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This presentation includes forward-looking statements including statements regarding the timing and

outcome of clinical trials, potential regulatory approvals, future demand for and sales of our products and

the

future

development

new

products.

These

statements

are

not

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future

performance

and the Company's actual results could differ materially and adversely from those expressed in any

forward looking statements. Additional information concerning factors that could cause such differences

is contained in Accentia’s filings with the Securities and Exchange Commission. Such forward-looking

statements are subject to known and unknown risks, uncertainties, and other factors that may cause our

actual results to be materially different 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

Accentia’s

clinical

trials

and

product

development

programs.

All

forward

looking statements in this presentation are qualified in their entirety by this cautionary statements and we

undertake

obligation

revise

update

this

presentation

reflect

developments,

events

circumstances after the date hereof.

Chronic sinusitis

Symptoms

•

Chronic nasal obstruction

•

Chronic post-nasal drip and rhinorrhea

•

Chronic periocular

headaches

•

Recurrent bouts of acute bacterial sinusitis

Signs

•

Intranasal polyps on endoscopy

•

Mucosal thickening on CT of sinuses

Costs

•

$5.8 Billion per year in direct costs

•

30 Million antibiotic prescriptions per year

•

9.2 Million office visits

•

0.6 Million sinus surgeries/year

Chronic Sinusitis : Mucosal changes due to eosinophilic

infiltration of tissue…fungus is non-invasive

Chronic Sinusitis : Mucosal changes due to eosinophilic

infiltration of tissue…fungus is non-invasive

Eosinophils

in tissue

migrate into mucus to

attack fungus

Polyps by endoscopy

Sinus mucosal thickening

by CT scan

Eosinophils

and

fungus in mucus

How bad is it? Impact on Quality of Life is worse than back pain,

congestive heart failure, chronic obstructive pulmonary disease

How bad is it? Impact on Quality of Life is worse than back pain,

congestive heart failure, chronic obstructive pulmonary disease

CS impact on bodily pain scores (lower is worse), compared to congestive heart failure,

COPD, angina, and back pain/sciatica. (Glicklich, 1994).

Prior management of CS

Hampered by lack of understanding of the pathogenesis

No approved pharmaceutical

Nothing has ever been in phase 3 study

Development pipeline: intranasal antibiotic

Functional endoscopic surgery

•Improve airway and sinus drainage by excising polyps

•Improve sinus drainage by enlarging the natural ostia

Intranasal steroids

Intranasal antihistamine

Short pulse of oral steroids

Lavage

with saline

paradigm

shift:

The

cause

chronic

sinustis

host sensitivity to a common mold (Alternaria)

paradigm

shift:

The

cause

chronic

sinustis

host sensitivity to a common mold (Alternaria)

•

Airborne Alternaria

spores are ubiquitous

•

Pigmented saprophytic mold (decaying vegetation)

•

Also part of the black mold on damp gypsum board (sick buildings)

•

Hyphal

elements are very large (~200 microns in diameter)

•

Patients with and without chronic sinusitis have the mold in the

mucus

•

Patients with chronic sinusitis are sensitive to a secreted protein

•

Eosinophilic

response in patients with chronic sinusitis to the secreted protein

•

Eosinophils

migrate into the mucus and degranulate

injuring mold and tissue

CRS: An Immune Response to Fungi

Electron microscopy image:

Eosinophil

(blue) releasing

major basic protein as it

comes into contact with a

fungal hyphae

(green).

This toxic protein is

damaging to both the

fungus and the mucosal

tissue of the sinus and

nose.

Reactivity to fungus is responsible for CS

Eosinophils

target fungi in the mucin

of CS

patients. When that occurs, the eosinophils

release toxic granule proteins, such as

major basic protein (MBP). MBP in mucin

indicates a reaction to the fungus.

