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- charel01
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Re: UCB
Re: UCB
De analisten van ING starten de opvolging van UCB UCB0,49% .
De farmagroep krijgt een koopadvies met een koersdoel van 130 euro. 'Het middel bimekizumab kan een gamechanger zijn voor UCB op vlak van immuuntherapie', zeggen analisten Maxime Stranart en David Vagman. De analisten voorspellen een piekverkoop van 3,4 miljard euro tegen eind 2029.
UCB is 25 procent goedkoper dan zijn peers ondanks een hogere winst per aandeel.
MAXIME STRANART - ANALIST ING
'We appreciëren het groeipotentieel ondanks het nakende verlies van de exclusieve rechten op de middelen Vimpat en Cimzia in 2022 en 2024', zeggen de analisten. 'Bovendien handelt UCB aan 16 keer zijn verwachte winst van 2021. Dat is, ondanks zijn hogere winst per aandeel, een korting van een 25 procent in vergelijking met zijn belangrijkste sectorgenoten.
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Re: UCB
UCB’s VIMPAT[®] (lacosamide) CV now approved by FDA in U.S. for primary generalized tonic-clonic seizures and expanded pediatric use for people living with epilepsy
· New approval for VIMPAT[®] (lacosamide) CV in the U.S. as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older
· All three VIMPAT formulations, including injection for intravenous use, are now indicated for the treatment of partial-onset seizures and as adjunctive therapy in the treatment of PGTCS in patients four years of age and older
· These approvals further help patients with epilepsy who may have had limited treatment options in the past, while reinforcing UCB’s leadership in transforming epilepsy care
· In October, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy
Brussels, Belgium, Atlanta, Ga., November 17, 2020: UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VIMPAT® (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older.1 PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes.2
“These approvals underscore UCB’s commitment to people living with epilepsy and our focus on finding solutions for specific unmet needs within the epilepsy community.” said Mike Davis, Head of U.S. Neurology at UCB. “We are pleased that VIMPAT is now available as a treatment option for people living with primary generalized tonic-clonic seizures on their journey to seizure control.”
The PGTCS approval is based, in part, on results of a Phase 3 study recently published in the Journal of Neurology, Neurosurgery & Psychiatry.3 Adjunctive treatment with VIMPAT resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment period, with the corresponding risk reduction being 45% (p=0.001), and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, p=0.011).1
People living with generalized tonic-clonic seizures have an increased risk of injury4 and those who experienced three or more in one year had a fifteen-fold increased risk of sudden unexpected death in epilepsy.5
“The treatment of primary generalized tonic-clonic (convulsive) seizures is challenging, with about one-third of patients still being refractory while on therapy,” said David Vossler, MD, FAAN FACNS FAES, Department of Neurology, University of Washington, Seattle, USA. “Bolstered by a wealth of data demonstrating VIMPAT’s efficacy and safety, this new indication gives people suffering from PGTCS a chance at freedom from these seizures, which many have never experienced.”
Results from the Phase 3 study showed that VIMPAT was generally tolerated in patients with idiopathic generalised epilepsy (IGE) and PGTCS. The most common adverse reactions (≥10%) reported in patients treated with VIMPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo.1
Regarding the expanded pediatric population, VIMPAT tablets and oral solution were already approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy. In the US, VIMPAT injection was previously approved for the treatment of partial-onset seizures only in adult patients (17 years of age and older).
In Europe VIMPAT is currently not indicated in patients with PGTCS, however, in October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy.6 Regulatory reviews for use of VIMPAT in the treatment of PGTCS are also underway in the Japan and Australia.
About Epilepsy
Epilepsy is the main symptom of a variety of chronic disorders of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.7
About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies, and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.
About UCB
UCB, Brussels, Belgium (www.ucb-usa.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or the central nervous system. With more than 7,600 people in approximately 40 countries, the company generated revenue of €4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
About VIMPAT® (lacosamide) CV in the U.S.1
VIMPAT® was approved in the U.S. in 2008 as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. VIMPAT was approved as monotherapy for adults in August 2014, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2017. VIMPAT is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.
- charel01
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Re: UCB
UCB heeft de goedkeuring van de Amerikaanse toezichthouder FDA gekregen voor het gebruik van Vimpat bij epilepsie met voornamelijk tonisch clonische aanvallen bij kinderen vanaf vier jaar. Dit maakte de Brusselse farmaceut dinsdagmiddag bekend.
Tonisch clonische aanvallen zijn epilepsie-aanvallen waarbij eerste alle armen en benen verstijven, gevolgd door schokken in de armen en benen.
De goedkeuring volgt op de fase 3 studieresultaten die in de Journal of Neurology, Neurosurgery & Psychiatry gepubliceerd werden.
De onderzoeksdata toonden dat Vimpat goed getolereerd werd na toediening.
Door: ABM Financial News.
Re: UCB
- charel01
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Re: UCB
Volgens het databedrijf Symphony Health Solutions zijn de verkopen van UCB's Cimzia - een middel dat onder andere wordt gebruikt voor de ziekte van Crohn - op basis van een viermaands voortschrijdend gemiddelde met 5,9 procent gedaald in oktober ten opzichte van de maand daarvoor. Het middel was goed voor een derde van de kwartaalomzet van de farmaspeler.
Bron:"De Tijd"
- charel01
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- Berichten: 24811
- Lid geworden op: 02 jan 2012 20:17
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Re: UCB
Volgens de Zwitserse bank ontbreekt het tot medio 2021, als bimekizumab wordt gelanceerd, aan aanjagers. Wel zijn de analisten te spreken over deze behandeling voor psoriasis. Zij rekenen op een piekverkoop van meer dan 2 miljard euro tegen 2030. De omzet in de eerste jaren zal echter wat tegenvallen, vreest UBS, door de sterke concurrentie van Cosentyx en Taltz.
Deze lagere curve in combinatie met het wegvallen van patenten in 2023 en 2024 heeft volgens UBS "een grote impact" op de waardering. Daarbij voorzien de analisten ook dat de kosten voor marketing en verkoop langere tijd hoger zullen uitvallen dan eerder voorzien.
Wel voorziet UBS dat UCB zijn margedoelstelling van 31 procent in 2022 zal halen. De bank mikt op 30,9 procent. "Maar als er een risico is, dan zal dat eerder neerwaarts zijn dan opwaarts", waarschuwden de analisten.
Door: ABM Financial News.
Re: UCB
Nieuws via RSS voor UCB
18 november 2020 19:49
ATLANTA, Nov. 18, 2020 /PRNewswire/ -- UCB and Stanford Medicine have established a multi-year collaboration to enhance patient value for people living with severe diseases. In line with UCB's digital business transformation, the goal of the collaboration is to jointly develop unique solutions that combine clinical, real-world, omics, and other data sets — along with the required expertise — to identify which patients will respond best and ultimately, deliver better patient outcomes.
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