Paratek Pharmaceuticals (PRTK) 8-K A specialty pharmaceutical company focused on the development

January 2011

January 2011

A specialty pharmaceutical company focused on the development

and commercialization of proprietary products to address important

therapeutic needs in the field of neuroscience

Exhibit 99.1

Forward looking statements

Forward looking statements

This

presentation

contains

forward-looking

statements

that

involve

substantial

risks

and

uncertainties.

All

statements,

other

than

statements

of

historical

facts,

included

in

this

presentation

are

forward-looking

statements.

Examples

of

such

statements

include

our

expectation

regarding

the

acceptance

of,

and

the

PDUFA

date

for,

the

resubmitted

Intermezzo

®

NDA;

FDA

having

a

favorable

view

of

the

Intermezzo

®

residual

effect

profile;

the

sufficiency

of

the

Intermezzo

®

NDA

to

gain

FDA

approval;

that

Intermezzo

®

will

become

the

first

prescription

sleep

aid

indicated

for

use

in

the

middle

of

the

night

and

the

first

strongly

differentiated

insomnia

treatment

strategy

since

Ambien

®

launch;

the

potential

market

size

for

a

middle

of

the

night

sleep

aid;

plans

to

commercialize

Intermezzo

®

under

favorable

market

conditions

through

the

Purdue

collaboration

and

the

receipt

by

Transcept

of

payments

from

Purdue

thereunder;

reimbursement

coverage

for

Transcept

product

candidates;

intellectual

property

protection

being

obtained

and

maintained

for

Transcept

product

candidates;

and

plans

to

begin

a

Phase

2

study

of

Setrodon™

in

Q1

2011

and

report

results

therefrom

in

H1

2012.

Transcept

may

not

actually

meet

these

expectations

and

carryout

these

plans.

Various

important

factors

that

could

cause

actual

events

to

differ

materially

from

such

forward-looking

statements

include

FDA

deemed

insufficiencies

in

our

Intermezzo

®

NDA

resubmission,

competitive

product

commercialization;

adverse

patent

decisions

at

the

USPTO

or

in

court;

the

willingness

of

Purdue

to

commercialize

Intermezzo

®

and

its

ability

to

do

so

successfully;

payer

opinion

of

Intermezzo

®

,

if

approved;

dependence

on

third

parties

to

manufacture,

and

carry-out

the

planned

study

of

Setrodon™ ,

and

variability

in

the

business

of

Transcept

generally.

These

and

other

risks

are

described

in

greater

detail

in

the

"Risk

Factors"

section

of

Transcept

periodic

reports

filed

with

the

Securities

and

Exchange

Commission.

Forward-looking

statements

do

not

reflect

the

potential

impact

of

any

future

in-licensing,

collaborations,

acquisitions,

mergers,

dispositions,

joint

ventures,

or

investments

Transcept

may

enter

into

or

make.

Transcept

does

not

assume

any

obligation

to

update

any

forward-looking

statements,

except

as

may

be

required

by

law.

2

Therapeutic focus

Large markets,

unmet needs

Commercial

platform

U.S. primary care partnership: Purdue Pharma

Co-promote

option

1

yr

post

Intermezzo

®

launch

9/30/10: $74M cash, equivalents and investments

No debt

Neuroscience / psychiatry

Intermezzo

®

: middle of the night awakenings

Setrodon

™

: treatment resistant OCD

Transcept: preparing for Intermezzo

®

commercialization

Transcept: preparing for Intermezzo

®

commercialization

3

Strong balance

sheet

Intermezzo

®

PDUFA expected July 2011

Setrodon

™

Phase 2 results: anticipated H1 2012

Near term

catalysts

Intermezzo

®

(zolpidem

tartrate

sublingual tablet)

Intermezzo

®

(zolpidem

tartrate

sublingual tablet)

Proposed

indication

statement:

Intermezzo

®

is

indicated

for use as needed for the treatment of insomnia when a

middle of the night awakening is followed by

difficulty returning to sleep

*

*

* 

*

*                    *

*

*

* 

*

*                    *

Middle of the night (MOTN) awakening:

A major unmet medical need in the insomnia category

Middle of the night (MOTN) awakening:

A major unmet medical need in the insomnia category

Large U.S. insomnia market

–

$2.1 billion (ex-factory)

(1)

–

78

million

new

and

refill

prescriptions

(2)

Insomnia is an under-treated condition

–

11 million patients receive Rx

(3)

