Paratek Pharmaceuticals 8K Novacea, Inc. and Transcept Pharmaceuticals, Inc. Sign Merger Agreement | PRTK 2 Sep 08

September 2008

Exhibit 99.3

Safe harbor statement

This slide deck contains forward-looking statements that are based upon current

expectations

within

the

meaning

the

Private

Securities

Reform

Act

1995.

intend

that such statements be protected by the safe harbor created thereby. Forward-looking

statements involve risks and uncertainties and our actual results and the timing of events

may differ significantly from the results discussed in the forward-looking statements. We

undertake no obligation to revise or update the forward-looking statements made herein

whether as a result of new information, future events or otherwise. Examples of such

forward-looking statements include, but are not limited to, statements about or relating to:

the submission for regulatory approval of Intermezzo with the U.S. FDA, the timing of such

submission,

and

the

scope

indications

potentially

covered,

well

the

potential

timing

for marketing approval and product launch based on such submission; clinical trials with

respect to our other drug candidates, including TO-2060 and TO-2061, including the

anticipated dates of data availability under currently ongoing trials; the size and scope of

potential markets and potential revenues for Intermezzo and our other drug candidates and

expected benefits of our drug candidates.

Such forward-looking statements involve risks and uncertainties, including, but not limited to,

those risks and uncertainties relating to: difficulties or delays in development, obtaining

regulatory approval for, and undertaking production and marketing of our drug candidates;

unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates

that

could

slow

prevent

product

approval;

positive

results

clinical

trials

may

not

sufficient to obtain FDA approval; physician or patient reluctance to use Intermezzo, if

approved; our ability to obtain additional financing if necessary; changing standards of care

and the introduction of products by competitors or alternative therapies for the treatment of

indications we target; the uncertainty of protection for our intellectual property, through

patents, trade secrets or otherwise; and potential infringement of the intellectual property

rights or trade secrets of third parties.

Deriving new patient benefits from proven CNS drugs

–

Enhanced performance and new indications

–

Known safety and efficacy profile from established parent compounds

–

Reduced risk development strategy

–

Proprietary products; significant market opportunities

Intermezzo

: low-dose sublingual zolpidem, MOTN insomnia

–

Phase 3 complete, NDA planned late 2008

–

New indication in the $4+ billion insomnia market

Founded 2002; SF Bay Area; 37 employees

Cash at June 30, 2008: $24.2 million

Specialty pharmaceutical company: large and growing

markets; first NDA submission planned late 2008

Specialty pharmaceutical company: large and growing

markets; first NDA submission planned late 2008

Experienced management team

Idenix, Novartis

Susan Koppy,

VP Corp Dev

Peninsula Pharmaceuticals

Sharon Sakai, PhD,

Sr Dir Regulatory

Alza

Nipun Davar, PhD,

VP Pharm Sci

Abbott, Lorex, Sanofi

Steinberg,

DO,

consulting

CMO

Montreux Equity Partners

Thomas P. Soloway,

CFO

Organon, Wyeth, J&J, Lilly

Terrence Moore,

VP Marketing/Sales

Procter & Gamble, Searle, Watson

Nikhilesh Singh, PhD,

CSO/Founder

BMS, Allergan, Neutrogena,

Oclassen Pharmaceuticals

Glenn A. Oclassen,

CEO/President

Pfizer, Abbott, Genentech

G. Kirk Raab,

Chairman

Intermezzo

Low dose zolpidem for

middle of the night (MOTN) insomnia

Proposed indication statement:

“Intermezzo

(zolpidem tartrate sublingual lozenge) is indicated for the

treatment of insomnia characterized by difficulty returning to sleep after

awakening in the middle of the night”

10% to 15% seek

physician help

(3)

$1.4B 2002 to $5B 2010

(2)

New understanding of

insomnia leads to new

products

100

million

people

(2)

Insomnia market growth (‘07 over

‘06): 9% in demand (TRx),

5% in value

(1)

