Myelofibrosis

Myelofibrosis is a disorder of the bone
marrow, in which the marrow is
replaced by scar (fibrous) tissue.



FDA APPROVES JAKAFI FOR
MYELOFBROSIS
In November 2011 Incyte Corporation  
announced the FDA has granted
marketing approval for Jakafi
(ruxolitinib) for the treatment of
patients with intermediate or high-risk
myelofibrosis (MF), including primary
MF, post-polycythemia vera MF and
post-essential thrombocythemia MF.

Patients with intermediate and
high-risk MF represent 80 to 90
percent of MF patients. Jakafi
(JAK-ah-fye) is the first and only
product to be approved by the FDA for
MF, and the first in a new class of
drugs, known as JAK inhibitors, to be
approved for any indication. Jakafi is
an oral JAK1 and JAK2 inhibitor.

The FDA approval was based on
results from two randomized Phase III
trials (COMFORT-I and COMFORT-II),
which demonstrated that patients
treated with Jakafi experienced
significant reductions in splenomegaly
(enlarged spleen). COMFORT-I also
demonstrated improvements in
symptoms as measured by the
modified Myelofibrosis Symptom
Assessment Form (MFSAF) v.2.0
electronic diary and the MFSAF Total
Symptom Score (TSS) comprised of six
specific symptoms (abdominal
discomfort, pain under the left ribs, an
early feeling of fullness, night sweats,
bone and muscle pain and itching) all
of which contributed to the overall
benefit. Most patients taking placebo
experienced worsening of these same
parameters.





PROMISING RESULTS FROM YM
BIO'S MYELOFIBRIOSIS DRUG:
CYT387 IN  MIDSTAGE TRIALS
In December 2011  anticipated results
from a mid-stage and multi-center
study of YM Bio's myelofibrosis drug
CYT387 were released.

Of the 68 myelofibrosis patients who
were transfusion dependent when the
study started, 46% became transfusion
independent for a minimum of 12
weeks and maintained hemoglobin
levels equal to or above 8 g/dl.

If this drug can reverse the anemia
associated with myelofibrosis, it will
have a legitimate superiority claim over
Incyte's   recently approved
myelofibrosis drug Jakafi, which has no
effect on anemia.

Based on the positive anemia
response data released Monday, the
current valuation gap between Incyte
($1.8 billion market cap) and YM Bio
($170 million market cap) is way too
big even considering '387 is two or
three years behind in clinical
development.

Myelofibrosisis is a disorder in which
abnormal bone marrow stem cells
produce scar tissue that replaces
healthy marrow. Patients with
myelofibrosis suffer from anemia and
enlarged spleens. YM Bio's '387 and
Incyte's Jakafi belong to a class of oral
drugs that block the effects of Janus
kinase (JAK) enzymes which play a
role in diseases that cause bone
marrow cells to grow uncontrollably.