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Ucb SA (UCB.BR)

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Latest Key Developments (Source: Significant Developments)

UCB Receives CHMP Positive Opinion For Adjunctive Use Of Briviact
Friday, 1 Jun 2018 11:59am EDT 

June 1 (Reuters) - UCB SA ::RECEIVES CHMP POSITIVE OPINION FOR ADJUNCTIVE USE OF BRIVIACT.OPINION EXTENDS THERAPEUTIC INDICATION TO INCLUDE ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARY GENERALISATION IN PATIENTS WITH EPILEPSY FROM 4 YEARS OF AGE..EUROPEAN COMMISSION IS EXPECTED TO MAKE A DECISION BASED ON THIS CHMP POSITIVE OPINION OVER THE COMING WEEKS.  Full Article

UCB FY Net Sales Up At ‍​4.18 Billion Euros
Thursday, 22 Feb 2018 02:23am EST 

Feb 22 (Reuters) - UCB SA ::FY: REVENUE EUR 4.53‍​ BILLION VERSUS EUR 4.43 BILLION IN REUTERS POLL, NET SALES EUR ‍​4.18 BILLION VERSUS EUR 3.83 BILLION YEAR AGO.FY: RECURRING EBITDA EUR ‍​1.38 BILLION VERSUS EUR 1.28 BILLION IN REUTERS POLL; VIMPAT NET SALES EUR ‍​976 MILLION VERSUS EUR 970 MILLION IN REUTERS POLL.FY: CIMZIA NET SALES EUR 1.42‍​ BILLION VERSUS EUR 1.40 BILLION IN REUTERS POLL; KEPPRA NET SALES EUR ‍​778 MILLION VERSUS EUR 795 MILLION IN REUTERS POLL.FY NEUPRO NET SALES EUR ‍​314 MILLION VERSUS EUR 312 MILLION IN REUTERS POLL.2018 REVENUE IS EXPECTED TO REACH APPROXIMATELY € 4.5 BILLION – EUR 4.6 BILLION‍​.2018 RECURRING EBITDA IN THE RANGE OF € 1.3 BILLION – EUR 1.4 BILLION.CORE EARNINGS PER SHARE EXPECTED BETWEEN € 4.30 – EUR, 4.70 BASED ON AN AVERAGE OF 188 MILLION SHARES OUTSTANDING.PROPOSES A DIVIDEND OF € 1.18 PER SHARE (GROSS), AN INCREASE BY THREE €-CENTS OR BY 2.6%.PROFIT FOR THE GROUP AMOUNTED TO € 771 MILLION (+42%) OF WHICH € 753 MILLION IS ATTRIBUTABLE TO UCB SHAREHOLDERS.  Full Article

UCB Announces That EMA Has Approved Label Change For Cimzia
Tuesday, 9 Jan 2018 01:13am EST 

Jan 9 (Reuters) - UCB SA ::EMA HAS APPROVED LABEL CHANGE FOR UCB’S CIMZIA.LABEL CHANGE MAKING IT FIRST ANTI-TNF FOR POTENTIAL USE IN WOMEN WITH CHRONIC RHEUMATIC DISEASE, DURING PREGNANCY AND BREASTFEEDING.  Full Article

UCB Announces Positive Top Line Results Of Phase 2b Bimekizumab Study
Wednesday, 20 Dec 2017 01:11am EST 

Dec 20 (Reuters) - UCB SA ::BIMEKIZUMAB DEMONSTRATES IMPRESSIVE JOINT AND SKIN RESPONSES FOR PSORIATIC ARTHRITIS PATIENTS‍​.ANNOUNCES PHASE 2B BE ACTIVE STUDY MET THE PRIMARY OBJECTIVE OF ESTABLISHING DOSE RESPONSE FOR BIMEKIZUMAB WITH STATISTICAL SIGNIFICANCE.  Full Article

UCB Bimekizumab Announces Results For Phase 2b Of BE Agile Study ‍​
Thursday, 14 Dec 2017 01:16am EST 

Dec 14 (Reuters) - UCB SA ::BIMEKIZUMAB ADVANCES WITH SIGNIFICANT RESULTS IN ANKYLOSING SPONDYLITIS PATIENTS‍​.POSITIVE FIRST RESULTS IN ANKYLOSING SPONDYLITIS FROM PHASE 2B BE AGILE STUDY OF BIMEKIZUMAB SHOW STATISTICAL SIGNIFICANCE IN MULTIPLE DOSE GROUPS.BIMEKIZUMAB WAS GENERALLY WELL TOLERATED AND NO UNEXPECTED SAFETY SIGNALS WERE OBSERVED.THE STUDY ACHIEVED THE PRIMARY ENDPOINT (ASAS40)‍​.RESULTS FROM THIRD PHASE 2B STUDY OF BIMEKIZUMAB IN PSORIATIC ARTHRITIS EXPECTED SOON.UP TO 47% OF PATIENTS ACHIEVE AT LEAST 40% IMPROVEMENT VERSUS 13% OF PATIENTS RECEIVING PLACEBO, AT WEEK 12 ‍​.  Full Article