•70%

submitted

(10,000+)

specimens

are

MBP

positive

•100% of all CS patients (299/299) in trial are MBP positive

•

This

strong

correlation

supports

the

paradigm

shift

fungal-driven inflammatory etiology (cause) for CS

CRS Treatment Strategy: Topical Antifungals

•

Systemic antifungals associated with side effects

•

All side effects are dose related

•

Fungi are only in the mucus

•

Intranasal delivery would avoid systemic effects

•

Direct mucoadministration: high dose to organism, low dose to

host

•

Reduction of antigenic load is the goal, NOT eradication of the fungus

SinuNase License

Accentia’s

License from the Mayo Foundation:

Exclusive global license for intranasal Amphotericin

B for

Exclusive option to license all other antifungals

until Dec

2008

Patent expires 2018: method of use for product and for

diagnostic.

Additional patents pending on formulations

Sales-based royalties : cumulative 23%

Estimated selling price $200/month (based on compounded

products) with 5% COGS

SinuNase Study Summary

(p<0.0012)

Pump Spray

2003 Geneva University

Study (Pump Spray)

(p<0.04)

SNOT-20

Lavage

2004 Mayo Clinic Study

Double blind, randomized

placebo controlled study

(p=0.018)

Pump Spray

2006 Corradini

Study (Pump

Spray)

Objective Improvement?

Subjective Improvement?

Lavage

or Pump Spray?

Study Center

(P<0.001)

Lavage

2002 Mayo Clinic Study

(p<0.0012)

Lavage

2002 Geneva University

Study

SinuNase: Study Protocol Pivotal Fast Track Phase 3

Complete resolution of both cardinal symptoms (eliminated debate

over what constitutes a clinically meaningful improvement in

symptoms). Objective secondary endpoints include endoscopy, CT

of sinuses, biomarkers in mucus

Primary Endpoint

Secondary Endpoints

Unblinding

commenced this week

Un-blinding

120 days

Study duration per patient

Over 60

Number of study centers

Patients who have clinically definite refractory, post-surgical CS will

be enrolled. Subjects must have signs and symptoms of recurrent

CS and a history of prior maxillary sinus surgery for CS consisting

of antrostomy with or without polypectomy at least 6 months prior to

study entry. Patients must report and experience cardinal

symptoms

of CS (nasal congestion and sinus headaches), must

have polyposis, and must have CT scan changes

Patient population

Pivotal Phase III (300 patients enrolled)

Study phase

Refractory (post-surgical) CS (chronic sinusitis)

Indication

Placebo (matches SinuNase pH, tonicity, appearance, and color)

Comparative drug

Amphotericin B intranasal suspension 0.01% (no burning, no taste,

no odor)

Study medication

ACC-05-01 -

Amphotericin B Suspension in Refractory Chronic

Sinusitis

Study Number

SinuNase Lavage

Formulation

SinuNase Lavage

Formulation

Designed to allow ease of dispensing and low

cost of goods

Stable: room temp for 18+ months

Simple: preparation consistent with

ubiquitous saline lavages

Demonstrated

greatest

in-vitro

efficacy

when

compared to previously tested formulations

Compliant: all CTM contractors experienced,

qualified

Validated: blend uniformity and fill volume;

diluent sterility

Nasaline syringe provides measured dose

applied to nose with positive pressure as with

bulb syringe

Is 100 ug/cc of Ampho

B adequate?

Is 100 ug/cc of Ampho

B adequate?

MIC50 for Amphotericin

B is ~1ug/cc or 100X less

than SinuNase clinical formulation

Placebo control for SinuNase clinical trial has no

antifungal effect in vitro

from

Pujol,

al.

Antimicrobial

Ther

(2000)

46,

323-342

Intent to Treat Analysis (ITT)

N = 147

N = 143

Resolution of Congestion

and Headache at Week 16

60%

20%

No Resolution

Partial Resolution

Complete Resolution

Note: Includes subjects discontinued from randomization

Change in Endoscopy Scores, by

Nostril, from Screening to Week 16

34%

18%

30%

13%

Decreased in Both

Decreased in One, Remained the Same in the Other

Remained the Same in Both

Increased in One, Remained the Same in the Other

Increased in Both

CT Scan Results (ITT; Week 16)

CT Scan Results at Week 16

57%

43%

Decrease in Percent Mucosal Thickening

Increase in Percent Mucosal Thickening

(Note: Does not include all subjects discontinued from randomization)

