Bavarian Nordic Res. Inst. - 500 Beiträge pro Seite

[Bozana]

Das dänische Unternehmen mit Sitz in Kopenhagen und einer Tochtergesellschaft in der
Münchener BioRegion Martinsried kündigte gestern den Beginn neuer klinischer Studien an.

Die Bavarian Nordic Research Institute GmbH initiiert klinische Studien der Phase I/II zur
Behandlung des als malignen Melanom bezeichneten bösartigen Hautkrebs. Die Studie, die in
Italien durchgeführt wird, soll bis Ende dieses Jahres die Wirksamkeit der Therapie erbringen.
Hierzu werden mit einer speziellen, sog. ex vivo-Immuntherapie, die Abwehrkräfte der
körpereigenen Zellen stimuliert. Mit ihrer Technologie zielen die Martinsrieder auf einen von der
World Health Organisation (WHO) mit 200.000 Neuerkrankungen pro Jahr bezifferten Markt ab.

Das neue Programm stellt inzwischen die vierten von Bavarian Nordic gestarteten klinischen
Studien am Menschen dar. Mit einer eigenen Wirkstoffpipeline ist die dänisch-deutsche
Unternehmensgruppe mit der seit kurzem am Neuen Markt notierenden GPC Biotech und der
kommenden Freitag erstmals notierenden MediGene, beide ebenfalls aus Martinsried,
vergleichbar. Zur weiteren Finanzierung der voranschreitenden klinischen Studien und aufgrund
der schwerpunktmäßig in München stattfindenden Forschung wird ein Zweitlisting am Neuen
Markt immer wahrscheinlicher.

Dazu eine aktuelle Analysteneinschätzung:

05.06.2000
Bavarian Nordic Outperformer
WestLB Panmure


Die Analysten von WestLB Panmure sehen für die Aktie der Bavarian Nordic (WKN 917165) ein
Kursziel von 350 DKK= ca.100DM

Der Konzern konzentriere sich auf die Entwicklung neuer, sicherer Vektorsysteme. Entwickelt
werde bis zur klinischen Phase III, um sie dann zur weiteren Lizenzierung und Vermarktung an
einen Partner auszulizenzieren.

Das Unternehmen habe bislang alle gesetzten Meilensteine erricht und erwarte gegen Wende
2000 die ersten Immundaten aus den klinischen Studien im Melanom-Programm und die
Toleranzen für den MVA-Impfstoff bei HIV-Patienten.

Die Ergebnisse könnten Bavarian die Tür für weitere Kooperationsvereinbarungen im Jahr 2001
öffnen. Des weiteren sollte ein damit verbundener positiver Newsflow den Aufwärtstrend der
Aktie stützen.

Dieses Jahr werde ein Verlust in Höhe von 21,5 DKK erwirtschaftet, in 2001 werde ein Verlust
von 13,3 DKK erwartet.

Bis zum Eintritt des Bauchspeicheldrüsenkrebs-Präparates in die klinische Phase III sei der
Titel ein spekulativer Kauf. Der Eintritt sei aber auch gleichzeitig als Durchbruch mit der
Möglichkeit, dass Investoren die Aktie nun als reifere Anlagemöglichkeit erkenne könnten, so
die Analysten.

AKTUELLE News:

Phase I/II Clinical Trial for the Treatment of Metastatic Malignant Melanoma

The Annual General Meeting 2000

Bavarian Nordic will inform the shareholders about a subsidiary in Vienna and Bioinformatics


Bavarian Nordic Research Institute A/S Initiates a Phase I/II Clinical Trial for the Treatment of
Metastatic Malignant Melanoma
Copenhagen, June 27, 2000

The Italian Health Authorities have approved the initiation of phase I/II studies for the treatment of
metastatic malignant melanoma, the most serious of all skin cancers. The study will take place
at Instituto dei Tumori in Milan/Italy with the recognised cancer scientist Professor Alessandro
Gianni as the principal investigator.

The treatment is an immunotherapy based on the company`s MVA-F6 tyrosinase vector that
overproduces human tyrosinase. Tyrosinase is a key enzyme in the production of the skin
pigment melanin and is also a prominent melanoma tumour antigen, which means it can induce
an immune response against the cancer cells. To provoke a strong immune response in this
study, antigen-presenting cells are isolated from the patient, grown with the MVA-F6 tyrosinase
vector and reinjected into the patient. This treatment is called ex vivo immunotherapy.

