On December 2, 2013 Sareum Holdings reported that it has signed a co-development agreement with Hebei Medical University Biomedical Engineering Center ("HMUBEC") to advance its Aurora+FLT3 cancer programme (Press release Sareum, DEC 2, 2013, View Source;year=2013 [SID:1234501235]).
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Under the terms of the agreement HMUBEC has been granted exclusive rights to carry out pre-clinical and clinical studies within Greater China* to obtain approval for sales in that territory. Sareum will receive a significant milestone payment once a product receives authorisation for marketing, and up to 15% of operating profit from sales generated in Greater China.
HMUBEC will be required to disclose and exclusively licence to Sareum all pre-clinical and clinical data it generates in the course of the development collaboration in order to facilitate Sareum’s own development and commercialisation activities. This would include conducting any further studies required for authorisation for clinical trials in the rest of the world as well as out-licensing and supporting applications for marketing authorisations outside Greater China. HMUBEC will be entitled to receive up to 10% of operating profit Sareum receives from any licence agreement or sales made outside Greater China, dependent on the stage at which Sareum out-licences data generated by HMUBEC to a third party.
HMUBEC is an independent research centre operating within Hebei Medical University Science & Technology General Company (HMUSTGC). Its capabilities include GLP† compliant laboratories, CGMP compliant manufacturing capabilities and well-established sales distribution channels in Greater China. HMUSTGC has successfully developed more than 85 therapeutic products and medical devices for the Chinese market since its formation in 1992.
Aurora+FLT3 kinase inhibitors have the potential to treat acute myeloid leukaemia (AML, the most common form of adult leukaemia) and various other forms of cancer. Aurora kinase is involved in the control of mitosis (cell division), and FLT3 kinase over-activation is the most common mutation in AML. The pre-clinical development candidate that has been licenced by Sareum to HMUBEC has showed particular promise against a range of haematological cancer models including AML and Acute Lymphoblastic Leukaemia (ALL) with an encouraging early safety profile and positive ADME (absorption, distribution, metabolism, excretion) properties.