Bavarian Nordic will establish a new separate sales- and marketing
function in order to strengthen the company's commercial activities
and increase the sales promotion for its third generation smallpox
vaccine, IMVAMUNE® and future vaccines, including HIV and cancer
vaccines.
The commercial function will, besides intensifying the sales
promotion of IMVAMUNE®, ensure that the company's research and
development is going in a commercial way to a still higher extent,
and that necessary market knowledge at an early stage is integrated
in the decision-making processes within clinical development.
Within the latest years Bavarian Nordic has used many resources on
obtaining the RFP-3 order from the U.S. government. The production
facility in Kvistgaard is completed, and the company has advanced its
clinical development of the IMVAMUNE® smallpox vaccine. With a strong
patent position on the company's MVA technology, Bavarian Nordic is
ready to fully exploit the commercial options worldwide. The company
sees a great potential in a market for IMVAMUNE® outside the U.S. In
order to cultivate this market, Bavarian Nordic will strenghten its
effort towards potential customers and partners.
To lead this new commercial function, Bavarian Nordic will employ an
Executive Vice President Commercial Affairs, who will join the
Corporate Management group and refer to Anders Hedegaard, CEO. The
company expects to appoint a person for this position within the end
of 2007. Furthermore a number of other people will be employed to
strengthen the sales and marketing work.
STATUS ON DEVELOPMENT PROGRAMMES
IMVAMUNE® - smallpox vaccine
The RFP-3 base contract with a total value of USD 500 million covers
a development contract followed by delivery contract.
As part of fulfilling a number of activities, Bavarian Nordic will
obtain advanced and milestone payments, which amount to USD 150
million. In 2007, the company expects to receive advanced payments of
USD 50 million and two milestone payments of each USD 25 million for
the fulfilment of a number of important milestones within the
following areas:
* Build-up of security systems
* Establishment of various procedues and training
* Validation of equipment and processes
* Report on the Phase II study in preparation for design of Phase
III studies
Other markets
Bavarian Nordic is currently in negotiations with the authorities in
a number of other countries on the manufacture and delivery of
IMVAMUNE® as a safe third-generation smallpox vaccine. The timing and
value of potential contracts is not yet known.
HIV vaccines
The company's most advanced HIV vaccine project is MVA HIV nef. Data
from the Phase II study are currently being analysed and are expected
to be presented in third quarter of 2007. Discussions with a clinical
expert panel on the data will form basis for the further development
of the programme.
Three ongoing Phase I studies are ongoing with MVA-BN® HIV polytope,
the company's second clinical development programme. Immunogenicity
data from the first study is expected in fourth quarter of 2007.
The development programme for the third HIV vaccine candidate,
MVA-BN® HIV multiantigen is proceeding as planned with an expected
release of the vaccine for clinical trials in 2007 and initiation of
Phase I in 2008.
Cancer
Bavarian Nordic's U.S. based subsidiary, BN ImmunoTherapeutics, has
initiated Phase I/II clinical studies with the company's breast
cancer vaccine candidate, MVA-BN®-HER2. Enrolment of patients for two
studies in the U.S. and Europe is on-going and proceeding as planned.
The prostate cancer programme is proceeding as planned and clinical
studies are expected to commence at the turn of the year 2007/2008.
Pipeline
+-------------------------------------------------------------------+
| Programme | Phase | Next milestone |
|----------------------+-------------+------------------------------|
| IMVAMUNE® (smallpox) | II | Start of Phase III (2008) |
|----------------------+-------------+------------------------------|
| HIV nef | II | Immunogenicity data (Q3, |
| | | 2007) |
|----------------------+-------------+------------------------------|
| HIV polytope | I/II | Immunogenicity data (Q4, |
| | | 2007) |
|----------------------+-------------+------------------------------|
| HIV multiantigen | Preclinical | Start of Phase I (2008) |
|----------------------+-------------+------------------------------|
| Breast cancer | I/II | Safety and immunogenicity |
| | | data (Q1, 2008) |
|----------------------+-------------+------------------------------|
| Prostate cancer | Preclinical | Start of Phase I (2007/2008) |
|----------------------+-------------+------------------------------|
| Measles | Preclinical | Start of Phase I (2007) |
|----------------------+-------------+------------------------------|
| RSV | Preclinical | Start of Phase I (2008) |
+-------------------------------------------------------------------+
Tropical diseases
The company's two projects in tropical diseases, dengue fever and
Japanese encephalitis are awaiting discussions with an external
partner.
Other development programmes
As part of the strategy process which was recently initiated, the
company's other development programmes, including the immunotherapy
programme (IMVABOOST(TM)), are being evaluated together with a number
of potential new projects.
Guidance for the 2007 results
Guidance for the full year result is maintained. Based on the planned
activities and milestone payments, the company expects revenue of
around DKK 380 million and a loss before tax of DKK 50 million. At
year-end the company's net liquidity is expected to amount
approximately DKK 900 million.
Asger Aamund
Chairman
Contacts:
Anders Hedegaard, President & CEO
Telephone: +45 33 26 83 83
Media: United Kingdom
Mary Clark, Capital MS&L
Telephone: +44 207 307 5330
Media: United States of America
Elizabeth Dempsey Becker, Bavarian Nordic Inc.
Telephone: +1 202 536-1576
Bavarian Nordic Strengthens its Commercial Organisation and Updates on Pipeline Progress
| Source: Bavarian Nordic A/S
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