Paratek Pharmaceuticals, Inc. - FORM 8-K - EX-99.1 - COMPANY SLIDE PRESENTATION DATED MAY 24, 2011

Attached files

file	filename
8-K - FORM 8-K - Paratek Pharmaceuticals, Inc.	d8k.htm

May 24, 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

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 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; the potential market size for a middle of the night sleep aid; plans to commercialize Intermezzo

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 the potential for

Intermezzo

to reduce patient exposure to zolpidem as compared to prophylactic use of other zolpidem products. 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; commercial acceptance

of Intermezzo

; 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.

Introduction:

Glenn A. Oclassen, CEO

Transcept Pharmaceuticals

Introduction:

Glenn A. Oclassen, CEO

Transcept Pharmaceuticals

Today’s agenda

Welcome and introduction

Glenn Oclassen, CEO

Insomnia overview

Andrew Krystal, MD

–

Definition, diagnosis and prevalence

–

Consequences and co-morbidities

–

Current treatment practices

Middle of the night awakenings

Thomas Roth, PhD

–

What are physicians and patients doing now?

–

Treatment rationale

Intermezzo

clinical overview

Thomas Roth, PhD

Concluding remarks

Glenn Oclassen, CEO

Andrew Krystal, MD, MS: professional biography

Professor, Department of Psychiatry

Duke University Medical Center

Director, Duke Sleep Research Laboratory, Insomnia Clinic,

Quantitative EEG Lab, Brain Stimulation Research Program

B.S. M.S. Biomedical Engineering, MIT

M.D. and Psychiatry Residency, Duke University

Andrew Krystal, MD, MS: consulting relationships

Consultant: Abbott, Actelion, Astellas, Kingsdown, Arena, AstraZeneca,

Axiom, Bristol-Myers Squibb, Cephalon, Eli Lilly, GlaxoSmithKline, Jazz,

Johnson & Johnson, King, Merck, Neurocrine, Neurogen, Novartis,

Organon, Pfizer, Philips/Respironics, Sanofi-Aventis, Sunovion, Somaxon,

Takeda, Transcept Pharmaceuticals

Grant/Research Support: Abbott, Astellas, Cephalon, Evotec,

GlaxoSmithKline, Merck, Neurocrine, Neurogen, Neuronetics, NIH, Pfizer,

Sanofi-Aventis, Philips/Respironics, Kingsdown, Sunovion, Somaxon,

Takeda, Transcept Pharmaceuticals

Thomas Roth, PhD: professional biography

Director of Sleep Medicine Henry Ford Hospital, Detroit

Clinical Professor, Department of Psychiatry, University of

Michigan

Past President National Sleep Foundation, American

Academy of Sleep Medicine, and Sleep Research Society

Former Chair NIH National Center of Sleep Disorders

Research, and World Health Organization, Worldwide

Projects on Sleep and Health

Past Editor in Chief of the journal SLEEP

Thomas Roth, PhD: consulting relationships

Consultant: Abbott, Acadia, Acologix, Actelion, Alkermes, Alza, Ancile,

Arena, AstraZeneca, Aventis, Baxter, Bristol-Myers Squibb, Cephalon,

Cypress, Dove, Eisai, Elan, Eli Lilly, Evotec, Forest, GlaxoSmithKline,

Hypnion, Intec, Jazz, Johnson & Johnson, King, Lundbeck, Ortho-McNeil,

MediciNova, Merck, Neurim, Neurocrine Biosciences, Neurogen, Novartis,

Orexo, Organon, Pfizer, Prestwick, Proctor & Gamble, Purdue, Resteva,

Roche, Sanofi, Schering-Plough, Sepracor, Servier, Shire, Somaxon,

Syrex, Takeda, Transcept Pharmaceuticals, Wyeth

Speaker's Bureau: Somaxon, Sepracor

Grant/Research Support: Aventis, Cephalon, Fund for Henry Ford

Hospital, GlaxoSmithKline, Neurocrine, NIH, Pfizer, Sanofi, Schering-

Plough, Sepracor, Somaxon, Syrex, Takeda, Transcept Pharmaceuticals,

Wyeth, XenoPort

Therapeutic focus

Large markets,

unmet needs

Commercial

platform

U.S. primary care partnership: Purdue Pharma

Co-promote

option

post

Intermezzo

launch

3/31/11: $63M cash, equivalents & investments

No debt

Neuroscience / psychiatry

Intermezzo

middle

the

night

awakenings

TO-2061

Transcept: preparing for Intermezzo

commercialization

Transcept: preparing for Intermezzo

commercialization

Strong balance

sheet

Intermezzo

PDUFA

date

July

14,

2011

TO-2061

Near term

catalysts

: treatment resistant OCD

Phase

results:

