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YM BioSciences Inc. (YMB)

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Friday 20 June, 2008

YM BioSciences Inc.

YM BIOSCIENCES ANNOUNCES FDA LIFTS CLINICAL HOLD


Attention Business Editors:
YM BIOSCIENCES ANNOUNCES FDA LIFTS CLINICAL HOLD ON AEROLEF(R) AND CLEARANCE
OF A PHASE II CLINICAL TRIAL

    - Dr. Ali Raza To Lead Further Development Of AeroLEF As President Of
    AeroLEF Division -

    MISSISSAUGA, ON, June 19 /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
Clinical Hold imposed by the US Food and Drug Administration (FDA) on the
development of YM's AeroLEF(R) has been lifted. The lifting of this Hold
permits YM to resume the expansion into the US of the Phase II clinical
development of AeroLEF.
    AeroLEF is being developed as a novel and effective approach to the
management of acute pain by delivering a proprietary formulation of inhaled,
nebulized, free-and-liposome-encapsulated fentanyl. The free fentanyl results
in rapid onset of analgesia while the liposome-encapsulated fentanyl produces
the unique extended duration of pain relief. The FDA cleared a Phase II
protocol in June 2007 to proceed with AeroLEF's first trial in the US,
however, immediately prior to the End-of-Phase II meeting scheduled and held
in January 2008, the FDA imposed a Clinical Hold, now lifted.
    YM is also pleased to announce that Dr. Ali Raza has been engaged as
President of the AeroLEF Division to lead the product's further development.
Dr. Raza has held a number of leadership roles in established and
development-stage pharmaceutical companies. He led the global development of
CRESTOR(R) (rosuvastatin), a product approved in more than 60 countries and
which is competing for market leadership with Lipitor(R). Earlier this year he
achieved regulatory clearance for and initiated a major Phase III clinical
program for a fentanyl product being developed in more than 50 research
centers in Europe.
    "I am delighted to have joined the AeroLEF team at YM BioSciences and
look forward to moving rapidly to the late-stage, international development of
this unique product," said Dr. Raza.
    "We welcome Dr. Raza and have high confidence that his breadth of
experience in global drug development will significantly reinforce our team's
ability to realize the substantial value of AeroLEF's unique approach to the
treatment of pain. The scientific pedigree and unique advantages of this
product have been established and safety and efficacy data have been reported
from previous clinical trials, including in three poster presentations at the
Annual Meeting of the American Pain Society in May 2008," said David Allan,
Chairman and CEO. "We also greatly appreciate the timely review by the FDA to
our responses and the constructive approach of the Agency."

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. In addition to
AeroLEF, the Company's other late-stage product, nimotuzumab, is a humanized
monoclonal antibody that targets the epidermal growth factor receptor (EGFR).
It is approved in several countries for treatment of various types of head and
neck cancer.

    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.

For further information: Enquiries: James Smith, the Equicom Group Inc., Tel.
(416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Thomas Fechtner, the
Trout Group LLC, Tel. (646) 378-2931, Email: tfechtner(at)troutgroup.com;
Nominated Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050
6500
(YM. YMI YMBA)