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Accentia Biopharmaceuticals Reports Fiscal Third Quarter 2006 Financial Results; Accentia Reaches Significant Milestones, Including Commercial Launch of MD Turbo in Late June.


TAMPA, Fla. -- Accentia Biopharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABPI ABPI Association of the British Pharmaceutical Industry
ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil)
ABPI Ankle Brachial Pressure Index
) has released the financial results for its fiscal 2006 third quarter, ended June 30, 2006.

During the period, the Company's primary focus was threefold: the commercial launch of MD Turbo(TM), the first and only device that transforms more than 90% of dispensed metered-dose inhalers (MDIs) into a breath-activated, dose-counting inhaler inhaler /in·hal·er/ (in-hal´er)
1. an apparatus for administering vapor or volatilized medications by inhalation.

2. ventilator (2).


in·hal·er
n.
; the development of SinuNase(R), its potential blockbuster intranasal in·tra·na·sal
adj.
Within the nose.
 Amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces.  formulation for Chronic Sinusitis chronic sinusitis Chronic sinus infection ENT Inflammation of the sinuses that empty into the nasal cavity Etiology Allergic rhinitis, nasal obstruction, deviated nasal septum, tooth abscesses, URIs  (CS); and, through its majority-owned subsidiary majority-owned subsidiary

A firm in which more than 50% of outstanding voting stock is owned by the parent company.
, Biovest International, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: BVTI), the development of another potential blockbuster product, BiovaxID(TM), a personalized biologic therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune intended to treat a viral infection by stimulating the immune system. See Vaccine therapy.  for follicular fol·lic·u·lar
adj.
1. Relating to, having, or resembling a follicle or follicles.

2. Affecting or growing out of a follicle or follicles.
 non-Hodgkin's lymphoma non-Hodg·kin's lymphoma
n.
Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells.


Non-Hodgkin's lymphoma 
.

Accentia has two business segments: specialty pharmaceuticals, which is a development stage business; and biopharmaceutical products and services. Biovest, a majority-owned subsidiary, is consolidated with Accentia for reporting purposes.

Financial Review

On a fully consolidated basis, including Biovest, net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
 for the third quarter of 2006 were $5.7 million, an increase of $0.1 million from the same period ended June 30, 2005. Research and development costs were $3.5 million during the third quarter this year, an increase of $0.3 million, or 11%, over the same three-month period in 2005. This was primarily attributable to increased activity in the Company's clinical trials with BiovaxID and SinuNase.

Accentia's third-quarter net loss, on a fully consolidated basis, including Biovest, was $12.1 million, a $2.2-million increase from the same three-month period in 2005. Of this loss, $1.9 million, or approximately 16%, was the result of non-cash charges such as depreciation, amortization of product rights, stock-based compensation, and amortization of debt discount.

The fully consolidated per-share loss was $0.40, of which $0.06 per share was the result of non-cash charges, and $0.14 per share reflected losses incurred by Biovest. On a fully consolidated basis, the Company's nine-month year-to-date loss was $0.98 per share, including adjustments for derivative accounting. When using the same number of outstanding shares to compute the per-share loss in the comparable nine-month period in 2005, the loss was $1.07 per share. When computing the loss per share for the nine months ended June 30, 2005 using the weighted number of outstanding shares for that period, prior to the Company's IPO (Initial Public Offering) The first time a company offers shares of stock to the public. While not a computer term per se, many founders, employees and insiders of computer companies have found this acronym more exciting than any tech term they ever heard.  (initial public offering), the loss per share was $5.56.

On a fully consolidated basis Accentia's capital resources at the end of the third quarter for 2006 were approximately $9.1 million, consisting of cash, restricted cash and availability under lines of credit. Additionally, at June 30, 2006 Accentia carried an inter-Company demand note from Biovest in the amount of $7.1M, which Accentia anticipates will be repaid by Biovest as it completes additional financings. At June 30, 2006 Accentia also owned Biovest common shares valued in excess of $50 million based on BVTI's market price at the close of the quarter.

Recent Company Highlights:

"Since the start of the third quarter of our fiscal year, April 1, 2006, Accentia Biopharmaceuticals and its majority-owned subsidiary, Biovest International, have reached substantial developmental and commercial milestones," said Frank E. O'Donnell, Jr., M.D., the Company's Chairman and Chief Executive Officer.

