Vaccinogen Announces Submission of Final Documentation to Swissmedic for Pivotal Review of OncoVAX®
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- Vaccinogen Announces Submission of Final Documentation to Swissmedic for Pivotal Review of OncoVAX®
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Frederick, MD, USA – July 24, 2009 – Vaccinogen, Inc. announces that it has submitted its final documentation to Swissmedic for pivotal review of OncoVAX®. Swissmedic is expected to issue final decision to approve full registration thus Swiss reimbursement for OncoVAX®.
OncoVAX® currently has a marketing authorization from Swissmedic, Switzerland’s medical authority, in the category of “procedes therapeutiques”. This authorization permits foreign and domestic Swiss patients to purchase OncoVAX® on a self-pay basis. During this period, Swissmedic required Vaccinogen to apply for full registration of OncoVAX® as a transplant therapy. A final positive decision will permit Vaccinogen to apply for insurance reimbursement within Switzerland.
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.
Vaccinogen’s scientists prepare a vaccine from the patient’s own tumor and then administer the vaccine to the patient by three weekly injections one month after surgery. A fourth “booster” is administered six months later. OncoVAX® reduces recurrence and deaths by over 50%.
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, antiinflammatory diseases and fully human monoclonal antibodies in various stages of clinical development. The Company maintains a European subsidiary in Emmen, The Netherlands that operates a fully functioning cGMP manufacturing center for producing OncoVAX® vaccines.
About Swissmedic
Swissmedic, the Swiss agency for therapeutic products, is the Swiss surveillance authority for medicines and medical devices, registered in Berne. It started operations on January 1, 2002 as successor of Interkantonale Kontrollstelle fur Heilmittl (IKS), which was itself the successor of Schweizerische Arzeimittelnebenwirkugszentrale (SANZ). Swissmedic is affiliated to the Federal department of Home Affairs.
www.vaccinogeninc.com
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Contact:
Andrew L. Tussing
Vaccinogen
atussing@vaccinogeninc.com
301-668-8400