European Bio Pharmaceutical Leader Announces Cancer Vaccine Research Subsidiary in the United States; Bavarian Nordic to Launch BN ImmunoTherapeutics in Early 2005
WASHINGTON & COPENHAGEN, Denmark -- December 17, 2004 -- Bavarian Nordic A/S announced today that it is establishing BN ImmunoTherapeutics Inc., a cancer vaccine research subsidiary in the Palo Alto area of California, to initially focus on the research and development of cancer vaccines against breast, prostate and colon cancers.
Best known for its state-of-the-art, third-generation smallpox vaccine, Bavarian Nordic will utilize its patented MVA-BN(R) vaccine vector in the development of these cancer vaccine development programs.
“The combination of new and promising data from our earlier cancer projects combined with the strong safety profile of our MVA-BN(R) technology has led us to expand our research in the development of these cancer vaccines,” said Peter Wulff, President and CEO of Bavarian Nordic.
“New data from an earlier clinical study in melanoma cancer with a Bavarian Nordic trial vaccine based on the MVA-F6 vector expressing the melanoma antigen, (tyrosinase), demonstrate that the MVA-BN(R) vector is able to break tolerance towards the self-antigen and induce a prolonged relevant therapeutic immune response over a period of more than a year.”
BN ImmunoTherapeutics Inc. will initially focus on research, preclinical and clinical development activities while relying on Bavarian Nordic’s operations in Europe for virology, clinical batch manufacturing and quality management.
The US based cancer vaccine research organization will be led by Dr. Reiner Laus, who until recently was the Vice President of Research & Development at Dendreon Corporation in Seattle, Washington.
“We are very pleased to have secured the expertise and leadership of Dr. Laus for BN ImmunoTherapeutics Inc,” said Wulff. “His research will be a high priority for the company and we anticipate that by 2006 we will be in the position to file an Investigational New Drug (IND) application.”
About cancer immune therapy
The most promising new therapies for cancer are based upon immune therapy approaches. Over recent years several new cancer drugs based upon passive immune therapy have reached the market. However, the drawback with passive immune therapy is that it relies on only one arm of the immune system-- the humoral arm (anti-bodies). Work on the next generation immune therapies is targeting both arms of the immune system (humoral and cellular arm - T-cells). These approaches are based upon vaccination. Though no such drugs have yet reached the market, several are expected to be approved in the next few years. Bavarian Nordic’s cancer therapy approach is to develop vaccines targeting both the humoral and cellular arm of the immune system.
According to the BioSpace cancer report, the cancer drug market worldwide was USD 30 billion in 2003.
Reiner Laus, MD
Effective January 1, 2005, Dr. Reiner Laus, M.D. will join Bavarian Nordic A/S as Chief Executive Officer of BN ImmunoTherapeutics Inc., which is the company’s new subsidiary in the USA, to focus on cancer vaccine research and development. Dr. Laus was previously Vice President of Research and Development at Dendreon Corporation in Seattle, Washington. At Dendreon, he was responsible for discovery, pre-clinical and development functions. He led the discovery and development of Dendreon’s portfolio of therapeutic cancer vaccines, including Provenge(R), a therapeutic vaccine for the treatment of prostate cancer currently in Phase III clinical development.
Prior to his position at Dendreon, Dr. Laus was a member of the faculty of the Department of Immunology at the University of Kiel in Germany. He received his Medical Doctor degree from the University of Kiel and was a fellow at Stanford University in the USA. Dr. Laus is the author of numerous scientific publications and co-owner/applicant of patents in the field of cancer immunology. He is a member of the American Society of Haematology, American Association of Immunologists, and American Association for Cancer Research.
About Bavarian Nordic:
Founded in 1994, Bavarian Nordic A/S is a leading international biopharmaceutical company developing, producing and marketing innovative vaccines to prevent and treat infectious diseases. With operations in Denmark and Germany, Bavarian Nordic employs over 160 people and is listed on the Copenhagen Stock Exchange under the trading symbol BAVA (CSE:BAVA).
Bavarian Nordic’s patented core technology, MVA-BN(R), is one of the world’s safest, multivalent vaccine vectors and is ideally suited for use against various infectious diseases such as smallpox, HIV/AIDS, Japanese Encephalitis and Dengue Fever. Several MVA-BN(R)-based HIV and smallpox vaccines are in clinical Phase I and Phase II trials. MVA-BN(R) is patented under US Patent No. 6,761,893 and covers the MVA-BN(R) virus and derivatives thereof, IMVAMUNE(TM) (Bavarian Nordic’s smallpox vaccine), and its use as a vector technology.
With respect to smallpox vaccines, Bavarian Nordic has supply and development contracts with the governments of Germany, the U.S.A., and other countries. One of the company’s agreements includes two contracts(1) (awarded in September 2004 and February 2003) with the U.S. government to develop IMVAMUNE(TM) as a safe third-generation smallpox vaccine. Bavarian Nordic’s advanced clinical development program has been further expedited by the US government with the FDA’s grant of “fast track” status for IMVAMUNE(TM), the first-ever smallpox vaccine candidate to be given this designation. Bavarian Nordic is one of the few companies in the world able to supply the growing demand for smallpox vaccines, particularly safe smallpox vaccines. With a combined global manufacturing capacity consisting of the build-up of its own production facility in Denmark (able to produce up to 120 million doses per year), an international collaboration with GlaxoSmithKline, and an established partnership with vaccine producer, Impfstoffwerk Dessau-Tornau (IDT), Bavarian Nordic has ensured supply of its current and future vaccines. Bavarian Nordic’s partners include GlaxoSmithKline, Epimmune in the U.S.A., Gerolymatos in Greece, Impfstoffwerk Dessau-Tornau (IDT) in Germany, and Vaccine Solutions in Australia.
For more information please visit www.bavarian-nordic.com
(1) The award of RFP-ll has been funded in full or in part with federal funds from the National Institutes of Allergy and Infectious Diseases, the National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200400072C, ADB Contract No. 1-AI-40072.
“Safe Harbour” Statement Under the Private Securities Litigation Reform Act of 1995:
Except for the historical information contained herein, this release contains “forward-looking statements” within the meaning of the Private Securities Reform Act of 1995. No “forward-looking statement” can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any “forward-looking statement”, whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic’s periodic reports, if any, which we incorporate by reference.
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