Paratek Pharmaceuticals, Inc. - FORM 8-K - EX-99.1 - COMPANY SLIDE PRESENTATION DATED JUNE 2010

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

June 2010

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 slide deck contains forward-looking statements that are based upon current expectations within the meaning of the

Private Securities Reform Act of 1995 and for which we intend that protection be gained by the safe harbor created thereby.

Such statements involve risks and uncertainties. Actual results

and the timing of events may differ significantly from that

discussed in the forward-looking statements.

Examples

such

statements

include,

but

are

not

limited

to,

expectations

with

respect

to:

plans

resubmit

the

Intermezzo

NDA; Intermezzo

being the first commercially available sleep aid in the United States in its target indication; plans for a

highway driving study of Intermezzo

and studies of ondansetron; and the ability of Transcept

to resubmit the Intermezzo

NDA with sufficient content to warrant FDA approval; the cost of

planned studies and the sufficiency of cash resources to

address the FDA Complete Response Letter issues and fund currently planned studies; the ability of Transcept

to obtain and

maintain patent protection and regulatory exclusivity for Intermezzo

; the satisfaction of conditions under our collaboration

agreement

with

Purdue

obtain

payments

thereunder;

plans

Transcept

exercise

the

option

co-promote

Intermezzo

and to develop a specialty sales force; plans of Purdue to prioritize Intermezzo

commercialization; plans to enter into

partnerships outside the U.S. for the commercialization of Intermezzo

; and the ability of Transcept

to identify potential

neuroscience products to complement any co-promotion of Intermezzo

Various important factors could cause actual results or events to differ materially from the forward-looking statements that

Transcept

makes, including risks related to the following: our ability to

carry out planned studies successfully and in a timely

manner; new information arising out of clinical trial results; the FDA's view of the sufficiency of the anticipated content of the

planned resubmission to support review and approval of the Intermezzo

NDA; unforeseen expenses related to FDA approval

and the business of Transcept

generally; a decision by Purdue to terminate the Collaboration Agreement, before or even if

the Intermezzo

NDA is approved; obtaining, maintaining and protecting the intellectual property rights for our product

candidates; dependence on third parties to manufacture product candidates for our planned studies and carry out clinical

trials; and the ability of Transcept

to obtain additional funding, if needed, to support its business activities.

These and other risks are described in greater detail in the "Risk Factors" section of Transcept

periodic reports filed with the

SEC. 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. 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.

Transcept

Pharmaceuticals: company profile

Transcept

Pharmaceuticals: company profile

Public listing through reverse merger in Jan 2009 –

Nasdaq:TSPT

Intermezzo

(zolpidem

tartrate

sublingual tablet): lead

product candidate

U.S. primary care partnership with Purdue Pharma,

psychiatry co-promote option

Strong balance sheet: $83.1M of cash, cash

equivalents and marketable securities on Mar 31, 2010

Management team with consistent history of

pharmaceutical product development and commercial

success

Transcept

Pharmaceuticals: key corporate events

Transcept

Pharmaceuticals: key corporate events

Intermezzo

: Preclinical program and two Phase 3

studies completed: 2004-2008

Intermezzo

NDA submitted: September 2008

U.S.

commercial

partnership:

Purdue,

Intermezzo

primary care marketing and sales: July 2009

Intermezzo

Complete Response Letter received from

FDA: October 2009

Transcept

plans

resubmit

the

Intermezzo

NDA

Q1 2011 for six-month FDA Class 2 review

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

U.S. insomnia market:

~76 M insomnia Rxs

and ~5% Rx growth: March 2009-March 2010

U.S. insomnia market:

~76 M insomnia Rxs

and ~5% Rx growth: March 2009-March 2010

Source: Wolters

Kluwer

Pharma

Solutions

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

Large scale population based sleep epidemiology

study

, ~9,000 subjects over 4 years

35% report awakenings at least 3x per week

>90% report awakenings persist more than six months

Fewer than 25% of the middle of the night awakening

group reported difficulty going to sleep at bedtime

10.9% of study subjects who experienced middle of the

night awakenings consulted a physician

(1)

Maurice

Ohayon,

MD,

DSc,

PhD:

Nocturnal

Awakenings

and

comorbid

disorders

the

American

general

population,

Psych

Research

(2008)

Intermezzo

: no product currently indicated for prn

treatment of middle of the night awakening

Middle of the night awakenings typically did not occur every

night, even in a more severely affected patient

group

Commonly prescribed 7 to 8 hour sleep aids require

bedtime prophylactic dosing before an awakening occurs

and are not designed for use in the middle of the night

An ideal therapeutic would:

–

Be used 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 enough dose to avoid next day residual effects

