Medigene gains SynCore as global EndoTAG®-1 partner and strategic core investor
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Medigene gains SynCore as global EndoTAG®-1 partner and strategic core investor
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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.
Contact Medigene
Julia Hofmann, Claudia Burmester
Tel.: +49 - 89 - 20 00 33 - 33 01
Fax: +49 - 89 - 20 00 33 - 29 20
Email: investor(at)medigene.com
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www.medigene.de/unsubscribe
Press release as PDF:
http://hugin.info/132073/R/1704676/563680.pdf
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originality of the information contained therein.
Source: Medigene AG via Thomson Reuters ONE
[HUG#1704676]
Unternehmensinformation / Kurzprofil:
Datum: 27.05.2013 - 08:04 Uhr
Sprache: Deutsch
News-ID 263522
Anzahl Zeichen: 9965
contact information:
Town:
Martinsried / München
Kategorie:
Business News
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