Dutch Authorize Manufacture of Vaccinogen’s New Cancer Vaccine;
License Clears Path to European Production, Final FDA Trial
October 22, 2009
Vaccinogen Announces New Relationship with CRO Clinipace Worldwide
July 24, 2009
Vaccinogen Announces Submission of Final Documentation to Swissmedic for Pivotal Review of OncoVAX®
July 17, 2009
May 15, 2009
April 20, 2009
Vaccinogen Announces That Michael G. Hanna, Jr., Ph.D. is Scheduled to Speak at the Barcelona Vaccine Forum 2009 in June 2009
March 1, 2009
Vaccinogen Announces Addition of David Hatt to its Board of Directors
November 14, 2008
November 13, 2008
OncoVAX, Other Vaccines Provide Hope for Colorectal Cancer Treatment, Prevention
June 4, 2008
Thomson Reuters' Pharma Matters highlights Vaccinogen’s OncoVAX® as “One to Watch”
May 7, 2008
February 27, 2008
Vaccinogen's New Anti-Cancer Vaccine Commercially Available in Europe This Year
February 11, 2008
Cancer Pioneer Reaches Key Agreement On Colon Cancer Drug OncoVAX®
November 10, 2007
Vaccinogen Announces the Successful Acquisition of Key Management and Staff
November 4, 2007
Vaccinogen Announces Successful Acquisition of cGMP Manufacturing Facility
November 3, 2007
Vaccinogen Announces Completion of its Initial Capitalization Plan
October 1, 2007
Vaccinogen Announces Formation of Company
July 19, 2006
FDA Grants Special Protocol Assessment
July, 2006
FDA Grants Intracel “Fast Track ” Designation for the Development of Its Colon Cancer Vaccine
Frederick, MD, USA – May 7, 2008 – 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 $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 $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™. 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’s online press kit: www.vaccinogeninc.com/press_kit.cfm
Contact:
Andrew L. Tussing
Vaccinogen
atussing@vaccinogeninc.com
301-668-8400