YMB YM Bio.'b'ser1

    YM BioSciences receives FDA fast track designation for tesmilifene in

    advanced breast cancer

 

    MISSISSAUGA, Canada, Feb. 13 /CNW/ - YM BioSciences Inc. (AMEX:YMI,

TSX:YM, AIM:YMBA), the cancer product development company, today announced

that the U.S. Food and Drug Administration (FDA) has designated as a fast

track product the Company's lead drug, tesmilifene, for use in combination

with an anthracycline chemotherapeutic for the treatment of women with

advanced breast cancer. While the Company is seeking clarification from the

FDA on certain aspects of the letter, the letter confirms that YM BioSciences'

lead drug, tesmilifene, meets the criteria for fast track designation for

treatment of metastatic/recurrent breast cancer.

    The Fast Track program facilitates the development and expedites the

review of new therapeutics that are intended to treat serious or life

threatening diseases and demonstrate the potential to address unmet medical

needs. The FDA will also provide input into product development plans and may

accept portions of the marketing application prior to the completion of the

final registration package. Most drugs that are designated for the Fast Track

Program are given priority review once a New Drug Application (NDA) is filed.

 

    About tesmilifene (DPPE)

    Tesmilifene is a small molecule chemopotentiator currently undergoing a

700-patient pivotal Phase III trial in metastatic and recurrent breast cancer

that has completed enrolment. The trial compares tesmilifene combined with

epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women

with rapidly progressing metastatic and recurrent breast cancer.

    YM is also initiating a Phase II trial in collaboration with Sanofi-

Aventis combining tesmilifene with Taxotere for the treatment of metastatic

and recurrent breast cancer. Separately, YM has licensed tesmilifene to the

Shin Poong Pharmaceutical Company of Seoul, South Korea, under which Shin

Poong plans to expand the development program into gastric cancer.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer product development company. In addition

to tesmilifene, YM is developing nimotuzumab, an anti-EGFr humanized

monoclonal antibody, in a number of indications. A Phase II monotherapy trial

of nimotuzumab produced cytotoxic efficacy and evidence of survival benefit in

children with recurrent brain cancer. In May 2005, the Company acquired DELEX

Therapeutics Inc., a private clinical stage biotechnology company developing

AeroLEF(TM), a unique inhalation delivered formulation of the established

drug, fentanyl, to treat acute pain including cancer pain. A randomized Phase

IIb pain trial with AeroLEF(TM) has been initiated. YM BioSciences is also

developing its anti-GnRH, anti-cancer vaccine, Norelin(TM), for which Phase II

data have been released. The Company also has a portfolio of preclinical

compounds shown to act as chemopotentiators while protecting normal cells.

 

    Except for historical information, this press release may contain forward-

looking statements, which reflect the Company's current expectation regarding

future events. These forward-looking statements involve risk and

uncertainties, which may cause 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.

 

    For further information: Enquiries: Thomas Fechtner, The Trout Group

LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028, Email:

tfechtner(at)troutgroup.com; Carolyn McEwen, YM BioSciences Inc., Tel.

(905) 629-9761, Fax (905) 629-4959, Email: ir(at)ymbiosciences.com; James

Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,

Email: jsmith(at)equicomgroup.com

    (YMBA YM. YMI)



END

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