =E2=80=9CAfter a fracture, postmenopausal women with osteoporosis are five = times more likely to fracture in the subsequent year,^2 and these fractures= can be life-changing,=E2=80=9D said David M. Reese, M.D., executive vice p= resident of Research and Development at Amgen. =E2=80=9CWe are pleased by t= he Committee=E2=80=99s opinion, which brings romosozumab one step closer to= becoming a new osteoporosis treatment option for patients with severe oste= oporosis at high risk of fracture in Europe.=E2=80=9D Romosozumab is approved in U.S, for the treatment of osteoporosis in postme= nopausal women at high risk for fracture.^3 Romosozumab is also approved in= Japan and South Korea for the treatment of osteoporosis for women and men = at high risk for fracture, in Canada for the treatment of osteoporosis for = postmenopausal women at high risk for fracture and in Australia for the tre= atment of osteoporosis in postmenopausal women at high risk of fracture and= as a treatment to increase bone mass in men with osteoporosis at high risk= of fracture.^4-7 1. Cosman F, de Beur SJ, LeBoff MS, et al. =C2=A0Clinician=E2=80=99s Guide = to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25(10): = 2359=E2=80=932381. 2. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture= in the year following fracture. JAMA. 2001;285(3):320-323.=C2=A0 3. EVENITY=E2=84=A2 (romosozumab-aqqg) U.S. Prescribing Information https:/= /u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBwmMb94tc2HK= D0JOL-2BJI06zm1wh1UDoA7Topcv6m9LnXP5vmPtokUnXsJbCwNlVQtB6Hi0O-2BQoxx0xt1bAC= TeLps5apnJ-2FiYR-2FlLxjEU-2BmnoikFzzoBzVFxX55tdqC7fBg-3D-3D_-2B-2Ft0TnE1oEb= VIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTef= ElHQ9EZfLoWbvi8z1TsAAZcKVZHkpy-2BrGgPw85DKCCEpBMiHLdhR8y2MTyabI7sd4IwgSaFPL= mjNUia-2BuNkLg-2FJq5stKIX1gq9KYhi95J-2FtLOvfD6HX5N-2BtdnavXtKLosyOMNCaCFEke= GZenGPZqYKiU4MluWv2k1j5M3itHPCPaI-2BiyNh2fVzVaw5LMcV3pAIW2s5XHRazAeejjRBsVc= FXWVJHF7-2FA9CSGysRycnYGXVSN47rEoHCIu5-2BHck8-2FPzHem2bYDFWpBqnbKU1hy8-3D 4. Pharmaceuticals and Medical Devices Agency Prescription Drug Database ht= tps://u7061146.ct.sendgrid.net/wf/click?upn=3D84Em28S1K9SvtzcUtu04Es9sbuFVj= Ud9W-2F-2FUO4o8okhLvUYIEQdz6pN-2FaGfH6-2B7aoaZP5QZNqGAMJ3M5VLVwXw-3D-3D_-2B= -2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7r= BLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAZcKVZHkpy-2BrGgPw85DKCCEpBMiHLdhR8y2MTyabI= 7sd4IwgSaFPLmjNUia-2BuNkLg-2FJq5stKIX1gq9KYhi95J-2FtLOvfD6HX5N-2BtdnavXtKLs= cVsOQ5zBy3aol5Hcgdcoff4obg5VY7oq9vPgfr9qFWnaYln1zmC-2FJUWJsNAS-2BlUBr-2BKkJ= bCB49XOj3exF2en5vgIOgHPjt2-2FYMla9U-2FJIquz-2FN8kn2amspaE1s8jRFyvQxlEd33xra= HGgB-2Bwwlfg0-3D 5. Ministry of Food and Drug Safety, Import Drug License. 20190531. 6. EVENITY=E2=84=A2 Product Monograph. Amgen Canada Inc. (June 2019). 7. Australian Government. Department of Health. Therapeutic Goods Administr= ation Database https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2= F12d8lSllQB4ZQ9I-2FTYVlmHVGuV4uWJgY1WhWQRM4KygqPy3TvOFITANhfp5Hkav2w4X8vh3f= sik8nL6J-2FvQ-2BjFQOWRjBIJl-2Bi4W-2Fq58o2VmJ24d7j-2BiXGRJuLIbEeM2ZWkxPJs5Bk= MsdKGfhMcEPoYuoM67bjl6Dn1j8RyejnIfFlekhIxg1tJXMAT7BzqiwH3TFldn4dOhh3C9uNBEg= Fw7ftUW5bNi8-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTj= zwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAZcKVZHkpy-2BrGgPw85DKCC= EpBMiHLdhR8y2MTyabI7sd4IwgSaFPLmjNUia-2BuNkLg-2FJq5stKIX1gq9KYhi95J-2FtLOvf= D6HX5N-2BtdnavXtKLv-2BJOfCm2RCd8WstyrIVRvw-2BxuLcQeU0x-2Fx8rKgQZUVZNPElrPAo= 4PljavzsJdj1GkQKNdb0vKP9B-2FCGz91XMdRfAbwQ-2BS2Mg30P-2FM1aPWmQ497BdIITIZClt= 0-2FNKMv6BiIwQ1hzkQc6b9J-2F5kAs-2B68-3D Accessed October 2019. About EVENITY^=C2=AE (romosozumab) Romosozumab is a bone-forming monoclonal antibody. It is designed to work b= y inhibiting the activity of sclerostin, which simultaneously results in in= creased bone formation and to a lesser extent decreased bone resorption. Th= e romosozumab development program includes 19 clinical studies that enrolle= d approximately 14,000 patients. EVENITY has been studied for its potential= to reduce the risk of fractures in an extensive global Phase 3 program tha= t included two large fracture trials comparing romosozumab to either placeb= o or active