UCB (EBR:UCB) UCB agrees to acquire Ra Pharmaceuticals: Joining forces to improve treatment options for people living with myasthenia gravis and other rare diseases

Directive transparence : information réglementée

10/10/2019 07:02
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6Hnxec3y8eC5enNv3Ba9b4oazGRiYSQWWloOvls2a-2BAJj71i38q83r3a-2FHD= q0qHzFlaJvrHOv0xaauqSDr9MfPMjKHm_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFR= w6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACvGkC-2= Fzo-2BSe7EiUSdPlQdv5TgiG3H-2FsDfjsZ0j7BxNtY2QLcpKC11L4Q-2B8H3wdahmJqE8li6wx= oLG0oUMuBv3-2F-2B2LDzBDNNjqzlYniq5jp1dgqglN0F6MAgWlHAw6j2dG0ZQx4in90jmMyOll= tau7oeP2rOdaad4Extk0edNc6ojCyTM-2F-2FLZ0vf6EE2m8ZXpWMuqukHp8c8BdsDqaITCBRmc= mHS-2FXHCkMLRx6r9e-2Fk9wKZS4J3sVoyaWjiFoflzlQ-3D ** UCB agrees to acquire Ra Pharmaceuticals: Joining forces to improve trea= tment options for people living with myasthenia gravis and other rare disea= ses ------------------------------------------------------------ =C2=B7 Will enhance UCB=E2=80=99s leadership potential in myasthenia gravis= by adding zilucoplan, a peptide inhibitor of complement component 5 (C5) c= urrently in phase 3, to the UCB pipeline alongside to UCB=E2=80=99s rozanol= ixizumab, an FcRn targeting antibody also in phase 3 =C2=B7 Will enrich UCB=E2=80=99s pipeline; zilucoplan is a novel, potential= ly best-in-class investigational molecule also being evaluated in other com= plement-mediated diseases including amyotrophic lateral sclerosis (ALS) and= immune-mediated necrotizing myopathy (IMNM). UCB will develop and, if appr= oved, launch zilucoplan worldwide, accelerating and diversifying company gr= owth =C2=B7 Will accelerate UCB=E2=80=99s long-term innovation capabilities thro= ugh the addition of Ra Pharmaceuticals ExtremeDiversity=E2=84=A2 technology= platform =C2=B7 Plan to maintain productive and innovative Ra Pharma unit in Cambrid= ge, MA, to complement UCB=E2=80=99s research hubs=C2=A0 =C2=B7 The acquisition will enable accelerated top and bottom line growth f= rom 2024 onwards =C2=B7 Total transaction value of approximately US$ 2.1 billion / =E2=82=AC= 2.0 billion (net of Ra Pharma cash) based on US$ 48 in cash per Ra Pharmac= euticals share (approximately US$ 2.5bn / =E2=82=AC 2.2bn) =C2=B7 This acquisition will not impact UCB=E2=80=99s 2019 financial guidan= ce. It would be dilutive to UCB=E2=80=99s mid-term earnings level and hence= move the mid-term target of UCB reaching a rEBITDA ratio (to revenue) of 3= 1% to 2022 from 2021 as previously guided. Brussels (Belgium) and Cambridge, Mass U.S.=C2=A010 October 2019 =E2=80=93 = 7:00 (CEST) - regulated information =E2=80=93 inside information =E2=80=93 = UCB and Ra Pharmaceuticals Inc. (NASDAQ: RARX, Ra Pharma) announced today t= heir entry into a merger agreement pursuant for which UCB will acquire Ra P= harma. Under the terms of the agreement, Ra Pharma shareholders will receiv= e US$ 48 in cash for each Ra Pharma share at closing. The Boards of Directo= rs of both companies have unanimously approved the transaction, which remai= ns subject to approval by Ra Pharma shareholders and to obtaining antitrust= clearance and other customary closing conditions. Ra Pharma is a clinical-stage biopharmaceutical company leveraging a propri= etary peptide chemistry platform to develop novel therapeutics for the trea= tment of serious diseases caused by excessive or uncontrolled activation of= the complement system, a critical component of the innate immune system. T= he company was founded in 2008 and is headquartered in Cambridge, MA, U.S. = The company=E2=80=99s ExtremeDiversity=E2=84=A2 platform enables the produc= tion of synthetic macrocyclic peptides combining the diversity and specific= ity of antibodies with the pharmacological properties of small molecules.