Message #29 From:
NewsBot Date: February 20, 2008 06:18:10 PM
Accentia Biopharmaceuticals Reports Fiscal First Quarter 2008 Financial Results
Company Affirms Plans to Unblind and Report Fast TrackPivotal
Phase 3 Results for SinuNase™ in March
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI stock message board) today announced 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 stock message board), for its first fiscal quarter ended December 31, 2007. The
Company also provided an update on its anticipated timetable to unblind
and publicly-release results on the primary end-point for its Fast Track
pivotal Phase 3 clinical trial for SinuNase™,
intending to unveil the data on or before March 24, 2008. The Company is
scheduled to present at the BioCentury “Future
Leaders in the Biotech Industry” Conference on
March 27th in New York City. In other news
related to the Company’s strategic focus on
Ear, Nose and Throat (ENT) products, Accentia announced that is has
entered into an agreement with Arbor Pharmaceuticals, Inc., granting
Accentia U.S. commercial marketing rights to Neotic™,
a novel, patented, prescription solution indicated for acute middle ear
infections (acute otitis media).
Accentia reports that the interim blinded Intent-To-Treat (ITT) results
in the randomized clinical trial in which 50% of patients receive
SinuNase and 50% receive a placebo-control shows that in the more than
250 patients who have finished the trial (approximately 84% of enrolled
patients), there continues to be evidence of significant therapeutic
effect with about 22% achieving the primary endpoint of complete
resolution of both cardinal symptoms of chronic sinusitis and another
23% achieving a complete resolution of at least one of the two cardinal
symptoms. Also, as previously reported, there continues to be a strong
positive correlation of complete symptom resolution and objective
evidence of reduced inflammation as judged by reduction in polyposis by
endoscopy and by reduction in sinus mucosal inflammation as measured by
CT scan. As previously announced, the last enrollee in the clinical
trial completes the 16-week endpoint assessment during this month.
For more information on SinuNase Phase 3 interim, blinded results to
date, see: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5611646.
Accentia continued to build its specialty pharmaceuticals sales and
marketing division which focuses on ENT products by obtaining the rights
to Neotic, a patient-convenient, patent-protected topical ear product
that comprehensively addresses the symptoms associated with acute middle
ear infections and is the only ear product with a unique three-mode
mechanism of action to optimize symptom control. Preferred practice
guidelines have shifted away from the dependence on oral antibiotics for
the treatment of otitis media based on evidence showing their relative
lack of clinical efficacy and a significant rise in antibiotic
resistance. Accentia and Arbor expect to launch the product in the
fourth calendar quarter of this year, targeting an indication that is
the cause of more than 30 million doctor office visits in the U.S.
annually. The topical otic analgesic market generates more than 2
million prescriptions each year for various products, representing an
estimated $500 million per year market. Neotic becomes the second
product that Accentia is commercializing for Arbor, as Arbor previously
granted Accentia the exclusive U.S. commercial marketing rights to
Zinotic™, a novel topical solution indicated
for use in common outer ear infections (acute otitis externa).
For more information on the BioCentury Conference, please visit:
www.biocentury.com/BCApp/BioCenturyCommon/BCConferences.aspx?ss=1.
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 sales for the
three months ended December 31, 2007 were $4.3 million, compared with
$5.9 million for the same period ended December 31, 2006. This decrease
was primarily attributed to a decrease of $1.3 million in net sales in
our Specialty Pharmaceuticals segment primarily due to the divestiture
of our Xodol and Histex product lines, the discontinuance of our
Respi-Tann G product line, product returns and, to a lesser extent, a
decrease in net sales of our Analytica subsidiary.
Consolidated research and development costs were $3.8 million for the
first fiscal quarter, compared with $4.4 million for the same fiscal
quarter in 2007. This 13% decrease was largely due to our Biovest
subsidiary reducing R&D expenses as its clinical trial costs have
declined considerably in advance of the pending interim analysis of
Phase 3 results for BiovaxID™. Biovest
expects to file for conditional approval for BiovaxID in the U.S. and
Europe, assuming positive results. The Biovest decrease in R&D expenses
of $2.0 million was partially offset by an increase of $1.4 million in
the Phase 3 clinical trial expense for SinuNase.
Accentia’s first quarter net loss, on a fully
consolidated basis, including Biovest, was $24.8 million, compared to
$30.6 million reported for the same three month period in fiscal 2007.
Of this loss, $17.6 million, or approximately 71% was the result of
non-cash charges such as accretion of capitalized finance cost,
derivative loss and loss on extinguishment of debt.
The fully consolidated loss per share for the quarter was $0.60, of
which $0.42 per share was the result of non-cash charges and $0.09 per
share reflected losses by Biovest, which are consolidated in Accentia’s
financial statements, although since February 2007, Biovest has been
self-funded. For the comparable 2007 quarter, the fully consolidated
loss per share was $0.97 of which $0.68 was the result of non-cash
charges and $0.76 per share reflected losses by Biovest. The Company
notes that the operating loss for Biovest has been substantially reduced
in part due to Biovest’s decision in
conjunction with the Data Monitoring Committee to temporarily halt
enrollment in the BiovaxID Fast-Tracked pivotal Phase 3 trial for data
lock and unblinding, and in part due to continued operating
profitability in its cell culture and instrumentation divisions.
At December 31, 2007, Accentia had approximately $0.6 million of cash
and cash equivalents, and approximately $5.0 million in restricted cash,
of which $3.2 million was attributed to Biovest. As previously reported,
Biovest secured an $8.5 million financing in December. Subsequent to
December 31, Accentia received proceeds from a private placement of
approximately $8.7 million of convertible preferred stock. The Company
expects to have access to additional sources of capital following the
unblinding of the SinuNase and BiovaxID Phase 3 clinical trials data,
including through potential corporate collaborations and licensing
agreements.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated
biopharmaceutical company focused on the development and
commercialization of drug candidates that are in late-stage clinical
development and typically are based on active pharmaceutical ingredients
that have been previously approved by the FDA for other indications.
Usually these drug candidates can access the accelerated 505(b)(2)
regulatory approval pathway, which is generally less time-consuming and
less expensive than the typical 505(b)(1) pathway that must be used for
new chemical entities. The Company's lead product candidate is SinuNase™,
a novel application and formulation of a known therapeutic to treat
chronic rhinosinusitis. SinuNase has been granted Fast Track status by
the FDA and it is currently in a pivotal Phase 3 clinical trial. During
this fiscal year, the Company also plans to file an Investigative New
Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune™,
to treat numerous autoimmune diseases with an initial indication
targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune
is based on pulsed, ultra-high dosing of a well-known chemotherapeutic
agent under a risk management program. Additionally, through an
investment strategy, the Company has acquired the majority ownership
interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty
interest in Biovest's lead drug candidate, BiovaxID™
and any other biologic products developed by Biovest. Biovest is
currently conducting a pivotal Phase 3 clinical trial for BiovaxID which
is a patient-specific anti-cancer vaccine focusing on the treatment of
follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track
status by the FDA. In addition to these product candidates, the Company
has a specialty pharmaceutical business, which markets products focused
on respiratory disease and an analytical consulting business that serves
customers in the biopharmaceutical industry.