2003

2004

2005

2006

2007

Rx insomnia therapeutics: a $4 billion market

(1) IMS Health, (2) In Vivo Feb 2006, (3) Business Week Oct 8, 2007

Under

penetrated

Large

Segmentation

Growth

Stanford Sleep Epidemiology Research Center:

MOTN awakening: the #1 insomnia symptom

Stanford Sleep Epidemiology Research Center:

MOTN awakening: the #1 insomnia symptom

Large scale population based sleep epidemiology study,

~9,000 subjects over 6 years

–

Ohayon

MM:

Nocturnal

Awakenings

and

comorbid

disorders

the

American general population, Journal of Psychiatric Research (2008)

–

Nocturnal awakenings: prevalence, comorbidity and daytime

consequences:

APSS

symposium,

June

2008,

Maurice

Ohayon,

MD, DSc, PhD, Thomas Roth, PhD, Michael Vitiello, PhD and James

Walsh, PhD

35% report MOTN awakenings at least 3 times per week

>90% report the condition persists more than six months,

>50% report more than 5 years

>6 million Americans consult with a physician regarding their

MOTN awakenings

200

400

600

800

1000

1200

1400

1600

8-9pm

9-10pm

10-

11pm

11-

12am

12-1am

1-2am

2-3am

3-4am

4-5am

5-6am

6-7am

All MOTN

treatment calls

MOTN calls with

>=4 hours

remaining in bed

Phase 3 outpatient study n = 294

Intermezzo

: outpatient study: 96% of > 5,000

awakenings had at least 4 hrs remaining in bed

Intermezzo

: outpatient study: 96% of > 5,000

awakenings had at least 4 hrs remaining in bed

MOTN

awakenings

typically

occur

nights

per

week

(1)

not every night, even in severe chronic insomnia

8 hour sleep aids require bedtime prophylactic dosing

before an awakening occurs

The ideal therapeutic would be used only when and if a

patient needs help returning to sleep, not every night

Hypothesis: availability of medication “as needed in the

middle of the night”

may reduce anxiety and enable

patients to more readily return to sleep without a sleep aid

(1)

Ohayon

MM:

Nocturnal

Awakenings

and

comorbid

disorders

the

American

general

population,

Journal

Psychiatric

Research

(2008),

and

Transcept

Pharmaceuticals

Phase

outpatient

study,

294

Sleep lab clinical result:

14 minute sleep onset with 3.5 mg dose

Patients reported greater next day alertness

vs. placebo

Sublingual lozenge dissolves in ~ 2 minutes

pH driven free base zolpidem

72% dose reduction vs. the most commonly

prescribed brand

Used only when needed

(1) Ohayon

MM:

Nocturnal

Awakenings

and

comorbid

disorders

the

American

general

population,

Journal

Psychiatric Research (2008)

Novel formulation

Low dose

Fast acting

Positive

next day effects

Patient control

Normal Saliva

pH = ~6

pH = 6.9

(“pKa”)

pH = 9.5

pH = pKa

pH < pKa

pH > pKa

Hydrophilic

zolpidem (88%)

Hydrophilic

zolpidem (50%)

Lipophilic zolp (12%)

Lipophilic zolpidem

(50%)

Lipophilic zolpidem

(~ 100%)

Bimucoral

technology drives pH above pKa

Rapid

bioavailability

driven

Bimucoral

technology

Rapid

bioavailability

driven

Bimucoral

technology

Intermezzo

3.5 mg delivered

zolpidem

earlier

than

~3x

higher

Ambien

dose

Intermezzo

3.5 mg delivered

zolpidem

earlier

than

~3x

higher

Ambien

dose

PK comparison study: Intermezzo

3.5mg vs. Ambien 10mg PO n=36

Time (min)

9.3x

2.9x

1.4x

Intermezzo

3.5 mg

Ambien

10 mg

Intermezzo 3.5mg

Ambien 10mg p.o.

