Biotech Values

[jq1234]

INCY presented very strong and convincing data to address the tolerability issue raised from post marketing experience. I suspect the reason YMI settled on lower dose was due to enrollment of sicker patients in their trial (higher percentage of PMF patients) which prevented dose escalation to as high dose as INCY did. INCY is now in much stronger position in JAK space. It would be interesting to see GILD's ph3 plan for CYT387. I suspect they are going to follow CTIC's pacritinib (JAK2/FLT3) ph3 plan - one against BAT excluding JAK, one against Jakafi. Pacritinib and SNY's JAK2/FLT3 SAR302503 don't have as good clinical profile as Jakafi and CYT387.

According to BioWorld, Pacritinib ph3 plan:

The trial, designated PERSIST-1 , will enroll 270 patients to be randomized 2-to-1 to oral pacritinib 400 mg or best
available therapy, excluding JAK inhibitors. Patients will not
be excluded by platelet count. The primary endpoint will
be a reduction in spleen volume of 35 percent or more as
measured by MRI or CT scan at 24 weeks of treatment.

A second Phase III trial will compare pacritinib to best
available therapy, including JAK inhibitors, in patients with
myelofibrosis whose platelet counts are less than 100,000/uL.