Galapagos NV (Seite 18)
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ID: 1.170.954
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ISIN: BE0003818359 · WKN: A0EAT9 · Symbol: GXE
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Galapagos publishes 2023 annual report and announces Annual and Extraordinary Shareholders’ Meetings 28.03.24 · globenewswire |
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von so einem Steuersatz können deutsche Firmen nur träumen ...
http://www.stockhouse.com/news/usreleasesdetail.aspx?n=86654…
Galapagos receives positive ruling on Patent Income Deduction
Galapagos NV
GLPYY | 11/12/2012 1:51:19 AM
Galapagos receives positive ruling on Patent Income Deduction
http://at.marketwire.com/accesstracking/AccessTrackingLogSer…
MECHELEN, BELGIUM -- (Marketwire) -- 11/12/12 -- Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it has received a positive ruling from the Belgian tax authorities, enabling Galapagos to benefit from the Belgian patent income deduction on patent related income arising from its global collaboration with Abbott on GLPG0634.
As a result of this ruling, 80% of Galapagos' qualifying income from the collaboration agreement with Abbott, based on the Galapagos patents covering JAK1 inhibitor GLPG0634 currently in Phase 2A clinical trials in RA, is exempt from Belgian corporate income tax. This will result in an effective income tax rate of under 5% for Galapagos for this income. This ruling is valid for 5 years and may be renewed thereafter. Galapagos received an $150 million initial upfront fee from Abbott for rights related to the global collaboration. Upon successful completion of the RA Phase II studies, Abbott will license the program for a one-time fee of $200 million if the studies meet certain pre-agreed criteria. Abbott will assume sole responsibility for Phase III clinical development and global manufacturing. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, Galapagos would be eligible to receive additional patent-based milestone payments from Abbott, potentially amounting to $1.0 billion, in addition to tiered double-digit royalties on net sales upon commercialization.
"The tax ruling announced today is very important for Galapagos and its shareholders," said Guillaume Jetten, Chief Financial Officer of Galapagos. "In this way, Galapagos may have more funds available to invest in its R&D programs coming up behind GLPG0634, thereby increasing our chances of developing valuable intellectual property in those programs as well. This is a clear benefit of our Mechelen headquarters and the supportive nature of the Belgian government towards biotech."
http://www.stockhouse.com/news/usreleasesdetail.aspx?n=86654…
Galapagos receives positive ruling on Patent Income Deduction
Galapagos NV
GLPYY | 11/12/2012 1:51:19 AM
Galapagos receives positive ruling on Patent Income Deduction
http://at.marketwire.com/accesstracking/AccessTrackingLogSer…
MECHELEN, BELGIUM -- (Marketwire) -- 11/12/12 -- Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it has received a positive ruling from the Belgian tax authorities, enabling Galapagos to benefit from the Belgian patent income deduction on patent related income arising from its global collaboration with Abbott on GLPG0634.
As a result of this ruling, 80% of Galapagos' qualifying income from the collaboration agreement with Abbott, based on the Galapagos patents covering JAK1 inhibitor GLPG0634 currently in Phase 2A clinical trials in RA, is exempt from Belgian corporate income tax. This will result in an effective income tax rate of under 5% for Galapagos for this income. This ruling is valid for 5 years and may be renewed thereafter. Galapagos received an $150 million initial upfront fee from Abbott for rights related to the global collaboration. Upon successful completion of the RA Phase II studies, Abbott will license the program for a one-time fee of $200 million if the studies meet certain pre-agreed criteria. Abbott will assume sole responsibility for Phase III clinical development and global manufacturing. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, Galapagos would be eligible to receive additional patent-based milestone payments from Abbott, potentially amounting to $1.0 billion, in addition to tiered double-digit royalties on net sales upon commercialization.
"The tax ruling announced today is very important for Galapagos and its shareholders," said Guillaume Jetten, Chief Financial Officer of Galapagos. "In this way, Galapagos may have more funds available to invest in its R&D programs coming up behind GLPG0634, thereby increasing our chances of developing valuable intellectual property in those programs as well. This is a clear benefit of our Mechelen headquarters and the supportive nature of the Belgian government towards biotech."