The most noteworthy recent developments, according to the Company, are the following:

--Independent market research sponsored by Thomas Weisel Partners Thomas Weisel Partners Group, Inc. (NASDAQ: TWPG), often shortened to just TWP or TWeisel, is a U.S. middle-market and growth focused investment banking firm based in San Francisco, California.  demonstrated that a majority of specialists are aware of and are receptive to the potential use of SinuNase as a treatment for chronic sinusitis. Accentia holds an exclusive worldwide license for SinuNase for the treatment of chronic sinusitis, for which there is currently no commercially available pharmaceutical treatment. Furthermore, Accentia signed an extension with the Mayo Foundation for Medical Education and Research of its exclusivity agreement for all other antifungals until December 6, 2007. This includes any non-prescription products, with the requisite antifungal activity, for this indication. Accentia is preparing to commence, under a Fast Track program, its phase 3 trials of SinuNase in severe refractory chronic sinusitis.

--BiovaxID was granted Orphan status for the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
.

--AutovaxID(TM) units were scheduled to be assembled for commercial launch in October 2006.

--Two new dosages of Xodol(R) were launched. The new dosages afford physicians additional choices in patients' dosage levels of hydrocodone, without exceeding the maximum daily dose of acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. . Accentia holds the exclusive U.S. license for the marketing and sale of these products.

--Accentia began detailing MD Turbo to physicians June 19, 2006. The Company has also successfully established MD Turbo as a covered prescription benefit in managed care plans covering approximately 150 million people, and as a covered benefit with plan sponsors under Medicare Part D. MD Turbo is a unique, patent-protected device that converts most MDIs into automated delivery by using a breath-actuated firing mechanism and which features an electronic dose counter. MD Turbo enhances the likelihood that the drug is delivered into the lungs. Published clinical studies have demonstrated that about 50% of MDI (1) (Multiple Document Interface) A Windows function that allows an application to display and lets the user work with more than one document at the same time.  doses are self-administered incorrectly, as optimal MDI use normally requires precise coordination of the manual firing of the MDI during the correct phase of inspiration. Typically, patients have no feedback as to whether the dose was administered to the lungs or ended up on the back of the throat instead. Additionally, MDIs typically lack a dose counter so patients often do not know how much drug is left in their MDI. Because MDIs usually have 20-80% more propellant pro·pel·lant also pro·pel·lent  
n.
1. Something, such as an explosive charge or a rocket fuel, that propels or provides thrust.

2.
 than active drug, patients often incorrectly assume that they are still getting the drug from their MDI when, in fact, it has exhausted its drug supply and all that is being released is propellant. MD Turbo's electronic dose counter has the potential to reduce the almost 80% prevalence of patients being at risk for using their MDIs after exhausting the available medication.

About Accentia Biopharmaceuticals, Inc.

Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase and BiovaxID. The Company's SinuNase product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. . In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, please visit our web site: www.accentia.net.

About Biovest International, Inc.

Biovest International, Inc. (OTCBB: BVTI.OB) is a pioneer in the development of advanced individualized in·di·vid·u·al·ize  
tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es
1. To give individuality to.

2. To consider or treat individually; particularize.

3.
 immunotherapies for life-threatening cancers of the blood system. Biovest is a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and for clinical trials. In addition, Biovest develops, manufactures, and markets patented cell culture systems, including the AutovaxID which is being developed as an automated vaccine manufacturing instrument. Biovest's therapy for follicular non-Hodgkin's lymphoma, BiovaxID, is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).

A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together.
 (CRADA CRADA Cooperative Research And Development Agreement ) with the National Cancer Institute. For further information, please visit Biovest's website: 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 SinuNase, BiovaxID, AutovaxID and any other statements relating to products, product candidates, product development programs the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 or clinical trial 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 Accentia 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 Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Comment:Accentia Biopharmaceuticals Reports Fiscal Third Quarter 2006 Financial Results; Accentia Reaches Significant Milestones, Including Commercial Launch of MD Turbo in Late June.
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Date:Aug 15, 2006
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