Re Agreement
November 17 2005 - 9:20AM
UK Regulatory
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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