GLPG0634 single center Proof of Concept results to be presented at
American College of Rheumatology Annual meeting
Mechelen, Belgium; 11 November 2012 – Galapagos NV (Euronext: GLPG) announced
today that the single center Proof of Concept results from 2011 in rheumatoid
arthritis with selective JAK1 inhibitor GLPG0634 will be presented during the
American College of Rheumatology (ACR) Annual meeting in Washington, D.C.
Furthermore, the Company will present a poster on Phase I results with excellent
safety at higher doses of GLPG0634, showing that no maximum tolerated dose was reached.
The oral presentation will form part of the session entitled: “Rheumatoid Arthritis Treatment -
Small Molecules, Biologics and Gene Therapy: Safety & Efficacy of Janus-Activated Kinase (JAK)
Inhibitors.” The presentation will highlight the differentiated safety and efficacy profile of
GLPG0634 in 36 rheumatoid arthritis patients treated for 28 days in a single center study in Moldova:
Selective JAK1 Inhibition in the Treatment of Rheumatoid Arthritis: Proof of Concept with
GLPG0634 (13-Nov, 3:30 PM, Ballroom C, Abstract #2489)
The poster data demonstrate that GLPG0634 shows selective JAK1 inhibition, good safety and
maintained JAK1-related biomarker response for up to 10 days after dosing of 300 mg and 450
mg in healthy volunteers. Biomarker data also show that JAK1 is inhibited throughout the day for
once-daily dosing of GLPG0634 in healthy volunteers. As 450 mg is the highest dose ever
investigated, no maximum tolerated dose for GLPG0634 was attained:
Once Daily Higher Dose Regimens of GLPG0634 in Healthy Volunteers Are Safe and Provide
Continuous Inhibition of JAK1 but not JAK2 (12-Nov, 9:00 AM – 6:00 PM, Poster Hall B, Abstract #1331)
The full abstracts can be accessed through the ACR website. The poster will be available in PDF
format on Galapagos’ website: www.glpg.com.
American College of Rheumatology Annual meeting
Mechelen, Belgium; 11 November 2012 – Galapagos NV (Euronext: GLPG) announced
today that the single center Proof of Concept results from 2011 in rheumatoid
arthritis with selective JAK1 inhibitor GLPG0634 will be presented during the
American College of Rheumatology (ACR) Annual meeting in Washington, D.C.
Furthermore, the Company will present a poster on Phase I results with excellent
safety at higher doses of GLPG0634, showing that no maximum tolerated dose was reached.
The oral presentation will form part of the session entitled: “Rheumatoid Arthritis Treatment -
Small Molecules, Biologics and Gene Therapy: Safety & Efficacy of Janus-Activated Kinase (JAK)
Inhibitors.” The presentation will highlight the differentiated safety and efficacy profile of
GLPG0634 in 36 rheumatoid arthritis patients treated for 28 days in a single center study in Moldova:
Selective JAK1 Inhibition in the Treatment of Rheumatoid Arthritis: Proof of Concept with
GLPG0634 (13-Nov, 3:30 PM, Ballroom C, Abstract #2489)
The poster data demonstrate that GLPG0634 shows selective JAK1 inhibition, good safety and
maintained JAK1-related biomarker response for up to 10 days after dosing of 300 mg and 450
mg in healthy volunteers. Biomarker data also show that JAK1 is inhibited throughout the day for
once-daily dosing of GLPG0634 in healthy volunteers. As 450 mg is the highest dose ever
investigated, no maximum tolerated dose for GLPG0634 was attained:
Once Daily Higher Dose Regimens of GLPG0634 in Healthy Volunteers Are Safe and Provide
Continuous Inhibition of JAK1 but not JAK2 (12-Nov, 9:00 AM – 6:00 PM, Poster Hall B, Abstract #1331)
The full abstracts can be accessed through the ACR website. The poster will be available in PDF
format on Galapagos’ website: www.glpg.com.
Ein gefährliches Spiel von Abbott! Man will wohl vermeiden, dass die Aktie steigt, damit man später noch entscheiden kann, Galapagos noch zu günstigerem Kurs aufzukaufen! Wenn man bedenkt, wieviel Abbott für die Lizenz zu zahlen hätte, wird klar, dass Galapagos insgesamt kaum teurer ist. Allerdings könnten andere große Fische im Pharma-Ozean Abbott den Brocken noch wegschnappen, wenn der Börsenwert des gesamten Unternehmens weiterhin so niedrig bleibt. Ich bin gespannt, wie die Jagd ausgeht. Dass Galapagos am Ende noch unabhängig und Herr im eigenen Haus wäre, erscheint mir immer unwahrscheinlicher. Der 0634-Brocken ist einfach zu groß als dass ein Unternehmen mit so niedrigem Börsenwert ihn für sich behalten (und vergrößern) könnte!