(1) Transcept

Pharmaceuticals Phase 3 outpatient study, n = 294

Novel formulation

Low dose

Fast acting

No next day

residual effects

Sleep lab clinical result: 14 minute sleep onset

with 3.5 mg dose

In two Phase 3 studies, no significant next day

residual effects as compared to placebo

Sublingual tablet dissolves in ~ 2 minutes

pH drives

zolpidem

base, rapidly absorbed

72%

lower

dose

than

Ambien

the

most

commonly prescribed insomnia brand

Intermezzo

: anticipated to be the first sleep aid for

use at the time of a middle of the night awakening

Intermezzo

: anticipated to be the first sleep aid for

use at the time of a middle of the night awakening

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

Regulatory Review

FDA Complete Response Letter: October 2009

FDA indicated Transcept

has submitted substantial evidence

of effectiveness for the use of Intermezzo

in its intended

indication

FDA recognized that the Intermezzo

data did not indicate

significant next-day residual effects at 4 hrs

However, given the unique Intermezzo

indication, FDA has

requested:

–

additional data on next-day effects, with reference to driving

ability

–

demonstration that inadvertent dosing errors can be minimized

•

inadvertent re-dosing in a single night

•

inadvertent dosing with < 4 hrs of bedtime remaining

Actions to address FDA Complete Response Letter

Inadvertent re-dosing in a single night

FDA has indicated that redesigned unit dose packaging appears

to reduce the potential for inadvertent re-dosing in a single night.

Inadvertent dosing with < 4 hours bedtime remaining

FDA has agreed to a pre-approval highway driving study to

characterize

the

safety

profile

dosing

Intermezzo

with

four

hours or less remaining in bed. Study has begun.

FDA

has

agreed

consider

part

the

overall

Intermezzo

NDA the Transcept

contention that a pre-approval in-use study

could not accurately measure patient ability to avoid inadvertent

dosing errors.

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, 4 hours post-dose

–

Intermezzo

3.5mg vs. placebo, 3 hours post-dose

–

Zopiclone

7.5mg vs. placebo (positive control)

Key measure of driving impairment: standard deviation

of lateral position (a measurement of ‘weaving’) as

compared to placebo

U.S. Commercial Partnership:

Purdue Pharma

U.S. Commercial Partnership:

Purdue Pharma

Purdue Pharma:

Intermezzo

U.S. primary care marketing partner

Purdue Pharma:

Intermezzo

U.S. primary care marketing partner

> $2 billion 2008 revenue, leading pain therapeutic

franchise, significant U.S. primary care marketing

and sales presence

Intermezzo

: an important new product opportunity

for Purdue

Purdue team actively engaged with Transcept

address issues raised in FDA Complete Response

Letter

Purdue Pharma

agreement: key Transcept

benefits

Purdue Pharma

agreement: key Transcept

benefits

Purdue

commercialize

Intermezzo

U.S.

primary

care

market

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

–

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

Base royalties

–

Double digit royalties up to the mid 20% level on net sales

Co-promote option: foundation for a commercial future

–

Additional double digit royalty on psychiatrist Rx net sales

–

Transcept

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

anniversary after Purdue launch

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 2005

–

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

Pipeline development

TO-2061: low-dose ondansetron

augmentation in treatment-resistant

obsessive compulsive disorder (TR-OCD)

TO-2061: low-dose ondansetron

augmentation in treatment-resistant

obsessive compulsive disorder (TR-OCD)

Proposed indication statement: For use as an adjunctive

therapy in adult patients with OCD who have not

adequately responded to treatment with an SSRI

Significant unmet medical need: Treatment Resistant

Obsessive Compulsive Disorder (TR-OCD)

Significant unmet medical need: Treatment Resistant

Obsessive Compulsive Disorder (TR-OCD)

Obsessive Compulsive Disorder

–

Psychiatric disorder characterized by intrusive thoughts and repetitive

actions that attempt to reduce the associated distress

–

1% to 2% of U.S. population

–

Significantly interferes with every day life activities for patients and

their families

–

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

treatment

with

SSRIs

(e.g.,

Prozac

Luvox

Paxil

Zoloft

)

No FDA-approved treatment for TR-OCD

–

SSRIs

are often augmented by off-label use of atypical antipsychotics

•

~68% of SSRI-resistant OCD patients do not respond to

augmentation treatment with atypical antipsychotics

•

Atypical antipsychotics may produce significant adverse effects

(weight gain, metabolic disorder)

Rationale for ondansetron

augmentation in TR-OCD

Rationale for ondansetron

augmentation in TR-OCD

Ondansetron: 5-HT

antagonist (Zofran

) approved for

chemotherapy-induced nausea and vomiting, typical

daily doses of 16 mg to 24 mg

Like SSRIs, ondansetron

affects serotonin pathways and

may enhance SSRI effects on OCD symptoms

Like atypical antipsychotics, ondansetron

reduces

dopaminergic

activity and may inhibit repetitive behavior

by down-regulating dopamine

Two Transcept

Paratek Pharmaceuticals, Inc. - FORM 8-K - EX-99.1 - COMPANY SLIDE PRESENTATION DATED JUNE 2010 - June 8, 2010

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Paratek Pharmaceuticals, Inc. Reports