Intermezzo

Phase 3 clinical results

Intermezzo

Phase 3 clinical results

Low dose zolpidem for

middle of the night (MOTN) insomnia

Intermezzo

: Phase 3 sleep lab study (October 2006)

Intermezzo

: Phase 3 sleep lab study (October 2006)

Principal investigators:

Thomas Roth, PhD and Martin Scharf, PhD

Study design:

Double-blind, placebo-controlled study for objective

(PSG) evaluation of sleep-onset safety and efficacy of 1.75 mg and

3.5

Intermezzo

after

MOTN

awakening

Study population:

82 non-elderly primary insomnia patients with a

history of difficulty falling back to sleep after MOTN awakening

Primary endpoint:

Intermezzo

3.5 mg Latency to Persistent Sleep

(LPS

MOTN

) vs. placebo

Scale:

Largest MOTN sleep lab study reported, among the largest

double-blind crossover sleep lab studies of any kind

Intermezzo

: achieved rapid sleep onset, even in

subjects with baseline awakenings >60 minutes

Intermezzo

: achieved rapid sleep onset, even in

subjects with baseline awakenings >60 minutes

44.6

17.0

30.7

p<0.003 vs.

placebo

p<0.001 vs.

placebo

14.2

23.7

37.3

p<0.001 vs.

placebo

p<0.001 vs.

placebo

Placebo

Intermezzo

1.75mg

Intermezzo

3.5mg

Phase 3 Sleep Lab Study n = 82

>60 min awakening (37/82)

All Patients (82/82)

Intermezzo

: put more patients back to sleep faster vs

baseline or placebo

Intermezzo

: put more patients back to sleep faster vs

baseline or placebo

75%

56%

28%

Phase 3 Sleep Lab Study n = 82

Intermezzo

No reported hangover effects at 4 hrs vs

placebo

Intermezzo

No reported hangover effects at 4 hrs vs

placebo

Objective (DSST)

Subjective (VAS)

61.88

61.59

60.57

62.36

64.25

63.56

p<0.62

vs.

placebo

p<0.15

vs.

placebo

p<0.44

vs.

placebo

p<0.91

vs.

placebo

Placebo

Intermezzo

1.75mg

Intermezzo

3.5mg

Placebo

Intermezzo

1.75mg

Intermezzo

3.5mg

Intermezzo

helped patients feel better the next day

Intermezzo

helped patients feel better the next day

p<0.001

vs. placebo

p<0.001

vs. placebo

p<0.017

vs. placebo

p<0.024

vs. placebo

p<0.009

vs. placebo

“Good”

or “Excellent”

next day ratings

Phase 3 Sleep Lab Study n = 82

Sleep Quality

Refreshing Sleep

Ability to Function

Principal investigators:

Andrew Krystal, MD and Thomas Roth, PhD

Study design:

Randomized, double-blind, placebo controlled,

outpatient

study

evaluate

the

safety

and

efficacy

Intermezzo

3.5 mg for the prn treatment of insomnia after MOTN awakening

Study population:

294 non-elderly primary insomnia patients

demonstrating

least

prolonged

MOTN

awakenings

min,

and

least

min

during

initial

two

week

placebo

run-in

Primary

endpoint:

Latency

Sleep

Onset

(LSO

MOTN

)

vs.

placebo

averaged

over the 4-week treatment period

Intermezzo

: Phase 3 outpatient study (January 2008)

Intermezzo

: Phase 3 outpatient study (January 2008)

