Regulatory Approval

    YM BioScience receives clearance to import nimotuzumab for clinical research
in the US

    - Clearance will allow YM to submit an Investigational New Drug (IND)
                           application to the FDA -

    MISSISSAUGA, ON, Sept. 25 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), a company engaged in the acquisition, development and
commercialization of oncology and acute care products, today announced that
the Office of Foreign Assets Control (OFAC) of the US Treasury Department has
approved a license that allows YM BioSciences' wholly-owned U.S. subsidiary to
import nimotuzumab into the United States for the purpose of clinical trials
in pediatric patients with pontine glioma. Nimotuzumab is a monoclonal
antibody that targets the Epidermal Growth Factor Receptor (known as EGFR) and
was developed at the Center for Molecular Immunology affiliated with the
University of Havana.
    As a result of the OFAC license, YM BioSciences plans to submit an IND to
the FDA to allow the investigation of nimotuzumab for the treatment of
children with intrinsic diffuse pontine glioma. Upon FDA granting permission
for the IND to proceed nimotuzumab, to the knowledge of the company, would be
the first anti-cancer drug from Cuba to be used in clinical trials in the US.
    "Diffuse pontine glioma is an inoperable malignant brain cancer that only
affects children and, furthermore, it is a treatment resistant tumor so that
children currently suffering from it have few treatment options," said David
Allan, Chairman and CEO of YM BioSciences. "With this license from OFAC, we
propose to submit an IND to the FDA to investigate nimotuzumab, thus
potentially allowing US children access to the drug through a controlled
clinical trial setting while collecting efficacy and safety data. Nimotuzumab
has been available to children in other countries through their participation
in clinical trials since 2004. At present median survival following diagnosis
and treatment with radiation or chemoradiation is approximately 8.5 months,
and median survival after recurrence following treatment is approximately
three months."
    Preliminary data from a Phase II nimotuzumab monotherapy study in Germany
in pediatric high-grade glioma were presented at SIOP in 2005 and at ASCO in
2006. Data from this study formed the basis for a currently ongoing Phase III
trial, combining nimotuzumab with radiation, in Europe through YM BioSciences'
licensee OncoScience AG. Final results of that Phase II trial were presented
at the 38th Congress of the International Society of Paediatric Oncology,
Geneva, Switzerland, September 18, 2006.
    The OFAC license permitting the import of nimotuzumab is an important
first step towards preparing to initiate US clinical trials, and provided that
the FDA concurs with the design a trial in diffuse intrinsic pontine glioma
will be undertaken in numerous US and Canadian hospitals with the principal
investigational site being the Hospital for Sick Children in Toronto, Canada.
The current OFAC license allows the import of nimotuzumab for use in clinical
trials only. The commercialization of the drug would require an additional
license from OFAC.
    Nimotuzumab, which is currently approved in India, China, Argentina, and
Columbia as well as Cuba, was recently licensed by YM to Daiichi
Pharmaceutical Co. for the Japanese market. In Europe and Canada, the drug is
in numerous clinical trials including non-small cell lung cancer, pediatric
glioma and refractory solid tumours (principally colorectal). That latter
study evaluated nimotuzumab as monotherapy. The study was conducted at The
Princess Margaret Hospital in Canada in 2006 and demonstrated significant
clinical benefit in this highly refractory patient population. Data from this
study will be submitted to upcoming medical meetings in 2007.

    About YM BioSciences
    YM BioSciences Inc. is engaged in the acquisition, development and
commercialization of oncology and acute care products.
    In addition to nimotuzumab, YM BioSciences is developing tesmilifene,
AeroLEF(TM) and Norelin.
    Tesmilifene is a small molecule that targets multi-drug resistant (MDR+)
cancer cells and is being tested in combination with various standard
chemotherapy regimens for the treatment of a number of cancers. The 'DEC'
pivotal trial for tesmilifene in metastatic and recurrent breast cancer has
been the subject of two interim analyses of safety and survival data which
indicated the drug continues to be safe and the trial continues to have the
prospect of meeting its survival endpoint. The third of a number of interim
analyses is anticipated in the coming months and mature data during calendar
2007. In addition to the Phase III DEC trial, which combines tesmilifene with
an anthracycline, a collaborative trial with Sanofi-Aventis is currently
ongoing combining tesmilifene with Taxotere(R) (docetaxel) a taxane drug. A
trial combining tesmilifene with epirubicin, cyclophosphamide, and 5-FU is
anticipated for the treatment of gastric cancer and additional trials are in
planning.
    AeroLEF(TM) is a unique inhaled-delivery composition of free and liposome
encapsulated fentanyl, for the treatment of moderate to severe acute pain,
including cancer pain. AeroLEF(TM) is currently enrolling post-surgical
patients in a randomized Phase IIb trial for which preliminary results will be
presented at the American Society of Anesthesiologists Annual Meeting,
McCormick Place - Chicago, IL, October 14-18, 2006.
    Norelin, an anti-cancer vaccine, stimulates the immune system to develop
antibodies to gonadotropin-releasing hormone (GnRH). In addition, YM
BioSciences also owns a portfolio of pre-clinical compounds.

    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 the pivotal tesmilifene Phase III trial will be completed
on schedule and yield mature data in calendar 2007; that the DSMB's
recommendations to continue the pivotal trial for tesmilifene based on two
early analyses implies that the trial continues to have the prospect of
meeting its primary endpoint; that nimotuzumab will continue to demonstrate a
competitive safety profile in ongoing and future clinical trials; 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 x31, Fax [phone], Email: tfechtner(at)troutgroup.com; James
Smith, The Equicom Group Inc., Tel. [phone] x 229, Fax [phone],
Email: jsmith(at)equicomgroup.com
(YMBA YM. YMI)




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