YMB YM Bio.'b'ser1

    YM BioSciences' TheraCIM Granted US Orphan Drug Status

 

    - EGFr antibody receives orphan drug designation from the FDA for

    treatment of glioma -

 

    MISSISSAUGA, ON, Nov. 30 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer drug development company with an advanced-stage

portfolio, and its majority-owned subsidiary CIMYM Inc., today announced that

the Office of Orphan Products Development of the U.S. Food and Drug

Administration (FDA) has granted Orphan Drug Designation to their EGF receptor

monoclonal antibody, TheraCIM hR3, for the treatment of glioma (brain cancer).

    The U.S. Orphan Drug Act is intended to assist and encourage companies to

develop safe and effective therapies for the treatment of rare diseases and

disorders. Orphan Drug Designation is granted to products that treat

conditions affecting fewer than 200,000 people in the U.S. Orphan Drug

Designation provides eligibility for a special seven-year period of market

exclusivity at marketing approval, potential tax credits for research,

potential grant funding for research and development, the possibility of

reduced filing fees for marketing applications and, particularly, assistance

with the review of clinical trial protocols.

    TheraCIM hR3 is currently undergoing two Phase II trials in Europe and is

expected to become a Phase III candidate in early 2005. The Company's European

licensee, Oncoscience AG, is enrolling children in a trial for pediatric brain

cancer; and another trial is underway in metastatic pancreatic cancer.

Oncoscience also expects to initiate the Phase III trial in adult glioma in

early 2005. Orphan Drug Designation for glioma in Europe has already been

conferred.

    "TheraCIM is currently undergoing a robust clinical program in Europe,

which we anticipate will be paralleled by additional North American trials

that we propose to initiate in 2005," said David Allan, Chairman of YM

BioSciences. "With Orphan Drug Designation in Europe and now North America,

TheraCIM will benefit from regulatory assistance and marketing exclusivity in

both territories (10 years in Europe and seven in the USA), ensuring that our

efforts to bring this promising new treatment to market are well supported."

    TheraCIM hR3 (nimotuzumab), Theraloc in Europe, is a humanized monoclonal

antibody that targets the Epidermal Growth Factor receptor (EGFr). Head and

neck cancer Phase II trial results, reported in the Journal of Clinical

Oncology, showed that the drug doubles a patient's response to radiation

treatment. TheraCIM with radiation (immunoradiation) appears to be equivalent

to aggressive chemo-radiotherapy without the burden to the patient of high

toxicity from chemoradiation. It has also demonstrated a superior side-effect

profile to functionally equivalent, already approved, EGFr antibody drugs.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer drug development company. Its lead drug,

tesmilifene, is a small molecule chemopotentiator (for taxanes and

anthracyclines) currently undergoing a pivotal Phase III trial in metastatic

breast cancer. Tesmilifene has completed a previous Phase III trial with

positive results. In addition to tesmilifene, the Company is developing an

EGFr humanized monoclonal antibody that is being tested in glioma and

pancreatic cancer in Phase II trials, has completed Phase II trials in head &

neck cancer, and is expected to enter a Phase III trial in 2005. A GnRH anti-

cancer vaccine is in earlier stage clinical trials.

 

    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: James Smith, The Equicom Group Inc.,

Tel. (416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Carolyn McEwen,

YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959, Email:

ir(at)ymbiosciences.com

    (YM. YMI YMBA)

 



END

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