anticipated

mid

2012

High salivary pH induced by Intermezzo

sublingual buffer

system facilitates penetration of zolpidem through oral mucosa

High salivary pH induced by Intermezzo

sublingual buffer

system facilitates penetration of zolpidem through oral mucosa

Buffer combination

raises salivary pH to 9.5

Zolpidem tartrate salt form

(hydrophilic) in

sublingual tablet

Zolpidem free base

(lipophilic)

Lipid lining of the

oral mucosa

Intermezzo

3.5 mg delivered

zolpidem

earlier

than

~3x

higher

Ambien

dose

Intermezzo

3.5 mg delivered

zolpidem

earlier

than

~3x

higher

Ambien

dose

comparison

study:

Intermezzo

3.5mg

vs.

Ambien

10mg

(n=33)

Time (min)

9.6x

3.0x

1.5x

Intermezzo

3.5 mg

Ambien

10 mg

Insomnia:

Definition, diagnosis, prevalence

Andrew Krystal, MD

Insomnia:

Definition, diagnosis, prevalence

Andrew Krystal, MD

Next-day consequences

Insomnia overview

Difficulty Falling

Asleep

At least 3x per week

Difficulty Staying

Asleep

(MOTN awakening)

At least 3x per week

Waking

Too

Early

At least 3x per week

Poor Quality of

Sleep

At least 3x per week

INSOMNIA

More than one type of disturbance may be present

Symptoms may vary over time

Diagnostic

and

Statistical

Manual

Mental

Disorders.

ed.1994;

The

International

Classification

Sleep

Disorders:

Diagnostic

Coding

Manual,

ICSD-2.

2005.

Sleep maintenance symptoms are the most commonly

reported sleep problem

Sleep maintenance symptoms are the most commonly

reported sleep problem

Roth et al., Biological Psychiatry, 2011.

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

Sleep onset

Maintenance

(MOTN awakening)

Early morning

awakening

Non-restorative

Sleep only

Stanford Sleep Epidemiology Research Center:

Middle of the night awakening: #1 insomnia symptom

Stanford Sleep Epidemiology Research Center:

Middle of the night awakening: #1 insomnia symptom

Population based epidemiology study: ~9,000 subjects over 4 years

Persistence:

>90% report awakenings persist more than 6 months

50% report awakenings persist more than 5 years

(1) U.S. Census data, 2010; (2) Ohayon, et al., World Sleep Conference 2007; (3) Estimate based on percentage applied to adults with

difficulty returning to sleep, with and without difficulty initiating sleep in Ohayon, et al., Sleep Medicine, 2010.

Ohayon, et al., Nocturnal Awakenings in the American

General Population: Prevalence and Consequences

235

U.S.

adults

(1)

Ohayon

83 M

36 M

22 M

3.6 M

MOTN sufferers at least 3x week

(2)

…with difficulty returning to sleep

(2)

…without difficulty initiating sleep

(2)

…who seek MD treatment

(3)

Insomnia: consequences and co-morbidities

Andrew Krystal, MD

Insomnia: consequences and co-morbidities

Andrew Krystal, MD

Consequences of insomnia

Walsh et al., World Association of Sleep Medicine, 2009.

Days out of work or role

>3x more for people with insomnia vs. people

with no insomnia

Prevalence of accidents or injury

>1.5x greater for people with insomnia vs.

people with no insomnia

> 25% of days out of work are attributable to insomnia

Accidents (%)

Days out of role/30 days (%)

Any insomnia

9.8

29.1

COPD

0.5

3.5

Diabetes

0.3

-1.5

Osteoarthritis

-0.1

2.6

GERD

0.9

4.0

Sleep apnea

-0.6

1.1

Neuropathic pain

2.6

2.9

Chronic heart failure

0.3

2.3

Climacteric symptoms

0.3

2.1

Hypertension

3.9

6.2

Major depressive disorder

1.5

3.9

Rheumatoid arthritis

-0.1

0.7

All of the above disorders

18.0

52.0

Significant results given in orange (P<0.05)

Hajak et al., World Association of Sleep Medicine, 2009.

