Galapagos NV (Seite 16)

[Joschka Schröder]

AbbVie gibt die Rechte an filgotinib an Galapagos zurück. Die Galapagos-Aktie verliert über 20 %:



AbbVie ($ABBV) is backing out of a roughly $1.4 billion deal with Galapagos ($GLPG), picking an internal rheumatoid arthritis treatment over the one it licensed from the Belgian biotech.

With the move, AbbVie is handing back the rights to filgotinib, a Galapagos-discovered drug that targets JAK1 to tamp down inflammation in rheumatoid arthritis and other autoimmune diseases. That brings to an end a 2012 deal through which AbbVie paid its partner $150 million up front and promised as much as $1.2 billion more tied to clinical and regulatory milestones.

In filgotinib's stead, AbbVie is moving forward with its own ABT-494, another JAK1 inhibitor with promise in arthritis. In tandem with its Galapagos announcement, AbbVie disclosed that ABT-494 met its primary goal in two Phase II studies, improving symptoms at a statistically significant rate compared with placebo over 12 weeks. Now AbbVie is planning to mount a Phase III effort for its drug by the end of 2015.

"We believe ABT-494 has the potential to become a best-in-class therapy for patients," AbbVie Chief Scientific Officer Michael Severino said in a statement, adding, in reference to filgotinib: "In our view, ABT-494 also offers a faster path to Phase III development with less uncertainty."

Meanwhile, uncertainty abounds for Galapagos, whose shares fell more than 25% on the news. AbbVie's exit follows similar breakups with Johnson & Johnson ($JNJ) and GlaxoSmithKline ($GSK), and investors were betting heavily that filgotinib could be the asset that propelled Galapagos toward a high-dollar buyout.

Such optimism helped the company pull off a $275 million U.S. IPO in May. Before Friday's drop, Galapagos' share price had risen more than 45%.


http://www.fiercebiotech.com/story/abbvie-dumps-galapagos-ar…

[stangman67]

Antwort auf Beitrag Nr.: 49.567.835 von Fostr am 15.04.15 11:57:35

Hallo Leute !

Habt ihr alle schon "sell on good news" umgesetzt oder gibt es noch ein paar Hartgesottene hier, die noch höhere Kurse erwarten ?

[Fostr]

Sold the good news!

[Fostr]

http://www.bidnessetc.com/36604-galapagos-nv-adr-emerges-as-…

Market cap : 700 Million

Mid April Phase2 Ergebnisse. 2 Millarde peak sales.

Rally seit Oktober.

Sind die Phase2 Ergebnisse positiv, waere es ein guter Kursverdoppler..

[Bruessel-Scout]

Es gab lange keine Diskussionsbeiträge mehr in diesem Forum, obwohl der Kurs doch wieder deutlich gestiegen ist, auch heute wieder um fast 50 Cent... Es sind Käufe im Gang im Biomed-Bereich den USA (Andromeda), die auch für GPLPG- und EVOTEC-Anlieger interessante Rückwirkungen haben können. Möglicherweise kommt morgen, 27.2., hierzu eine wichtige NAchricht auf den Markt. Schade, dass in diesem Forum dazu nichts zu lesen war, ich selbst weiß leider nicht genug darüber...Ich tippee dennoch auf eine freudige Überraschung!

[SLGramann]

CF-Programm ist verpartnert:

AbbVie and Galapagos to co-develop cystic fibrosis therapies

• Both parties contribute key technologies and funding
• Goal to develop novel potentiator and corrector therapies for main mutations of CF
• Galapagos leads discovery and development through Phase 2, shares Phase 3 responsibility with AbbVie

---

ziemlich früher Zeitpunkt finde ich. verstehe den Sinn nicht.

[Nase_weis_nix]

Antwort auf Beitrag Nr.: 44.845.889 von Nase_weis_nix am 13.06.13 21:10:52

Vielleicht hätte ich noch den Wirkstoff nennen können - sorry!
GLPG0634

[Nase_weis_nix]

Galapagos hat heute Ergebnisse eine 4-wöchigen Studie mit variierenden Dosierungen präsentiert.

Folgende Dosierungen: 0mg (Plazebo), 30mg, 75mg, 150mg u. 300mg

Leider hatte die Plazebogruppe relativ gut und die 150mg Dosisgruppe schlecht abgeschnitten. Somit hatten gesteigerte Dosierungen entsprechende Verbesserungen zur Folge, mit Ausnahme der beiden Dosisgruppen.

Darunter leidet die Stimmigkeit der Ergebnisse der Dosis-Eskalation. Des weiteren hatte bei der vorausgegangenen Studie gerade die 200mg Dosis (nahe an 150mg) sehr gute Ergebnisse erzielt.

Hiermit erklärt sich wohl der heutige Kursrückgang.

Galapagos begründet die Ausreißer folgendermaßen:
1. Plazebogruppe hatte durchschnittlich geringere Zeitdauer der Erkrankung (weniger als die Hälfte der anderen Dosisgruppen)
2. die 150mg Dosisgruppe hatte zu Beginn das schwerste Krankheitsbild und die geringste Personenzahl

M.e. muss man beachten, dass abermals über einen sehr kurzen Zeitraum von 4 Wochen gute Ergebnisse mit einem oral zu verabreichenden Wirkstoff erzielt wurden. Das Nebenwirkungsprofil war weiterhin akzeptabel / gut.

Interessant zu beobachten, wie sich die Ergebnisse (inkl. Nebenwirkungen) über längere Zeiträume entwickeln und somit an der Konkurrenz messen lassen.

