Dutch Authorize Manufacture Of Vaccinogen's New Anti-Colon Cancer Vaccine; License Clears Path To European Production, Final FDA Trial

Main Category: Colorectal Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Immune System / Vaccines;  Cancer / Oncology
Article Date: 08 May 2008 - 2:00 PST

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Vaccinogen Inc. said Dutch health authorities licensed it to manufacture its break-through OncoVAX anti-colon cancer vaccine, immediately clearing the path to more than US$100 million of potential European sales.

The Dutch approval of the company's facility based in Emmen, The Netherlands also paves the way to its pivotal US FDA Phase IIIb clinical trial -- the final step before the vaccine can be sold in the United States.

"The facility can produce up to 3,500 vaccines annually, equivalent to US$130 million in revenues," said Michael G. Hanna, Jr., Ph.D., Vaccinogen CEO. "That number only scratches the surface of potential demand for a Stage II colon cancer vaccine. One of every three patients who have their cancer removed see it return -- and the results are usually fatal."

"Our experience with OncoVAX has resulted in increasing the patients' chance of survival by more than 50%," he concluded. "This represents an opportunity for a new lease on life for tens of thousands of patients around the world."

The Dutch license permits the company to commercialize the vaccine, first in Switzerland and then in seven other countries in Eastern Europe. The OncoVAX vaccine represents a potential medical breakthrough because it uses a patient's own cancer cells to prevent the cancer from returning after a successful operation to remove it.

"This manufacturing license being granted by the most stringent and respected biotech manufacturing reviewers in Europe is a major milestone for Vaccinogen as it begins to generate revenues from OncoVAX," Dr. Hanna said. "It's also a major leap towards the worldwide acceptance of individualized cancer vaccines."

About OncoVAX

OncoVAX immunotherapy is based on a decades-long attempt by scientists to transform the body's immune response and its long-term memory to prevent the return of disease years after surgery. Such an approach has already been successful in preventing a number of infectious diseases.

About Vaccinogen

Vaccinogen is a biopharmaceutical company that develops and commercializes cancer vaccines and other immunotherapeutic products -- Turning Cancer on Itself(TM). Based in Frederick, MD, the company has a portfolio of product candidates for the treatment of cancer, infectious disease, autoimmune, anti-inflammatory diseases and fully human monoclonal antibodies in various stages of clinical development.

Vaccinogen