YM BioSciences Announces Milestone Payment

    YM BioSciences Announces Milestone Payment For Approval Of Nimotuzumab In The
Philippines And Indonesia

    MISSISSAUGA, Canada, Dec. 12 /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 announced
that its majority-owned subsidiary CIMYM BioSciences Inc. received a milestone
payment from its licensee Innogene Kalbiotech Ltd (IGK) in recognition of the
recent marketing approval of nimotuzumab in the Philippines and Indonesia. IGK
is the biotech subsidiary of P.T Kalbe Farma Tbk (Jakarta, Indonesia), one of
the largest pharmaceutical companies in the region with more than 8,100
employees and annual revenues exceeding US$300 million.
    "With the addition of the Philippines and Indonesia, nimotuzumab has now
received marketing approval in twelve countries. Demand for novel medicines is
growing rapidly in the emerging markets of the world and nimotuzumab is well
positioned to become a key cancer therapeutic in these territories due to its
unique safety profile compared with the other EGFR-targeting drugs," said
David Allan, Chairman and CEO of YM BioSciences. "Highlighting this
competitive advantage, reports have increased in frequency describing
toxicities associated with the combination of the other EGFR drugs and
radiation. In addition to Grade III/IV rash, Grade IV radiation dermatitis,
another serious and debilitating toxicity, has recently been reported
affecting approximately 28% of patients treated with a currently marketed
EGFR-targeting antibody together with radiation while absent in patients
treated with radiation alone."
    In none of the clinical trials of nimotuzumab to date, to YM's knowledge,
have any of the patients developed Grade III/IV acneiform rash, also a severe
and dose-limiting side-effect observed in all of the other antibodies and with
small molecules targeting the EGF tyrosine kinase signaling pathway. Unrelated
to the rash, Grade III/IV radiation dermatitis is a severe toxicity reported
in almost half the patients treated with other EGFR-targeting antibody drugs
in combination with radiation while absent in nimotuzumab/radiation treated
patients. Reports of any severe incidents of the other side-effects that are
typical of EGFR-targeting molecules have been rare. These severe side-effects
can result in treatment interruptions, one of the leading causes of treatment
failure and, unlike cetuximab, nimotuzumab patients do not have to be
pre-medicated to prevent infusion reactions.
    Nimotuzumab is being developed to compete as best-in-class therapy
against the currently marketed EGFR-targeting drugs. This drug has displayed
efficacy in numerous tumour types (published and presented at major
conferences including ASCO), having completed more than 27 clinical trials
demonstrating anti-cancer activity that rivals the other EGFR-targeting
antibody drugs.
    Nimotuzumab is currently being advanced in several randomized Phase II
and III trials in Japan, Europe and elsewhere and is undergoing a YM-sponsored
confirmatory trial in pediatric glioma in Canada and the US.

    NYSE Alternext US notice

    The Company received an audit opinion for the fiscal year ended June 30,
2008 which included an explanatory paragraph referencing note 1 to the
consolidated financial statements of the Company's fiscal 2008 annual report
which discusses substantial doubt about the Company's ability to continue as a
going concern as the Company has no net earnings, minimal revenue and negative
operating cash flows. YM had net cash of more than CDN $52 million at
September 30, 2008 which it believes is sufficient to continue its development
activity well beyond the 2009 fiscal year. The disclosure in note 1 is
consistent with YM's disclosure in previous financial reports and is intended
to alert readers to the risks inherent to the industry in which it operates,
which include the reliance on the capital markets and uncertain partnership
revenues.

    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: [e-mail]; James Smith, the
Equicom Group Inc., Tel. [phone] x 229, Email:
[e-mail]; Nominated Adviser: Canaccord Adams Limited, Ryan
Gaffney, Tel. [phone]
(YMBA)

 



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