YMB YM Bio.'b'ser1

    YM BioSciences expands development program for EGFR inhibitor

    nimotuzumab

 

    - YM Partners with Kuhnil Pharmaceutical Co. to Develop Nimotuzumab

    (TheraCIM-hR3) for Non-Small Cell Lung Cancer -

 

    MISSISSAUGA, ON, June 15 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer drug development company, today announced that its

subsidiary, CIMYM Inc., has partnered with Kuhnil Pharmaceutical Company of

Seoul, Koreato expand the development program for nimotuzumab (TheraCIM-hR3),

its monoclonal antibody against the EGF receptor, for specific population of

patients with non-small cell lung cancer (NSCLC).

    "This agreement furthers our strategy of expanding the value of

nimotuzumab by advancing it into clinical trials targeting additional cancer

patient populations, building on the clinical efficacy that the drug has

already demonstrated in glioma and cancers of the head & neck," said

David Allan, Chairman and CEO of YM BioSciences. "Kuhnil proposes to file an

IND application in Koreain Q3 of this year for a phase II study in patients

with NSCLC who are unfit for chemotherapy, and CIMYM expects to file in Canada

and elsewhere in the same timeframe, adding to our ongoing clinical program."

    Kuhnil will join the Joint Development Team, already comprised of YM,

Oncoscience A.G. and CIMAB S.A. management, to oversee the development of

nimotuzumab. Kuhnil will fund Korean development costs and provide an

undisclosed amount of up-front, milestone and royalty payments. In addition,

Kuhnil will launch bridging studies in the local population as required by the

Korean health regulatory authority, KFDA, in order to support all indications

currently under study by CIMYM and Oncoscience to permit them to be launched

in Koreaand other Asian countries. In Europe, Oncoscience is currently

awaiting advice from EMEA for two pivotal trials with nimotuzumab in glioma

where the drug is currently undergoing a phase II monotherapy trial in

pancreatic cancer.

    "Kuhnil has a history of relationships with Western companies dating to

the mid-1970's and YM is pleased to be added to a list that has included Merck

& Co., Schering-Plough Wyeth-Ayerst and King Pharmaceuticals. In 2005, Kuhnil

established an Oncology and Specialty Business Unit to serve the Korean market

and has licensed nimotuzumab to add to its initial product portfolio that

includes the GLIADEL(R) Wafer, Lipoplatin(R) and oxaliplatin. Our partnership

with Kuhnil will include studies that will conform to International Committee

for Harmonization (ICH) standards. The NSCLC program will be the first study

stemming from our relationship, which aims to expand the global regulatory

dossier for nimotuzumab. Further opportunities will be pursued as our

relationship develops," said Sean Thompson, Director of Corporate Development

for YM BioSciences.

    Lung cancer is the leading cause of cancer-related mortality in both men

and women. The prevalence of lung cancer is second only to that of prostate

cancer in men and breast cancer in women. Most lung carcinomas are diagnosed

at an advanced stage, conferring a poor prognosis. Non-small cell lung cancer

(NSCLC) accounts for approximately 75% of all lung cancers. A certain

population of patients with NSCLC are unfit for treatment with chemotherapy

because of ECOG status, age or general health and numerous patients are

unwilling to submit to treatment with chemotherapy. This population would

receive palliative care with radiation, the benefit of which has been

demonstrated in other indications to be enhanced by the addition of TheraCIM.

Nimotuzumab was recently approved in China based on a 75% improvement in the

complete response rate (91% vs 52%) in patients diagnosed with squamous cell

nasopharyngeal carcinoma who were treated with nimotuzumab + radiotherapy

versus radiotherapy alone.

 

    About Kuhnil

    Kuhnil Pharmaceutical Company is a privately-held company established in

1951 in Seoul, South Korea. It is a top ranked marketer of pharmaceuticals in

Korea and is developing a leading position in biopharmaceuticals through its

Bio Business Unit.

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer product development company. Its lead

drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a

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

Published results from tesmilifene's first Phase III trial in the same

indication demonstrated a substantial increase in survival for women treated

with the combination of tesmilifene and chemotherapy compared to chemotherapy

alone, demonstrating that tesmilifene significantly enhanced the therapeutic

effect of chemotherapy. In addition to tesmilifene, the Company is developing

TheraCIM hR3, an EGFr humanized monoclonal antibody on which Phase II clinical

data have recently been released in pediatric glioma and nasopharyngeal

cancer, and for which Phase III IND applications have been filed; and

Norelin(TM), a GnRH anti-cancer vaccine. YM BioSciences recently 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. This

product has completed a Phase IIa trial with positive results and YM proposes

to advance AeroLEF(TM) through a Phase IIb pain trial in 2005.

 

    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, Fax (416) 815-0080, Email:

jsmith(at)equicomgroup.com; YM BioSciences Inc., Tel. (905) 629-9761, Fax

(905) 629-4959, Email: ir(at)ymbiosciences.com

    (YMBA YM. YMI)

 

 



END

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