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Draadje OT, bijzaken & geleuter in de marge!

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flosz
0
Gene Therapy Comes of Age. The Promise of Immuno-Oncology www.genengnews.com/gen-articles/magaz...

Keeping Tabs On Gene Therapy? Big Pharma Is Closing In www.clinicalleader.com/doc/keeping-ta...

Koekje erbij....

WO2015061665) JAK1 SELECTIVE INHIBITOR AND USES THEREOF .
Applicants: ABBVIE INC. [US/US]; 1 North Waukegan Road North Chicago, IL 60064 (US)
Inventors: VOSS, Jeffrey, W.; (US).
CAMP, Heidi, S.; (US).
PADLEY, Robert, J.; (US)

EN)The invention relates to the use of a JAKl kinase- selective inhibitor that has minimal inhibitory activity towards Jak2 kinase for treating a disease, such as an inflammatory disease (e.g., moderate to severe Rheumatoid Arthritis) and/or bone loss, either alone or in combination with a DMARD (disease modifying anti-rheumatic drug), such as methotrexate. The invention also provides pharmaceutical composition, dosage formulation, administration route, and dosage schedule thereof.
patentscope.wipo.int/search/en/detail...
patentscope.wipo.int/search/en/result...
Bijlage:
aston.martin
0
quote:

flosz schreef op 14 mei 2015 om 00:37:


Gene Therapy Comes of Age. The Promise of Immuno-Oncology www.genengnews.com/gen-articles/magaz...

Keeping Tabs On Gene Therapy? Big Pharma Is Closing In www.clinicalleader.com/doc/keeping-ta...

Koekje erbij....

WO2015061665) JAK1 SELECTIVE INHIBITOR AND USES THEREOF .
Applicants: ABBVIE INC. [US/US]; 1 North Waukegan Road North Chicago, IL 60064 (US)
Inventors: VOSS, Jeffrey, W.; (US).
CAMP, Heidi, S.; (US).
PADLEY, Robert, J.; (US)

EN)The invention relates to the use of a JAKl kinase- selective inhibitor that has minimal inhibitory activity towards Jak2 kinase for treating a disease, such as an inflammatory disease (e.g., moderate to severe Rheumatoid Arthritis) and/or bone loss, either alone or in combination with a DMARD (disease modifying anti-rheumatic drug), such as methotrexate. The invention also provides pharmaceutical composition, dosage formulation, administration route, and dosage schedule thereof.
patentscope.wipo.int/search/en/detail...
patentscope.wipo.int/search/en/result...




Goed gevonden flosz. Hier heb je tenminste wat aan!


[verwijderd]
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Pfizer begint wellicht ook te beseffen dat Xeljanz geen toekomst heeft en werkt ook aan selectieve JAK-1 inhibitoren. Voorbeeld 2 uit www.google.be/patents/US20140243312?d... zou PF-04965842 voorstellen. PF-04965842 werd al klinisch getest op gezonde vrijwilligers ( www.clinicaltrials.gov/ct2/results?te... ). Afwachten of Pfizer er brood in ziet in RA.
flosz
0
Casht familie Adri Strating miljoenen met beursgang van Galapagos?
Biotechparel Galapagos verwacht $275 miljoen op te halen met zijn beursgang op de Nasdaq in New York. Dat maakte het, biotechnologiebedrijf donderdagochtend bekend. Aandeelhouders in het succesverhaal zijn onder meer de erven van superbelegger Adri Strating.

De Nederlandse biotech gloeit. Deze week investeerde Pfizer dik $83 miljoen in biostartup AM Pharma. Mogelijk levert de investering nog eens $500 miljoen op als AM Pharma een medicijn tegen nierfalen oplevert. Galapagos, een andere Nederlandse parel, wil $275 miljoen ophalen met een emissie op de biotechbeurs van de Nasdaq. Galapagos, dat werkt aan de ontwikkeling van anti-reumamedicijn Filgotinib, is een biotechstartup waar - anders dan bij AM Pharma - nog wel Nederlandse aandeelhouders in participeren.

Familie van Herk, die ooit al in Pharming en Crucell stapte, bezit 8% in het biotechbedrijf. In het aandeelhoudersregister treffen we verder ook Delta Lloyd, Crucell en (opvallend) twee BV's aan van de in 2012 overleden Adri Strating, ooit roemrucht aandeelhouder in Ajax en semi-conductor bedrijf Besi.

Volgens het register stapte de voormalige beurshandelaar in 2010 in met T.W.E. Beheer BV en met Gestion BV. De twee vennootschappen, die nu staan geregisteerd op de Minervalaan 103, vertegenwoordigden toen samen een belang van 5,2%.

Wie even snuffelt in de jaarverslagen van T.B.W. Beheer Holding kan niet anders dan constateren dat de erfenis van Strating, ooit een gevallen beursman, goed gevuld is. De effectenrekening pluste in 2013 met maar liefst 10% tot € 42 miljoen. Aan financiële activa ronkt er nog eens $108 miljoen op de balans.

