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MediGene AG
Oncology  AutoImmune  Vaccines
DELEGATE(S)
Elias Papatheodorou, SVP Business Development
Lochhamer Strasse 11
82152 Planegg/Martinsried
Germany
HIGHLIGHTS
Recent
Upcoming
www.medigene.com
Veregen®: Regulatory authorities of 17 additional
European countries accepted the marketing
authorization applications for Veregen®
ointment using the mutual recognition
procedure.
Veregen®: Market approvals and
launches in additional countries
Incorporated: 1994
Employees:
54
Ownership:
Public
Frankfurt Stock Exchange: MDG
EndoTAG®-1: Overall Survival Data from a Phase II
Trial of EndoTAG®-1 in Triple-Negative Breast
Cancer (TNBC) presented at San Antonio Breast
Cancer Symposium. Positive efficacy trend of
EndoTAG®-1/Paclitaxel combination therapy
confirmed.
RhuDex®: The United Kingdom Medicines and
Healthcare Products Regulatory Agency (MHRA)
granted the authorization of the planned clinical
formulation study of RhuDex®, a drug candidate
being developed for the treatment of rheumatoid
arthritis.
Submission of additional market
approval applications
Additional marketing partnership
agreements.
RhuDex®: Clinical formulation trial
and further clinical development.
EndoTAG®-1: Achieve global or
regional licenses for the continued
development.
MISSION/BACKGROUND
MediGene AG is a publicly listed biotechnology company headquartered in Martinsried/Munich, Germany. MediGene focuses on clinical
research and development of novel drugs against cancer and autoimmune diseases.
MediGene generates revenue from two drugs on the market, Veregen® against genital warts and Eligard® for the treatment of prostate
cancer. Both drugs are distributed by partners. In addition, MediGene has a research and development portfolio in the fields of oncology
and immunology:
RhuDex® is an oral small molecule. It is being developed as a disease modifying active agent to treat autoimmune diseases such as
rheumatoid arthritis. Recently, MediGene developed a new formulation strategy for RhuDex® customized for chronic treatment. It will
be further tested and optimized in an upcoming clinical trial. In October 2011, MediGene was granted approval from the UK authorities
to conduct this trial.
EndoTAG®-1, a clinical drug candidate against solid tumors is a novel composition of paclitaxel combined with neutral and cationic
lipids. MediGene has successfully completed two phase II clinical trials of EndoTAG®-1 in pancreatic cancer and triple-negative breast
cancer and has recently developed a more cost efficient production process.
The AAVLP platform developed by MediGene is an innovative technology platform for the development of prophylactic vaccines that
permanently protect the body against infectious diseases. It is based on adeno-associated viruses (AAV) and uses virus-like particles
(VLP or AAVLP) as a structure for the development of new vaccines. MediGene is currently conducting research into the use of AAVLP
technology to treat infections and various types of cancer, as well as the use of AAV libraries for the systematic identification of suitable
vaccine candidates.
TECHNOLOGY
MediGene’s EndoTAG®-1 represents an innovative therapeutic approach directed against newly developed tumor blood vessels, thereby
suppressing tumor growth.
MediGene has successfully provided proof of concept of EndoTAG®-1. A controlled phase II clinical trial for pancreatic cancer showed
significantly increased survival rates of those patients treated with EndoTAG®-1 and gemcitabine combination therapy. A phase II
clinical trial in triple negative breast cancer also showed a positive efficacy trend of EndoTAG®-1 combination therapy.
MediGene continues to target signing one or more partnerships for the further development and future commercialization of
EndoTAG®-1.
ALLIANCES
Veregen®: MediGene has entered into several marketing partnerships for Veregen®, including Fougera (formerly Nycomed) for the
United States; Abbott for Germany, Austria, and Switzerland, Laboratoires Expanscience for France, Teva for Israel, Pierre Fabre
Medicament for Mexico, Central America, Venezuela and Colombia; and with a number of other partners across Europe, America, and
Asia. MediGene is planning to continue this global licensing strategy.
AAVLP: In 2011, MediGene signed a development collaboration agreement with The Johns Hopkins University in Baltimore, USA. The
objective of the collaboration is to test preclinically the first vaccine candidates of the AAVLP platform for the prevention of HPVassociated cancers and to further the development of the AAVLP platform.
PRODUCTS
Name
Phase
Indication
Milestone
EndoTAG-1
Phase II, IIa,
IIb
Pancreatic cancer
Positive Phase II data obtained.
EndoTAG-1
Phase II, IIa,
IIb
Triple receptor negative
breast cancer
Positive Phase II data obtained.
Company Profiles – 31
PRODUCTS
RhuDex
Phase I
Rheumatoid Arthritis
Novel Oral Small Molecule.
AA VLP
Platform
Preclinical
Vaccine development
Development Cooperation with Johns Hopkins University for first
vaccine candidates for the prevention of HPV-associated diseases.
Veregen
On Market
Genital Warts
Eligard
On Market
Prostate Cancer
Company Profiles – 32