–

4x

to

6x

more

are

not

diagnosed

or

treated

by

a

physician

(3)(4)

MOTN awakening: the most prevalent insomnia symptom

(5)

–

35% of Americans suffer from MOTN awakenings at least 3x / week

–

>90% report awakenings persist more than six months;

50% report awakenings persist more than five years

5

(1)

IMS

NSP

2009;

(2)

Wolters

Kluwer,

PHAST

2010;

(3)

BluePrint

Research

Group;

(4)

Institutes

of

Medicine

-

Sleep

disorders

and

sleep

deprivation

Apr. 2006; (5) Ohayon, Difficulty in resuming or inability to resume sleep and the links to daytime impairment, J of Psych Research (2009).

No product currently indicated for prn

treatment at the

time of a middle of the night awakening

No product currently indicated for prn

treatment at the

time of a middle of the night awakening

MOTN awakenings typically do not occur every night

7-8 hr sleep aids (Ambien

®

, Ambien

CR

®

, Lunesta

®

) require

bedtime prophylactic dosing to prevent awakenings

An ideal therapeutic would:

–

Be used only at the time patients need help returning to sleep,

not every night in advance of a problem that may not occur

–

Return patients to sleep rapidly

–

Use a low dose to avoid next day residual effects

6

Novel formulation

Low dose

Fast acting

Sleep lab, objective data: 14 minute sleep

onset with 3.5 mg dose

No residual next-morning effects vs. placebo in

sleep lab and outpatient studies

Driving study primary statistical analysis: no

significant next morning effect vs. placebo 4 hrs

after dosing, consistent with proposed label

Sublingual tablet dissolves in ~ 2 minutes

pH drives

zolpidem

base, rapidly absorbed

72%

lower

dose

than

Ambien

CR

®

Intermezzo

®

: anticipated to be the first sleep aid for

use in the middle of the night at the time of awakening

Intermezzo

®

: anticipated to be the first sleep aid for

use in the middle of the night at the time of awakening

7

Favorable residual

effects profile

Intermezzo

®

3.5 mg delivered greater early zolpidem

bioavailability

than

a

~3x

higher

Ambien

®

dose

Intermezzo

®

3.5 mg delivered greater early zolpidem

bioavailability

than

a

~3x

higher

Ambien

®

dose

8

Intermezzo

®

commercial opportunity

Intermezzo

®

commercial opportunity

*

*

*

*

*

*

*

*

*

*

Estimating the MOTN market size at branded prices

Estimating the MOTN market size at branded prices

Ohayon, et al., Nocturnal Awakenings in the American

General Population: Prevalence and Consequences

235 M U.S. adults

3

x Ohayon

MOTN sufferers at least 3x week

35.5%

1

=

…with difficulty returning to sleep

43.0%

1

=

…without difficulty initiating sleep

62.6%

1

=

…who seek MD treatment

16.0%

2

=

x course of therapy, currently marketed Rx sleep aids

108 to 169 days

4

x per tablet branded pricing, currently marketed Rx sleep aids

$5.05 to $5.67

5

= 100% market estimate: treatment seeking MOTN patients

$1.9 B to $3.4 B

10

(1) Ohayon, et al., Nocturnal awakenings in the American general population: Prevalence and consequences. World Sleep Conference 2007; (2)

Estimated

based

on

percentage

applied

to

adults

with

difficulty

returning

to

sleep,

with

and

without

difficulty

initiating

sleep

in

Ohayon,

et

al.,

Using

difficulty resuming sleep to define nocturnal awakenings. Sleep Medicine 11 (2010); (3) U.S. Census data, 2010, adults 18 and over; (4) IMS: Length

of

Therapy

in

the

Sleep

Disorder

Market,

March

2007.

Products

evaluated

are

indicated

for

bedtime

use:

Ambien

®

,

Ambien

CR

®

,

Lunesta

®

,

Restoril

®

,

Rozerem

®

,

Sonata

®

,

Desyrel

®

;

(5)

Wolters

Kluwer

WAC

pricing

(branded).

Jan

2011.

Products

evaluated:

Ambien

®

,

Ambien

CR

®

,

Lunesta

®

, Silenor

®

. Ambien

®

and Ambien

CR

®

are currently available in generic form.