Antwort auf Beitrag Nr.: 43.801.306 von Bruessel-Scout am 08.11.12 12:51:11Ach Du Gott, da wünscht Abbott wohl etwas mehr Diskretion als früher?!
Sehr schade.
Sehr schade.
GALAPGAOS hat heute die Ergebnisse der Phase IIa zu 0634 veröffentlicht:
GLPG0634 Phase 2A multicenter trial shows dose-response, confirms excellent safety and significant clinical benefit in rheumatoid arthritis patients
In a 4-week multicenter trial GLPG0634 repeats its excellent safety profile: it shows no serious adverse events and an absence of anemia and changes to LDL and liver enzymes, which are typical side-effects reported for other JAK inhibitors Clinical improvements seen in RA patients with once-daily dosages of 75-300mg, significant over placebo and the lower 30 mg dose Statistically significant improvements in ACR, HAQ-DI, CRP, and DAS28
Mechelen, Belgium; 8 November 2012 – Galapagos NV (Euronext: GLPG) announced today that a second Phase 2A clinical trial with GLPG0634 repeated the excellent safety of the drug, as well as the clinical benefit to RA patients within 4 weeks. Clinical improvements were seen in RA patients with once-daily dosages of 75-300mg. GLPG0634 is the first selective JAK1 inhibitor in development for RA. In February 2012, Galapagos and Abbott announced a global collaboration for GLPG0634 to treat autoimmune diseases.
In this four week, multi-center, Phase 2A trial in 91 RA patients, GLPG0634 was administered in five study arms at a wide range of once-daily dosages of placebo, 30, 75, 150 or 300 mg. Despite the fact that the study was not powered for statistical significance, GLPG0634 did achieve statistically significant improvement in CRP (C-reactive protein), DAS28, HAQ-DI and ACR response rates at the 300mg dose. Efficacy endpoints showed a rapid onset and sustained effect until the end of the study. GLPG0634 was well-tolerated, with none of the patients discontinuing the trial for safety reasons. No serious adverse events were reported. The safety profile of GLPG0634 was confirmed: an absence of the typical findings reported with other JAK inhibitors such as anemia, increases in blood lipids (LDL) and effects on liver enzymes (ALT/AST). An improvement rather than a decrease in hemoglobin was observed in patients receiving GLPG0634.
“This larger, multi-center Phase 2A trial further supports the competitive positioning of GLPG0634: clinical efficacy combined with a differentiated safety profile. This distinguishes GLPG0634 from other JAK inhibitors in development in RA. Dosing between 75 and 300 mg once daily demonstrated activity across several clinical parameters,” said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. “These results enable us to move rapidly forward into global Phase 2B trials early next year.”
Details of the Phase 2A clinical trial design
The Phase 2A trial for GLPG0634 enrolled 91 patients with active RA (rheumatoid arthritis), showing an insufficient response to the standard-of-care treatment, methotrexate (MTX). The aim was to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in treating rheumatoid arthritis. Five groups of patients with active disease took the once-daily regimen of GLPG0634 or placebo for a period of four weeks, while all continued to take their stable background therapy of MTX. Efficacy endpoints included the
ACR20 and ACR50 response rates, the disease activity score DAS28, and the reduction in C-reactive protein (CRP), the primary blood marker of inflammation. Galapagos conducted the study in 19 test centers in Hungary (4 sites), Moldova (1), Russia (5), and Ukraine (9).
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 showed excellent clinical benefit and safety in Phase 2A studies in RA patients. GLPG0634 is a fully proprietary program to Galapagos. Upon successful completion of the RA Phase 2B trials, Abbott will license the program and will assume sole responsibility for Phase 3 clinical development, global manufacturing and registration.
