Printer Friendly
The Free Library
19,585,946 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Accentia Biopharmaceuticals in Discussions with Pharmaceutical Companies on SinuNase Partnership.


SinuNase is Fast-Tracked and the First and Only Phase 3 Product for Chronic Sinusits

TAMPA, Fla. -- Accentia Biopharmaceuticals (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 entered into mutual confidentiality agreements with several pharmaceutical companies that have established respiratory care franchises. These companies have approached Accentia regarding SinuNase[TM], a unique formulation of low-dose 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. , in development for the treatment of 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 . Accentia believes that potential relationships with appropriate pharmaceutical partners could provide upfront and milestone payments as well as enhance the commercial opportunity for SinuNase, especially within the primary care market in the U.S. and in international markets.

Interest from pharmaceutical companies to partner has been stimulated by the fact that Accentia has commenced a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  for SinuNase in patients with severe chronic sinusitis that are refractory to sinus surgery. SinuNase is the first and only product in a Phase 3 clinical trial for chronic sinusitis. Moreover, SinuNase has been granted Fast-Track status by the Food and Drug Administration (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.
). There is currently no approved pharmaceutical available for chronic sinusitis, a condition that affects 31 million patients, and represents a market almost twice the size of the asthma market, which is the next largest among respiratory diseases. To date, 43 clinical trial sites have been initiated and 29 have been cleared to enroll patients.

Upon the anticipated approval of SinuNase by the FDA, Accentia plans to focus its commercial efforts using its respiratory sales force on the approximately 15,000 U.S. ear nose & throat (ENT ENT ears, nose, and throat (otorhinolaryngology).

ENT
abbr.
ear, nose, and throat



ENT

ear, nose and throat.

ENT Ears, nose & throat; formally, otorhinolaryngology
) and allergist al·ler·gist
n.
A physician specializing in the diagnosis and treatment of allergies.


allergist Immunology A physician, who is often trained in both internal medicine and clinical immunology and who manages Pts with
 specialists who treat patients with the most severe cases of chronic sinusitis. These specialists are considered opinion leaders in the diagnosis and management of chronic sinusitis. Relationships with these specialists have been facilitated by Accentia's ongoing marketing of MD Turbo[TM], an FDA-cleared medical device that optimizes the use of metered dose inhalers (MDIs) for asthma patients, a condition that is found in at least 60% of chronic sinusitis patients, and CRSFungal Profile[TM] test, the only lab test available for the diagnosis of chronic sinusitis. Additionally, all of the physician investigators in the current Phase 3 trial are ENTs or allergists.

About Accentia Biopharmaceuticals, Inc.

Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development of late-stage "disruptive" clinical products. Accentia has a portfolio of currently marketed respiratory products and a pipeline of products in clinical development. The company's lead respiratory product candidate is SinuNase[TM], which is under clinical development to treat chronic sinusitis (rhinosinusitis). SinuNase is a novel application and formulation of a known anti-fungal exclusively licensed from the Mayo Foundation for Medical Education and Research. The product has been Fast Tracked by the FDA and we will commence Phase 3 trials soon. The Company's other lead product is BiovaxID[TM], a patient-specific anti-cancer vaccine for the treatment of 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 
. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:BVTI) is currently in a Fast-Tracked Phase 3 clinical trial. Additionally, the Company has a family of respiratory specialty pharmaceutical products, including MDTurbo[TM], an FDA approved, commercially available product that transforms over 90% of dispensed metered-dose inhalers 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.
. For further information, please visit www.accentia.net.

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[TM], BiovaxID[TM], AutovaxID[TM] and any other statements relating to products, product candidates, product development programs the FDA 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.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Dec 21, 2006
Words:758
Previous Article:Medivir: Tibotec Files Application to Start a Phase I Clinical Trial for HCV Inhibitor.
Next Article:A.M. Best Affirms Ratings of Sony Life Insurance Company Limited.
Topics:



Related Articles
Accentia Biopharmaceuticals Receives FDA Approval for Three Unique Dosage Combination Pain Product ANDAs; Accentia's Portfolio Expands to Six...
Accentia Biopharmaceuticals To Raise $ 8.2M in Equity Financing.
Accentia Biopharmaceuticals, Inc. to Present at the Jefferies Life Sciences Conference.
Accentia Biopharmaceuticals Commences Fast-Tracked Phase 3 Clinical Trial of SinuNase for the Treatment of Chronic Sinusitis.
Report Shows Use of a SinuNase Formulation is Associated With a Significant, 74% Reduction in Reoperations for Chronic Sinusitis Patients Who Are...
Accentia Biopharmaceuticals, Inc. Enters into a Definitive Agreement for a $25 Million Exchangeable Convertible Debenture Financing.
Accentia Biopharmaceuticals to Present at Rodman & Renshaw 8th Annual Healthcare Conference on November 6, 2006.
Accentia Biopharmaceuticals Reports Fiscal 2006 Year-End Results.
Accentia Biopharmaceuticals, Inc. Updates Results of Nationwide Testing with CRSFungal Profile: The First Diagnostic Test Available for the...
Accentia Biopharmaceuticals Makes Milestone Payment Based on Fast Tracked Pivotal Phase 3 Study with SinuNase for the Treatment of Chronic Sinusitis.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles