Medigene and SynCore enter into Co-Development and Commercialization Agreement for EndoTAG®-1
(Thomson Reuters ONE) -
MediGene AG /
Medigene and SynCore enter into Co-Development and Commercialization Agreement
for EndoTAG®-1
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The issuer is solely responsible for the content of this announcement.
* 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.
Dr. Frank Mathias, CEO of Medigene AG stated, "EndoTAG(®)-1 has shown promising
overall survival data in patients with TNBC, a type of breast cancer for which
only limited treatment options are available. We are excited to continue with
the development of EndoTAG(®)-1 and look forward to working with our partner,
SynCore, to advance the product through a pivotal study and to seek worldwide
marketing approval for the benefit of breast cancer patients. Medigene is now
very well positioned with the ongoing development of two advanced clinical drug
candidates and a solid financial profile supporting the company's growth
strategy."
Dr. Frank Why-Ju Chu, CEO of SynCore commented: "We are pleased to expand our
partnership with Medigene, which started in 2011 with Veregen(®). With
EndoTAG(®)-1, we seek to provide another innovative product to our Asian
patients. The co-development of EndoTAG(®)-1 fits very well with our strategy to
build an innovative late-stage pipeline."
The Sinphar Group specializes in the sales and marketing of pharmaceutical
products as well as in manufacturing for several global pharmaceutical companies
like Johnson & Johnson, Takeda, Shionogi and Astellas. Additionally, Sinphar is
one of the largest producers of paclitaxel (Phyxol(®)) in Asia.
Rationale for EndoTAG(®)-1 in TNBC: EndoTAG(®)-1 has demonstrated encouraging
efficacy in a Phase II trial in combination with paclitaxel in patients with
TNBC. In a sub-group of patients with first line treatment for
metastatic/relapsed TNBC and ECOG performance 0/1 in this study (total of 119
out of 133 patients), EndoTAG(®)-1 plus paclitaxel resulted in a median overall
survival of 17.8 months (10.1 months for the paclitaxel alone group)(1). Subject
to clinical trial approval, about 400 patients will have to be enrolled to
demonstrate clinical benefit in terms of overall survival, as previously
discussed with the European Medicines Agency (EMA). This is a significantly
smaller number of patients needed compared to trials in other indications, e.g.
pancreatic cancer. Patients will be randomized 1:1 to receive EndoTAG(®)-1 plus
paclitaxel weekly or paclitaxel weekly alone (same total dose of paclitaxel in
both arms).
About EndoTAG(®)-1: EndoTAG(®)-1 is a novel composition of the established
cytostatic drug paclitaxel combined with neutral and positive lipids. The
positively charged lipids imply that EndoTAG(®)-1 interacts with newly
developed, negatively charged endothelial cells, which are primarily required
for the growth 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 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 the indications pancreatic cancer and triple-negative breast cancer (TNBC).
EndoTAG(®)-1 is protected by a number of patent families. In TNBC, EndoTAG(®)-1
is protected by granted patents with terms up to 2029 (USA). In Europe and other
countries, patent applications in TNBC with a term until 2027 are pending.
Additional patent applications covering the product with terms up to 2031 (USA,
Europe, Asia and other countries) are pending.
About Triple-negative breast cancer (TNBC): Triple-negative breast tumors are
malignant and do not show any HER2 receptors or hormone receptors for estrogen
or progesterone. About 15% of all breast cancer cases rank among this group.
There are very few treatment options available, since conventional anti-hormonal
treatments or treatments targeting HER2 are not appropriate. In case of relapse
following initial surgery, the only remaining treatment option is chemotherapy.
About SynCore Bio: SynCore Biotechnology Co., Ltd, a joint venture between the
publicly listed pharmaceutical company Sinphar Pharmaceutical Co., Ltd and the
National Health Research Institute of Taiwan, is focused on the development of
new drugs. Currently, it is conducting a phase I first-in-man trial on an anti-
cancer new chemical entity. Another anti-cancer NCE project is in the pre-IND
stage. In addition, SynCore Biotechnology Co. also obtained an exclusive
development and commercialization right of an anti-dry AMD new drug, MC 1101, in
Asia at 2011 from a US Biotech company, MacuCLEAR. MC 1101 is currently
undergoing a US FDA phase II/III trial.
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 in manufacturing for several global pharma companies like Johnson &
Johnson, Takeda, Shionogi and Astellas. Additionally, Sinphar is one of the
largest producers of paclitaxel (Phyxol(®)) in Asia. It is also involved in the
research and development of botanical new drugs. Two projects are currently
undergoing US FDA phase II trials. Its manufacturing facilities are approved by
the Taiwanese FDA and Japan PMDA according to PIC/s GMP guidelines. Further
information can be obtained at: www.sinphar.com.
About Medigene: Medigene AG is a publicly listed (Frankfurt: MDG, prime
standard) biotechnology 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
have revenues from marketed products, which are distributed by partner
companies. It has two drug candidates in clinical trials and is developing an
innovative vaccine technology.
For further details, please visit www.medigene.com.
(1)) see press release from December 9, 2011
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(®) is a registered trademark of Medigene AG.
- End -
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Fax: +49 - 89 - 20 00 33 - 29 20
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Press release as pdf:
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Source: MediGene AG via Thomson Reuters ONE
[HUG#1624974]
Unternehmensinformation / Kurzprofil:
Datum: 06.07.2012 - 16:59 Uhr
Sprache: Deutsch
News-ID 162942
Anzahl Zeichen: 10444
contact information:
Town:
Martinsried / München
Kategorie:
Business News
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