Leading pain therapeutic franchise

2009 rev: >$2.5 billion

Branded products include:

OxyContin

®

, MSContin

®

, Dilaudid

®

, Butrans

®

Sales force of >500 field reps calling on primary care

physicians and high prescribing specialists

High value pain prescribers tend to be significant insomnia

prescribers

Multi-year sales and marketing agreement with psychiatry 

co-promote option, royalties and milestone payments

Commercialization partnership with Purdue Pharma

Commercialization partnership with Purdue Pharma

11

Commercialization agreement: key Transcept

benefits

Commercialization agreement: key Transcept

benefits

Co-promote option: foundation for a commercial future

–

Transcept

option: co-promote to psychiatrists as early as the first

anniversary after Purdue launch

Milestone payments

–

Upfront license fee: $25M received August 2009

–

FDA approval milestone of $30M, reduced by $2M each 30-day period

after

June

30,

2010

(estimated

$0

-

$6M

upon

approval)

–

Up to $90M additional upon the achievement of certain patent

milestones and net sales targets, including $10M for first formulation

patent listed in Orange Book

Royalty structure

–

Base royalty: double digit up to the mid 20% level on net sales

–

Co-promote royalty: additional double digit  royalty on psychiatrist Rx

net sales

12

Intermezzo

®

partnership structure enables

significant Transcept

marketing efficiency

Intermezzo

®

partnership structure enables

significant Transcept

marketing efficiency

Purdue responsibilities

–

U.S. product launch

–

Primary care sales and marketing activities

–

Managed care and formulary placement

–

Manufacturing and distribution

–

Post marketing studies, if required

–

Book revenues

Transcept

responsibilities

–

U.S. product approval

–

Psychiatry co promote option 1 yr after commercial launch

13

Favorable market conditions for Intermezzo

®

launch

Favorable market conditions for Intermezzo

®

launch

Intermezzo

®

: anticipated to be the first strongly

differentiated insomnia treatment strategy since

launch of Ambien

®

in 1993

Continuing decline in sales presentations to

physicians in insomnia segment

Significantly reduced DTC spending

14

Intermezzo

®

managed markets research: broad

reimbursement coverage expected

Intermezzo

®

managed markets research: broad

reimbursement coverage expected

Research conducted with Pharmacy and Medical Directors

from health plans covering 170M lives

Statement of unmet medical need generally well accepted

by payers

–

Unique insomnia indication

–

Low dose used less often

–

Delivery technology drives rapid action

Tier 3 formulary placement anticipated, utilization

management criteria consistent with other hypnotic brands

Intermezzo

®

brand parity pricing not viewed as a major

barrier with managed markets

Purdue managed markets team to drive formulary access

15

Intermezzo

®

NDA resubmission

Intermezzo

®

NDA resubmission

*

*

*

*

*

*

*

*

*

*

FDA Complete Response Letter (October 2009) and

subsequent discussions

FDA Complete Response Letter (October 2009) and

subsequent discussions

FDA indicated Transcept

has submitted substantial evidence

of effectiveness for Intermezzo

®

in its intended indication

FDA recognized that the Intermezzo

®

Phase 3 data did not

indicate significant next morning residual effects at 4 hrs

However, given the unique MOTN indication, FDA requested:

–

additional data on next morning driving effects

–

demonstration that inadvertent dosing errors can be minimized,

or that the consequences of such errors are acceptable

•

inadvertent re-dosing in a single night

•

inadvertent dosing with < 4 hrs of bedtime remaining

–

arguments against the conduct of an in-use study

17

Intermezzo

®

NDA resubmitted Jan 2011: 6 month

review cycle anticipated

Intermezzo

®

NDA resubmitted Jan 2011: 6 month

review cycle anticipated

Driving study primary statistical analysis: no significant

next morning effect when dosed per proposed label

Comparative analysis vs. previous driving study data: 

even when dosed off label (< 4hrs prior to driving),

Intermezzo

®

next day effects are relatively small

New epidemiology study offers first demonstration of

current and widespread middle of the night (off-label)

use of 7-8 hour sleep aids

Packaging changes, patient tools and instructions to

address FDA concerns re: dosing errors

18

Redesigned unit dose packaging for NDA resubmission

Redesigned unit dose packaging for NDA resubmission

19

Intermezzo

®

highway driving study overview

Intermezzo

®

highway driving study overview

Approximately 40 healthy adult volunteers

Highway driving over a one-hour period

Single-center (Maastricht), double-blind,            

randomized, placebo-controlled                       

crossover design

Key comparisons:

–

Intermezzo

®

3.5mg vs. placebo, dosed 4 hours prior to driving

–

Intermezzo

®

3.5mg vs. placebo, dosed 3 hours prior to driving

–

Zopiclone 7.5mg vs. placebo (positive control)

