ots Ad hoc-Service: MediGene AG <DE0005020903>
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Developer of therapeutics against heart and tumor diseases publishes healthy half year report
Stock market newcomer MediGene presents first half year report
- The biopharmaceutical company MediGene AG (NMarkt: MDG) succeeded in continuing its positive growth trend of the year 1999 and reports a very successful flow of business according to US-GAAP figures: in comparison to the first half of 1999 revenues increased by 122%.
MediGene AG increased its revenues by 122% from EUR 1.04 million to EUR 2.31 million in comparison to the first half of 1999. Main sources of revenues were its co-operation and license agreements with the pharmaceutical companies Aventis and Schering for the joint development of tumor vaccines against malignant melanoma and cervical cancer respectively.
The half year result 2000 of EUR -5.68 million is according to budget. MediGene was able to cover 29% of total expenditure by revenues although R&D expenditure increased significantly in the first half of 2000. Break-even is planned for the year 2003.
Liquidity amounted to EUR 116.17 million on June 30th, 2000. Additional liquidity from the greenshoe will flow into MediGene's accounts in the third quarter.
In the first half of 2000, significant progress was made in the fields of indications MediGene is focusing on, namely heart and tumor diseases. All development projects were pushed ahead according to plan. MediGene's broad technology platform could be further enlarged.
MediGene's blockbuster candidate Etomoxir is being developed to
treat congestive heart failure. A sufficient amount of the substance
was produced according to international standards ("GMP") for further
clinical studies. The documents for the clinical phase 2 study were
submitted to the ethic commission. The study will start as soon as
permission from the authorities is granted.MediGene was able to identify further gene targets connected to heart disease with the help of its ITD-technology platform. These now serve as a starting point for the development of new heart therapeutics. Thereby, MediGene was able to increase its technological lead in this field even further.
Important milestones could be met in the development of
technologies for the treatment of tumor diseases: Viral gene vectors
("rAAV") were successfully produced under GMP-conditions. With the
help of these vectors immune stimulatory molecules can be brought
into patient tumor cells to cure malignant melanoma. The documents
necessary for approval by the authorities have already been submitted
in some countries. As soon as the approval of the authorities is
granted, a combined clinical phase 1 and 2 study can be started which
should deliver the proof of concept of the technology. If the study
is successful, this tumor vaccine is going to be used to treat other
tumor diseases as well.MediGene's Polyphenon E is a drug to treat human papilloma virus-caused benign genital tumors. First signs of efficacy and a very good safety profile could be shown in a combined phase 1 and 2 as well as in a just shortly completed phase 2 study. A comprehensive clinical phase 2 and 3 study is currently being prepared.
MediQene's tumor vaccine based on chimeric virus like particles
("CVLPs") is used to treat malignant tumors, such as cervical cancer
caused by specific types of human papilloma viruses. Pre-clinical
studies for the vaccine against cervical cancer and its precursors
have been successfully completed. A production process for the
vaccine has been established, sufficient amounts of the vaccine were
produced under GMP conditions and the documents for the approval of
the clinical studies have been prepared.Total research and development expenses amounted to EUR 5.36 million in comparison to EUR 3.23 million in the first half of 1999. Total operating costs and expenses were EUR 6.30 million in the first half of 2000, Depreciation came up to only EUR 0.18 million. Therefore, the operating profit amounted to EUR -4.17 million.
In April 2000, MediGene acquired an approx, 10% stake in the American Biotechnology company NeuroVir, Inc. to enlarge its product- and technology portfolio and to establish a location in the USA. In the course of this equity investment, MediGene was granted an exclusive option to buy the exclusive rights of NeuroVir's tumor vaccine technology based on genetically modified herpes simplex viruses, The purchase was financed by a credit, which was repaid after the IPO. The interest expenses amounted to EUR 1.50 million. Greatly influenced by these payments, the interest result amounted to EUR -1.43 million for the first half of 2000.
MediGene expects a continuing dynamic growth for the second half of this year. Further clinical studies are supposed to start and additional technologies and products should enlarge the existing portfolio. Market entry for the first product is expected for the year 2003.
This press felaase contains forward-looking statement that involve risky and uncertainties The forward-looking statements contained herein represent the judgement of MediGene as of the date of this release. MediGene disclaims any intent or obligation to update any of these forward-looking statements.
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For further information please contact: MediGene AG email: investor@mediqene.de Fax: ++49 - 89 - 89 56 32-20 Angelika Heinz, Vice President, Head of Finance Phone: ++49 - 89 - 89 56 32-0 Christine Bohner, Public Relations Officer Phone: ++49 - 89 - 89 56 32-16
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