Galapagos NV (Seite 19)

[chiptrader]

habe ich was verpasst oder warum gehts hier heute so nach oben!?

[Bruessel-Scout]

Galapagos hat mit dem japanischen Pharma-Konzern ONO einen Vertrag zur Entwicklung von Medikamenten bei Krankheiten des Nervensystems abgeschlossen:
http://www.lecho.be/actualite/entreprises_pharma/Galapagos_s…

[Ackergaul]

http://www.clinicaltrials.gov/ct2/show/NCT01665924?term=glpg…
Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
This study is currently recruiting participants.
Verified August 2012 by Galapagos NV


First Received on August 14, 2012. No Changes Posted
Sponsor: Galapagos NV
Information provided by (Responsible Party): Galapagos NV
ClinicalTrials.gov Identifier: NCT01665924

Purpose
The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects.

During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.


Condition Intervention Phase
Healthy
Drug: GLPG0634 100mg capsule QD for 10 days
Phase 1



Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects


Further study details as provided by Galapagos NV:


Primary Outcome Measures:
•The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634 [ Time Frame: From predose (before first study drug administration) up to 72 hours post last study drug administration ] [ Designated as safety issue: No ]
To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging



Secondary Outcome Measures:
•The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634 [ Time Frame: From predose (before first study drug administration) up to 24 hours post last study drug administration ] [ Designated as safety issue: No ]
To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - after multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging


•Number of adverse events [ Time Frame: From screening up to 10 days after the last study drug administration ] [ Designated as safety issue: Yes ]
To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of the number of adverse events reported


•Changes in vital signs as measured by heart rate, blood pressure and body temperature [ Time Frame: From screening up to 10 days after the last study drug administration ] [ Designated as safety issue: Yes ]
To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported


•Changes in 12-lead ECG measures [ Time Frame: From screening up to 10 days after the last study drug administration ] [ Designated as safety issue: Yes ]
To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in 12-ECG measures reported


•Changes in physical exam measures [ Time Frame: From screening up to 10 days after the last study drug administration ] [ Designated as safety issue: Yes ]
To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in physical examination reported


•Changes in blood and urine safety lab parameters [ Time Frame: From screening up to 10 days after the last study drug administration ] [ Designated as safety issue: Yes ]
To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in blood and urine safety lab parameters assessed



Estimated Enrollment: 36
Study Start Date: July 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

[Ackergaul]

Zu den Zahlen noch rückwirkend: Denke das Ergebnis ist in Ordnung. Das 2te H2012 sollte besser laufen. Mit der Marge des Service Geschäfts kann GLPG zufrieden sein!

Zum Thema 0634:

08/10/2012 10:34:57 PM EDT -- BioWorld Insight

Will New RA Therapies Cause a Paradigm Shift?

I'm All Right JAK

August could be the month when all patients suffering from rheumatoid arthritis (RA) have a new treatment alternative to injectable TNF-inhibitors, such as Humira (adalimumab, Abbott), Enbrel (etanercept, Amgen Inc.) and Remicade (infliximab, Johnson & Johnson).

Pfizer Inc.'s Janus kinase (JAK) inhibitor tofacitinib for the treatment of adults with moderate-to-severe active RA has a scheduled PDUFA date of August 21. The compound represents the first in a wave of potential new oral therapies for RA now in clinical trials. There is a possibility that the PDUFA data may be extended as Pfizer did say during its second quarter 2012 earnings call that the FDA has requested additional analysis of the existing data in their new drug application (NDA) for tofacitinib.

The company plans to provide the information in early August, which is why it anticipates the FDA may require additional time to review the analysis.

Supporting Data

Supporting the NDA submission are top-line results from the Phase III ORAL Start study, a global clinical development program that included approximately 5,000 patients. Data showed that the drug met the primary endpoints at both the 5-mg and 10-mg twice-daily doses. Tofacitinib was found to be superior to methotrexate, with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Share Score, and in reducing signs and symptoms of RA, as measured by ACR70 responses. Both primary endpoints assessed tofacitinib vs. methotrexate at six months. The data are from a planned analysis at one year. (See BioWorld Today, Aug. 1, 2012.)

The Arthritis Advisory Committee (AAC) voted 8-2 to recommend approval for tofacitinib as a second-line treatment in RA. If the FDA eventually goes along with that recommendation, tofacitinib would become the first JAK inhibitor in the RA space and the first new disease modifying anti-rheumatic drug (DMARD) in 10 years. (See BioWorld Today, May 8, 2012.)

RA, an autoimmune disease that causes inflammation in the joints, affects an estimated 1.3 million people in the U.S., or 1 percent of the population, according to the Arthritis Foundation. The overall market for disease sufferers worldwide has been estimated at more than $13 billion, with tofacitinib expected to grab a piece of that large pie and achieve blockbuster status if it gets the green light from the FDA.

