HansGarrincha schreef op 16 november 2015 12:32:
morganstanley $glpg Risk/Reward Into December Crohn's
Data
Our bull case moves to $107 (+~$10) as we now include positive
Crohn's data. While Pfizer's JAK tofacitinib failed in Crohn's we see
much better chances for filgotinib on better study design and drug
properties. Positive Crohn's data would also offer mgt. add'l
leverage in partnership discussions.Phase II filgotinib Crohn's data expected in early December: Galapagos
is running a ~180 patient PhII Crohn's disease study with its JAK inhibitor
filgotinib. Mgt. is studying 200mg of filgotinib once-daily with a primary
endpoint at 10 weeks. There is also an additional 10 weeks of maintenance
dosing for a full study duration of 20 weeks. We expect to receive top-line data
from the 10 week induction period, including the percentage of patients in
remission, in early December. The full study design is available here.
Study design and drug properties suggest filgotinib can work in
Crohn's Disease: Galapagos has included two key study design features
which should limit the placebo response and allow filgotinib to separate: (1)
All patients must have confirmed disease by endoscopy to enter the study
which should limit the placebo response. Further, the week 10 endpoint also
uses endoscopy, so in addition to remission by CDAI, remission will be
confirmed by endoscopy; (2) The primary endpoint is at 10 weeks (unlike 4
weeks with Pfizer's tofacitinib) which should allow ample time for filgotinib to
separate from placebo. Finally, (3) filgotinib's lack of impact on hemaglobin
should not impede efficacy (baricitinib was not studied in this population for
that reason and tofacitinib had a short duration study).
Risk/Reward skewed positively with limited investor expectations for
Crohn's: With positive data we see potential upside of ~$10/share assuming
~$1B in peak Crohn's sales. We have now added explicit Crohn's forecasts to
our bull case. Given that many investors have yet to focus on Crohn's, we
believe there is little expectation of positive Crohn's data among investors.
Further, we believe GLPG could rise above our theoretical potential upside on
positive Crohn's data given that it would further differentiate filgotinib (it
would be the only JAK with positive Crohn's data) and likely help cement a
strong deal with a new commercial partner.
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with certain strategic initiatives. There is no guarantee that any specific
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