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Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), recently announced that the company is seeking marketing approval in Canada for BiovaxID®, its personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system. Biovest plans to file a New Drug Submission (NDS) later this year with Health Canada, the Agency responsible for approving drugs in Canada. If approved, BiovaxID would represent the world’s first cancer vaccine available for lymphoma patients.

Biovest based its decision to pursue Canadian marketing approval following a formal pre-filing advisory meeting with Health Canada’s Biologics and Genetic Therapies Directorate (BGTD). The meeting with the BGTD included a comprehensive presentation of the three BiovaxID clinical trials conducted as part of a nearly decade-long collaboration with the U.S. National Cancer Institute (NCI). The data review included long-term outcomes from two Phase II clinical studies and a controlled, randomized, double-blinded, multi-center Phase III clinical trial.

In addition to company representatives, the BGTD received presentations from two key lymphoma opinion leaders, Larry W. Kwak, M.D., Ph.D., Chairman of the Department of Lymphoma/Myeloma and Associate Director of the Center for Cancer Immunology Research at the University of Texas MD Anderson Cancer Center, and Neil L. Berinstein, M.D., Professor of Medicine, University of Toronto and Director of Translational Research, Ontario Institute for Cancer Research.

The decision to proceed with an NDS filing in Canada is a significant step in Biovest’s worldwide regulatory strategy. Following the positive meeting result in Canada, Biovest is in the process of conducting other clinical pre-filing meetings in various jurisdictions including with European authorities, the U.S. FDA and potentially other countries as part of the Company’s global commercialization plan for BiovaxID.

OneMedRadio interviewed, Biovest President and CEO, Sam Duffy and Sr. Vice President of Product Development and Regulatory Affairs, Carlos Santos, Ph.D. They discussed product development and global marketing of BiovaxID. Click below to hear full audio interview. See transcript that follows.

Brett Johnson:      Welcome. This is Brett Johnson with OneMed Radio in New York. Today, I’m with Samuel Duffey who is the president and CEO and Carlos Santos, Ph.D. who is the senior VP of product development and regulatory affairs for Tamp-based Biovest International, symbol BVTI, which is traded on the bulletin board. Thanks for joining us today, gentlemen.

Samuel Duffey:  Thank you.

BJ:     So you recently reported some exciting news on the prefiling with Health Canada and there’s support of a formal filing seeking approval for the BiovaxID, a personalized lymphoma vaccine. Starting with you, Sam, can you tell us what is the significance of this and what it means?

SD:    Certainly. This really is important news. It’s an important milestone development actually for Biovest and that’s because it successfully completes the first step in our global regulatory strategy. In fact, this announcement confirmed that Biovest’s first prefiling regulatory meeting was highly successful and it further confirmed that Biovest will be filing the formal NDS, which is the application for marketing approval in Canada, which is the final regulatory step necessary in order for BiovaxID to be evaluated in Canada for marketing approval. So this announcement means that Biovest could potentially be made available to Canadian patients in late 2013 and of course as we all know, BiovaxID represents the first cancer vaccine that will become available for lymphoma patients upon this approval.

Importantly, the prefiling meeting with Canada resolves a pivotal regulatory question and makes the regulatory pathway for BiovaxID certain. For example, we now know that the body of clinical evidence consisting of two phase II clinical trials and a phase III randomized clinical trial studying BiovaxID constitute the only clinical trials that we need now to file our NDS in Canada seeking marketing approval.

We have now confirmed then by this prefiling meeting that the existing clinical trials that we have already completed adequately demonstrates safety and efficacy necessary for us to start this marketing approval process. While we at Biovest and myself personally, have long been convinced of these answers, the market has continued to express uncertainty about this and we think it has probably been reflected in the market value for Biovest. It’s great to now have formal confirmation that no additional clinical trials are required before Biovest seeks its first marketing approval.

BJ: Terrific. So can we step back for a little bit and just talk about the disease, the problem that BiovaxID is addressing and how big that market is and what the patients are faced with today for treatments?

SD:     Well that’s an excellent question and, Carlos, I think that might be a good one for you to start out addressing and then I’ll help out as well.

Carlos Santos:   Certainly, Brett. Well BiovaxID, as you know, is a personalized vaccine non-Hodgkin’s lymphoma, for non-Hodgkin’s follicular lymphoma and mantle cell lymphoma have been the two indications where we each conducted our clinical trials. These are currently uncured cancers. They frequently are diagnosed in advanced stage disease and then patients right now currently receive any number of combination, rituximab containing first-line treatments.

The problem with current lymphoma treatment, Brett, is that the disease is a disease, which responds initially very strongly to that induction therapy, but it’s not a disease that’s cured by it and so it means that patients right now get minimal residual disease. About 60% of the patients achieve this and they then go on to over the course of time develop relapsed disease, which eventually transforms and leads to the death of the patient. Right now, the survival time for patients ranges anywhere from, if it’s indolent disease and follicular lymphoma is a median of about 10 to 13 years for people that get good initial outcomes. Then, for mantle cell lymphoma, it’s slightly shorter, it’s about six years.

But overall, it really brings us to what this meets the needs and it meets the needs of the patients diagnosed right now with these conditions that are looking for something to really extend the benefit achieved by those induction therapies, none of which are curative. So that really opens us up to saying where we think we’ll have patient uptake and physician uptake and it will be in that setting, in a consolidation setting for lymphoma.

BJ:   So about how many people are affected by this disease today?