Insomnia symptoms in common co-morbid conditions

MOTN patient demographics are similar to those of other insomnia

patients, but comorbid conditions seem to vary by presentation.

Insomnia presentation

MOTN only

Bedtime only

MOTN &

Bedtime

240

170

370

Comorbid conditions:

Depression

Anxiety

Pain

43.6%

21.0%

13.7%

42.5%

41.3%

7.5%

39.9%

28.2%

14.5%

Roth et al., International Forum on Mood and Anxiety Disorders, 2010.

Insomnia: Current treatment practices

Andrew Krystal, MD

Insomnia: Current treatment practices

Andrew Krystal, MD

Ancoli-Israel et al., SLEEP, 1999.

Patients with insomnia either present this as

a secondary complaint or, not at all

Patients with insomnia either present this as

a secondary complaint or, not at all

Never

discussed

69%

Discussed

sleep problem

during visit for

other

purposes

26%

Visited

specifically to

discuss sleep

problem

All currently approved sleep aids are indicated for

bedtime administration only

All currently approved sleep aids are indicated for

bedtime administration only

Drug (generic)

Brand name

Half-life (h)

Doses (mg)

Benzodiazepines

Estazolam

ProSom

8-24

1, 2

Flurazepam

Dalmane

48-120

15, 30

Quazepam

Doral

48-120

7.5, 15

Temazepam

Restoril

8-20

7.5, 15, 22.5, 30

Triazolam

Halcion

2-4

0.125, 0.25

Nonbenzodiazepines

Zolpidem

Ambien

1.5-2.4

5, 10

Zolpidem

extended-release

Ambien CR

2.8-2.9

6.25, 12.5

Zaleplon

Sonata

5, 10

Eszopiclone

Lunesta

5-7

1, 2, 3

Melatonin receptor agonist

Ramelteon

Rozerem

1-2.6

antagonist

Doxepin

Silenor

15.3

3, 6

Current dosing strategies for MOTN insomnia may

promote prophylactic (every night) use

Current dosing strategies for MOTN insomnia may

promote prophylactic (every night) use

Bedtime prophylactic dosing

–

The only current option/strategy

•

Approved hypnotics are indicated for bedtime use

–

Only Ambien CR, Lunesta and Silenor are indicated for sleep maintenance

•

MOTN awakenings generally occur 3-5x per week, not every night

•

Currently available 8 hr drugs often dosed nightly to prevent

awakenings, whether or not treatment would have been needed

•

A bedtime dosing strategy may be suited for patients who experience

MOTN awakening with difficulty returning to sleep >5 nights per week

only

Middle of the night awakenings: what are

physicians and patients doing now?

Thomas Roth, PhD

Middle of the night awakenings: what are

physicians and patients doing now?

Thomas Roth, PhD

No product is currently indicated or suited for prn

treatment at the time of a middle of the night awakening

No product is currently indicated or suited for prn

treatment at the time of a middle of the night awakening

MOTN awakenings, like other insomnia symptoms, typically

do not occur every night

An ideal therapeutic:

–

Used only at the time patients need help returning to sleep,

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

–

Rapid onset: only half the night remaining

–

Rapid offset: avoid next day residual effects despite MOTN dosing

Physician data: most MOTN patients do not experience

awakenings every night of the week

Physician data: most MOTN patients do not experience

awakenings every night of the week

n=294

Patients selected for multiple

and prolonged awakenings

Mean of 4-5 awakenings per

week

<20% awakening every night

Roth et al., International Forum on Mood and Anxiety Disorders, 2010.