The study results are expected to be available before end of this year. In addition to information
about possible therapeutic effect, this study will provide very important information about the
safety of the Company`s MVA-F6 vector in general and in immunocompromised people
especially.

According to the World Health Organisation (WHO), 200,000 people develop malignant
melanoma each year. The number of people suffering from this disease continues to grow.
Relapse from early stage malignant melanoma is uncommon, whereas the possibilities for cure
are very limited for the people with more advanced disease.

With the start of this study Bavarian Nordic has four ongoing clinical studies. This includes two
phase I/II studies for the treatment of malignant melanoma, one phase I/II study for the
treatment of HIV and a phase II study for the treatment of pancreatic cancer.

Bavarian Nordic is a biotechnology company listed on the Copenhagen Stock Exchange. The
company specializes in the development of cell and gene therapy technologies and products as
well as therapeutic vaccines for the treatment of serious diseases.

Wenn man nun berücksichtigt,daß Bavarian nur mit ca. 90 Mill Euro bewertet ist (zum Vergleich
GPC 800 Mill., Medigene 600 Mill. und Morphosys 900 Mill Euro) und daß das Unternehmen in
seiner Entwicklung deutlich weiter ist, als z.B. GPC oder Medigene - 4 Wirkstoffe sind schon in
Phase I/II erkennt man das enorme Potential dieses Wertes. Meiner Meinung nach heißt es hier
zugreifen bevor die breite Masse erkennt, um welche Perle es sich hier handelt. Die deutsche
Tochter ist übrigens wie GPC und Medigene in Martinsried ansässig.

Mehr Infos unter www.bavarian-nordic.com

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Press Release

Interim report from Bavarian Nordic Research Institute A/S for the six-month period ending June 30, 2000

Progress during the first half of 2000 has been very satisfactory, both scientifically and operationally.

Bavarian Nordic`s development programmes are proceeding according to plan:

· The Company`s research efforts have recently yielded further convincing data demonstrating that the Bavarian Nordic MVA is a highly efficient vaccination vector generating high antibody and cytotoxic T-cell responses. These findings considerably support our ambition that the Company`s MVA vector should be the vaccination vector of choice for future business collaborations.

· The Company has received permission (June) to initiate phase I/II studies for the treatment of metastatic malignant melanoma, the most serious of all skin cancers. The study will take place at Instituto Nazionale Tumori in Milan. The ongoing clinical study addressing non-metastatic malignant melanoma is progressing according to plan.

· The Company has also received permission to initiate a phase I/II safety study for the treatment of HIV.

· The Company`s clinical phase II study for the treatment of pancreatic cancer is now running at five centres in Germany and Switzerland. The report of the phase I/II study has been finalized and a scientific paper has been submitted to a leading international journal.

· The Company`s preclinical work on encapsulated cells/chemotherapy for the treatment of breast cancer and the programmes using the polytope principle for vaccination are progressing well.

Bavarian Nordic expects a deficit of DKK 65.0 to 70.0 million in 2000, which is in accordance with that predicted in the 1999 Annual Report.


Comments on the first six months of 2000


Bavarian Nordic met two very important milestones during the first six months of 2000. In June, the Company received permission from the Italian Health Authorities to initiate phase I/II studies for the treatment of metastatic malignant melanoma. In February, the Company received permission from the German Health Authorities to initiate phase I/II safety studies for the treatment of HIV. The clinical phase II programme for the treatment of pancreatic cancer and the clinical phase I/II programme for the treatment of non-metastatic malignant melanoma continued according to plan.

With a view to developing novel vaccines, Bavarian Nordic initiated a number of activities within bioinformatics research, host range gene research and gene promoter research.

In order to further focus the activities of the rapidly growing Company, Bavarian Nordic has divided its research and development activities into three units: Clinical development, vaccine research and development and encapsulation development. The Company`s gene therapy (retrovirus) research in Vienna has been reorganized as a separate subsidiary, currently 100% owned. To allow for further significant expansion of the Vienna subsidiary`s activities, Bavarian Nordic plans to obtain separate financing for the subsidiary through a private placement in autumn 2000.