Dermira and UCB agree to end collaboration agreement for Cimzia
Monday, 6 Nov 2017 04:01pm EST 

Nov 6 (Reuters) - Dermira Inc :Dermira and UCB agree to end collaboration agreement for Cimzia.Dermira Inc - ‍Dermira to transition development and commercialization responsibility for Cimzia (Certolizumab Pegol) in psoriasis back to UCB​.Dermira Inc - ‍collaboration agreement will terminate on February 15, 2018 and companies anticipate completion of transition by such date​.Dermira Inc - ‍pursuant to collaboration agreement, there are no termination or penalty payments required by either party​.Dermira - for repurchase of all product rights, licenses and intellectual property relating to cimzia, ucb will pay to dermira $11.0 million by Nov 13.  Full Article

UCB 9-month revenue up at 3.3 billion euros, 2017 outlook increased
Friday, 20 Oct 2017 01:21am EDT 

Oct 20 (Reuters) - UCB SA ::9-MONTH REVENUE INCREASED TO € 3.3 BILLION, BY 9%; MAIN PRODUCTS GREW BY 15% TO € 2.6 BILLION .9-MONTH NEUPRO REVENUE EUR 230 MILLION VERSUS EUR 217 MILLION YEAR AGO‍​.9M VIMPAT REVENUE EUR 707‍​ MILLION VERSUS EUR 586 MILLION YEAR AGO.9M KEPPRA REVENUE EUR 607‍​ MILLION VERSUS EUR 538 MILLION YEAR AGO.9M IMMUNOLOGY/CIMZIA REVENUE EUR ‍​1.02 BILLION VERSUS EUR 927 MILLION YEAR AGO.9-MONTH NEUPRO REVENUE EUR 230 MILLION VERSUS EUR 217 MILLION YEAR AGO.9-MONTH BRIVIACT REVENUE EUR 57 MILLION VERSUS EUR 11 MILLION YEAR AGO.FINANCIAL OUTLOOK 2017 INCREASED: NOW REVENUE EXPECTED BETWEEN €4.4 - 4.5BN. REBITDA BETWEEN €1.25 - 1.35BN‍​.9M NEUROLOGY REVENUE EUR ‍​ 1.60 BILLION VERSUS EUR 1.35 BILLION YEAR AGO.FINANCIAL OUTLOOK 2017 INCREASED: NOW EXPECTED CORE EPS BETWEEN €4.10 – 4.50.BRIVIACT APPROVED AS MONOTHERAPY IN THE U.S.‍​.VIMPAT APPROVED AS MONOTHERAPY IN JAPAN AND FOR CHILDREN AS ADD-ON THERAPY IN THE EU. ‍​.  Full Article

‍Partners Connected Health and UCB announce epilepsy partnership​
Wednesday, 11 Oct 2017 10:45am EDT 

Oct 11 (Reuters) - UCB SA ::‍PARTNERS CONNECTED HEALTH AND UCB ANNOUNCE COLLABORATION TO DEVELOP HEALTHCARE SOLUTIONS TO SUPPORT PEOPLE LIVING WITH EPILEPSY​.  Full Article

UCB anti-epileptic drug Vimpat (Lacosamide) receives EU approval for paediatric use
Thursday, 21 Sep 2017 01:31pm EDT 

Sept 21 (Reuters) - UCB SA : :ANTI-EPILEPTIC DRUG VIMPAT (LACOSAMIDE) RECEIVES EU APPROVAL FOR PAEDIATRIC USE.VIMPAT APPROVED FOR MONOTHERAPY AND ADJUNCTIVE THERAPY OF PARTIAL-ONSET (FOCAL) SEIZURES IN CHILDREN AGED 4 YEARS AND OLDER.  Full Article

UCB H1 net sales up at EUR 2.04 billion; increases FY 2017 outlook
Thursday, 27 Jul 2017 01:04am EDT 

July 27 (Reuters) - UCB SA : :H1 REBITDA EUR 742 MILLION VERSUS EUR 549 MILLION YEAR AGO.H1 NET SALES EUR 2.04 BILLION VERSUS EUR 1.85 BILLION YEAR AGO.H1 GROSS PROFIT INCREASED TO € 1.67 BILLION (+17%, +15% CER).FOR FY17, REVENUE ARE NOW EXPECTED TO REACH € 4.35 - 4.45 BILLION, RECURRING EBITDA SHOULD INCREASE TO € 1.15 – 1.25 BILLION.FOR FY17, CORE EARNINGS PER SHARE ARE EXPECTED IN THE RANGE OF € 3.70 – 4.15 BASED ON AN EXPECTED AVERAGE OF 188 MILLION SHARES OUTSTANDING.  Full Article

CORRECTED-BRIEF-UCB's Midazolam Nasal Spray Granted Orphan Drug Designation

* FDA ACCEPTS NEW DRUG APPLICATION (NDA) TO REVIEW MIDAZOLAM NASAL SPRAY