Insomnia patient-record survey, n=890

Intermezzo

outpatient study

n=232 (MOTN patients)

34.1%

5 to 6 nights

per week

35.3%

3 to 4 nights

per week

8.6%

< 3 nights

per week

22.0%

every night

Epidemiologic data: off-label patient use of bedtime

hypnotics in the middle of the night is common

Epidemiologic data: off-label patient use of bedtime

hypnotics in the middle of the night is common

1,927 subjects who received a hypnotic Rx in last year

Results:

–

~11% of all hypnotic users sometimes take their sleep

aid in the middle of the night in order to return to sleep

–

~50% of those hypnotic users who reported middle of

the night awakening as their most bothersome insomnia

symptom sometimes take their bedtime sleep aid in the

middle of the night

Patients allow on average ~6.6 hrs between hypnotic use

after MOTN awakening and time to get up the next morning

Roth, Kessler et al., Society of Biological Psychiatry, 2011.

Exclusively at

bedtime (se)

Exclusively

MOTN (se)

MOTN awakening: the most bothersome sleep problem (%)

28.4 (3.0)

43.0 (3.9)

When MOTN is the most bothersome problem:

Mean number of nights per week with MOTN waking

Never get back to sleep after MOTN waking (%)

Average (mean) time to get back to sleep (in minutes)

4.3 (0.3)

1.9 (1.0)

73.7 (9.9)

3.5 (0.3)

2.9 (1.7)

86.1 (6.6)

Exclusive bedtime users in this table represent a 20% random sub-sample of all respondents in the main sample who

reported exclusive bedtime use.

Epidemiologic data: characteristics of patients

taking hypnotics at bedtime vs MOTN

Epidemiologic data: characteristics of patients

taking hypnotics at bedtime vs MOTN

Characteristics of middle of the night sleep problems prior to beginning medication use among

respondents who take prescription sleep medication either exclusively at bedtime (n = 303) or

MOTN

(but

never

twice

single

night)

209)

Roth, Kessler et al., Society of Biological Psychiatry, 2011.

Intermezzo

Clinical

Data

Thomas Roth, PhD

Intermezzo

Clinical

Data

Thomas Roth, PhD

Intermezzo

proposed indication statement

Intermezzo

proposed indication statement

Intermezzo

(zolpidem tartrate sublingual tablet)

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

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

28%

Ambien

dose

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

Favorable 4 hr

residual effects

PK comparison study: Intermezzo

3.5mg vs. Ambien 10mg PO (n=33)

Time (min)

9.6x

3.0x

1.5x

Intermezzo

3.5 mg

Ambien

10 mg

Intermezzo

3.5 mg delivered

zolpidem

earlier

than

~3xhigher

Ambien

dose

Intermezzo

3.5 mg delivered

zolpidem

earlier

than

~3xhigher

Ambien

dose

Intermezzo

offers potentially significant reduction in

patient exposure to zolpidem

Intermezzo

offers potentially significant reduction in

patient exposure to zolpidem

Nights of dosing

4 x 3.5mg=14mg

7 x 12.5mg=87.5mg

~84% reduction in

overall exposure

Hypothetical case based on 7 nights of prophylactic

bedtime dosing of Ambien CR vs. 4 nights of dosing with

Intermezzo

at the time a MOTN awakening occurs

Phase 3 sleep lab study

Intermezzo

: proportion of patients asleep following a

middle of the night awakening

Intermezzo

: proportion of patients asleep following a

middle of the night awakening

75%

56%

28%

Phase 3 sleep lab study n = 82

Next-day residual effects of Intermezzo

1.75 mg

and 3.5 mg vs. placebo

Next-day residual effects of Intermezzo

1.75 mg

and 3.5 mg vs. placebo

Phase 3 sleep lab study n = 82

Objective (DSST)

61.88

61.59

60.57

Placebo

Intermezzo®

1.75 mg

Intermezzo®

3.5 mg

Intermezzo

1.75mg

p<0.62

vs.

Placebo

p<0.44

vs.

Placebo

p<0.15

vs.

Placebo

p<0.91

vs.

Placebo

Intermezzo

3.5mg

Placebo

Subjective (VAS)

62.35

64.25

63.56

Intermezzo

: “Good”

or “Excellent”

next day ratings

Intermezzo

: “Good”

or “Excellent”

next day ratings

Phase 3 sleep lab study n = 82

Sleep Quality

Refreshing Sleep

Ability to Function

23.5

32.9

42.6

23.5

36.5

40.0

39.5

47.6

51.3

Placebo

Intermezzo®

1.75 mg

Intermezzo®

3.5 mg

Intermezzo

1.75mg

p<0.017

vs.

