News

Ad hoc: Medigene and SynCore enter into Co-Development and Commercialization Agreement for EndoTAG®-1

 

  • SynCore receives exclusive rights to co-develop and commercialize EndoTAG®-1 in Asia, Australia and New Zealand  

 

  • Medigene retains all US, European and remaining RoW rights 

 

  • Medigene will receive an upfront, milestone payments and royalties  

 

  • Medigene plans global pivotal phase III trial in triple-negative breast cancer (TNBC) 

 

  • SynCore will assume costs for the Asian part of the global pivotal phase III trial  

Martinsried/Munich, July 6, 2012. Medigene AG (Frankfurt: MDG, Prime Standard) announced that it has granted exclusive rights for co-development and commercialization of EndoTAG®-1 in Asia, Australia and New Zealand to SynCore Biotechnology Co., Ltd. ("SynCore"), a subsidiary of the Sinphar Pharmaceutical Group (Taiwan Stock Exchange, Symbol: 1734).

Medigene plans a pivotal global phase III trial of EndoTAG®-1 in triple-negative breast cancer (TNBC) with the aim of achieving worldwide market approval. Under the terms of the agreement, SynCore will fund the Asian part of the clinical trial, representing about 50% of the total number of patients to be included. Subject to clinical trial approval, approximately 400 patients are expected to be enrolled in the global pivotal phase III trial in TNBC. Furthermore, Medigene receives an upfront payment from SynCore and is eligible to payments upon certain development and approval milestones as well as royalties. Medigene retains all US, European and remaining rest-of-the-world (RoW) rights to EndoTAG®-1 with the ability to grant further licenses. Medigene anticipates submission for market approval for EndoTAG®-1 in 2018.

The agreement does not impact Medigene's financial guidance for 2012 and the management confirms that the company's funding is expected to be secured beyond 2013.

For more information please see today's press release at www.medigene.com/press

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