Although multiple treatments are available, many patients do not adequately respond, and there remains a need for additional options. In fact, Pfizer estimates that 30 percent to 40 percent of RA patients fail to respond to the injectable therapies.

The approval of tofacitinib would represent a huge boost to other companies developing oral medicines to treat RA, according to J.P. Morgan analyst Cory Kasimov in a research report. These include: Rigel Pharmaceuticals Inc.'s fostamatinib, a Phase III syk inhibitor partnered with AstraZeneca plc and Incyte Corp.'s baricitinib (INCB28050), which is licensed to Eli Lilly and Co. Both compounds are in Phase II trials.

Incyte and Eli Lilly recently presented 12-week results from a Phase IIb study of baricitinib in patients with active RA at the European League Against Rheumatism's Annual European Congress of Rheumatology. The randomized double-blind, placebo-controlled, dose-ranging study (JADA) involved 301 patients with active RA on stable doses of methotrexate. Patients were randomized to receive either placebo or one of four once-daily doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) for 12 weeks. The primary endpoint was achieved, demonstrating a statistically significant difference in the American College of Rheumatology 20 response between the combined 4-mg and 8-mg baricitinib groups (76 percent) compared with placebo (41 percent) after 12 weeks of treatment (p < 0.001). (See BioWorld Today, June 11, 2012.)

AstraZeneca expects to report Phase III results from OSKIRA-1, OSKIRA-2 and OSKIRA-3 in the first half of 2013. It also expects to report data from OSKIRA-4 (a Phase IIb monotherapy study) by late 2012. In addition, AstraZeneca has stated that it expects to file an NDA with the FDA for fostamatinib in the second half of 2013.

While fostamatinib and baricitinib could be the second and third oral RA drugs to reach the market, Kasimov said that these drugs could benefit from Pfizer's "heavy lifting" to trigger a paradigm shift in RA treatment practice.

Partnering Deals in RA

Rigel and AstraZeneca have inked a potential $1.2 billion collaboration covering upfront and milestones, and at the back end Rigel will receive a double-digit sales royalty if the drug makes it to market. Importantly, AstraZeneca is responsible for all development, regulatory, manufacturing and commercialization expenses.

For its part, Incyte could earn up to $665 million in potential development, regulatory and sales milestones under its collaboration with Lilly.

Other JAK inhibitors in development for RA include Vertex Inc.'s VX509, which is in an ongoing Phase IIb study in the U.S. and Europe. The Phase IIa trial resulted in substantial and statistically significant improvements in multiple measurements of RA activity, the company reported. The 12-week study met its two primary endpoints, defined as a statistically significant improvement in the proportion of people who achieved at least a 20 percent improvement in the signs and symptoms of RA, also known as ACR20, and a statistically significant improvement from baseline in Disease Activity Score 28 (DAS28).

Galapagos NV recently landed a deal with Abbott worth $1.35 billion, plus royalties, for its JAK1 inhibitor, GLPG0634, which is in Phase II development for RA. The agreement, the company said, is the largest for a Phase II compound in the history of the industry.

The Phase IIa trial of GLPG0634 delivered positive results on ACR20, the standard measure of disease activity, and also on the standard test for inflammation, serum levels of C-reactive protein. Like Humira, the product could have potential in other autoimmune diseases. (See BioWorld Today, March 1, 2012.)

If JAK inhibitors don't prove their worth then maybe stem cells will become the next therapies for RA.

TiGenix NV, of Leuven, Belgium, completed patient enrollment in a Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in three cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance and optimal dosing. The company expects the final results to be available in the first half of 2013.

Mesoblast Ltd., of Melbourne, Australia, recently reported positive results in a large animal model of RA following a single intravenous injection of its allogeneic immunomodulatory adult mesenchymal precursor cells (MPCs). The study was conducted on 30 sheep with established collagen-induced arthritis, comparing a single intravenous injection of allogeneic MPCs at one of three doses (0.3, 1 and 2 million MPCs/kg) to saline. Thirty days later, joint synovial tissues from arthritic sheep were examined. The findings demonstrated that MPCs are immunoregulatory and concomitantly suppress the activation and proliferation of T-cells, monocytes and synoviocytes seen in active rheumatoid arthritis. (See BioWorld Today, July 25, 2012.)


(c) 2012 Thomson BioWorld, All Rights Reserved.

Copyright © 2012 Acquire Media. All rights reserved

[Bruessel-Scout]

KBC Securities hat jetzt einen Kurswert (oder Kursziel) von 16,50 € als realistisch bezeichnet:
http://www.lecho.be/actualite/marche_placements_marches/Marc…

[SLGramann]

Die Halbjahreszahlen sind übrigens da:

http://www.glpg.com/index.php/download_file/view/1065/1/

• Group revenues €64.5 M compared to €39.7 M in H1 2011 (+62%)
• Group net loss €11.3 M compared to €27.7 M loss last year
• Cash position of €122.6 M on 30 June 2012
• Service division external revenues €32.9 M compared to €24 M last year (+37%)
• Services EBITDA €5.7 M compared to €3.7 M last year (+54%)
• Full year guidance reiterated: €150 M in revenues, positive operating result and cash flow, and net profitability

Was ich wirklich ganz stark finde ist:

The Company is well on track in its global collaboration with Abbott to develop and commercialize GLPG0634. Patient recruitment for the Phase 2a dose-range finding study is complete

Ich habe in der Vergangenheit bei anderen Biotechs viele schlechte Erfahrungen mit Verzögerungen bei Trials gemacht. Aber was GLPG bei 0634 ankündigt, wird auch geliefert.