As part of the Company`s efforts to protect its intellectual property rights, Bavarian Nordic has built up an extensive portfolio of patent applications. In this connection the company has recently achieved significant progress in two key areas: Patents have been allowed in Europe regarding "ProCon" - the basic vector for safe gene transfer - and patents have been allowed in both the US and in Europe regarding "MLV/MMTV Pseudotype Virus" - particularly useful for the treatment of breast cancer.

For the first six months of 2000 Bavarian Nordic realized a total loss of DKK 35.1 million, in line with the expected result. Expenses for the period totalled DKK 36.2 million, compared to DKK 31.4 million for the same period in 1999. The increase is attributable to higher development costs due to the growing level of activity within the Company`s clinical programmes. Bavarian Nordic`s cash and cash equivalents decreased from DKK 141.7 million as of 31 December 1999 to DKK 106.9 million as of 30 June 2000.

The interim financial statements were prepared according to the same accounting policies as employed in the 1999 Annual Report. The interim financial statements are unaudited.


Outlook for 2000

A deficit of DKK 65.0 to 70.0 million is expected for 2000, which is in line with that predicted in the 1999 Annual Report. The research and development programmes are expected to proceed according to plan as outlined below.


Research and development programmes


Pancreatic cancer
Under Bavarian Nordic`s CapCell programme for the treatment of pancreatic cancer, the clinical phase II study is now running at five centres in Germany and Switzerland. The first data from these ongoing phase II studies is expected towards the end of 2000. The final report of the phase I/II study has been finalized and a scientific paper has been submitted to a leading international journal.

Malignant melanoma
Bavarian Nordic recently received permission from the Italian Health Authorities to initiate a phase I/II safety study for the treatment of metastatic malignant melanoma. The study will take place at Instituto Nazionale Tumori in Milan (Italy) under the direction of the renowned cancer scientist Professor Alessandro Gianni. The treatment approach is based upon ex vivo immunotherapy using the patient`s own immune cells. The first data are expected to be available before the end of 2000. The study will provide important safety information relating to the Company`s MVA vector as well as preliminary efficacy data.

The non-metastatic malignant melanoma vaccination phase I/II study is proceeding according to plan in Germany. Bavarian Nordic expects to have completed enrolment of the patients over the next few months. The study will provide important safety information concerning the Company`s MVA vector, as well as important information concerning the vector`s ability to induce immune responses.

HIV infection
In Q1 2000, Bavarian Nordic received permission from the German Health Authorities to initiate a phase I/II safety study for the treatment of HIV with the Company`s MVA vector containing the Nef gene. The study will take place in a clinical centre in Munich (Germany). Bavarian Nordic is also working on a second MVA vector expressing multiple HIV epitopes (i.e. a polytope) and which is expected to be useful in overcoming the problem of HIV resistance. The Company expects to initiate clinical trials with this treatment in the first half of 2001.

Breast cancer
Bavarian Nordic is conducting extended efficacy studies in a dog model of breast cancer. Six dogs have hitherto been treated and a further 10 dogs will be treated to confirm the promising effects seen. Pending the outcome of these studies, Bavarian Nordic expects to start a clinical phase I/II study in the first half of 2001.

Vector technologies

The Company`s research efforts have recently yielded further convincing data demonstrating that the Bavarian Nordic MVA is a highly efficient vaccination vector generating high antibody and cytotoxic T-cell responses. These findings considerably support our ambition that the Company`s MVA vector should be the vaccination vector of choice for future business collaborations.

In addition to the activities listed above, Bavarian Nordic has continued its research and development activities concerning additional therapeutic uses of pox virus and encapsulation delivery technologies. To enhance the potential of the MVA vector, Bavarian Nordic is conducting extensive research regarding host range genes, immune modulatory genes and virus promoters. The goal is to develop MVA vectors with selective infection spectra and targeted at specific immune responses.

Bavarian Nordic has initiated development of a canary pox vector as a second vaccine vector in addition to the Company`s MVA. As the biological profile of canary pox is very different to that of MVA, canary pox vectors could complement the use of the Company`s MVA.

Bavarian Nordic`s cell encapsulation programme is currently focussing on the development of a standardized commercial process for capsule production based on synthesis of the capsule material cellulose sulphate and optimization of both the capsule properties and the encapsulation equipment. Important progress has been achieved in all areas.

[Bozana]

Die deutsche Division der Bavarian Nordic will mittelfristig an den Neuen Markt! Da sollte man doch jetzt schon in die Muttergesellschaft einsteigen!