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

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

February 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

the

Intermezzo

residual

effect

profile;

the

sufficiency

the

Intermezzo

NDA

gain

FDA

approval;

that

Intermezzo

will

become

the

first

prescription

sleep

aid

indicated

for

use

the

middle

the

night

and

the

first

strongly

differentiated

insomnia

treatment

strategy

since

Ambien

launch;

the

potential

market

size

for

middle

the

night

sleep

aid;

plans

commercialize

Intermezzo

under

favorable

market

conditions

through

the

Purdue

collaboration

and

the

receipt

Transcept

payments

from

Purdue

thereunder;

reimbursement

coverage

for

Transcept

product

candidates;

intellectual

property

protection

being

obtained

and

maintained

for

Transcept

product

candidates;

and

plans

begin

Phase 2

study

TO-2061

2011

and

report

results

therefrom

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

the

USPTO

court;

the

willingness

Purdue

commercialize

Intermezzo

and

its

ability

successfully;

payer

opinion

Intermezzo

approved;

dependence

third

parties

manufacture,

and

carry-out

the

planned

study

TO-2061,

and

variability

the

business

Transcept

generally.

These

and

other

risks

are

described

greater

detail

the

"Risk

Factors"

section

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,

investments

Transcept

may

enter

into

make.

Transcept

does

not

assume

any

obligation

update any forward-looking statements, except as may be required by law.

U.S. primary care partnership: Purdue Pharma

Co-promote

option

post

Intermezzo

launch

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

No debt

Neuroscience / psychiatry

Intermezzo

middle

the

night

awakenings

Transcept: preparing for Intermezzo

commercialization

Transcept: preparing for Intermezzo

commercialization

Intermezzo

PDUFA

date

July

14,

2011

TO-2061

Phase

results:

anticipated

2012

Large markets,

unmet needs

Therapeutic focus

Commercial

platform

Strong balance

sheet

Near term

catalysts

: treatment resistant OCD

TO-2061

Intermezzo

(zolpidem

tartrate

sublingual tablet)

Intermezzo

(zolpidem

tartrate

sublingual tablet)

Proposed

indication

statement:

Intermezzo

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)

–

million

new

and

refill

prescriptions

(2)

Insomnia is an under-treated condition

–

million

patients

receive

(3)

–

are

not

diagnosed

treated

physician

(3)(4)

MOTN awakening: the most prevalent insomnia symptom

(5)

–

35%

Americans

suffer

from

MOTN

awakenings

least

week

(5)

–

>90% report awakenings persist more than six months;

50%

report

awakenings

persist

than

five

years

(6)

(1) IMS

NSP

2009;

(2)

Wolters

Kluwer,

PHAST

2010;

(3)

BluePrint

Research

Group;

(4)

Institutes

Medicine

Sleep

disorders

and

sleep

deprivation

Apr. 2006;

(5)

Ohayon,

Nocturnal

awakenings

and

comorbid

disorders

the

American

general

population.

Psych

Research

(2009);

(6)

Ohayon,

Difficulty

resuming

inability

resume

sleep

and

the

links

daytime

impairment,

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

, 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

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

drives

zolpidem

base,

rapidly

absorbed

72%

lower

dose

than

Ambien

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 residual

effects profile

Fast acting

Low dose

Novel formulation

Intermezzo

3.5 mg delivered greater early zolpidem

bioavailability

than

~3x

higher

Ambien

dose

Intermezzo

3.5 mg delivered greater early zolpidem

bioavailability

than

~3x

higher

Ambien

dose

PK comparison study:

Intermezzo

3.5mg vs. Ambien

10mg PO n=33

Time (min)

9.3x

2.9x

1.4x

Intermezzo

3.5 mg

Ambien

10 mg

Intermezzo

commercial

opportunity

Intermezzo

commercial

opportunity

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)

83 million

…with difficulty returning to sleep

43.0%

(1)

…without difficulty initiating sleep

62.6%

(1)

…who seek MD treatment

16.0%

(2)

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)

Ohayon,

al.,

Nocturnal

awakenings

the

American

general

population:

Prevalence

and

consequences.

World

Sleep

Conference

2007;

(2)

Estimated

based

percentage

applied

adults

with

difficulty

returning

sleep,

with

and

without

difficulty

initiating

sleep

Ohayon,

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

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

are

currently

available

generic

form.

3.6

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

–

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

net sales

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

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

Intermezzo

managed markets research: broad

formulary access expected

Intermezzo

managed markets research: broad

formulary access 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 bioavailability

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

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

effectiveness

for

Intermezzo

its

intended

indication

FDA

recognized

that

the

Intermezzo

Phase

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

Intermezzo

NDA: PDUFA date July 14, 2011

Intermezzo

NDA: PDUFA date July 14, 2011

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

driving),

Intermezzo

day

effects are relatively small

New epidemiology study demonstrates widespread middle of the

night (off-label) use of 7-8 hour sleep aids

–

Results suggest ~11% of all hypnotic users sometimes take their sleep

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

Packaging changes, patient tools and instructions to address FDA

concerns re: dosing errors

Redesigned unit dose packaging for NDA resubmission

Prototype

package:

Intermezzo

not

approved

the

U.S.

FDA

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

–

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

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

Hum.

Psychopharmacol.

Clin.

Exp.

1998;13:S64–S69.

0.05%

0.08%

USA

DUI blood

alcohol

concentration

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.

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

TO-2061

(ultra low dose ondansetron)

TO-2061

(ultra low dose ondansetron)

Proposed indication: adjunctive therapy in adult 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

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

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

(1)

Adjunctive

ondansetron

therapy

patients

who

responded

poorly

least

weeks

SSRIs

combined

with

atypical antipsychotic, n=14

–

Pilot

Study

(2)

Adjunctive

ondansetron

therapy

patients

who

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

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

ondansetron,

Poster

presentation,

American

College

Neuropsychopharmacology

Annual

Conference,

December 2010.

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)

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

50%

40%

30%

20%

10%

All patients

Week

50%

40%

30%

20%

10%

Responders

Non-responders

Week

Relapse following discontinuation in responders

38.3%

YBOCS

worsening

from Week 12

Phase 1

Ondansetron

augmentation

Phase 2

Discontinuation

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

TO-2061: 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

* SDI Physician Drug and Diagnosis Audit

Financial overview

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:

Key Transcept

activities and goals

Key Transcept

activities and goals

Completed Intermezzo

US marketing partnership: July 2009

Patent coverage: two Intermezzo

formulation patents issued

Highway driving study data: Oct 2010

Intermezzo

NDA resubmitted and accepted: Jan 2011

Begin TO-2061 Phase 2 study Q1 2011

Intermezzo

NDA action date: July 14, 2011

Intermezzo

pre-launch planning

Intermezzo

is a registered trademark of Transcept

Pharmaceuticals, Inc.

Ambien

and Ambien

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.

Paratek Pharmaceuticals, Inc. - FORM 8-K - EX-99.1 - COMPANY SLIDE PRESENTATION DATED FEBRUARY 2011 - February 7, 2011

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Paratek Pharmaceuticals, Inc. Reports