Accentia subsidiary vaccine granted orphan drug status; stock listed

By Caroline Salls

Pittsburgh, July 26 - Accentia BioPharmaceuticals, Inc. subsidiary Biovest International, Inc.'s personalized cancer vaccine has been granted "orphan drug designation" by the U.S. Food and Drug Administration for a second lymphoma indication for mantle cell lymphoma, according to an 8-K filed with the Securities and Exchange Commission.

With FDA orphan drug status granted for the second indication, Biovest said it gains seven years of market exclusivity for the vaccine upon approval for the treatment of mantle cell lymphoma and/or indolent follicular lymphoma, thereby offering competitive protection from similar drugs of the same class.

In addition, orphan drug status makes Biovest eligible to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

"As we prepare to exit reorganization as a fully restructured public company, we remain firmly committed to our goal to bring needed new therapies to patients suffering with lymphoma," Biovest president Samuel S. Duffey said in the release.

According to a separate release, Biovest's publicly traded shares are now being quoted on the newly launched OTCQB Market as a result of the company filing its annual and quarterly reports with the SEC.

As previously reported, Accentia and Biovest filed their plans of reorganizations earlier this year, with plans to emerge from Chapter 11 bankruptcy this summer.

"I am proud to report that we continue to timely execute our business plan to emerge from reorganization, and most importantly, to advance our mission of developing needed new treatment options for lymphoma patients," Duffey said in the release.

"We're also pleased to again be a fully reporting public company and to be listed on the OTCQB Market, reflecting the beginning of our commitment to reintroduce Biovest to the capital markets as a fully restructured public company.

"This is an important step toward our ultimate goal of a future listing on a major exchange."

Accentia, a biopharmaceutical company based in Tampa, Fla., filed for bankruptcy on Nov. 10, 2008 in the U.S. Bankruptcy Court for the Middle District of Florida. Its Chapter 11 case number is 08-17795.

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