BiostockAddict schreef op 11 november 2015 14:58:
$GLPG Morgan Stanley We hosted a bullish dinner with Galapagos mgt. at ACR. We remain
hopeful that mgt. can re-partner filgotinib by YE on favorable terms
and see filgotinib Chron's data in Dec, GLPG1205 data in Ulcerative
Colitis in 1Q16 and progress in the CF pipeline as key catalysts over
the next 6 months.
We recently hosted a dinner with Galapagos mgt. including CEO Onno
van de Stolpe, head of the JAK program Gerben van't Klooster and IR Elizabeth
Goodwin. Key topics discussed included on-going efforts to re-partner
filgotinib, differentiation from other JAK inhibitors and mgt.'s plans for its CF
franchise.
Key filgotinib updates: (1) On 11/8 at ACR both DARWIN1 and DARWIN2
were presented. The data largely replicated the datasets that mgt. had already
provided when it announced the 6 month data. There were a few more details
on ALT/AST (which were not meaningful), lipids and some secondary efficacy
data. We see filgotinib as a clean, potentially best-in-class JAK1 inhibitor; (2)
Mgt. indicated that it believes it has more than the required data to move
ahead with the 200mg filgotinib dose. It has completed additional animal
studies to establish the therapeutic window and also has data with ~100 males
who received the 200mg dose internationally with no change in hormones.
Finally, mgt. highlighted that many other drugs have been approved with
testicular toxicity concerns (see Exhibit 1); (3) Mgt. continues to work toward a
new filgotinib licensing deal with the hope of signing a deal by YE15; (4) Mgt.
is also targeting its final briefing package to the FDA in time for a 1Q16 end of
PhII meeting. It would prefer to have signed a partner ahead of that meeting;
(5) Filgotinib's Chron's data remains on track for a December readout. This
data could be an important driver of value in filgotinib licensing deals.
Key CF updates: (1) Mgt. is working toward updating its AbbVie licensing
deal on CF to more fully encompass the three drug combo; (2) While mgt.
acknowledges that there may be a ceiling effect for homozygous CFTR
correction (>50% correction may not create additional clinical benefit), mgt.
also believes that its CF triple combo could achieve better clinical results than
Vertex's triple combo on the basis of its preclinical results in the heterozygote
population where it does not see such a ceiling effect.
We continue to see sig. upside to GLPG into a new deal: For us the key
near-term upside for GLPG is the signing of a new filgotinib deal. We have
confidence mgt. can sign an attractive deal and believe that a deal will ease
concerns around the 200mg toxicity question. Beyond that Chron's, CF and
GLPG1205 in Ulcerative Colitis offer upside into mid-2016.