YM BioSciences reports successful regulatory reviews of nimotuzumab
manufacturing

    MISSISSAUGA, ON, May 24 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, and its majority owned
subsidiary CIMYM BioSciences Inc., today announced that the manufacturing
facility for nimotuzumab, the Company's humanized monoclonal antibody for the
treatment of cancer, has been successfully scaled up to a 500 litre-capacity
continuous perfusion fermentation process.
    YM also reported that Health Canada has issued a No Objection Letter for
the product manufactured at the 500 litre capacity to be used in clinical
trials in Canada. A competent regulatory authority in the EU has also
inspected and certified the manufacturing process and infrastructure at the
Center for Molecular Immunology. A further increase in the manufacturing
capacity to 1,000 litre scale continuous fermentation is also anticipated to
be completed in 2007.
    Nimotuzumab is manufactured in a continuous process using a stirred tank
perfusion bioreactor. This production method delivers higher production
capacity than batch production in bioreactors of the same size.
    "The 500 litre-capacity fermentation process is sufficient for the
initial commercialization of nimotuzumab. This drug is also being manufactured
for other licensees at Biocon Biopharmaceuticals Limited, a subsidiary of
Biocon Ltd. in Bangalore, India, and at Biotech Pharmaceuticals Limited in
Beijing, China, where production is anticipated to start shortly," said David
Allan, Chairman and CEO of YM BioSciences.

    About Nimotuzumab

    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR) and is approved in several countries for
treatment of various types of head and neck cancer. Global development of
nimotuzumab through a number of licensees and the licensor of the drug is
ongoing in multiple tumour types, including: pediatric and adult glioma,
pancreatic cancer, prostate cancer, non-small cell lung cancer, esophageal
cancer, cervical cancer, and breast cancer.
    Daiichi Sankyo Co., Ltd., the Japanese licensee of nimotuzumab, has
obtained approval by Japanese regulatory authorities to start a Phase I
clinical trial of nimotuzumab for the treatment of solid tumours. Oncoscience
AG in Germany is expected to complete enrollment during the first half of 2007
in a Phase III trial of nimotuzumab as first-line therapy in pediatric pontine
glioma. YM is in the planning stages of a Phase II study in the same
indication in the United States and Canada and also anticipates filing an IND
for a Phase II trial evaluating nimotuzumab in colorectal cancer in the
immediate future.
    Nimotuzumab continues to be differentiated from the other antibodies and
small molecules targeting the tyrosine kinase pathway. These other drugs in
this class have been shown to produce the debilitating and unpleasant
side-effects of rash, hypomagnesemia, conjunctivitis, painful paronychial
inflammation, diarrhea and constipation. Such side-effects have rarely been
reported in patients treated with nimotuzumab.

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer, and
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.

    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; 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: Thomas Fechtner, The Trout Group LLC, Tel. (212)
477-9007 x 31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com; James
Smith, The Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith(at)equicomgroup.com
(YMBA)


 



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