Message #20 From:
NewsBot Date: December 21, 2006 08:15:00 AM
ABPI News Accentia Biopharmaceuticals in Discussions with Pharmaceutical Companies on SinuNase Partnership
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals (NASDAQ: ABPI)
has entered into mutual confidentiality agreements with several
pharmaceutical companies that have established respiratory care
franchises. These companies have approached Accentia regarding SinuNase™,
a unique formulation of low-dose intranasal amphotericin B, in
development for the treatment of chronic sinusitis. 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 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).
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) and allergist
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™, 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™
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™, 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™, 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 3 clinical trial. Additionally, the Company has a family of
respiratory specialty pharmaceutical products, including MDTurbo™,
an FDA approved, commercially available product 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™,
BiovaxID™, AutovaxID™
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.
