YM BioSciences Receives FDA Clearance for an IND for its Fentanyl-Based Pain Product AeroLEF(TM)



    - YM to initiate trial in the U.S. and plans End of Phase II meeting with
    FDA -

    MISSISSAUGA, ON, June 27 /CNW/ - YM BioSciences Inc. (AMEX:   YMI, TSX: YM,
AIM: YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today announced that the U.S.
Food and Drug Administration (FDA) has cleared its Investigational New Drug
(IND) application for AeroLEF(TM).
    AeroLEF(TM) is a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. In contrast to fixed-dose approaches to
opioid delivery, where a significant titration period is often required to
determine the suitable dose for the patient, AeroLEF(TM) is being developed as
a non-invasive delivery system designed to enable patients to self-titrate.
Using AeroLEF(TM), patients can identify and select a personalized dose for
each pain episode, achieving both rapid onset and extended duration of
analgesia.
    "This clearance marks the start of a formal path towards regulatory
approval for AeroLEF(TM) in the U.S. and builds on the momentum of having
recently reported positive Phase II data for this unique and important
product," said David Allan, Chairman and CEO of YM BioSciences. "Under this
IND, YM plans to initiate an open-label Phase II trial designed to expand the
target patient population of AeroLEF(TM) and in parallel is planning an End of
Phase II meeting with the FDA to gain agreement on the design of the Phase III
program. The Phase II study is planned to recruit up to 50 post-surgical
patients across three sites in the U.S. and will include a number of opioid
tolerant patients to evaluate AeroLEF(TM) in this increasingly important
market segment."
    YM recently reported that AeroLEF(TM) met its primary endpoint in a 99
patient, randomized, placebo-controlled, multi-center Phase IIb trial
(DLXLEF-AP4) in opioid-naive patients with post-operative pain following
orthopedic surgery. AeroLEF(TM) showed a statistically significant difference
in SPRID4 (a summary of the combined changes in pain relief and in pain
intensity that patients report over the first four hours following initiation
of dosing) from placebo for the treatment of the first pain episode
(p=0.0194). YM is completing a detailed analysis of the numerous secondary
endpoints and safety data from this study to extend the information it will
make available.

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company is
advancing 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; that AeroLEF(TM) 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.

    %SEDAR: 00004652E          %CIK: 0001178347




For further information:

For further information: Thomas Fechtner, the Trout Group LLC, Tel.
(212) 477-9007 x31, Fax (212) 460-9028, Email: tfechtner@troutgroup.com; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith@equicomgroup.com


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