Veröffentlicht auf http://www.glpg.com/
GLPG0634 Phase 2A multicenter trial shows dose-response, confirms excellent safety and significant clinical benefit in rheumatoid arthritis patients
In a 4-week multicenter trial GLPG0634 repeats its excellent safety profile: it shows no serious adverse events and an absence of anemia and changes to LDL and liver enzymes, which are typical side-effects reported for other JAK inhibitors Clinical improvements seen in RA patients with once-daily dosages of 75-300mg, significant over placebo and the lower 30 mg dose Statistically significant improvements in ACR, HAQ-DI, CRP, and DAS28
Mechelen, Belgium; 8 November 2012 – Galapagos NV (Euronext: GLPG) announced today that a second Phase 2A clinical trial with GLPG0634 repeated the excellent safety of the drug, as well as the clinical benefit to RA patients within 4 weeks. Clinical improvements were seen in RA patients with once-daily dosages of 75-300mg. GLPG0634 is the first selective JAK1 inhibitor in development for RA. In February 2012, Galapagos and Abbott announced a global collaboration for GLPG0634 to treat autoimmune diseases.
In this four week, multi-center, Phase 2A trial in 91 RA patients, GLPG0634 was administered in five study arms at a wide range of once-daily dosages of placebo, 30, 75, 150 or 300 mg. Despite the fact that the study was not powered for statistical significance, GLPG0634 did achieve statistically significant improvement in CRP (C-reactive protein), DAS28, HAQ-DI and ACR response rates at the 300mg dose. Efficacy endpoints showed a rapid onset and sustained effect until the end of the study. GLPG0634 was well-tolerated, with none of the patients discontinuing the trial for safety reasons. No serious adverse events were reported. The safety profile of GLPG0634 was confirmed: an absence of the typical findings reported with other JAK inhibitors such as anemia, increases in blood lipids (LDL) and effects on liver enzymes (ALT/AST). An improvement rather than a decrease in hemoglobin was observed in patients receiving GLPG0634.
“This larger, multi-center Phase 2A trial further supports the competitive positioning of GLPG0634: clinical efficacy combined with a differentiated safety profile. This distinguishes GLPG0634 from other JAK inhibitors in development in RA. Dosing between 75 and 300 mg once daily demonstrated activity across several clinical parameters,” said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. “These results enable us to move rapidly forward into global Phase 2B trials early next year.”
Details of the Phase 2A clinical trial design
The Phase 2A trial for GLPG0634 enrolled 91 patients with active RA (rheumatoid arthritis), showing an insufficient response to the standard-of-care treatment, methotrexate (MTX). The aim was to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in treating rheumatoid arthritis. Five groups of patients with active disease took the once-daily regimen of GLPG0634 or placebo for a period of four weeks, while all continued to take their stable background therapy of MTX. Efficacy endpoints included the
ACR20 and ACR50 response rates, the disease activity score DAS28, and the reduction in C-reactive protein (CRP), the primary blood marker of inflammation. Galapagos conducted the study in 19 test centers in Hungary (4 sites), Moldova (1), Russia (5), and Ukraine (9).
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 showed excellent clinical benefit and safety in Phase 2A studies in RA patients. GLPG0634 is a fully proprietary program to Galapagos. Upon successful completion of the RA Phase 2B trials, Abbott will license the program and will assume sole responsibility for Phase 3 clinical development, global manufacturing and registration.
Veröffentlicht auf http://www.glpg.com/
Morphosys hat im Bereich der rheumatoiden Arthritis einen Antikörper gefunden, dem ein großer Markt zugeschrieben wird. Bleibt abzuwarten, ob GLPG 0634 den gleichen Indikationsbereich oder andere Bereiche abdeckt. Außerdem bleibt die Effizienz der beiden Moleküle zu vergleichen. Hier die Meldung zu diesem Thema:
"LONDON (dpa-AFX) - Die Commerzbank hat das Kursziel für Morphosys (MorphoSys) nach einem Studienerfolg mit dem Antikörper Mor103 von 27,00 auf 30,00 (Kurs: 23,670) Euro angehoben und die Einstufung auf "Buy" belassen. Das Medikament könne bei rheumatoider Arthritis eine wichtige Behandlungsoption werden, schrieb Analyst Daniel Wendorff in einer Studie vom Montag. Verglichen mit anderen, in ähnlichen Entwicklungsstadien befindlichen Behandlungsmöglichkeiten sei die Effizienz ebenfalls gut.