Key measure of driving performance: standard

deviation of lateral position (variability in lane position)

as compared to placebo

20

Intermezzo

®

highway driving study results

Intermezzo

®

highway driving study results

4 hrs after MOTN Intermezzo

®

dosing

–

Test condition consistent with proposed label

–

Primary analysis (symmetry): no statistically significant effect

–

Secondary analysis (mean): statistically significant but small

effect of 0.8 cm

SDLP

3 hrs after MOTN Intermezzo

®

dosing

–

Test condition included to characterize risk profile of

Intermezzo

®

when not used according to label

–

Primary analysis (symmetry): statistically significant effect

–

Secondary analysis (mean): statistically significant but small

effect of 1.5 cm

SDLP

–

One drive discontinued due to excessive drowsiness

FDA may consider other statistical analyses

21

0

1

2

3

4

5

6

7

8

4h

post-dose

3h

post-dose

9h

post-dose

10-11h

post-dose

10-11h

post-dose

10-11h

post-dose

10-11h

post-dose

10-11h

post-dose

Effect on driving produced by various hypnotics and

blood alcohol concentrations: cross study comparison

Effect on driving produced by various hypnotics and

blood alcohol concentrations: cross study comparison

Intermezzo

®

highway driving study

Zopiclone

and US-marketed hypnotics

Brookhuis

K.

Hum.

Psychopharmacol.

Clin.

Exp.

1998;13:S64–S69.

0.05%

EU

Note: The cross study comparisons reflected above should be viewed with caution. Cross study meta-analyses are subject to interpretational and other risks due

to

a

number

of

factors,

including

unaccounted

for

variables

that

may

render

comparisons

difficult

or

invalid,

and

potential

inconsistencies

in

methods

of

normalizing

study

results.

Additional

studies

from

the

Brookhuis

publication

reflecting

data

from

drugs

not

approved

in

the

United

States

are

not

reflected

above.

The

above

collection

of

studies

is

not

presented

as

a

complete

presentation

of

highway

driving

studies

analyzing

hypnotic

drugs

approved

in

the

United

States.

0.08%

USA

DUI blood

alcohol

concentration

22

Intermezzo

®

:

intellectual property

Intermezzo

®

:

intellectual property

*

*

*

*

*

*

*

*

*

*

Intermezzo

®

: two formulation patents issued; method

of use patents pending

Intermezzo

®

: two formulation patents issued; method

of use patents pending

Formulation for transmucosal absorption

–

Two issued U.S. patents -

7,682,628 and 7,658,945

–

Patents expire no sooner than February 2025

–

Low dose zolpidem, ~1mg to ~5mg

–

Formulation with buffer system for transmucosal absorption

Method of treating MOTN awakenings

–

Priority date: May 2006

–

Low dose zolpidem, ~1mg to ~5mg

–

Treatment of middle of the night awakenings

Administration as needed after the subject awakens

–

Proposed claims cover multiple dosage forms

24

Setrodon™

(ultra low dose ondansetron)

Setrodon™

(ultra low dose ondansetron)

25

Adjunctive therapy in patients with obsessive compulsive

disorder not adequately responsive to SSRI treatment

*

*

*

*

*

*

*

*

*

*

Significant unmet medical need: OCD patients not

responding adequately to SSRI treatment

Significant unmet medical need: OCD patients not

responding adequately to SSRI treatment

Obsessive Compulsive Disorder

–

Intrusive thoughts and repetitive actions to reduce distress

–

Affects 1% to 2% of U.S. adult population, 40% to 50% seek treatment

–

Significantly impacts everyday life activities of patients and their families

–

40% to 60% of OCD patients do not respond adequately to first-line

SSRI

treatment

(e.g.,

Prozac

®

,

Luvox

®

,

Paxil

®

,

Zoloft

®

)

No FDA approved treatment for SSRI resistant OCD

–

Atypical antipsychotics are often used off-label to augment SSRIs

•

~68% of SSRI resistant OCD patients do not respond

•

Frequently reported adverse events: weight gain, metabolic disorder

26

Pilot studies: ultra low dose adjunctive ondansetron

therapy in SSRI resistant OCD

Pilot studies: ultra low dose adjunctive ondansetron

therapy in SSRI resistant OCD

Ondansetron

(5-HT

3

antagonist approved as Zofran

®

)

