worldwide rights to the commercialisation of CVacT
Prima BioMed successfully negotiates licence variation with Biomira Inc to secure worldwide rights to the commercialisation of CVacTM
Key Points:
- Prima
BioMed (“Prima”) has successfully negotiated a variation
to the License and Development Agreement with Biomira Inc.
(“Biomira”)
- Prima secures worldwide
commercialisation rights for the Mucin-1 antigen for
dendritic cell (DC) based therapies. Mucin-1 is the
therapeutic target for Prima’s lead product candidate,
CVacTM
- Prima now has the opportunity to
pursue the development of CVacTM for worldwide registration
and marketing. CVacTM’s first target indication is
ovarian cancer
- The worldwide market for
ovarian cancer was estimated at US$1.9 billion in 2006. The
same market in Australia and New Zealand has been estimated
at A$100 million
- Milestone and royalty
payments payable to Biomira under the Licence and
Development Agreement have been reduced as part of the
variation.
Tuesday 13 February 2007, Melbourne, Australia: Prima BioMed Limited (ASX:PRR) (“Prima”) today announced that it has successfully negotiated a variation of its Licensing and Development Agreement (“Licence”) with Biomira Inc. (NASDAQ: BIO; TSX:BRA) (“Biomira”). The variation confirms that Prima has worldwide commercialisation rights to the key tumour based antigen, Mucin-1, for the use in dendritic cell-based cancer therapies. Mucin-1 is an antigen expressed on a variety of solid tumours. The variation allows Prima to pursue the development of CVac™ with an internationally focused clinical development program.
The License, signed in March 2004, granted Prima worldwide access to Mucin-1 for use with the CVac™ platform technology. The License also granted Biomira an option, expiring 120 days post completion of the phase IIa clinical trial, to commercialise CVac™ outside of Australia and New Zealand (ANZ). The variation of the Licence confirms that Biomira will not be exercising the option, as the program no longer fits strategically with its portfolio of small molecule drugs and synthetic vaccines.
Mr Eugene Kopp, Executive Chairman of Prima said, “Licensing Mucin-1 from Biomira has been a critical step in the development of our CVac™ technology. Prima is now in a stronger position to develop an internationally competitive immunotherapy-based oncology product. We now have certainty that we can access markets beyond just Australia and New Zealand.”
Under the varied License, milestone payments and royalty obligations owed to Biomira by Prima have been reduced.
The final Phase IIa trial results for CVac™ are due to be released this quarter. Biomira has not assessed the statistical package or the Clinical Study Report being generated by Prima’s clinical research organisation.
Whilst successful development and/or commercialisation of CVac™ cannot be assured due the inherent risks associated with drug development, Prima is approaching the development of this product with enthusiasm. This variation to the License allows Prima to pursue a clinical development plan that aligns with an international product registration process rather than the previously stated ANZ only strategy.
ENDS
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