YM BioSciences EU Regulatory Update

    YM BIOSCIENCES PROVIDES EU REGULATORY UPDATE

    MISSISSAUGA, ON, Dec. 5 /CNW/ - YM BioSciences Inc. (NYSE Alternext
US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today reported
that Oncoscience AG, the European licensee of nimotuzumab from YM's
subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the
European Medicines Agency (EMEA) for marketing authorization of nimotuzumab.
Withdrawal of an application does not prejudice the possibility of a company
making a new application at a later stage.
    The application for the marketing authorization for nimotuzumab was
submitted to the EMEA on October 4th, 2007. At the time of the withdrawal it
was under review by the Agency's Committee for Medicinal Products for Human
Use (CHMP). In its official letter Oncoscience AG states that the withdrawal
of the application was made 'because it was not able to adequately address the
concerns of the CHMP regarding the quality and efficacy of the medicine within
the required time schedule'.
    "The questions from EMEA regarding the efficacy of nimotuzumab are based
only on data submitted by Oncoscience AG from an unplanned, retrospective,
subgroup analysis of a single arm, open label, monotherapy Phase II study of
47 patients with pediatric glioma. This analysis in no manner reflects on the
overall efficacy of nimotuzumab, which already has been approved for marketing
in twelve countries with efficacy demonstrated in numerous indications," said
David Allan, Chairman and CEO of YM BioSciences. "We are very pleased that
Oncoscience AG withdrew its application in anticipation of a later
resubmission as this application was based on a very small sample that was not
prospectively studied. We note that this withdrawal is consistent with actions
taken by numerous large and development stage pharmaceutical companies under
similar circumstances and we believe it was the correct means for managing the
quantity of information that is required in these submissions."
    YM's subsidiary CIMYM BioSciences Inc. is the licensee for the highly
differentiated EGFR-targeting drug, nimotuzumab, for most of the major market
territories including Japan, Europe and North America. Nimotuzumab is already
approved for sale in a number of countries and the data continues to
demonstrate the prospect for this molecule to be best-in-class in an
established area of cancer therapy. It is currently undergoing a YM sponsored
confirmatory trial in pediatric glioma in Canada and the US while being
advanced in several Phase II and III trials by YM's licensees and other
companies advancing the drug internationally.
    CIMYM continues with its application to the London Court of International
Arbitration for resolution of matters related to the license with Oncoscience
AG.

    About YM BioSciences

    YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
a number of countries, is significantly differentiated from all other
currently marketed EGFR-targeting agents because of a remarkably benign
side-effect profile. In more than 3,000 patients treated worldwide, to date,
no Grade III/IV rash or radiation dermatitis has been reported and reports of
any of the other side-effects that are typical of EGFR-targeting molecules
have been rare. AeroLEF(R) is in development for the treatment of moderate to
severe pain, including cancer pain. The product completed a randomized trial
in 2007 and is being prepared for late-stage development internationally.

    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: Enquiries: Thomas Fechtner, the Trout Group LLC,
Tel. [phone], Email: tfechtner(at)troutgroup.com; James Smith, the
Equicom Group Inc., Tel. [phone] x 229, Email:
jsmith(at)equicomgroup.com; Nominated Adviser, Canaccord Adams Limited, Ryan
Gaffney, Tel. [phone]
(YM. YMI YMBA)

 



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