MISSISSAUGA, ON, May 31, 2011 /CNW/ - YM BioSciences Inc. (NYSE Amex: YMI), (TSX: YM), today announced that it has received positive opinions from the
Committee for Orphan Medicinal Products of the European Commission to
grant Orphan Medicinal Product Designation to its JAK1/JAK2 inhibitor,
CYT387, for the treatment of primary myelofibrosis, post-polycythaemia
vera myelofibrosis and post-essential thrombocythaemia myelofibrosis.
Myelofibrosis is a chronic debilitating unmet medical need in which a
patient's bone marrow is replaced by scar tissue, and for which
treatment options are limited or unsatisfactory.
"CYT387 has demonstrated early efficacy in improving the key aspects of
myelofibrosis including anemia, splenomegaly and a range of
debilitating symptoms," said Dr. Nick Glover, President and CEO of YM
BioSciences. "Having our JAK inhibitor designated as an orphan drug for
the treatment of myelofibrosis in Europe, in addition to our previously
obtained orphan designation in the US, will help ensure that we are
able to advance this drug as efficiently as possible for these patient
Orphan Medicinal Product Designation from the European Commission is
granted to medicines intended for the treatment of life-threatening or
chronically debilitating conditions that affect no more than 5 in
10,000 people in the EU. Developers of medicines that have received
orphan designation may receive fee reductions, protocol assistance,
access to the centralized authorization procedure, as well as 10 years
of marketing exclusivity once authorized.
The U.S. Food and Drug Administration (FDA) has previously granted
Orphan Drug Designation to CYT387 for the treatment of myelofibrosis.
About YM BioSciences
YM BioSciences Inc. is a drug development company advancing three
clinical-stage products: CYT387, a small molecule, dual inhibitor of
the JAK1/JAK2 kinases; nimotuzumab, an EGFR-targeting monoclonal
antibody; and CYT997, a vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of both the JAK1 and JAK2
kinases, which have been implicated in a number of immune cell
disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. CYT387 is currently in a Phase
I/II trial in myelofibrosis. Nimotuzumab is a humanized monoclonal
antibody targeting EGFR with an enhanced side effect profile over
currently marketed EGFR-targeting antibodies. Nimotuzumab is being
evaluated in numerous Phase II and III trials worldwide. CYT997 is an
orally-available small molecule therapeutic with dual mechanisms of
vascular disruption and cytotoxicity, and has completed a Phase II
trial for glioblastoma multiforme. In addition to YM's three clinical
stage products, the Company has a library of more than 4,000 novel
compounds identified through internal research conducted at YM
BioSciences Australia which are currently being evaluated.
This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may
cause actual results, events or developments to be materially different
from any future results, events or developments expressed or implied by
such forward-looking statements. Such factors include, but are not
limited to, changing market conditions, the successful and timely
completion of clinical studies, the establishment of corporate
alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process
or the ability to obtain drug product in sufficient quantity or at
standards acceptable to health regulatory authorities to complete
clinical trials or to meet commercial demand; and other risks detailed
from time to time in the Company's ongoing quarterly and annual
reporting. Certain of the assumptions made in preparing forward-looking
statements include but are not limited to the following: that CYT387,
nimotuzumab and CYT997 will generate positive efficacy and safety data
in ongoing and future clinical trials, and that YM and its various
partners will complete their respective clinical trials and disclose
data within the timelines communicated in this release. Except as
required by applicable securities laws, we undertake no obligation to
publicly update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
SOURCE YM BioSciences Inc.
For further information:
VP Corporate Communications
YM BioSciences Inc.
Tel. +1 905.361.9518