comparator in over 11,000 postmenopausal women with osteoporosi= s. Amgen and UCB are co-developing romosozumab. About the Amgen and UCB Collaboration Since 2004, Amgen and UCB have been working together under a collaboration = and license agreement to research, develop and market antibody products tar= geting the protein sclerostin. As part of this agreement, the two companies= continue to collaborate on the development of romosozumab for the treatmen= t of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB= are joining forces to translate a genetic discovery into a new medicine, t= urning conceptual science into a reality. CONTACT: UCB, Brussels Scott Fleming, Bone Communications, UCB, T +44 7702777378, scott.fleming@uc= b.com France Nivelle, Global Communications, UCB, T +32.2.559.9178, france.nivell= e@ucb.com Laurent Schots, Media Relations, UCB, T+32.2.559.92.64, laurent.schots@ucb.= com Antje Witte, Investor Relations, UCB, T +32.2.559.94.14, antje.witte@ucb.com Isabelle Ghellynck, Investor Relations, UCB, T+32.2.559.9588, isabelle.ghel= lynck@ucb.com CONTACT: Amgen, Thousand Oaks Kelley Davenport, 202-585-9637 (media) Kristen Davis, 805-447-3008 (media)=C2=A0 Arvind Sood, 805-447-1060 (investors) About UCB 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 7 500 people in approxima= tely 40 countries, the company generated revenue of =E2=82=AC 4.6 billion i= n 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twit= ter: @UCB_news. UCB Forward-Looking Statements This press release contains forward-looking statements based on current pla= ns, estimates and beliefs of management. All statements, other than stateme= nts of historical fact, are statements that could be deemed forward-looking= statements, including estimates of revenues, operating margins, capital ex= penditures, cash, other financial information, expected legal, political, r= egulatory or clinical results and other such estimates and results. By thei= r nature, such forward-looking statements are not guarantees of future perf= ormance and are subject to risks, uncertainties and assumptions which could= cause actual results to differ materially from those that may be implied b= y such forward-looking statements contained in this press release. Importan= t factors that could result in such differences include: changes in general= economic, business and competitive conditions, the inability to obtain nec= essary regulatory approvals or to obtain them on acceptable terms, costs as= sociated with research and development, changes in the prospects for produc= ts in the pipeline or under development by UCB, effects of future judicial = decisions or governmental investigations, product liability claims, challen= ges to patent protection for products or product candidates, changes in law= s or regulations, exchange rate fluctuations, changes or uncertainties in t= ax laws or the administration of such laws and hiring and retention of its = employees. UCB is providing this information as of the date of this press r= elease and expressly disclaims any duty to update any information contained= in this press release, either to confirm the actual results or to report a= change in its expectations. There is no guarantee that new product candidates in the pipeline will prog= ress to product approval or that new indications for existing products will= be developed and approved. Products or potential products which are the su= bject of partnerships, joint ventures or licensing collaborations may be su= bject to differences between the partners. Also, UCB or others could discov= er safety, side effects or manufacturing problems with its products after t= hey are marketed. Moreover, sales may be impacted by international and domestic trends toward= managed care and health care cost containment and the reimbursement polici= es imposed by third-party payers as well as legislation affecting biopharma= ceutical pricing and reimbursement. About Amgen Amgen is committed to unlocking the potential of biology for patients suffe= ring from serious illnesses by discovering, developing, manufacturing and d= elivering innovative human therapeutics. This approach begins by using tool= s like advanced human genetics to unravel the complexities of disease and u= nderstand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologi= cs manufacturing expertise to strive for solutions that improve health outc= omes and dramatically improve people=E2=80=99s lives. A biotechnology pione= er since 1980, Amgen has grown to be the world=E2=80=99s largest independen= t biotechnology company, has reached millions of patients around the world = and is developing a pipeline of medicines with breakaway potential.