= =C2=A0 Ra Pharma=E2=80=99s phase 3 product candidate, zilucoplan, is a once-daily = self-administered, subcutaneous peptide inhibitor of C5. In December 2018, = Ra Pharma announced positive top-line results from a phase 2 trial of ziluc= oplan in patients with generalized myasthenia gravis (gMG), achieving clini= cally meaningful and statistically significant reductions in both, primary = and key secondary endpoints. Zilucoplan is currently being tested in phase = 3 for the treatment of gMG with top-line results expected in early 2021. Fu= rther potential indications that are potentially addressable by zilucoplan = include immune-mediated necrotizing myopathy (IMNM), amyotrophic lateral sc= lerosis (ALS) and other tissue-based complement-mediated disorders with hig= h unmet medical need. Ra Pharma is also developing an extended release form= ulation of zilucoplan, as well as a potential first-in-class oral small mol= ecule C5 inhibitor. Jean-Christophe Tellier, CEO UCB said: =E2=80=9CRa Pharma is an excellent s= trategic fit addressing multiple areas of UCB=E2=80=99s patient value growt= h strategy. Upon closing, the acquisition will add to our strong internal g= rowth opportunities =E2=80=93 six potential product launches in the next fi= ve years, strengthening our neurology and immunology franchises with late a= nd early-stage pipeline projects. In addition, the combination will provide= us with the opportunity to become a leader in treating people living with = myasthenia gravis, an auto-antibody mediated neurological orphan disease wi= th high unmet medical need, as well as adding a highly productive technolog= y platform to our innovation engine.=E2=80=9D Strategic Rationale=C2=A0 The proposed acquisition is part of UCB=E2=80=99s strategic growth path, na= mely the =E2=80=9CAccelerate and Expand=E2=80=9D phase since January 2019. = The addition of Ra Pharma=E2=80=99s =E2=80=98pipeline in a product=E2=80=99= investigational peptic C5 inhibitor zilucoplan alongside UCB=E2=80=99s ant= i-FcRn rozanolixizumab, could create an opportunity to provide more people = living with myasthenia gravis with better treatment options. Beyond myasthe= nia gravis, this acquisition has the potential to enable UCB to offer new t= reatment opportunities for several rare diseases in neurology and immunolog= y as well as different delivery forms, including extended release and orall= y available products. The combined portfolio may also offer synergies in th= e outreach to people with rare diseases and the health care market. Additionally, UCB would gain access to a proprietary technology platform to= produce synthetic macrocyclic peptides. The platform, known as ExtremeDive= rsity=E2=84=A2, is based on messenger ribonucleic acid (mRNA) display and c= ombines the diversity, specificity and high affinity of therapeutic antibod= ies with the attractive pharmacological properties of small molecules. It h= as the potential to augment UCB=E2=80=99s drug discovery capabilities and p= rovide access to Ra Pharma=E2=80=99s proven expertise and talent in this ar= ea. UCB will also further strengthen its presence in the U.S., in particula= r the innovation hub in the Boston, Massachusetts area (U.S.). Doug Treco, Ph.D., President and Chief Executive Officer of Ra Pharmaceutic= als commented: =E2=80=9CUCB shares our commitment to the rare disease patie= nt community and our goal of developing novel, accessible, and cost-effecti= ve therapies in the areas of immunology and neurology. I firmly believe it = is the right partner for us to advance new treatment options from our uniqu= e early and late stage pipeline to patients. Ra Pharma=E2=80=99s technology= platform is an ideal addition to UCB=E2=80=99s leading innovation capabili= ties, and our scientists are looking forward to working with the entire tea= m at UCB.