hugbu schreef op 10 januari 2012 18:49:
[quote alias=flosz id=6044923 date=201201101709]
[...]
BSH
**************
Mbt JP Morgan HC:
Galapagos NV GLPG:BB
Presenting: Thursday, January 12, 2012 at 08:30 AM
Contact
james.d.gordon@jpmorgan.comLeesvoer @ de liefhebbers.
Ik heb het leesvoer even vlug overlopen.
Slechts één conclusie : voor deze heren staat Galapagos nog altijd voor een eilandengroep vol met rare beesten.
Noch onder het R.A. catern, noch in het lijstje van Europese Biotechs
een vermelding of verwijzing naar GLPG.Increasing focus on emerging oral therapies, driven by PFE’s tofacitinib. We expect increasing focus on late-stage oral RA compounds in development in 2012.Leading the charge will be Pfizer’s tofacitinib (oral JAK inhibitor), which has produced efficacy in-line with the anti-TNFs in a large phase 3 program and what we view as a manageable safety profile. Pfizer expects to file for approval by YE11, and we assume the product will be approved and launched in 2012. In addition, AstraZeneca/Rigel’s fostamatinib (an oral syk kinase inhibitor) is in phase 3 with data expected in 2H12. Earlier data demonstrated “anti-TNF-like” efficacy, and we believe this level of activity will be reproduced in phase 3. We also believe that the blood pressure increases with fostamatinib can be managed over long-term dosing with standard medications, and do not result in elevated CV risk. Hypertension is relatively easy to treat and blood pressure is something which is regularly monitored in RA patients. Furthermore, Eli Lilly/Incyte’s oral JAK inhibitor, INCB28050, is
currently in a phase 2b trial, with data expected in early 2012. Although biologics are well entrenched in the RA market and rheumatologists have experience managing their adverse events, there is clear enthusiasm regarding the emergence of these new oral therapies. While general physician consensus at this stage is that the oral agents
may initially find a place in the treatment paradigm behind the anti-TNFs, there is potential for the oral therapies to leap-frog the injectables over time as comfort with safety increases (especially if they’re priced at a discount, as expected).
Een interessant gegeven ivm met GLPG0187 is hier wel te vinden : een verlenging van het levensvooruitzicht met 4 maanden wordt door de FDA omwille van de kostprijs in vraag gesteld, maar de dokters zelf vinden 3 maanden levensverlenging al de moeite waard. Onthou dus deze 2 gegevens tegen dat we eindelijk eens een update van de 187 krijgen.Bone Disease
Focus will be on regulatory action for Xgeva in BMP; we anticipate approval. The PDUFA for XGEVA in bone metastases prevention (BMP) is set for April 26th, Recall, in the pivotal 147 Study, Xgeva significantly
improved bone metastases free survival by 4.2 months versus placebo. We would expect a panel to discuss the clinical relevance of a 4 month benefit in the indication. Based on physician feedback, we believe a 3+ month benefit is clinically meaningful. As such, we expect approval of Xgeva in BMP.
Onno zal uit z'n pijp moeten komen.......