Message #19 From:
NewsBot Date: November 28, 2006 05:00:00 AM
ABPI News Surveys Confirm Clinical Acceptance of Fungal Etiology in Chronic Sinusitis
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), presented three posters
at the American College of Allergy, Asthma and Immunology from November 9th
-15th in Philadelphia, PA. These posters
discussed findings from surveys of U.S. and EU otolaryngologists (ENTs),
and U.S. allergists on the fungal etiology associated with chronic
sinusitis (CS), especially in patients refractory to surgery, and the
overall need for effective pharmacotherapies in CS patients in general.
The first two posters, entitled "Chronic Sinusitis Survey: Comparing EU
and U.S. Otolaryngologists” by Sherris, et al
and “Burden of Chronic Sinusitis: Survey of
U.S. Otolaryngologists and Allergists” by
Stergiou, et al, provided results from a survey administered to 60 U.S.
and EU (Germany, France and United Kingdom)-based ENTs and 80 U.S. ENTs
and allergists, respectively, on the prevalence and severity of chronic
sinusitis. The majority of surveyed U.S. ENTs saw more than 500 CS
patients per year, compared to 100-299 patients per year in EU. More
than 90% of U.S. and EU physicians saw up to 399 surgery-refractory CS
patients per year. The majority of physicians indicated that about 25%
of their CS patients are those refractory to surgery. More than 90% of
U.S. and EU physicians were dissatisfied with current treatment options
for CS, and wished a novel approved treatment was available.
Furthermore, 88.7% of physicians agreed that patients refractory to
surgery suffer from a severe and debilitating condition.
The third abstract, entitled “Fungal Etiology
of Chronic Sinusitis: Endorsement by Otolaryngologists and Allergists”
by Katz, et al,provided results from a survey of 80 U.S. ENTs
and allergists on the fungal etiology of CS. 75% of physicians believed
there is fungal etiology to CS and 83.6% agreed that surgery-refractory
CS patients are one sub-population where fungal etiology is more likely.
Furthermore, 68.6% believed intranasal antifungals are appropriate
treatment for CS patients and 73.9% supported antifungal treatment in
surgery-refractory CS patients.
Dr. Angelos Stergiou, Accentia Biopharmaceuticals Medical Director,
commented, “The fungal etiology paradigm shift
is gaining more acceptance in the U.S. and EU. The seriousness of the
disease and the potential of SinuNase™ to
become the first approved treatment for chronic sinusitis allowed the
FDA to recently grant us Fast Track status for the development program.
The enthusiasm across the medical community for our phase 3 study is
great.”
Dr. David Sherris, Professor and Chair of the Department of
Otolaryngology, at the University of Buffalo, commented, “The
growing belief in antifungal treatment in chronic sinusitis patients,
particularly in those refractory to surgery, accentuates the need for
this important Phase 3 study to determine the efficacy of amphotericin B
because surgery alone is not the solution to treating those
surgery-refractory patients.”
Conservative estimates suggest that chronic sinusitis results in 18 to
22 million office visits to physicians in the U.S. each year. Chronic
sinusitis is a debilitating disease with severe quality of life
impairment that has been compared to that of patients with congestive
heart failure. Nasal congestion and thick mucous production are just
some of the symptoms plaguing these patients.
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 for Phase III clinical
trials. The Company's other lead product is BiovaxID(TM), a
patient-specific anti-cancer vaccine for the treatment of follicular
non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's
subsidiary Biovest International, Inc.,(OTCBB:BVTI) is currently in a
Fast-Tracked Phase III clinical trial. Additionally, the Company has a
family of respiratory specialty pharmaceutical products, including
MDTurbo(TM), an FDA cleared , commercially available device that
transforms over 90% of dispensed metered-dose inhalers into a
breath-activated, dose-counting inhaler. 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.