=E2=80=9D Transaction Terms, Approvals and Timing to Close=C2=A0 Upon closing, Ra Pharma shareholders will receive US$48.00 in cash for each= Ra Pharma share (approximately US$ 2.5 billion / =E2=82=AC 2.2 billion), w= hich represents a transaction value of approximately US$ 2.1 billion / =E2= =82=AC 2.0 billion, net of Ra Pharma cash at June 30, 2019 of approximately= US$315 million. The cash consideration represents an approximately 93% pre= mium to Ra Pharma shareholders based on the 30-day volume weighted average = closing stock price of Ra Pharma prior to signing. The transaction has been= unanimously approved by the Boards of Directors of both, UCB and Ra Pharma= and remains subject to approval by Ra Pharma shareholders, obtaining anti-= trust clearance and other customary closing conditions. UCB and Ra Pharma e= xpect to complete the transaction by the end of Q1 2020.=C2=A0 Funding The acquisition of Ra Pharma will be financed by a combination of existing = cash resources and new bank term loans, arranged and underwritten by BNP Pa= ribas Fortis and Bank of America Merrill Lynch. Pro-forma for this acquisit= ion, UCB=E2=80=99s new net debt / rEBITDA ratio would be in the range betwe= en 1.5 and 2.0 times with rapid de-leveraging expected allowing UCB to main= tain significant balance sheet flexibility. Financial Guidance This acquisition will not impact UCB=E2=80=99s 2019 financial guidance. The= acquisition would be dilutive to UCB=E2=80=99s mid-term earnings level due= to R&D investments. As a result, the mid-term target of UCB reaching a rEB= ITDA ratio (to revenue) of 31% would move to 2022 from 2021 as previously g= uided. The acquisition is expected to be core EPS accretive from 2024 onwar= ds and would enable accelerated top and bottom line growth for UCB from 202= 4 onwards. Advisors Bank of America Merrill Lynch and Lazard are acting as financial advisors t= o UCB in relation to the transaction. Covington & Burling LLP is acting as = legal advisor to UCB on this transaction. Centerview Partners is acting as exclusive financial advisor to Ra Pharma o= n this transaction. Latham & Watkins LLP is acting as legal advisor to Ra P= harma on this transaction. Conference call Today, at 9:00am (EDT) / 2:00pm (BST) / 15:00 (CEST), UCB will host a confe= rence call for the financial community. The login details can also be found= on: https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQ= B7X3kY45D7w88RKNKEbAnX3z-2B0lHRIdKimZI6veH9fqo_-2B-2Ft0TnE1oEbVIWS8vHM8JK8e= u8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbv= i8z1TsACvGkC-2Fzo-2BSe7EiUSdPlQdv5TgiG3H-2FsDfjsZ0j7BxNtY2QLcpKC11L4Q-2B8H3= wdahmJqE8li6wxoLG0oUMuBv3-2F-2B2LDzBDNNjqzlYniq5jp1airx30OaiUIYLoU2sh7lQ-2F= k2sr8-2FEu29HRngdzgaVb7MpVkpc-2B1hXmFC6N1Mpeb-2BJ3yTAikGQd6n2R3gqtHzHy-2BOr= bjyVZ-2FeXi2kIrv1GGK8mo4q1cS2TaqV-2BhEBL0ElBQq2jf64SkzCuLIw3emolQ-3D US: +1 6467224916; =C2=A0 =C2=A0 UK: +442071943759; =C2=A0 =C2=A0 Belgium: = +3224035816; =C2=A0 =C2=A0 France: +33 172727403 PIN: 20542874# About Generalized Myasthenia Gravis (gMG) Generalized myasthenia gravis is an unpredictable, chronic auto-immune cond= ition in which auto-antibodies attack specific proteins in the neuro-muscul= ar junction. This disrupts the way that nerves can communicate with muscles= , resulting in muscle weakness and fatigue. Both men and women are impacted= equally, and it can occur at any age and in any race. Myasthenia Gravis is= a rare disease impacting almost 200,000 patients in the US, EU and Japan (= Gilhus N, N Engl J Med 2016;375:2570-812015). Those living with gMG can exp= erience a variety of symptoms, including drooping eyelids and double vision= as well as severe muscular weakness that can result in life threatening we= akness of muscles of respiration.