[Bruessel-Scout]

Zum "fairen Wert" ohne 0634 kann ich keine begründete Aussage machen. Kleine Biotechnologiefirmen sind natürlich sehr abhängig von den Ergebnissen in einem oder zwei Projekten. Nachdem aber Baker Brothers auch alles geprüft und daraufhin zum Sturm (-Kauf) geblasen haben, rechne ich mit weiter steigenden Kursen bis zur Veröffentlichung der 0634-IIa-Ergebnisse. Wie es danach weitergeht, hängt natürlich ganz von den Forschungsergebnissen und dem Verhalten von Abbott ab.
Da viele jetzt auf Baker Brothers vertrauen, vermutlich auch andere Fonds und natürlich Privatanleger ausserhalb Belgiens, denke ich, dass der Kurs bis Dezember doch halb-spekulativ schon auf 20 Euro steigen kann, denn niemand möchte ja mit leerem Portefeuille daneben stehen, wenn die GLPG-Aktie nach Veröffentlichung positiver 0634-ERgebnisse wie eine Rakete abzieht. Natürlich kann auch schon im Oktober oder November etwas von den Ergebnissen durchsickern - denn viele Scouts werden ihre Ohren da sehr weit aufsperren...

[Ackergaul]

Zitat von SLGramann: Eigentlich hatte ich vor, die Ergebnisse der zweiten PIIa Ende des Jahres abzuwarten und dann ggf. beträchtlich aufzustocken. Vielleicht war dieses Zögern ein Fehler.

Nehmen wir mal an, 0634 scheitert komplett. Wo kann man dann den fairen Wert des Unternehmens verorten? Oder anders gefragt, wie viel vom Kurs geht heute schon auf den 0634?
Die Frage ist für eine Risikoabschätzung nicht unwichtig.

Meinem Gefühl nach würde Galapagos ohne den 0634 so zwischen 8 und 10 Euro / Aktie wert sein.

Halten andere das für zu konservativ?

Persönlich sehe ich den fairen Wert dann auch um 10 Euro also ungefähr 270 mil Euro MK. Doch wahrscheinlicher ist, das den Kurs halbiert wird, sollte 0634 scheitern. Der Markt reagiert sehr übel gelaunt auf solche Ergebnisse...

Ich denke anders herum das zum Jahresende Kurse um 17 bis 18 Euro dann wahrscheinlich sind. Und Dank der kleinen Meldung von gestern sehe ich dies als wahrscheinlicher zur Zeit an.

Zuzüglich kommt bei GLPG das Upside hinzu: Verpartnerung der Merck Pipeline; Neue Partnerschaften durch den Service Bereich; positive Ergebniss bei 974... Aber natürlich können solche Ereignisse auch mal negativ werden.


grüße

[SLGramann]

Antwort auf Beitrag Nr.: 43.402.966 von Ackergaul am 19.07.12 12:52:58

Eigentlich hatte ich vor, die Ergebnisse der zweiten PIIa Ende des Jahres abzuwarten und dann ggf. beträchtlich aufzustocken. Vielleicht war dieses Zögern ein Fehler.

Nehmen wir mal an, 0634 scheitert komplett. Wo kann man dann den fairen Wert des Unternehmens verorten? Oder anders gefragt, wie viel vom Kurs geht heute schon auf den 0634?
Die Frage ist für eine Risikoabschätzung nicht unwichtig.

Meinem Gefühl nach würde Galapagos ohne den 0634 so zwischen 8 und 10 Euro / Aktie wert sein.

Halten andere das für zu konservativ?

[Ackergaul]

es sieht mir fast danach aus, dass die Baker Brothers sich mit Ihrem fast 6,5 % Anteil an GLPG nicht zufrieden geben.
Die Frage die ich mir stelle: Baker Brothers hatten nun knapp 1/2 Jahr Zeit sich mit den 0634 Ergebnissen zu beschäftigen und wie es "üblich" ist eigene Ärzte bezüglich 0634 zu einer Analys zu beauftragen. Mag sein das man von dieser Seite ein Signal bekommen hat?
Klar ist: wird 0634 der JAK-Pott dann kann sich der Kurs noch fast verzehnfachen. Aber das wird noch einige Jahre andauern, um zu sehen wie es um die 0634 Zukunft steht...

Grüße