MISSISSAUGA, ON, May 31, 2011 /PRNewswire/ - 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
groups."
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.