Key Developments: UCB SA (UCB.BR)

UCB.BR on Brussels Stock Exchange

24 Dec 2014
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Latest Key Developments (Source: Significant Developments)

UCB SA, Advent International and Avista Capital Partners terminate acquisition of Kremers Urban, and confirms FY 2014 outlook
Tuesday, 16 Dec 2014 01:01pm EST 

UCB SA:UCB, Advent International and Avista Capital Partners mutually agree to terminate acquisition agreement for Kremers Urban.Says mutual agreement driven by conflicting timing for acquisition (including financing) and regulatory process.Says intention to divest Kremers Urban, its United States specialty generics business, remains unchanged.Says 2014 financial outlook unchanged.  Full Article

UCB SA announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam
Monday, 8 Dec 2014 01:00am EST 

UCB SA:Announces primary efficacy and safety data from the latest Phase 3 study evaluating brivaracetam (fixed doses of 100 and 200 mg/day with no up-titration) as adjunctive treatment in adult epilepsy patients with partial-onset seizures.Says this study with brivaracetam represents the Phase 3 study conducted in epilepsy patients with partial-onset seizures.Brivaracetam is an investigational antiepileptic drug (AED) and is not approved by any regulatory authority worldwide.This study showed statistical significance for the two primary endpoints (p<0.001 for brivaracetam 100 and 200 mg/day).The primary efficacy endpoint in the US was the percent reduction in partial-onset seizure frequency per 28 days over placebo.The primary efficacy endpoint in the EU was the responder rate, i.e., the proportion of patients showing a 50 pct. or greater reduction in partial-onset seizure frequency.Says the most frequent treatment-emergent adverse events were somnolence, dizziness and fatigue.The two primary outcomes in this study evaluating adjunctive brivaracetam in the treatment of partial-onset seizures in adults with epilepsy were statistically and clinically relevant.  Full Article

UCB SA announces partnership with Daiichi Sankyo in Japan
Friday, 28 Nov 2014 01:02am EST 

UCB SA:Announces partnership with Daiichi Sankyo for co-commercialization of Lacosamide in Japan.Says it will manufacture and supply product for commercialization, Daiichi Sankyo will manage distribution and book sales.Says it will receive from Daiichi Sankyo up to total of about 180 million euros of upfront and milestones payments during coming years.Payment is based on agreement and subject to achievement of certain milestones in future.Agreement does not change UCB's financial outlook for 2014.Impact from agreement on Daiichi Sankyo's business results of current fiscal year will be announced at later date.  Full Article

UCB Phase 3 clinical study on VIMPAT meets primary efficacy endpoint
Tuesday, 28 Oct 2014 02:02am EDT 

UCB SA:Phase 3 clinical study evaluating VIMPAT (lacosamide) meets its primary efficacy endpoint.Says study evaluated VIMPAT as adjunctive therapy in treatment of Japanese and Chinese adult patients with partial-onset seizures.Regulatory applications to be submitted for VIMPAT in Japan and China in 2015.  Full Article

UCB and Amgen announce results from several exploratory analyses of Phase 2 study of romosozumab
Tuesday, 16 Sep 2014 01:00am EDT 

UCB SA:Announces together with Amgen results from several exploratory analyses of Phase 2 study of romosozumab.Says romosozumab evaluated in postmenopausal women with low bone mineral density (BMD).Says results from one analysis showed that treatment with romosozumab led to significant increases in lumbar spine and total hip BMD.Says results of romosozumab Phase 3 program expected in 2016.  Full Article

Wilex returns rights from collaboration in oncology to UCB
Wednesday, 21 May 2014 06:49am EDT 

Wilex AG:Says collaboration agreement with UCB for clinical product candidates WX-554 and WX-037 and for three preclinical antibody programmes has been terminated by mutual agreement.To return all rights granted and will transfer all intellectual property, data and documents generated in connection with programs to UCB.Agreement regarding antibody program for non-oncology indications signed last year has also been terminated.Wilex will receive final payment for reimbursement of R&D expenses.UCB has agreed to waive repayment of 2.5 million euro shareholder loan granted in Dec. 2010 on completion of transfer.  Full Article

UCB announces data from extension clinical trial of Cimzia
Monday, 5 May 2014 09:07am EDT 

UCB SA:Announces results from PRECiSE 3 seven-year open label extension clinical trial of Cimzia (certolizumab pegol), evaluating long-term safety in Crohn's disease.Remission also assessed over trial period.595 patients enrolled in PRECiSE 3 following completion of PRECiSE 1 and 2 pivotal studies (354 enrolled from PRECiSE 1 and 241 enrolled from PRECiSE 2).No new safety signals identified during study.Patients treated with Cimzia are at increased risk for developing serious infections that may lead to hospitalization or death.  Full Article

UCB SA confirms FY 2014 outlook
Wednesday, 23 Apr 2014 08:00pm EDT 

UCB SA:Confirms FY 2014 outlook of revenue growing about 3.5 to 3.6 bln euros; recurring EBITDA increasing about 740 to 770 mln euros and core earnings per share expected in range of 1.90 to 2.05 euros.FY 2014 revenue 3,553 mln euros; EBITDA 766.03 mln euros; EPS 2.05 euros - Thomson Reuters I/B/E/S Estimates.  Full Article

UCB SA issues FY 2014 financial guidance and proposes FY 2013 dividend
Sunday, 2 Mar 2014 07:00pm EST 

UCB SA:Expects FY 2014 revenue to grow to about 3.5-3.6 billion euros.Expects FY 2014 EBITDA to increase to about 740-770 million euros.Sees FY 2014 core EPS of 1.90-2.05 euros.FY 2014 revenue 3.591 billion euros - Thomson Reuters I/B/E/S Estimates.FY 2014 EBITDA 786.21 million euros - Thomson Reuters I/B/E/S Estimates.FY 2014 EPS 2.10 euros -Thomson Reuters I/B/E/S Estimates.Proposes gross FY 2013 dividend of 1.04 euro per share (+2 pct).  Full Article

Biogen Idec Inc and UCB SA Enters in to agreements to Commercialize Multiple Sclerosis and Hemophilia Therapies in Asia
Thursday, 30 Jan 2014 01:10am EST 

Biogen Idec Inc:Says it has signed exclusive agreements granting UCB the right to commercialize Biogen Idec products in South Korea, Hong Kong, Thailand, Singapore, Malaysia and Taiwan, and both develop and commercialize products in China.As part of the relationship, Biogen Idec will supply UCB with its portfolio of multiple sclerosis therapies and investigational candidates, including TECFIDERA, FAMPYRA, AVONEX, TYSABRI, PLEGRIDY and Daclizumab High-Yield Process.Says the relationship also includes ELOCTATE and ALPROLIX, Biogen Idec`s investigational long-acting recombinant candidates for hemophilia A and B, respectively.  Full Article

BRIEF-UCB, Advent International and Avista Capital Partners terminate acquisition of Kremers Urban

* UCB, Advent International and Avista Capital Partners mutually agree to terminate acquisition agreement for Kremers Urban

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