Placebo

p<0.001

vs.

Placebo

p<0.001

vs.

Placebo

Intermezzo

3.5mg

Placebo

p<0.024

vs.

Placebo

p<0.009

vs.

Placebo

Intermezzo

outpatient study

Intermezzo

outpatient study

Intermezzo

: Latency to Sleep Onset, weekly

Intermezzo

: Latency to Sleep Onset, weekly

Phase 3 outpatient study n = 294

Baseline

week 1

week 2

week 3

week 4

Placebo

Intermezzo®

3.5 mg

Intermezzo

3.5mg

Placebo

p<0.0001

vs.

Placebo

p<0.0001

vs.

Placebo

p<0.0001

vs.

Placebo

p<0.0001

vs.

Placebo

Intermezzo

: average weekly treatment exposure

Intermezzo

: average weekly treatment exposure

Phase 3 outpatient study n = 294

Placebo

wk 1

Placebo

wk 2

week 1

week 2

week 3

week 4

Placebo

Intermezzo®

3.5 mg

Intermezzo

3.5mg

Placebo

Intermezzo

highway driving study

Intermezzo

highway driving study

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

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 up

4.0

SDLP

–

Secondary analysis (mean): statistically significant but small

effect

1.5

SDLP

–

One drive discontinued at 3 hour condition due to excessive

drowsiness

Mean change in SDLP (cm) and 95% confidence intervals (cross-study comparison)

2.5

4.0

Mean change in SDLP (cm)

(1)

Mean change in SDLP produced

by 0.05% blood alcohol is 2.4 cm

(EU DUI concentration limit). 2.5

cm was used as primary cutpoint

TSPT driving study.

(2)

Mean change in SDLP produced

by 0.08% blood alcohol is 4.2 cm

(USA DUI concentration limit). 4.0

cm was used as a secondary

cutpoint

in TSPT driving study.

Flurazepam

30mg

10-11hrs

Temazepam

20mg

10-11hrs

Zaleplon

20mg

4-5 hrs

Lormetazepam

1mg

10-11hrs

Intermezzo

3.5mg

4-5 hrs

Nitrazepam

10mg

10-11hrs

Loprazolam

1mg

10-11hrs

Intermezzo

3.5mg

3-4 hrs

Lormetazepam

1mg 10-11hrs

Flunitrazepam

2mg

10-11hrs

Lormetazepam

2mg 10-11hrs

Zopiclone

7.5mg

10-11hrs

Zolpidem

20mg

4-5 hrs

Flurazepam

30mg 10-11hrs

Loprazolam

2mg

10-11hrs

Zolpidem

10mg

4-5 hrs

Flurazepam

15mg 10-11hrs

Oxazepam

50mg

10-11hrs

Zopiclone

7.5mg

9-10 hrs

Drug & dose Drive time

Zaleplon

10mg

4-5 hrs

Zolpidem

10mg

5-6 hrs

0.08%

(2)

0.05%

(1)

~ SDLP produced by BAC of

Estimated probability of exceeding SDLP 2.5 cm

threshold for various hypnotics

and 95% confidence intervals (cross-study comparison)

Zaleplon 10mg

4-5 hrs

Zaleplon 20mg

4-5 hrs

Intermezzo

3.5mg

4-5 hrs

Lormetazepam 1mg 10-11hrs

Intermezzo

3.5mg

3-4 hrs

Lormetazepam 1mg

10-11hrs

Temazepam 20mg

10-11hrs

Nitrazepam 10mg

10-11hrs

Zolpidem 10mg

4-5 hrs

Zopiclone 7.5mg

9-10 hrs

Flurazepam 15mg

10-11hrs

Flunitrazepam 2mg

10-11hrs

Loprazolam 1mg

10-11hrs

Lormetazepam 2mg 10-11hrs

Flurazepam 30mg

10-11hrs

Flurazepam 30mg

10-11hrs

Oxazepam 50mg

10-11hrs

Loprazolam 2mg

10-11hrs

Zolpidem 20mg

4-5 hrs

Drug & dose Drive time

SDLP 2.4 cm

driving impairment

associated with 0.05% blood alcohol

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Estimated probability of exceeding SDLP 4.0 cm threshold for various hypnotics

and 95% confidence intervals (cross-study comparison)

