YMB YM Bio.'b'ser1

    YM Biosciences expands development and commercialization program for

EGFr inhibitor nimotuzumab

 

    MISSISSAUGA, ON, Nov. 17 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

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

majority-owned subsidiary, CIMYM Inc., has partnered with Innogene Kalbiotech

Ltd (IGK) of Singapore to expand the development program for its humanized,

EGF receptor-targeting monoclonal antibody, nimotuzumab. IGK is the biotech

subsidiary of P.T Kalbe Farma Tbk (JK.KLBF), a public company based in

Jakarta, Indonesiawith more than 8,100 employees and revenues exceeding

US$300 million.

    Terms of the license include an up-front payment of US$1 million,

undisclosed milestones and a royalty on sales. The licensed territories

include Singapore, Taiwan, Thailand, Indonesia, Malaysia, the Philippines and

South Africa in addition to a number of other emerging markets. IGK will be

responsible for development costs in its territories and also proposes to

undertake the registration in its territories of all other indications

developed by CIMYM and its licensees elsewhere as well as those of other

licensees of CIMAB SA, YM's partner in CIMYM Inc.

    "This agreement is another milestone in our strategy to expand

nimotuzumab's market potential by partnering with a major regional

pharmaceutical company. IGK will initially target head & neck cancer for which

it proposes to file INDs in its territories for a study combining nimotuzumab

and radiation. Subsequently, additional trials in other cancers are

anticipated," said David Allan, Chairman and CEO of YM BioSciences.

    "We are very pleased to conclude this agreement for CIMYM's nimotuzumab.

We believe that this safe and well tolerated EGFr inhibitor will drive our

oncology business going forward and strengthen Kalbe's position in its

overseas market," added Dr. Rikrik Ilyas, Director of Innogene Kalbiotech.

    Nimotuzumab has not only demonstrated efficacy, it also has the unique

side-effect profile of an absence of rash, diarrhea or conjunctivitis

demonstrated by the other products targeting the EGFR pathway. Nimotuzumab was

recently approved in China based on a 75% improvement in the complete response

rate in patients diagnosed with squamous cell nasopharyngeal carcinoma (91% in

patients treated with nimotuzumab plus radiotherapy versus 52% for those

treated with radiotherapy alone).

    "P.T. Kalbe Farma is committed to oncology and has an extensive reach in

Southeast Asia and Africathat complements YM's corporate aspirations. CIMYM

will be added to a list of strategic alliances formed by Kalbe that has

included Baxter, Astellas and Daiichi Pharmaceutical Company," said Sean

Thompson, Director of Corporate Development for YM BioSciences.

    Head & neck cancer is a leading cause of cancer-related mortality in both

men and women in Southeast Asia. Many other cancers for which nimotuzumab is

being developed are serious public health issues in Southeast Asia and Africa.

 

    About IGK

 

    Kalbe Farma is Indonesia's largest public pharmaceutical company and was

founded in 1966 in Jakarta. It has set up a research and development base in

Singapore with the establishment of Innogene Kalbiotech Pte Ltd. (IGK). IGK

develops new drugs and patents for Kalbe Farma to market globally; one of its

leading products is Kalsolac, for the treatment of traumatic brain injury.

Singapore was chosen because of the country's strength in biomedical research

and available talent pool. The parent company owns several factories that are

ISO9001, ISO14001 and OHSAS certified. Its workforce exceeds 8,100 and it has

operating subsidiaries in countries throughout Southeast Asia and Africa.

 

    About YM BioSciences

 

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

drug, tesmilifene, is a small molecule chemopotentiator which has completed

enrollment in 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 nimotuzumab in a number of indications. YM

BioSciences is also developing its anti-GnRH, anti-cancer vaccine,

Norelin(TM), for which Phase II data have been released. DELEX Therapeutics

Inc., YM BioSciences' subsidiary, is developing AeroLEF(TM), a unique,

nebulized, inhalation-delivered formulation of the established drug, fentanyl,

to treat acute pain including cancer pain. A randomized Phase IIb pain trial

is expected to enroll first patients in Q4 2005. The Company also has a broad

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: James Smith, the Equicom Group Inc.,

Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email:

jsmith@equicomgroup.com; Carolyn McEwen, YM BioSciences Inc., Tel.

(905) 629-9761, Fax (905) 629-4959, Email: ir@ymbiosciences.com

    (YMBA)



END

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