CT Scan Results at Week 16

Percent Change in Mucosal Thickening

Symptom Resolution and Endoscopy Score Change

SinuNase vs. Placebo (1:1) (Week 0 to 16)

Randomization (Week 0)

Saline Wash

(Week -2 to 0)

n=32; Does not include subjects discontinued from randomization

Only includes subjects who had complete resolution at week 16

Visit at which Subjects First Experience Relief of Congestion, Headache, or Both and

Endoscopy Score Change

44%

60%

79%

82%

88%

94%

97%

100%

28%

42%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

-2

Week

10%

15%

20%

25%

30%

35%

40%

45%

Symptoms

Endoscopy

Median Score

10%

19%

24%

40%

33%

30%

10%

15%

20%

25%

30%

35%

40%

45%

Placebo

Active (Minimum response for

statistical significance)

Imputed % of SinuNase

responders

Imputed % of SinuNase responders for any given % of placebo responders and the

corresponding minimum SinuNase response rate for statistical significance.

Imputed % of SinuNase responders for any given % of placebo responders and the

corresponding minimum SinuNase response rate for statistical significance.

Un-blinded Results (ITT)

299 patients enrolled/299 randomized

eMBP

in nasal mucus

100% (299 out of 299)

Implications: virtually 100% of CS due to fungal-induced inflammation

Safety

Two arms indistinguishable

Not one serious adverse event attributable to drug

Not one example of allergic reaction

Primary endpoint (Patient Reported Outcome)

Complete Resolution of Two Cardinal Symptoms

Throughout study and at week 16:

Superiority of SinuNase arm to placebo control lavage

(O'Brien composite ranking P=0.14)

Why Placebo Responders?

Why any placebo control responders??

True placebo or some therapeutic effect?

Secondary endpoints

Endoscopy score changes ...pending

CT scan changes ...pending

Biomarkers* in nasal mucus...pending

Composite symptom score...pending

*Biomarkers include fungal antigens, inflammatory cytokines

Saline Lavage

Trials in Chronis Sinusitis (CS)

Saline Lavage

Trials in Chronis Sinusitis (CS)

6 point visual analog scale: 0.3

pt. delta for each

6 point visual analog scale:

0.3 pt. delta for each

Ems salt solution

and saline

Yes

Bachmann

(2000)

Yes

Confirmed

Polyposis

recurred in 44% of

saline treated pt’s

N/A

Saline lavage

intranasal

steroids

Bross-Soriano

(2004)

Worsened CT scans

Increased inflammation

Did not improve endoscopy

staging

Sterile water

lavage

Ponikau, et

al(2005)

Objective Improvement?

Effect on Symptoms?

Placebo Solution

Description

(control groups)

Study

Conclusion: No evidence that saline or water lavage

can eliminate

symptoms, reduce polyposis, or improve mucosal thickening on CT scan

Ebbens

and Fokkens

Study (JACI Nov 2006)

Ebbens

and Fokkens

Study (JACI Nov 2006)

No significant differences were observed

after 13 weeks of treatment

Results

Primary outcomes included a reduction in total visual analog scale

(VAS)

score

symptoms

and

nasal

endoscopy

score.

Endpoints

116 patients with CRS

were

instructed

instill

amphotericin

(100

mg/mL)

placebo

each

nostril

twice

daily

for

months.

Patients

Double-blind,

placebo-controlled,

multicenter

study

comparing

the

effectiveness

compounded

amphotericin

nasal

lavages

with

placebo

using

the

EMCUR

delivery

device.

Objective

Why no effect? Insufficient delivery with Emcur

device (no pressure). SinuNase

Study uses Nasaline

device to deliver lavage

under pressure.

Summary: 10 Key Points on SinuNase

1. Largest

untapped

pharma

market

and

2. No competitor in the pipeline

3. Patent-protected product

4. Patent-protected companion diagnostic

5. Well-tolerated formulation

6. Very low risk of adverse effects

7. Low cost of goods

8. Acceptance of a fungal-induced etiology by specialists

9. Built in user-base at launch (off-label compounding)

10. Evidence for efficacy in well-documented severe CS…unfolding