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Prepares to seek FDA approval for anti-cancer vaccine
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Poised to file IND to commence Phase 3 trial for MS drug
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that the
Company has filed its Quarterly Report (Form 10-Q) with the SEC,
reporting the results of its operations, including consolidated results
with its majority-owned subsidiary, Biovest International, Inc.
(OTCBB:BVTI), for its third fiscal quarter ended June 30, 2008.
Accentia is primarily focused on the commercialization of its three
late-stage potential blockbuster therapeutics which are in or entering
Phase 3 clinical trials including: BiovaxID™,
a personalized anti-cancer vaccine initially targeting indolent
follicular non-Hodgkin’s lymphoma; Revimmune™
(ultra-high-dose cyclophosphamide) targeting the treatment of up to 80
autoimmune diseases, with an initial indication of multiple sclerosis;
and SinuNase™ for the treatment of chronic
sinusitis.
Significant recent milestones include:
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BiovaxID Phase 3 results demonstrated a clinically and statistically
significant improvement of disease-free survival, providing highly
encouraging safety and efficacy data which is expected to provide the
basis for seeking accelerated and/or conditional approvals in the U.S.
and Europe, respectively. Discussions are now planned with the FDA as
to the pathway to commercialization of BiovaxID.
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Leading researchers at Johns Hopkins University published
unprecedented study results in the treatment of multiple sclerosis,
showing therapy with Revimmune to be capable of restoring physical and
neurological functions with the potential to eliminate autoimmunity.
Preparations are now ongoing to file an Investigational New Drug
Application (IND) in order to commence a Phase 3 clinical trial.
Based on these key achievements, Accentia and Biovest are currently
engaged in discussions and negotiations with regards to securing
strategic alliances and licensing agreements for its products.
Financial Review:
Accentia has two operating segments consisting of specialty
pharmaceuticals (Accentia Pharmaceuticals) and product development and
market services (Analytica International). Accentia also has an
approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI),
which is consolidated for reporting purposes with Accentia’s
product development and market service business.
On a fully consolidated basis, including Biovest, net revenues for the
three months ended June 30, 2008 were $3.0 million, compared with $3.8
million for the same period ended June 30, 2007. The decrease in net
revenues was attributed to a slight decrease in net sales reported by
our subsidiaries Biovest and Analytica and our specialty pharmaceuticals
division.
Consolidated research and development costs were $1.6 million for the
third fiscal quarter, compared with $5.2 million for the same fiscal
quarter in 2007.