=C2=A0 About Immune-Mediated Necrotizing Myopathy (IMNM)=C2=A0 Immune-mediated necrotizing myopathy (IMNM) is a rare, serious, progressive= neurological condition marked by severe proximal (for example hip and shou= lder) muscle weakness. Auto-immune myopathies have a prevalence of around 1= 5 cases per 100,000 with IMNM about 10-15% of all IMM cases. This suggests = that there are=C2=A0more than 6,000 patients in each of the US and EU. (Anq= uetil et al. Autoimmunity Reviews 18 (2019) 223=E2=80=93230) IMNM is only r= ecently understood to be a distinct entity within the broad group of idiopa= thic inflammatory myopathies and as of yet there are no approved therapies.= =C2=A0 Amyotrophic Lateral Sclerosis (ALS) is a rare and progressive degenerative = disease of the motor neurons affecting more than 200,000 people globally (3= 0,000 in the US alone). in the central nervous system (brain and spinal cor= d) involved in muscle movement, leading to muscle weakness and ultimately p= aralysis. For more information, please visit www.ALS.org Zilucoplan is a macrocyclic peptide designed to bind complement C5 with sub= -nanomolar affinity and allosterically inhibit its cleavage into C5a and C5= b upon activation of the classical, alternative, or lectin pathways and blo= ck the membrane attack complex (MAC) assembly. Zilucoplan is in clinical de= velopment at Ra Pharmaceuticals and is not approved in any region of the wo= rld. In addition to a recently-initiated phase 3 study in gMG and an upcomi= ng phase 2 study in IMNM, zilucoplan was selected as one of the first drugs= to be tested in a multi-center ALS platform study sponsored by the Sean M.= Healey & AMG Center for ALS at Mass General. About Ra Pharmaceuticals Inc. Ra Pharma is a clinical-stage biopharmaceutical company focused on leading = the field of complement biology to bring innovative and accessible therapie= s to patients with rare diseases. Ra=C2=A0Pharma discovers and develops pep= tides and small molecules to target key components of the complement cascad= e. For more information, please visit: www.RaPharma.com. 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 more than 7 500 people in= approximately 40 countries, UCB generated revenue of =E2=82=AC 4.6 billion= in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Tw= itter: @UCB_news For further information=C2=A0 UCB Corporate Communications France Nivelle =C2=A0 Global Communications, UCB T +32.2.559.9178 france.nivelle@ucb.com Laurent Schots=C2=A0 Media Relations, UCB =C2=A0 T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0 UCB Investor Relations Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com Isabelle Ghellynck, =C2=A0Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 Ra Pharmaceuticals, Inc. Investors: Ra Pharmaceuticals, Inc. Natalie Wildenradt, 617-674-9874 nwildenradt@rapharma.com=C2=A0 Media: Argot Partners David Rosen, 212-600-1902 david.rosen@argotpartners.com Forward looking statements UCB 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.=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. UCB is providing this information as of the date of this document an= d expressly disclaims any duty to update any information contained in this = press release, either to confirm the actual results or to report a change i= n 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. Forward-Looking Statements of Ra Pharmaceuticals Certain statements contained in this press release may be considered forwar= d-looking statements within the meaning of the Private Securities Litigatio= n Reform Act of 1995Section 27A of the Securities Act of 1933, as amended, = and Section 21E of the Securities Exchange Act of 1934, as amended, includi= ng without limitation statements regarding the merger and the ability to co= nsummate the merger. =C2=A0These forward-looking statements generally inclu= de statements that are predictive in nature and depend upon or refer to fut= ure events or conditions, and include words such as =E2=80=9Cbelieves,=E2= =80=9D =E2=80=9Cplans,=E2=80=9D =E2=80=9Canticipates,=E2=80=9D =E2=80=9Cpro= jects,=E2=80=9D =E2=80=9Cestimates,=E2=80=9D =E2=80=9Cexpects,=E2=80=9D =E2= =80=9Cintends,=E2=80=9D =E2=80=9Cstrategy,=E2=80=9D =E2=80=9Cfuture,=E2=80= =9D =E2=80=9Copportunity,=E2=80=9D =E2=80=9Cmay,=E2=80=9D =E2=80=9Cwill,=E2= =80=9D =E2=80=9Cshould,=E2=80=9D =E2=80=9Ccould,=E2=80=9D =E2=80=9Cpotentia= l,=E2=80=9D or similar expressions. =C2=A0Statements that are not historica= l facts are forward-looking statements. =C2=A0Forward-looking statements ar= e based on current beliefs and assumptions that are subject to risks and un= certainties. =C2=A0Forward-looking statements speak only as of the date the= y are made, and Ra Pharma undertakes no obligation to update any of them pu= blicly in light of new information or future events. =C2=A0Actual results c= ould differ materially from those contained in any forward-looking statemen= t as a result of various factors, including, without limitation: (1) Ra Pha= rma may be unable to obtain shareholder approval as required for the merger= ; (2) conditions to the closing of the merger may not be satisfied and requ= ired regulatory approvals may not be obtained; (3) the merger may involve u= nexpected costs, liabilities or delays; (4) Ra Pharma=E2=80=99s business ma= y suffer as a result of uncertainty surrounding the merger; (5) the outcome= of any legal proceedings that may arise related to the merger; (6) Ra Phar= ma may be adversely affected by other economic, business, and/or competitiv= e factors; (7) the occurrence of any event, change or other circumstances t= hat could give rise to the termination of the merger agreement; and (8) the= ability to recognize benefits of the merger; (9) risks that the merger dis= rupts current plans and operations and the potential difficulties in employ= ee retention as a result of the merger; and (10) other risks to consummatio= n of the merger, including the risk that the merger will not be consummated= within the expected time period or at all. =C2=A0If the merger is consumma= ted, Ra Pharma shareholders will cease to have any equity interest in Ra Ph= arma and will have no right to participate in its earnings and future growt= h. =C2=A0Additional factors that may affect the future results of Ra Pharma= are set forth in its filings with the SEC, including its Annual Report on = Form 10-K for the year ended December 31, 2018, which is available on the S= EC=E2=80=99s website at www.sec.gov. =C2=A0Readers are cautioned not to pla= ce undue reliance on these forward-looking statements, which speak only as = of the date thereof. =C2=A0 GenericFile UCB Ra Pharma press release Final (https://u7061146.ct.sendgrid.net/wf/clic= k?upn=3DG62jSYfZdO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxec3y8eC5enNv3Ba9b4oazGRL= DATovL2QdJs4UQmZY3709GmfrPAxns2sLp2Wkc381c-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu= 8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi= 8z1TsACvGkC-2Fzo-2BSe7EiUSdPlQdv5TgiG3H-2FsDfjsZ0j7BxNtY2QLcpKC11L4Q-2B8H3w= dahmJqE8li6wxoLG0oUMuBv3-2F-2B2LDzBDNNjqzlYniq5jp1QwFa7W4u1OBBs7K-2FCF2xgh3= x85wmj61rZlSKLSMqCfT-2BwifWjeWNA9QycUJWs9gQnRXdeh57yNJ447QxsjgUchUMqwc-2BiO= 8wCzfmMKTIU1Hb3gFhJXL6YdzUO9dUHcH8bkMhs7Rhqqwac-2B5anh7WeQ-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-2BzKSgNKq4mrfGu6pWEapyaCAbFmNCmvznBPW= JaxKGuviNjBiRhVo0ADWBZPfRnszov52Nfdn7zB-2FRIVu8gXAwq8zslGFi25ddJVO-2BscNFzo= m6p6g0d-2BDsU-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZT= jzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACvGkC-2Fzo-2BSe7EiUSdPl= Qdv5TgiG3H-2FsDfjsZ0j7BxNtY2QLcpKC11L4Q-2B8H3wdahmJqE8li6wxoLG0oUMuBv3-2F-2= B2LDzBDNNjqzlYniq5jp1QBQ5M6EtKXNGIV35jZ-2BssWyD-2B-2BCeFpJTFEjKGvfxEC50zSvC= ITDYTwnKMp3gF-2FQRuTcIE1XWXQk1nP9RyjeY-2F6AsWxK-2B8raq77bwsWxBzPTjifrizrOkL= tYm-2Bd6L6Yi0QGyNLUqzK7XtayImIn-2B4Ow-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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