Wendorff geht davon aus, dass das Biotech-Unternehmen innerhalb von sechs Monaten Lizenzverträge zu attraktiven Konditionen abschließen wird. Die Wahrscheinlichkeit einer Marktzulassung von Mor103 erhöhte er von 35 auf 50 Prozent und den Kapitalwert verdoppelte er auf 6 Euro je Aktie. Seine Spitzenumsatz-Schätzung für Therapien unter Einsatz des Antikörpers von 1 Milliarde Euro bezeichnete der Experte als konservativ."
"LONDON (dpa-AFX) - Die Commerzbank hat das Kursziel für Morphosys (MorphoSys) nach einem Studienerfolg mit dem Antikörper Mor103 von 27,00 auf 30,00 (Kurs: 23,670) Euro angehoben und die Einstufung auf "Buy" belassen. Das Medikament könne bei rheumatoider Arthritis eine wichtige Behandlungsoption werden, schrieb Analyst Daniel Wendorff in einer Studie vom Montag. Verglichen mit anderen, in ähnlichen Entwicklungsstadien befindlichen Behandlungsmöglichkeiten sei die Effizienz ebenfalls gut.
Wendorff geht davon aus, dass das Biotech-Unternehmen innerhalb von sechs Monaten Lizenzverträge zu attraktiven Konditionen abschließen wird. Die Wahrscheinlichkeit einer Marktzulassung von Mor103 erhöhte er von 35 auf 50 Prozent und den Kapitalwert verdoppelte er auf 6 Euro je Aktie. Seine Spitzenumsatz-Schätzung für Therapien unter Einsatz des Antikörpers von 1 Milliarde Euro bezeichnete der Experte als konservativ."
Ich bin selbst Forscher gewesen. Es ist nicht möglich, NICHT von dem zu sprechen, was man gerade macht, insbesondere wenn vielsprechendes Neues dabei herauskommt oder bestätigt wird. Der eine sagt etwas, der andere hört es, der dritte gibt es weiter ... und so fort. Und so kommt es auch in die Ohren des einen oder anderen Anlegers, und wer noch mehr einsetzen kann als er es ohnehin schon getan hat, schickt auch gerne mal einen Späher.
Antwort auf Beitrag Nr.: 43.665.605 von Bruessel-Scout am 01.10.12 17:58:49Würde gar nichts durchsickern, wäre dies eine rein spekulative Bewegung, gegründet auf die Hoffnung eventuell guter 0634-Resultate.
Dafür halte ich es im Prinzip auch. Eine Spekulation darauf, dass die hervorragenden Ergebnisse aus der Mini-PIIa durch die neue Studie zumindest im Wesentlichen gestützt werden können.
Ich selbst gehe ja auch von diesem positiven Szenario aus und werde damit ganz sicher nicht der Einzige sein.
Dafür halte ich es im Prinzip auch. Eine Spekulation darauf, dass die hervorragenden Ergebnisse aus der Mini-PIIa durch die neue Studie zumindest im Wesentlichen gestützt werden können.
Ich selbst gehe ja auch von diesem positiven Szenario aus und werde damit ganz sicher nicht der Einzige sein.
Tja, wie soll man sonst erklären, dass da in den letzten 10 Tagen wieder starke Kursbewegung entsteht, ohne dass eine offizielle Mitteilung herausgegangen ist? Sicher haben viele notiert5 oder im Kopf, dass im Dezember neue Daten kommen, aber wie die aussehen, kann eigentlich niemand wissen. Würde gar nichts durchsickern, wäre dies eine rein spekulative Bewegung, gegründet auf die Hoffnung eventuell guter 0634-Resultate.
Antwort auf Beitrag Nr.: 43.664.843 von Bruessel-Scout am 01.10.12 15:31:55Dein Kursziel halte ich nicht für abwegig, Deine wiederholt vorgetragenen Theorien über ein beständiges Durchsickern von Studiendaten an bestimmte Marktteilnehmer hingegen schon.
30.04.24 · globenewswire · Galapagos |
04.04.24 · globenewswire · Galapagos |
Galapagos publishes 2023 annual report and announces Annual and Extraordinary Shareholders’ Meetings 28.03.24 · globenewswire · Galapagos |
26.03.24 · globenewswire · Galapagos |
22.02.24 · globenewswire · Galapagos |
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31.01.24 · globenewswire · Galapagos |
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