–

Affects serotonin and dopamine pathways

–

Typical daily Zofran

®

doses of 16 mg to 24 mg for chemotherapy-

induced nausea and vomiting

Two 12 week open-label adjunctive therapy studies

with ondansetron

titrated to 0.5 mg BID dose

–

Pilot Study A

(1)

: Adjunctive ondansetron

therapy in patients who

responded

poorly

to

at

least

12

weeks

of

SSRIs

combined

with

an

atypical antipsychotic, n=14

–

Pilot Study B

(2)

: Adjunctive ondansetron

therapy in patients who

responded poorly to at least 12 weeks of SSRI treatment, n=21

27

(1) S. Pallanti, S. Bernardi, S. Antonini, N. Singh, E. Hollander: Ondansetron

augmentation in Treatment-Resistant Obsessive-Compulsive Disorder,

CNS Drugs (2009); (2) S. Pallanti, S. Bernardi, E. Hollander: Ondansetron

augmentation in Treatment-Resistant OCD (TR-OCD): Relapse in Y-BOCS

symptoms

following

discontinuation

of

ondansetron,

Poster

presentation,

American

College

of

Neuropsychopharmacology

49

Annual

Conference,

December 2010.

th

Improvement: measured as a % decrease over baseline on the

Yale Brown Obsessive Compulsive Scale (YBOCS)

Improvement: measured as a % decrease over baseline on the

Yale Brown Obsessive Compulsive Scale (YBOCS)

28

All Patients: n=21

26.3% improvement at 12 weeks

Responders: n=12 of 21 (57%)

44.3% improvement at 12 weeks

Pilot Study B, n=21

Week

2

Week

4

Week

6

Week

8

Week

10

Week

12

50%

40%

30%

20%

10%

0%

All patients

Week

2

Week

4

Week

6

Week

8

Week

10

Week

12

50%

40%

30%

20%

10%

0%

Responders

Non-responders

Week

0

Week

2

Week

4

Week

6

Week

8

Week

10

Week

12

Week

14

Week

16

10

20

30

40

Relapse following discontinuation in responders

Relapse following discontinuation in responders

29

38.3%

YBOCS

worsening

from Week 12

Phase 1

Ondansetron

augmentation

Phase 2

Discontinuation

Pilot Study B, n=12 of 21 (responders only)

Setrodon™:

development

overview

Setrodon™:

development

overview

505b2 NDA pathway

Phase

2

study,

n

150

–

To start Q1 2011, top-line results 2012

–

Approx. $10M investment through end of Phase 2 study

Intellectual property

–

Method of use patent application filed, priority date May 19, 2009

–

Ondansetron, up to ~1.5 mg/day

–

Pending claims for treating SSRI resistant OCD with ondansetron

augmentation

Managed care survey (~108M lives): unmet medical need

acknowledged, Tier 3 formulary placement expected

Strategic fit: psychiatry

–

~87% of patient visits for OCD were to psychiatrists in 2009

*

–

Complementary

to

Intermezzo

®

psychiatry

co-promote

option

with

Purdue

30

* SDI Physician Drug and Diagnosis Audit

Financial overview

Financial overview

*

*

*

*

*

*

*

*

*

*

Financial position: September 30, 2010

Financial position: September 30, 2010

Cash & investments:

$74.2 M

Q3 2010 cash burn rate:

$  1.6 M / month

Shares outstanding:

13.4 M

Options / warrants / other:

2.5

Total:

15.9 M

Employees:

31

32

Key Transcept

activities and goals

Key Transcept

activities and goals

Completed Intermezzo

®

US marketing partnership, July 09

Patent coverage: two Intermezzo

®

formulation patents issued

Highway driving study data, Oct 2010

Intermezzo

®

NDA submitted Jan 2011

Intermezzo

®

pre-launch planning

Intermezzo

®

PDUFA date Jul 2011 (estimate)

Begin Setrodon

™

Phase 2 study Q1 2011

33

Intermezzo

®

is a registered trademark of Transcept

Pharmaceuticals, Inc.

Ambien

®

and Ambien

CR

®

are registered trademarks of sanofi-aventis

Lunesta

is a registered trademark of Sunovion

Pharmaceuticals Inc.

Zofran

®

and

Paxil

®

are

registered

trademarks

of

The

GlaxoSmithKline

Group

of

Companies

Prozac

®

is a registered trademark of Eli Lilly & Co.

Luvox

®

is a registered trademark of Solvay Pharmaceuticals, Inc.

Zoloft

®

is a registered trademark of Pfizer Inc.