=C2=A0 For more information, visit www.amgen.com and follow us on www.twitter.com/= amgen.=C2=A0 Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the= current expectations and beliefs of Amgen. All statements, other than stat= ements of historical fact, are statements that could be deemed forward-look= ing statements, including estimates of revenues, operating margins, capital= expenditures, cash, other financial metrics, expected legal, arbitration, = political, regulatory or clinical results or practices, customer and prescr= iber patterns or practices, reimbursement activities and outcomes and other= such estimates and results. Forward-looking statements involve significant= risks and uncertainties, including those discussed below and more fully de= scribed in the Securities and Exchange Commission reports filed by Amgen, i= ncluding its most recent annual report on Form 10-K and any subsequent peri= odic reports on Form 10-Q and current reports on =C2=A0Form 8-K. Unless oth= erwise noted, Amgen is providing this information as of the date of this ne= ws release and does not undertake any obligation to update any forward-look= ing statements contained in this document as a result of new information, f= uture events or otherwise. No forward-looking statement can be guaranteed and actual results may diffe= r materially from those Amgen projects. Discovery or identification of new = product candidates or development of new indications for existing products = cannot be guaranteed and movement from concept to product is uncertain; con= sequently, there can be no guarantee that any particular product candidate = or development of a new indication for an existing product will be successf= ul and become a commercial product. Further, preclinical results do not gua= rantee safe and effective performance of product candidates in humans. The = complexity of the human body cannot be perfectly, or sometimes, even adequa= tely modeled by computer or cell culture systems or animal models. The leng= th of time that it takes for Amgen to complete clinical trials and obtain r= egulatory approval for product marketing has in the past varied and Amgen e= xpects similar variability in the future. Even when clinical trials are suc= cessful, regulatory authorities may question the sufficiency for approval o= f the trial endpoints Amgen has selected. Amgen develops product candidates= internally and through licensing collaborations, partnerships and joint ve= ntures. Product candidates that are derived from relationships may be subje= ct to disputes between the parties or may prove to be not as effective or a= s safe as Amgen may have believed at the time of entering into such relatio= nship. Also, Amgen or others could identify safety, side effects or manufac= turing problems with its products, including its devices, after they are on= the market.=C2=A0 Amgen=E2=80=99s results may be affected by its ability to successfully mark= et both new and existing products domestically and internationally, clinica= l and regulatory developments involving current and future products, sales = growth of recently launched products, competition from other products inclu= ding biosimilars, difficulties or delays in manufacturing its products and = global economic conditions. In addition, sales of Amgen=E2=80=99s products = are affected by pricing pressure, political and public scrutiny and reimbur= sement policies imposed by third-party payers, including governments, priva= te insurance plans and managed care providers and may be affected by regula= tory, clinical and guideline developments and domestic and international tr= ends toward managed care and healthcare