Intermezzo

: primary sleep onset

endpoint confirmed in second Phase 3 study

Intermezzo

: primary sleep onset

endpoint confirmed in second Phase 3 study

p<0.0001

vs. placebo

69.42

Latency

Sleep

Onset

(LSO

MOTN

)

week

average

Phase 3 outpatient study n = 294

56.37

68.13

38.22

week

treatment

Baseline

week

treatment

Baseline

Placebo

Intermezzo

3.5mg

Baseline

Intermezzo

: achieved consistently faster sleep onset

vs. placebo over the entire 4 week treatment period

Intermezzo

: achieved consistently faster sleep onset

vs. placebo over the entire 4 week treatment period

Latency to Sleep Onset (LSO

MOTN

) weekly

Phase 3 outpatient study n = 294

Placebo

Intermezzo

3.5mg

p<0.0001

vs. placebo

p<0.0001

vs. placebo

p<0.0001

vs. placebo

p<0.0001

vs. placebo

Intermezzo

: produced ~30 minute improvement

in sleep onset vs. baseline

Intermezzo

: produced ~30 minute improvement

in sleep onset vs. baseline

Latency

Sleep

Onset

(LSO

MOTN

)

improvement

over

baseline

Phase 3 outpatient study n = 294

Placebo

Intermezzo

3.5mg

Intermezzo

reported next day effects better than placebo

Intermezzo

reported next day effects better than placebo

p<0.0041

vs. placebo

4.71

Next day alertness 4 week average

Phase 3 outpatient study n = 294

5.24

4.87

5.59

ALERT

SLEEPY

4 week treatment

Baseline

4 week treatment

Baseline

Placebo

Intermezzo

3.5mg

Baseline

Average weekly treatment exposure

Phase 3 outpatient study n = 294

Intermezzo

: no evidence of increased medication

use during four week study

Intermezzo

: no evidence of increased medication

use during four week study

Intermezzo

development timeline

Intermezzo

development timeline

Ph 3: sleep lab

FDA meeting

Bridging PK

Elderly PK

Ph 3: outpatient

3.5 mg Fed/Fast

Mfr. 300kg batch

Swallowed PK/PD

Pre NDA meeting

Projected NDA submission

Projected launch

2007

2008

2006

Complete

Projected

2009

Q4 2008

2010

H1 2010

Intermezzo

Maximizing market potential

Intermezzo

Maximizing market potential

Intermezzo

: commercialization strategy

Intermezzo

: commercialization strategy

Intermezzo

anticipated to be the first prn

insomnia therapeutic

specifically for treatment of middle of the night awakenings

Key marketing factors

–

Insomnia direct to consumer advertising spending in decline:

•

Q1 08: Lunesta

-42%, AmbienCR

-33%, Rozerem

-74%

(1)

–

Market research indicates concentrated high prescriber base

and $600 to $800 million revenue potential

Preparing for launch to specialty and high Rx primary care

audiences via ~125 Transcept representatives

Seeking primary care marketing partner

(1) DTC Perspectives June 4 2008

Intermezzo

Intellectual property

Intermezzo

Intellectual property

Intermezzo

: formulation and method of use patents

pending in US and international markets

Intermezzo

: formulation and method of use patents

pending in US and international markets

Formulation for transmucosal absorption:

–

priority date of February 17, 2004

–

low dose zolpidem (about 1mg to about 5 mg)

–

formulated with binary buffer for transmucosal absorption

Method of treating MOTN insomnia:

–

priority date of May 25, 2005

–

low dose zolpidem (about 1mg to about 5 mg)

–

treatment of MOTN insomnia

•

administration as needed after the subject awakens

–

claims cover multiple dosage forms

Pipeline development

TO-2060:

–

Fixed combination product: olanzapine / ondansetron

–

Successful proof of concept study in alcohol abusing patients

–

Active IND: April 2008

–

Seeking NIAAA and/or corporate partner funding

TO-2061:

–

Fixed combination product: risperidone / ondansetron

–

Obsessive compulsive disorder pilot trial, data expected late 2008

NIH licensing opportunity:

–

Application submitted to NIMH for exclusive IP license re: the

treatment of major depressive disorders

Psychiatry pipeline product candidates

Intermezzo

is a registered trademark of Transcept Pharmaceuticals, Inc.

Paratek Pharmaceuticals (PRTK) 8-KNovacea, Inc. and Transcept Pharmaceuticals, Inc. Sign Merger Agreement