Biovest Secures Financing from State of Minnesota and City of Coon Rapids to Establish Manufacturing Site for Lymphoma Cancer Vaccine

Biovest Manufactures Cancer Vaccine in AutovaxID Bioreactor (Photo: Business Wire)

Biovest Manufactures Cancer Vaccine in AutovaxID Bioreactor (Photo: Business Wire)

TAMPA, Fla. & MINNEAPOLIS--()--Biovest International, Inc. (PINK SHEETS: BVTI), the State of Minnesota Department of Employment and Economic Development (DEED), and the City of Coon Rapids, Minnesota, today jointly announced that the State of Minnesota, the City of Coon Rapids, Minnesota, and JMS Holdings, LLC, a Minnesota real estate developer, have provided financial support to Biovest to establish Coon Rapids (a suburb of Minneapolis) as the U.S. manufacturing site for BiovaxID®, Biovest’s personalized cancer vaccine for the treatment of non-Hodgkin’s lymphoma. The total loan package is approximately $1.5 million, and this investment is earmarked to support the initial expansion of Biovest’s existing 35,000 sq. ft. bio-manufacturing facility in Coon Rapids to accommodate production for its cancer vaccine, which was developed in collaboration with the U.S. National Cancer Institute (NCI).

The announcement was made today during a press conference at the Capitol in St. Paul, where Company leadership was joined by Minnesota Governor Mark Dayton, U.S. Senator Al Franken, DEED Commissioner Mark Phillips and other officials.

According to Biovest’s President, Samuel S. Duffey, “Today marks a significant milestone for Biovest as we are receiving the funding to begin the process of transforming our Minnesota cell culture center into a best-in-class production site to manufacture our proprietary cancer vaccine, BiovaxID. When this initial expansion is complete, cancer cells collected from individual lymphoma patients will be transported to this facility, and vaccines will be produced on a patient-specific basis to empower their body’s own immune system to potentially delay or prevent the recurrence of follicular lymphoma and likely other B-cell blood cancers. This is the first step in addressing our production capacity needs as we execute our business plan, and I congratulate our employees in Coon Rapids for their outstanding performance. The Minneapolis area is rich with resources vital to a biotechnology company’s growth needs, and it is with great appreciation that we thank the State of Minnesota, the City of Coon Rapids and JMS Holdings for investing in the future of personalized medicine.”

As part of the financing agreement, Biovest has committed to create at least 14 new high-paying jobs within the next two-years, with such jobs to include bio-manufacturing professionals, production managers, quality control and quality assurance experts, engineers and technical personnel.

“Biovest is a fine example of the type of accomplished bioscience company that has chosen to be based in Minnesota with a potential to emerge as a leader in the new field of cancer vaccines,” said DEED Commissioner Mark Phillips. “Biovest has expressed a willingness to work with our universities and other Minnesota-based life science companies to explore other areas of collaborative research that could result in spinoff technologies and foster industry growth in Minnesota.”

Coon Rapids Mayor Tim Howe added that the facility is a milestone for patients who will benefit from the vaccine and for the citizens of Coon Rapids. “The successes achieved by Biovest, both now and in the future, will greatly benefit our community and contribute to our continued success in attracting and retaining science and technology based businesses,” Howe said.

For nearly 30 years, Biovest has leased its cell culture center in Coon Rapids where the Company has produced biologics for clients as a contract manufacturer, while also manufacturing and marketing its line of hollow-fiber bioreactor instruments. Biovest formerly operated this facility as the National Cell Culture Center for its client, the National Institutes of Health (NIH). The new BiovaxID production space is currently under construction, and Biovest expects to make a formal announcement when completed later this year.

A recent report by the BioBusiness Alliance of Minnesota found that bio-business jobs in Minnesota grew 20 percent from 2002 to 2007, and that the state has opportunities for further growth in the sector. “This didn’t happen by chance,” said Dale Wahlstrom, CEO of the nonprofit group. “Biovest’s decision to expand here is a testament to the collaboration and increased dialogue between industry, academia and government.”

About BiovaxID®

BiovaxID is a personalized cancer vaccine developed in collaboration with the U.S. National Cancer Institute (NCI). Each patient’s vaccine is individually manufactured from a tissue biopsy obtained from the patient’s own tumor. This approach is used because there is a unique protein called an “idiotype” expressed exclusively on the cancerous B-cells. When a full, high-fidelity copy of the idiotype is linked to a foreign protein (KLH), and administered with an immune-enhancing agent (GM-CSF), the resulting vaccine can mount a highly-specific anti-lymphoma attack that “trains” the body’s own immune system to solely recognize the idiotype as a “foreign invader”; stimulating and recruiting the patient’s own immune system to destroy micro-pockets of cancer cells that may remain following chemotherapy and potentially target and destroy newly arising lymphoma cells, thus delaying or preventing cancer recurrence. Through its unique mode of action, and exemplary safety record, BiovaxID represents a new therapeutic approach to treating follicular lymphoma.

BiovaxID has completed a randomized, multi-center, double-blind, controlled Phase III clinical trial. Patients with follicular lymphoma in first remission were treated with BiovaxID or a control vaccine. In the study, patients who received BiovaxID demonstrated an average of 13.6 months of additional disease-free survival (duration of remission) compared to patients who received a non-specific control vaccine. BiovaxID represents the only lymphoma vaccine, and the second cancer vaccine overall, to demonstrate positive clinical benefit in a completed Phase III clinical trial.

About Biovest International, Inc.

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific, cancer vaccine, BiovaxID®, with three clinical trials completed, including a Phase III study, demonstrating evidence of safety and efficacy for the treatment of indolent follicular non-Hodgkin’s lymphoma.

Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB™ Market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”).

For further information, please visit: http://www.biovest.com

Forward-Looking Statements: Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID®, AutovaxID™, events occurring after dates hereof, 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. 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.

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Contacts

Biovest International, Inc.
Douglas Calder, 813-864-2558
Vice President, Strategic Planning & Capital Markets
dwcalder@biovest.com

Release Summary

The State of Minnesota has provided financial support to Biovest to establish Minnesota as the manufacturing site for BiovaxID, a cancer vaccine for the treatment of non-Hodgkin's lymphoma.

Contacts

Biovest International, Inc.
Douglas Calder, 813-864-2558
Vice President, Strategic Planning & Capital Markets
dwcalder@biovest.com