Pressemeldung: http://www.glpg.com/index.php/download_file/view/1554/1/

Poster u. Präsentationen direkt zu finden unter: http://www.glpg.com/

[SLGramann]

Interessant!
(verursacht natürlich erst mal weitere Kosten und das Risiko liegt voll bei Galapagos, m.E. aber trotzdem positiv zu werten):


AbbVie and Galapagos extend GLPG0634 collaboration to include Crohn’s disease

• First selective JAK1 inhibitor to enter Phase 2 studies in Crohn’s disease
• Galapagos to fund and complete Phase 2 study; AbbVie to pay Galapagos $50 million upon successful completion, expected in 2015

North Chicago, USA and Mechelen, Belgium; 17 May 2013 – Galapagos NV (Euronext: GLPG) and AbbVie (NYSE: ABBV) announced today an extension of their GLPG0634 clinical development collaboration to include Crohn’s disease. Galapagos will fund and complete a Phase 2 program in Crohn’s disease, which is designed to facilitate rapid progression into Phase 3. Upon successful completion of the study, expected in Q2 2015, AbbVie will pay Galapagos $50 million. The terms of the collaboration extension are in addition to previously agreed upon financial terms. AbbVie will be responsible for funding and performing clinical development beyond Phase 2, and completing regulatory and commercialization activities.
Galapagos will start an innovative 20-week, Phase 2A/B study with GLPG0634 in 180 patients suffering from Crohn’s disease by early 2014. The study will measure both induction of disease remission and early maintenance of its beneficial effects in Crohn’s disease, and is expected to read out topline results in Q2 2015.

[SLGramann]

THU0229

SAFETY AND EFFICACY OF GLPG0634, A SELECTIVE JAK1 INHIBITOR IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS OF A 4-WEEK PHASE II A DOSE RANGING, MULTI-CENTER TRIAL

F. P. Vanhoutte 1,*, A. Van der Aa 1, L. Meuleners 1, G. van 't Klooster 1 and The GLPG0634-CL-202 study group

1Galapagos NV, Mechelen, Belgium



Background: GLPG0634 is an orally-available, selective inhibitor of Janus kinase 1 (JAK1). JAKs are critical in signaling for cytokines and growth factors, including those involved in rheumatoid arthritis (RA). Non-selective JAK inhibitors have demonstrated efficacy in patients with RA, but also dose-limiting toxicity. GLPG0634 has demonstrated encouraging efficacy and safety in a previous 4-week trial.

Objectives: Evaluate short-term safety and efficacy of a dose range of GLPG0634 in RA patients with insufficient response to methotrexate (MTX) alone.

Methods: A 4-week, double-blind, placebo-controlled Phase IIA dose-ranging trial in patients with active RA showing an insufficient response to MTX and naïve to biologicals was conducted to evaluate the safety and efficacy of GLPG0634 at doses of 30, 75, 150 and 300 mg or placebo (pbo), all once-daily (QD). All patients continued to take their stable background therapy of MTX.

Results: 91 patients initiated treatment. Some variation in patient and disease characteristics was apparent for the dose groups at baseline, e.g., the average duration of RA was 4.4 years for pbo vs. ≥8 years of RA for all treatment groups, correlating with a younger age in the pbo group. DAS28 scores ranged from 5.7 to 6.4. The 150 mg dose group had consistently worse disease than other groups (10 years of RA, DAS28 6.4, highest scores for HAQ-DI, TJC and SJC). Overall, patients were 51 y of age and 78% were female.

GLPG0634 was generally well tolerated. Most adverse events (AEs) were mild and no serious AEs were reported. No patient discontinued due to AEs. In contrast to observations with JAK inhibitors with other selectivity profiles, no anemia but rather a modest improvement in hemoglobin was induced by GLPG0634. There was a limited decrease in absolute neutrophil count, no neutropenia, and no impact on lymphocyte differentials. Likewise, no increases in LDL-C and no elevations in liver transaminases (ALT/AST) were observed in this trial.

Within 4 weeks, GLPG0634 showed encouraging dose-dependent trends in efficacy with little improvement seen for the 30 mg dose and the best results being achieved at the 300 mg dose. Compared to other studies in RA, there was a relatively high pbo response, potentially related to a lower level of disease activity in this group. In spite of the short duration and small size of the study, several efficacy read-outs showed statistical significance: for 75 mg through 300 mg, changes in endpoints such as reductions in serum CRP (-15 to -21 mg/L, p<0.01 vs pbo, all 3 doses), in DAS28 (-1.7 to -2.3, p<0.01 at 300mg) and in HAQ-DI (-0.47 to -0.57, p<0.05 at 300 mg). This was not the case for ACR20 (41% of patients on placebo vs. 65% on 300 mg), but it was for ACR50 (6% for placebo vs. 45% on 300mg). Consistent improvements were observed for tender and swollen joint counts, but the 4-week duration was insufficient to yield statistical significance.

Conclusions: These early clinical results demonstrate that selective inhibition of JAK1 by once-daily dosing of GLPG0634 from 75 mg to 300 mg is efficacious and generally well tolerated for 4-weeks treatment of RA, and confirm data from a previous study at a 200 mg daily dose. A dose of 30 mg QD was sub-optimal for efficacy. Larger, longer term studies in RA are being initiated to evaluate optimal doses for efficacy and safety.



Disclosure of Interest: F. Vanhoutte Employee of: Galapagos NV, A. Van der Aa Employee of: Galapagos NV, L. Meuleners Employee of: Galapagos NV, G. van 't Klooster Employee of: Galapagos NV