Date: 2013-05-27
Type of information: Development agreement
Compound: EndoTAG®-1
Company: Medigene (Germany) SynCore Biotechnology (Taiwan)
Therapeutic area: Cancer - Oncology
Type agreement: co-development
commercialisation
Action mechanism: EndoTAG®-1 is a novel composition of paclitaxel combined with neutral and positive lipids. It attacks activated endothelial cells that are needed for the formation of new tumor blood vessels. The drug candidate selectively attaches itself to newly developed, negatively charged tumor blood vessels, thus attacking only the blood supply of the tumor and not the blood supply of healthy tissue. EndoTAG®-1 is expected to prevent the formation of new vessels and suppress further tumor growth.
Disease: triple-negative breast cancer (TNB, pancreatic cancer
Details: * On July 6, 2012, Medigene has granted exclusive rights for co-development and commercialization of EndoTAG®-1 in Asia, Australia and New Zealand to SynCore Biotechnology, a subsidiary of the Sinphar Pharmaceutical Group. 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. 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.
Medigene has successfully completed two clinical phase II trials of EndoTAG®-1 in the indications pancreatic cancer and triple-negative breast cancer (TNBC).
Financial terms: Medigene has received an undisclosed upfront payment from SynCore and is eligible to payments upon certain development and approval milestones as well as royalties. SynCore will assume costs for the Asian part of the global pivotal phase III trial.
Latest news: * On May 27, 2013, Medigene has announced that an exclusive global license and development agreement for the drug candidate EndoTAG®-1 was signed with SynCore Biotechnology. This agreement constitutes a major extension of the July 2012 EndoTAG®-1 agreement, which covered Asia, Australia, and New Zealand and will allow financing of a planned global pivotal phase III clinical trial of EndoTAG®-1 in triple-negative breast cancer (TNBC).
Moreover, Syncore will enter into a strategic alliance with Medigene, acquiring 6.09% of Medigene shares. This investment makes SynCore a strategic core investor and one of the largest shareholders of Medigene.Within the scope of the new license agreement, SynCore will provide complete financing of the planned phase III clinical trial of EndoTAG®-1, and will in turn receive the global marketing rights to EndoTAG®-1. Medigene receives an upfront payment from SynCore and is eligible to payments upon certain development and approval milestones as well as royalties after market approval of EndoTAG®-1. The partners expect to start the phase III clinical trial in the second half of 2014.
To substantiate the partnership with Medigene, Syncore will acquire 2,405,800 newly issued shares from authorized capital of Medigene AG at a price of € 1.00 per share. SynCore will be subject to a lock-up period of 12 months for the shares, which underscores the strategic aspect of this investment. In the course of this capital increase, Medigene receives proceeds of € 2,405,800.00.
