Biovest International, Inc. develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID™, which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest recently completed a pivotal Phase 3 clinical trial for BiovaxID®, which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin’s lymphoma. BiovaxID has been granted Fast Track status by the FDA and Orphan Drug status by the EMEA. Yesterday the company announced that it has executed a distribution agreement with IDIS Limited to exclusively supply BiovaxID®. IDIS is the world leader in the development and implementation of Named-Patient Programs
According to Steven Arikian, M.D., Chairman and CEO of Biovest, “A named-patient program is a compassionate-use drug access program under which physicians can legally prescribe investigational drugs to qualifying patients. Under this program, investigational drugs are administered to patients who are suffering from serious illnesses until the drug is approved by the European Medicines Agency (EMEA). The named-patient program will make BiovaxID available to patients with various B-cell related blood cancers.”
Dr. Arikian added, “We are very proud to be working with IDIS to make BiovaxID the very first personalized anti-cancer vaccine believed to be made available to patients in the EU. As we are frequently contacted by patients suffering from a variety of B-cell blood cancers, it is especially satisfying to provide a safe and effective therapeutic treatment option that selectively targets only cancerous cells, while sparing healthy cells. Based on our significant Phase 2 and Phase 3 clinical results, we believe BiovaxID can improve patients’ chances to maintain long-lasting, and in some cases, even durable remissions, potentially remaining cancer-free.”
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