CS:   So, you know, it’s in the number of markets, about 15,000 cases. There’s about 60% rate of those initially respond and would be great candidates for that and that’s in the US and then similar numbers in Europe. So the total market is – you know, and then that doesn’t include the patients that there’s about 400,000 patients that are currently living with lymphoma that have been treated in some way and have disease still that are still alive undergoing treatment. So the market is actually quite broad and we think the market is really defined by the market that Rituxan defined, which is patients at the numerous stages of disease that are looking for improved outcomes.

SD:     Not only is it a large market but it also is a market where the unmet need we believe is quite large. We’re just excited and proud to be one of the companies leading the charge bringing cancer vaccines in an active role for the immune system to the treatment needs of cancer patients.

BJ:    Well immunotherapy has really attracted a lot of attention and excitement in recent years. I guess you guys are demonstrating some real progress in that area.

SD:    Well that’s absolutely right. We sit on the position where BiovaxID will almost certainly be the first cancer vaccine in lymphoma to seek marketing approval, and we think this is ushering in an important development and important change for the entire cancer field but certainly for lymphoma.

BJ:     That’s exciting. So what is your sense about marketability and availability in Canada and also what your sense is about global availability whether it be Europe or the US?

SD:     Well the path forward we now know for Canada with some certainty. That was the result of the prefiling meeting. We now know that Canada eagerly awaits our submission of an NDA, again the application seeking marketing approval. With the data, clinical data that we have in hand, we would expect to file that application in Canada by the end of the year. I do point out, however, that the application in Canada like the one in Europe and with the FDA is a comprehensive in-depth submission and it’s followed by a rigorous review process. In Canada like at the FDA, the process generally is less than a year. So it’s our hope if the process goes as smoothly and as flawlessly as we hope that it will that we’ll be launching, commercially launching BiovaxID in Canada in the late part of 2013.

That leads us to the rest of the world and it’s important to point out that the real significance of our announcement about Canada is not the data point with Canada alone. It is that it is the first step and it’s a successful step in our global marketing and regulatory strategy. That strategy focuses not only on Canada, but it focuses on Europe and it focuses on the US. Our strategy successfully deployed in Canada will be followed in both Europe and at the FDA through then prefiling regulatory meetings and where appropriate followed by filings of applications for regulatory approval toward the end of this year.

Let me just point out what these regulatory meetings are like. They have two purposes for us. One purpose of the regulatory meeting is for us to have an in-depth forum where we can discuss in detail with the regulatory agencies the some 16-year regulatory development, clinical development history, for BiovaxID to discuss the three clinical trials and body of clinical evidence that we have amassed over that some 16-year period of time in collaboration with the NCI. It has a second purpose though and the second purpose is to learn from the regulatory agencies how we can best expedite the pathway to regulatory approval. So, therefore, the purpose of it is not only to give us an opportunity to share our data with the regulatory agencies, but for them to have an opportunity to share with us the process that can make regulatory approvals predictable, expeditious, smooth, and an orderly process. So the real significance here is it’s launching us not only through Canada but into our prefiling meetings with Europe and the FDA and we look forward to announcing those meetings.

BJ:      So with regard to with the approval getting closer, can you provide us an input into the anticipated pricing for BiovaxID?

SD:    Well we’ve not yet announced a pricing data or ranges of prices and so it would not be appropriate to do that today, but it is appropriate to discuss it. There, I would advise you and those listening, that Biovest is very much aware and supportive of the new paradigm in pricing for new drugs and that new paradigm connects very tightly the cost of the drug, the pricing of the drug with the clinical benefit that the patients can expect to receive. We embrace that paradigm because we think BiovaxID will fare very nicely in that pricing paradigm because the clinical benefit is so clearly demonstrated and that benefit is long term. That is to say that the immune response continues well beyond the completion of dosing and that’s quite important to hear in lymphoma where the cancer continues on an indolent course and the patients will continue to have to deal with their cancer for a long period of time. But in this therapy, they receive five subQ injections and the therapeutic benefit continues even though the dosing of the product stops at that juncture.

BJ:   That’s true, but I guess that’s the power of this whole immunotherapy approach and the whole idea of personalized medicine and immunotherapy. Is there anything else you’d like to add from an investors point of view? Is now a good time to be looking at buying the BVTI stock?

SD:   Well,  I think so. I think it’s clear that Biovest, with the announcement of Canada, has clearly shifted from a company that one might focus on as being in the earlier stages potentially of development of its vaccine to a company that’s now focused on and preparing for regulatory approvals and subsequently for a product launch. So we view ourselves now as later stage. I also think it should be interesting to the market that our regulatory strategy that we’ve deployed in Canada successfully is now clearly the strategy that we plan to deploy both in Europe and with the FDA. As previously announced, we expect those prefiling meetings to be completed before the end of the summer and to announce the results of those. So it is a dynamic and exciting time for Biovest.

BJ:  Well it sounds very exciting. We’ll be very keen to follow your progress. Thanks so much for joining us today.

SD:   Well thank you for having us.

BJ:     So that is Samuel Duffey who is the president and Carlos Santos senior VP of regulatory affairs and product development for Tampa-based Biovest International, symbol BVTI traded on the bulletin board. This is Brett Johnson signing off for OneMed Radio in New York. Good day.

Statements in this presentation/interview that are not strictly historical in nature constitute “forward-looking statements.“  Such statements include, but are not limited to, statements about Biovest and its product candidate, BiovaxID® and any other statements relating to products, product candidates, product development programs, the FDA 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 “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” or similar expressions. In particular (and without limitation), statements regarding the timing of anticipated filing of a New Drug Submission for BiovaxID with Health Canada, pre-filing meetings with the FDA, Europe or other jurisdictions an/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.