European Medicines Agency Accepts Marketing Authorization Application for Biovest’s Cancer Vaccine for Treatment of Non-Hodgkin’s Follicular Lymphoma
MINNEAPOLIS & TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (“Biovest”), a leader and pioneer in the development of personalized cancer immunotherapies, today reported that the European Medicines Agency (EMA) accepted the Company’s Marketing Authorization Application (MAA) for BiovaxID™ (submitted to EMA as “Dasiprotimut-T Biovest”), a personalized cancer vaccine for the treatment of non-Hodgkin’s follicular lymphoma. The MAA validation confirms the submission is complete and begins the formal EMA review process intended to secure approval to market BiovaxID in the European Union and to allow prescription and sale of BiovaxID for the treatment of non-Hodgkin’s follicular lymphoma in patients who have achieved a first complete remission.
“In addition to our clinical program, which yielded some of the most significant and positive personalized cancer vaccine data of which we are aware, we have successfully designed and deployed proprietary, highly-automated manufacturing and quality control systems for BiovaxID that will allow us to make this vaccine a commercial reality.”
“EMA’s acceptance of our Marketing Authorization Application for BiovaxID marks a major milestone in our efforts to bring BiovaxID to the European market. If approved, BiovaxID will receive marketing authorization in the 28 EU member states, as well as in Iceland, Liechtenstein and Norway. This vaccine, if approved, will offer patients diagnosed with non-Hodgkin’s follicular lymphoma, and who have achieved a first complete remission, a truly personalized therapy to delay or to prevent tumor recurrence following the completion of induction therapy. Using currently available treatments, more than half of the patients diagnosed with non-Hodgkin’s lymphoma achieve complete remissions, but will almost always suffer from tumor relapse and will ultimately require re-treatment for ongoing disease. We hope to change that with BiovaxID,” stated Carlos F. Santos, Ph.D., Biovest’s Chief Executive Officer. “BiovaxID offers patients a truly personalized immunotherapy to maintain durable remissions. In our multi-center, randomized, controlled Phase 3 clinical study, BiovaxID demonstrated that it can induce powerful anti-tumor immune responses while providing a median disease-free survival benefit of over 15 months, and a reduction of 42% in the risk of relapse, and in our Phase 2 clinical trial, 28% of patients who received BiovaxID remain in continuous remission at a median of 12.7 years of follow-up. We look forward to the day when we can provide all follicular lymphoma patients with this truly personalized vaccine to fight their disease.”
Biovest submitted its MAA following the successful completion and long-term follow-up of two Phase 2 clinical trials and of one multi-center, randomized, Phase 3 clinical trial (all conducted in partnership with the U.S. National Cancer Institute) in which BiovaxID demonstrated it could induce powerful anti-tumor immune responses, eradicate residual tumor cells from patients’ blood following chemotherapy, and improve the duration of complete remissions by a median of 15.4 months relative to control. The Company also embarked upon an extensive effort to automate nearly all aspects of manufacturing and of quality control in order to ensure the commercial viability of BiovaxID. Dr. Santos noted, “In addition to our clinical program, which yielded some of the most significant and positive personalized cancer vaccine data of which we are aware, we have successfully designed and deployed proprietary, highly-automated manufacturing and quality control systems for BiovaxID that will allow us to make this vaccine a commercial reality.”
Appointment of Chief Financial Officer
Additionally, Biovest announced that it has appointed Robert E. Farrell, J.D. as Chief Financial Officer. Mr. Farrell joins Biovest from Sanovas, Inc., where he served as CFO from 2012 to 2013. Prior to Sanovas, Mr. Farrell served as CEO (2008-2010) and as EVP and CFO (1996-2008) of Titan Pharmaceuticals, Inc., a diversified biotechnology company that sought to develop early-stage therapeutic programs in oncology and in disorders of the central nervous system.
About Biovest International, Inc.
Biovest International, Inc. develops autologous active immunotherapies (personalized cancer vaccines) to treat B-cell non-Hodgkin’s lymphomas, which are cancers of the immune system. The Company’s lead personalized cancer vaccine candidate, BiovaxID, has undergone three clinical trials conducted in collaboration with the U.S. National Cancer Institute (NCI) that have demonstrated BiovaxID’s ability to increase the duration of cancer remission following chemotherapy and to induce immune responses which correlate highly with long-term survival. Biovest is currently in the process of pursuing European marketing approval for BiovaxID.
For further information, please visit: http://www.biovest.com
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements.” Such statements include, but are not limited to, statements about Biovest , its product candidate, BiovaxID™ and any other statements relating to products, product candidates, product development programs, the FDA, the EMA, or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as “proposed”, “proposes”, “seeking”, "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. In particular (and without limitation), statements regarding potential approval of a Marketing Authorization Application for BiovaxID by the European Commission, pre-filing meetings with the FDA or other jurisdictions and/or commercial plans reflect current expectations but are subject to inherent risks of delay in compilation and finalization of all components of the licensing application. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.