Press and analysts conference call with webcast (in English) today,
27 May 2013, 10:00 a.m. (CEST)
- Extended license and development agreement funds global phase III clinical trial for breast cancer drug EndoTAG®-1
- SynCore acquires 2,405,800 newly issued Medigene shares and holds 6% of Medigene AG
Martinsried/Munich, May 27, 2013. Medigene AG (MDG, Frankfurt, Prime Standard) announces that an exclusive global license and development agreement for the drug candidate EndoTAG®-1 was signed with its existing partner, SynCore Biotechnology Co., Ltd. ("SynCore"), a member of the Sinphar Pharmaceutical Group (Taiwan stock exchange, symbol: 1734). 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 EUR 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 EUR 2,405,800.00.
Dr. Frank Mathias, Chief Executive Officer of Medigene AG, comments: "The global EndoTAG®-1 partnership and our strategic alliance signifies important progress for Medigene. We are now in a position to expedite the clinical development of EndoTAG®-1 in an indication with high medical need by conducting a pivotal clinical trial. This is good news for the patients affected, their families, and physicians in charge. Patients suffering from TNBC tend to have a poor prognosis, and there are only very limited treatment options available. Previous clinical trials and the most recent data published on the occasion of the ASCO meeting support the potential of our drug candidate and our shared aim of establishing a new treatment option for this severe illness."
Tim C.W. Lee, Chairman of SynCore Biotechnology, comments: "With this investment and our EndoTAG®-1 license agreement, we would like to participate in Medigene's attractive development potential and expertise. We value Medigene as a successful drug developer and as a competent partner within our existing partnerships for Veregen® and EndoTAG®-1. With Medigene, we found a qualified and experienced partner for the further development of an interesting clinical phase III candidate. EndoTAG®-1 pursues an innovative approach and excellently supplements with our current oncologic product portfolio. The expansion of our existing license agreement for EndoTAG®-1 also opens up interesting marketing opportunities beyond Asia. This investment announced today marks our first step into Europe and is therefore strengthening our international strategy."
Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, adds: "We are delighted to further strengthen our existing partnership with SynCore, and to intensify it both financially and in terms of substance. In SynCore, Medigene has gained a core investor who actively supports the further development of our company in funding the phase III trial and stabilizes our shareholder structure. As a strategic partner, SynCore will also be instrumental in creating new opportunities for our operations in Asia."
About EndoTAG®-1: The clinical drug candidate EndoTAG®-1 is a novel composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. Because of the positively charged lipids, EndoTAG®-1 interacts with newly developed, negatively charged endothelial cells, which are particularly required for the generation of tumor blood vessels. The EndoTAG®-1 paclitaxel component attacks the endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the blood supply to healthy tissue. By doing this, EndoTAG®-1 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth. Medigene has successfully completed two clinical phase II trials of EndoTAG®-1 in pancreatic cancer and triple-negative breast cancer (TNBC). The drug candidate has also shown positive results in a recently concluded investigator-initiated trial (IIT) in HER2-negative breast cancer.
About SynCore: SynCore Biotechnology Co., Ltd, a joint venture between Sinphar Pharmaceutical Co., Ltd and the National Health Research Institute of Taiwan, is focused on the development of new drugs. Currently, SynCore has five products under development in different stages of clinical trial. Additionally, SynCore has been granted the exclusive development and marketing right in Asia for a new drug for the treatment of dry AMD (age-related macular degeneration) from MacuCLEAR, an US-based biotech company; the drug received approval to enter into phase II/III clinical trial in the US and Taiwan. For further information, please visit www.syncorebio.com.
About Sinphar Pharmaceutical: Sinphar Pharmaceutical Co, Ltd (Taiwan Stock Exchange, symbol: 1734), with subsidiaries in China and Canada, specializes in the sales and marketing of pharmaceutical products and dietary supplements as well as contract manufacture for several global pharma companies such as Johnson & Johnson, Takeda, Shionogi, and Astellas. Additionally, Sinphar is one of the major producers of paclitaxel (Phyxol®) in Asia. It is also involved in the research and development of botanical new drugs. Further information can be obtained at: www.sinphar.com.
Medigene AG (Frankfurt: MDG, Prime Standard) is a publicly listed biotech company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to generate revenues from a marketed product (Veregen®), which is distributed by partner companies. Medigene also has two drug candidates undergoing clinical trials, EndoTAG®-1 und RhuDex®, and is developing an innovative vaccine technology. For further details, please visit www.medigene.com
Press and analysts' conference call:
A press and analysts conference call (in English) will be held today at 10:00 a.m. CEST and will be webcast live. Please access the synchronized presentation slides and a recording via Medigene's website, www.medigene.com.
This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® EndoTAG®, RhuDex® and Veregen®are registered trademarks of Medigene AG. Polyphenon E® is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.
Julia Hofmann, Claudia Burmester
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