HARNESSING THE IMMUNE SYSTEM TO TREAT AND PREVENT DISEASE JANUARY 2014

HARNESSING THE IMMUNE
SYSTEM TO TREAT AND
PREVENT DISEASE
JANUARY 2014
CSE/OMX:BAVA, OTC:BVNRY
BAVARIAN NORDIC
CANCER IMMUNOTHERAPIES AND VACCINES FOR INFECTIOUS DISEASES
2
FACTS
BAVARIAN NORDIC IN BRIEF
Vertically integrated multinational biotech company
Revenue-generating
Leader in vector-based active immunotherapy two technology platforms
First product approved in 2013
Two Phase 3 programs: Prostate cancer and smallpox
Ebola vaccine license and supply agreement with Janssen
Commercial scale cGMP manufacturing facility
Long-term contracts with the US government
Founded 1994, IPO 1998
Headquartered in Denmark
Research centers in Mountain View, CA
and Munich, Germany
Listed on NASDAQ OMX Copenhagen: BAVA
REVENUES AND RESULTS, 5 YEARS
-500
0
500
1.000
2009 2010 2011 2012 2013 2014E
3
PIPELINE
1) Government funded programs
2) Sold to government stockpiles
3) Approved in the European Union under the trade name IMVANEX® and in
Canada under the trade name IMVAMUNE®
4) Phase 3 registration studies are ongoing in the United States
5) Licensed to Janssen
Preclinical
Phase 1 Phase 1/2 Phase 2 Phase 3 Market
IMVANEX®/ IMVAMUNE® 1-4) Smallpox
PROSTVAC® Prostate Cancer
IMVAMUNE® freeze-dried 1) Smallpox
CV-301 Colon 1) Colorectal Cancer
CV-301 Bladder 1) Bladder Cancer
CV-301 Breast 1) Breast Cancer
MVA-BN® PRO Prostate Cancer
MVA-BN® HER2 Breast Cancer
MVA-BN® Brachyury 1) Metastatic Tumors
MVA-BN® Filo 5) Filoviruses (Ebola/Marburg)
MVA-BN® RSV Respiratory Syncytial Virus
MVA-BN® FMDV 1) Foot-and-mouth Disease
MVA-BN® Anthrax 1) Anthrax
4
THE MVA-BN® VACCINE PLATFORM
Vaccine Platform
Approvals in EU and Canada
Balanced Immune Response
Strong IP Protection
MVA-BN Antigen(s)
+
Research & Development
Construct Optimization
Immune Enhancement
Preclinical Analysis
Manufacturing
Research Drug Product
Clinical Batch Production
Commercial Manufacturing
MVA-BN
(IMVAMUNE)
Recombinant
MVA-BN
POXVIRUS TECHNOLOGY PLATFORM
5
Vaccinia + Fowlpox (VF)
(Prime) (Boost)
TRICOM
TRIad of CO-stimulatory Molecules
PSA MUC-1 CEA
Prostate cancer
PROSTVAC CV-301
LFA-3 ICAM-1 B7.1
Colorectal, Breast, Lung,
Ovarian, Gastric, Bladder, Liver
and Renal cancer
GM-CSF can be used as adjuvant in both PROSTVAC® and CV-301
Immune Targets
(Antigens)
Vectors
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