YM BIOSCIENCES USA RECEIVES CLEARANCE

 
TIDMYMB 
 
YM BIOSCIENCES USA RECEIVES CLEARANCE FROM US TREASURY DEPARTMENT TO EXTEND 
CLINICAL PROGRAM FOR NIMOTUZUMAB 
 
    MISSISSAUGA, ON, Aug. 10 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI, 
TSX:YM, AIM:YMBA), a life sciences product development company that identifies 
and advances a diverse portfolio of promising cancer-related products at 
various stages of development, today announced that its wholly-owned 
subsidiary, YM BioSciences USA Inc. (YM-USA) has received a license from the 
US Department of the Treasury's Office of Foreign Assets Control (OFAC) to 
further develop its lead product, nimotuzumab, for patients with solid tumor 
cancers in the United States. 
    "This license from OFAC to develop nimotuzumab in any cancer indication 
is a major step forward in our US development program and will allow us to 
immediately discuss our IND submissions with the FDA to include US patients in 
our randomized, double-blinded lung cancer and brain metastases trials," said 
David Allan, Chairman and CEO of YM BioSciences. "Our development plans may 
also include extending some of the Phase III trials being conducted worldwide 
into the US. There are quantifiable physical, emotional and financial costs 
that result from the numerous and severe toxicities of the currently available 
EGFR-targeting drugs which are not evident with the administration of our 
drug. Nimotuzumab has been demonstrating efficacy in trials throughout the 
world and we are very pleased that US patients will now have the opportunity 
to receive the drug and that a broader group of US oncologists will gain 
experience with it. Our goal is to bring this therapeutic option, already 
approved for marketing in 18 countries, to patients in the US as rapidly as 
possible." 
    Mr. Allan added, "We have also applied to OFAC for a license to make 
nimotuzumab available to US patients upon marketing approval by the FDA. This 
is consistent with a 2009 Staff Report to the US Senate Committee on Foreign 
Relations (SCFR) entitled 'Changing Cuba Policy - In the United States' 
National Interest,' which recommended pharmaceutical imports from Cuba's 
rapidly developing biotech industry. We are most appreciative of the extensive 
support we have received for our application from SCFR Chairman Senator John 
Kerry (D-MA), Western Hemisphere Subcommittee Chairman Senator Chris Dodd 
(D-CT) and SCFR Ranking Member Senator Richard Lugar (R-IN) and for their 
acute understanding of the needs of cancer patients. Such licenses have been 
previously granted to two companies seeking to commercialize Cuban-origin 
therapeutics in the US and we have ongoing discussions with OFAC in this 
regard." 
    YM USA previously received a license from OFAC to import nimotuzumab into 
the US to conduct a study of nimotuzumab in children suffering from recurrent 
diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal 
oncology hospitals in the US and data is expected in 2010. Nimotuzumab is also 
available on a compassionate use basis in the US for children with this 
condition and is designated an Orphan Drug for adult and pediatric glioma by 
the FDA as well as the EMEA for Europe. 
    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal 
growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, 
CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of 
Molecular Immunology in Cuba. The drug has demonstrated efficacy in clinical 
trials without the serious side effects observed with the marketed 
EGFR-targeting drugs. Nimotuzumab has been administered to approximately 5,000 
patients worldwide and is currently in 32 trials internationally of which 11 
are being conducted by YM and its four licensees. Three of the latter are 
Phase III trials, including one being conducted by the internationally 
recognized National Cancer Center of Singapore, which selected nimotuzumab 
over the alternative antibodies because of its benign side effect profile. 
 
    About YM BioSciences 
 
    YM BioSciences Inc. is a life sciences product development company that 
identifies and advances a diverse portfolio of promising cancer-related 
products at various stages of development. The Company is currently developing 
two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized 
Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of 
free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical 
trial expertise and a diversified business model designed to reduce risk while 
advancing clinical products toward international approval, marketing and 
commercialization. 
 
    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 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 nimotuzumab will continue to demonstrate a competitive 
safety profile in ongoing and future clinical trials; that AeroLEF(R) will 
continue to generate positive efficacy and safety data in future clinical 
trials; and that YM and its various partners will complete their respective 
clinical trials within the timelines communicated in this release. We 
undertake no obligation to publicly update or revise any forward-looking 
statements, whether as a result of new information, future events or 
otherwise. 
 
 
For further information: James Smith, the Equicom Group Inc., Tel. (416) 
815-0700 x 229, Email: jsmith(at)equicomgroup.com; Thomas Fechtner, the Trout 
Group LLC, Tel. [phone], Email: tfechtner(at)troutgroup.com; Nominated 
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. [phone] 
(YM. YMI YMBA) 
 
 
 
 
 
 
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