cost containment. Furthermore, Amge= n=E2=80=99s research, testing, pricing, marketing and other operations are = subject to extensive regulation by domestic and foreign government regulato= ry authorities. Amgen=E2=80=99s business may be impacted by government inve= stigations, litigation and product liability claims. In addition, Amgen=E2= =80=99s business may be impacted by the adoption of new tax legislation or = exposure to additional tax liabilities. While Amgen routinely obtains paten= ts for its products and technology, the protection offered by its patents a= nd patent applications may be challenged, invalidated or circumvented by it= s competitors, or Amgen may fail to prevail in present and future intellect= ual property litigation. Amgen performs a substantial amount of its commerc= ial manufacturing activities at a few key manufacturing facilities, includi= ng in Puerto Rico, and also depends on third parties for a portion of its m= anufacturing activities, and limits on supply may constrain sales of certai= n of its current products and product candidate development. In addition, A= mgen competes with other companies with respect to many of its marketed pro= ducts as well as for the discovery and development of new products. Further= , some raw materials, medical devices and component parts for Amgen=E2=80= =99s products are supplied by sole third-party suppliers. Certain of Amgen= =E2=80=99s distributors, customers and payers have substantial purchasing l= everage in their dealings with Amgen. The discovery of significant problems= with a product similar to one of Amgen=E2=80=99s products that implicate a= n entire class of products could have a material adverse effect on sales of= the affected products and on its business and results of operations. Amgen= =E2=80=99s efforts to acquire other companies or products and to integrate = the operations of companies Amgen has acquired may not be successful. A bre= akdown, cyberattack or information security breach could compromise the con= fidentiality, integrity and availability of Amgen=E2=80=99s systems and Amg= en=E2=80=99s data. Amgen=E2=80=99s stock price may be volatile and may be a= ffected by a number of events. Amgen=E2=80=99s business performance could a= ffect or limit the ability of the Amgen Board of Directors to declare a div= idend or its ability to pay a dividend or repurchase its common stock. Amge= n may not be able to access the capital and credit markets on terms that ar= e favorable to it, or at all. The scientific information discussed in this news release related to Amgen= =E2=80=99s product candidates is preliminary and investigative. Such produc= t candidates are not approved by the U.S. Food and Drug Administration, and= no conclusions can or should be drawn regarding the safety or effectivenes= s of the product candidates.=C2=A0 GenericFile UCB CHMP Press Releases FINAL (https://u7061146.ct.sendgrid.net/wf/click?up= n=3DG62jSYfZdO-2F12d8lSllQBx1W27HkUdGSImvHQ6HnxecXG1JIbC-2BRoqEGnn-2FZVhT-2= BbS0fSnBtvSwh9JWlgWSBaRZm30TSY1WFobGbWLkqrOY-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8= eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWb= vi8z1TsAAZcKVZHkpy-2BrGgPw85DKCCEpBMiHLdhR8y2MTyabI7sd4IwgSaFPLmjNUia-2BuNk= Lg-2FJq5stKIX1gq9KYhi95J-2FtLOvfD6HX5N-2BtdnavXtKLmGPxepG-2BKpboywsLF-2B5LV= CfGonEK050pUTIqGyvBE8If9N5Dxce0bXOaBLSivT2w1TgG6rvmU2uH4-2BBEKEHVqrs-2BkB1d= 8vTzq8HrI93BW4pZZum-2BX08PdJkd6dAQHa7SyImhYhPTNjsYZ3hVaANx7g-3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQ= Bz2p53T0v-2BoEIvbo6vDi8C-2BOyFzyb6obo-2BzKSgNKq4mr3V7rGwv1Y-2B0WHgFxqaReiOF= wnQ3ez0DWVL8f-2F1Vxj8cjQ1S2c9fCscRC2M9C-2B4HKmQh14nO6kK6vepN8eEtrVq4POAE4QD= oEzzWPhu49a1k-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZT= jzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAAZcKVZHkpy-2BrGgPw85DKC= CEpBMiHLdhR8y2MTyabI7sd4IwgSaFPLmjNUia-2BuNkLg-2FJq5stKIX1gq9KYhi95J-2FtLOv= fD6HX5N-2BtdnavXtKLml6p1kwy8H-2BwQi5CUBZtUqDSkEnEZasoq0KyJHXuVF2r9RmpPt-2F1= z7opbi412LkWnjVh4uQaOtUHOa5qV7FxHuPm3E5OF49kxHEB1siAF8YYpALNBhwnqsDAUv25VZ3= AUcJ6wAz9tHEl89ucN9aBiI-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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