Galapagos staat er verder prima voor, blijkt uit recente jaarcijfers. Het bedrijf maakte over 2014 een nettowinst van €33 miljoen op een omzet van €108 miljoen. Volgens Galapagos is er nog tot eind 2016 geld in kas om medicijnen te testen. Eind 2014 was er nog €198 miljoen beschikbaar.

Tijd om eens uit te stappen. In maart halveerde T.W.E. Beheer ook al de helft van het belang in Besi.

www.quotenet.nl/Nieuws/Casht-familie-...
flosz
0
Galapagos Drug in Partnership With AbbVie Looks to Replace HUMIRA
Galapagos (GLPG) is the latest biotech stock to list on the Nasdaq Market with an impressive first day of trading as the stock traded up 20%. AbbVie (ABBV) and Johnson & Johnson (JNJ) are set to purchase a sizable slice of the offering as both companies have an interest about the long term visibility of their respective rheumatoid arthritis (RA) franchises. Filgotinib is an RA drug discovered by Galapagos, and in partnership with AbbVie, they are looking to replace the world’s largest selling drug HUMIRA when it goes off-patent. CEO Onno van de Stolpe tells TheStreet's Jill Malandrino GLPG attract a better valuation and increased liquidity with its NASDAQ listing.
www.thestreet.com/video/13152416/gala...
flosz
0
Jefferies: GLPG Focus on Significant Upcoming Headline
'634 Readouts

The critical Phase IIb '634 headline arthritis data are due mid-Apr & early-May
for an opt-in decision by partner AbbVie around late-Sep after final results. We
see attractive risk-reward based on earlier clinical data, ABBV's desire to own
a portfolio of immunology assets, and our '634 NPV. Possible incremental outlicensing
deals and the valuable cystic fibrosis alliance, also with ABBV, could
provide upside. Our PT rises 21% to €29/share mostly on USD/EUR.
GLGP0634 still the main value driver: We are encouraged by the dose-response,
magnitude of effect, and absence of safety issues for '634 in the two four-week Phase IIa
trials, supporting our $2.5bn WW peak sales, of which $2.2bn is in RA, after launch by YE18E.
Headline 12-week data from the RA Phase IIb (Darwin) trials are due in mid-April and early-
May for final 24-week results in July, then triggering AbbVie's decision late-September to
opt-in paying Galapagos $200m, plus $50m a few months later if the Phase II Crohn's trial
is positive too. A 40% risk adjustment yields a c.€22/share NPV. We acknowledge AbbVie's
own JAK-1 inhibitor ABT-494 potentially offers the pharma better economics, with its albeit
smaller Phase II dose-finding trials likely to read-out by 4Q15E (RA) and mid-18E (CD). We are
skeptical as to the extent to which AbbVie is "obligated" to opt-in if defined criteria are met
for '634, but nevertheless see attractive risk-reward from the current share price particularly
given its management's desire to build a leading portfolio of immunology assets (anti-IL-6R,
anti-CD4, etc).
FX boost to NPVs: Given the AbbVie '634 and cystic fibrosis deals are USD-denominated,
recent EUR weakness increases our NPVs, potentially narrowing future losses. YE14 cash beat
our estimate, more than offsetting likely higher 2015E R&D spend.
Cystic fibrosis momentum: We are encouraged by progress in the AbbVie CF alliance,
with a second corrector candidate to be chosen 2Q, and Phase I data from potentiator
GLPG1837 in 3Q15E. The commercially important triple combination could enter Phase II by
1H17E, with '1837 also likely to be developed in Phase II alone for the niche G551D patient
population.
Valuation/Risks
Our €29 Price Target is based on a sum-of-the-parts valuation largely comprising a 40%
probability-adjusted NPV for GLPG0634, plus Net Cash. Risks include: (1) efficacy, safety, or
regulatory setbacks for '634; (2) need to execute future out-licensing and alliances; and (3)
clinical trial failures.

Read more: bridgetunnelinvestor.freeforums.net/t...
(09-03-15)
Bijlage:
Pokerface
0
Das wel een beetje een achterhaald en oud artikel, Flosz. Maar toch bedankt voor het plaatsen.
flosz
1
Geleuter idd.! Met datum, dat is dan gelijk duidelijk. Is weer eens wat anders t.o.v. centje erbij, centje eraf.
[verwijderd]
0
Ik blijf het eigenaardig vinden dat Incyte geen brood gezien heeft in INCB39110/RA.

www.google.be/url?sa=t&rct=j&...,d.bGg

Mogelijke verklaringen zijn de focus van Incyte op oncologie en een groot vertrouwen in baricitinib
Bijlage:
flosz
1
Early comparison of JAK inhibitors in RA t.co/ofLxOfSurq $INCY $GLPG $PFE
via Ozgur Ogut
twitter.com/ogut_ozgur

JAK Inhibitors for Rheumatoid Arthritis
May 16, 2015
With Pfizer's Xeljanz (tofacitinib) already on the market for rheumatoid arthritis (RA), two investigational JAK inhibitors, baricitinib (JAK1/2 inhibitor) and filgotinib (selective JAK1 inhibitor), are in late stage development. With larger datasets slowly emerging, this post will be a placeholder to provide updated data and, within reason, head-to-head comparisons.