Intermezzo

3.5mg

4-5 hrs

Zaleplon 10mg

4-5 hrs

Zaleplon 20mg

4-5 hrs

Nitrazepam 10mg

10-11hrs

Lormetazepam 1mg

10-11hrs

Lormetazepam 1mg 10-11hrs

Intermezzo

3.5mg

3-4 hrs

Temazepam 20mg

10-11hrs

Flunitrazepam 2mg

10-11hrs

Lormetazepam 2mg 10-11hrs

Loprazolam 1mg

10-11hrs

Oxazepam 50mg

10-11hrs

Zopiclone 7.5mg

9-10 hrs

Zolpidem 10mg

4-5 hrs

Flurazepam 15mg 10-11hrs

Flurazepam 30mg 10-11hrs

Loprazolam 2mg

10-11hrs

Zolpidem 20mg

4-5 hrs

Drug & dose Drive time

SDLP 4.2 cm

driving impairment

associated with 0.08% blood alcohol

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Driving study results -

labeling vs. approvability:

HORIZANT

™

Prescribing Information

Driving study results -

labeling vs. approvability:

HORIZANT

™

Prescribing Information

Prescribing Information: Warnings and Precautions

“HORIZANT causes significant driving impairment.”

“Patients being treated with HORIZANT should not drive until they

have gained sufficient experience to assess whether HORIZANT

impairs their ability to drive.”

“However, prescribers and patients should be aware that patients’

ability to assess their own driving competence…can be imperfect.”

HORIZANT

™

(gabapentin enacarbil) NDA approval for the

treatment of Restless Legs Syndrome: April 6, 2011

A nightly 1,200 mg dose of HORIZANT

™

produced significant

impairment 14 hours after dosing in a driving simulator study

FDA approval letter contains agreements to conduct a further

post-marketing study of driving impairment

Question & answer

Concluding remarks:

Glenn A. Oclassen, CEO

Concluding remarks:

Glenn A. Oclassen, CEO

Estimating the MOTN market size at branded prices

x mean length 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

(1) U.S. Census data, 2010; (2) Ohayon, et al., World Sleep Conference 2007; (3) Estimate based on percentage applied to adults with difficulty

returning

sleep,

with

and

without

difficulty

initiating

sleep

Ohayon,

al.,

Sleep

Medicine

(2010).

(4)

IMS:

Length

therapy

the

sleep

disorder

market,

March

2007.

Products

evaluated

are

indicated

for

bedtime

use:

Ambien

Lunesta

Restoril

Rozerem

Sonata

Desyrel

;

(5) Wolters

Kluwer

WAC

pricing

(branded)

Jan

2011

(products

evaluated:

Ambien

, Lunesta

, Silenor

; Ambien

and Ambien CR

are currently available in generic form).

Ohayon, et al., Nocturnal Awakenings in the American

General Population: Prevalence and Consequences

235 M U.S. adults

(1)

x Ohayon

MOTN sufferers at least 3x week

(2)

83 M

…with difficulty returning to sleep

(2)

36 M

…without difficulty initiating sleep

(2)

22 M

…who seek MD treatment

(3)

3.6M

Leading pain therapeutic franchise

2010 net revenue: ~$2.4 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 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 ($6M if approved on July 14, 2011 PDUFA date)

–

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: mid-teens up to mid 20% level on net sales

–

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

net sales

U.S. primary care partnership: Purdue Pharma

Co-promote

option

post

launch

3/31/11: $63M cash, equivalents & investments

No debt

Neuroscience / psychiatry

Intermezzo

: middle of the night awakenings

Transcept: preparing for Intermezzo

commercialization

Transcept: preparing for Intermezzo

commercialization

Intermezzo

PDUFA date July 14, 2011

Large markets,

unmet needs

Therapeutic focus

Commercial

platform

Strong balance

sheet

Near term

catalysts

TO-2061

: treatment resistant OCD

TO-2061

Phase

results:

anticipated

mid

2012

Intermezzo

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.

Attached files

Paratek Pharmaceuticals, Inc. Reports

Also read