RA-BUILD VERSUS DARWIN 1
These two trials are in moderate to severe RA patients who continue on their background conventional disease modifying anti-rheumatic drug (cDMARD) in addition to the investigational drug. Both exclude prior use of biologic DMARDs (bDMARD), namely anti-TNF drugs such as adalimumab. Provided below are some relevant trial inclusion and exclusion criteria to better understand the comparison:



RA-Build (Baricitinib sponsored by Incyte / Eli Lilly)

Inclusion Criteria

Have a diagnosis of adult-onset RA as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement =1.2 times the upper limit of normal (ULN)
Have had an insufficient response or are intolerant to cDMARDs and either:
Have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
For participants not receiving a cDMARD at the time of entry, the investigator will document in the participant's history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD


Exclusion Criteria

Are currently receiving corticosteroids at doses >10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
Have ever received any biologic DMARD




DARWIN 1 (Filgotinib sponsored by Galapagos)

Inclusion Criteria

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III
have =6 swollen joints (from a 66 joint count) and =8 tender joints (from a 68 joint count) at Screening and at Baseline
Screening serum CRP =0.7 time ULN
have received MTX for =6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.


Exclusion Criteria

current therapy with any DMARD other than MTX
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.




Below are summarized the 12 week data from RA-Build and DARWIN1, focusing only on the percentage of patients meeting the ACR20, 50 and 70 endpoints. The first two bar graphs include the placebo arm in the respective trials, whereas the third graph compares both datasets with their placebo groups subtracted. The method is an inexact comparison, but is provided as a best approximation for head-to-head comparison. Although once daily and twice daily doses of filgotinib were tested, the two best twice daily doses are plotted. This is in part to simplify the presentation, while being mindful that the twice daily dosing appeared to provide qualitatively improved results for filgotinib. Included in this plot is a best comparison to the percentages achieved by the recommended dose of tofacitinib in Study IV of the tofacitinib registration package.
stappa
0
De filgotinib ACR50 kolom is torenhoog, beklimmen zonder ervaring is af te raden. Naar beneden kijkend vanaf de filgotinib ACR kolommen zie je slechts de kopjes van de concurrenten, waarschijnlijk al in nevel verhuld.
[verwijderd]
0
quote:

stappa schreef op 16 mei 2015 om 20:04:


De filgotinib ACR50 kolom is torenhoog, beklimmen zonder ervaring is af te raden. Naar beneden kijkend vanaf de filgotinib ACR kolommen zie je slechts de kopjes van de concurrenten, waarschijnlijk al in nevel verhuld.

Zoals Ozgur Ogut zelf al aangeeft (“The method is an inexact comparison, but is provided as a best approximation for head-to-head comparison. Although once daily and twice daily doses of filgotinib were tested, the two best twice daily doses are plotted. This is in part to simplify the presentation, while being mindful that the twice daily dosing appeared to provide qualitatively improved results for filgotinib.”) is de vergelijking niet echt waterdicht zolang er geen head-to-head studies gebeuren.

Vergelijk de once-daily data van beide producten en je hoeft echt niet ver meer naar beneden te kijken.

Mijn buikgevoel zegt me ook wel dat filgotinib een wat betere werking vertoont dan baricitinib maar Eli Lilly gaat wellicht 2 jaar de tijd hebben om zijn deel van de koek op te eisen door te stellen dat baricitinib minder nevenwerkingen heeft dan Xeljanz. En als filgotinib dan op de markt zou komen kan Eli Lilly de nadruk leggen op het once-daily aspect van baricitinib.

Pokerface
0
Die once en twice dosing discussie is een interessante waar ik nog weinig over kan vinden. De resultaten voor 2 x 100 mg waren beter dan 1 x 200 mg. Toch meen ik gelezen te hebben dat men verder wil gaan met 1 x 200 mg. Klopt dat? En wat zou daar de reden voor kunnen zijn? Gebruiksgemak boven werkzaamheid?
Pokerface
0
Die eerste is inderdaad het topic dat daar over gaat, maar daar komt niet duidelijk uit naar voren waarom er met 200 mg verder gegaan wordt. Die tweede stuurt me niet naar een pagina met een post van Maxen. Anyway, ik wacht het af. Wellicht dat de 24-weeks resultaten hier meer duidelijkheid over geven.
Thanks!
Hearts23
0
De eenmaal daagse monotherapie in de DARWIN 2 studie leidde tot een gelijkaardige werkzaamheid als werd gezien bij de hoge doses in DARWIN 1, waar patiënten werden behandeld met een één- of tweemaal daagse dosis filgotinib gecombineerd met methotrexaat.(Dr Piet Wigerinck)
flosz
1
So remarkable within one week patients of all dose groups report a statistical significant difference from placebo. At week 12, patients of all groups have reported at least 25-point drop measured as a mean, a very solid improvement of their disease and all groups easily reach a statistical significance here. So let there be no doubt, when we initiate treatment to filgotinib of the once a day and even as a monotherapy, patients and physicians observe and report improvements from the first week onwards, a clear proof of the fast onset of action.

www.glpg.com/files/4314/3037/7975/GLP... p.5
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