Recro Pharma, Inc. - FORM 8-K - EX-99.2

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8-K - 8-K - Recro Pharma, Inc.	d816641d8k.htm
EX-99.1 - EX-99.1 - Recro Pharma, Inc.	d816641dex991.htm

Relieving Pain….Improving Lives

Exhibit 99.2

Special Note Regarding Forward-Looking

Statements

This presentation includes forward-looking statements within the meaning of Section

27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of

1934. These statements, among other things, relate to our business strategy, goals

and expectations concerning our product candidates, future operations, prospects,

plans and objectives of management. The words "anticipate", "believe", "could",

"estimate", "expect", "intend", "may", "plan", "predict", "project", "will" and similar terms

and phrases are used to identify forward-looking statements in this presentation. Our

operations involve risks and uncertainties, many of which are outside our control, and

any one of which, or a combination of which, could materially affect our results of

operations and whether the forward-looking statements ultimately prove to be correct.

These forward-looking statements should be considered together with the risks and

uncertainties that may affect our business and future results included in our filings

with the Securities and Exchange Commission at www.sec.gov. These forward-

looking statements are based on information currently available to us, and we assume

no obligation to update any forward-looking statements except as required by

applicable law.

Company Highlights

•

Dex-IN –

intranasal, non-opioid in Phase II for acute

pain following surgery -

significant market opp’y

•

Multiple clinical studies demonstrate analgesic

effect, fast onset of action and well tolerated

•

Phase

post

pain

trial

ongoing

–

Day

dosing

•

Multiple clinical and regulatory milestones over next

few years

•

Experienced team with significant development,

regulatory and commercial experience

Experienced Management and Board

•

Gerri Henwood –

President and CEO

Founded Auxilium Pharmaceuticals (AUXL,

NASDAQ) and IBAH (former NASDAQ Co. –

acquired 1998); GSK

•

Chuck Garner –

CFO, CBO and Treasurer

Over 14 years of life sciences investment

banking experience –

Deutsche Bank, Burrill &

Co., Inverness Advisors; PwC

•

Randy Mack –

SVP, Development

Over 20 years of clinical development

experience –

Adolor, Auxilium, Abbott Labs

and Harris Labs

Board of Directors

Wayne B. Weisman –

Chairman

SCP VitaLife Partners

Winston J. Churchill

SCP VitaLife Partners

Gerri Henwood –

CEO

William L. Ashton

Harrison Consulting Group; frmly Amgen

Abraham Ludomirski, M.D.

SCP VitaLife Partners

Alfred Altomari

CEO, Agile Therapeutics

Michael Berelowitz

Former SVP, Specialty Care Business

Unit, Pfizer

Clinical Stage Pipeline

Product

III

Rights

Dexmedetomidine (“Dex”)

WW, exc. Europe, Turkey, CIS*

Dex-

IN (intranasal)

Acute post-operative pain

Cancer breakthrough pain

Dex-SL (sublingual)

Transdermal

Fadolmidine (“Fado”)

WW, exc. Europe, Turkey, CIS*

Intrathecal

Post-operative pain

Topical

Neuropathic pain

* CIS currently includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia,

Tajikistan, Turkmenistan, Ukraine, and Uzebekistan.

Post Op Pain Market Underserved

•

$5.9 billion market

(1)

•

Predominantly opioid

use

•

Significant side effects /

issues associated with

opioids

•

Dearth of non-opioid

drugs in development

Inpatient procedures

Total procedures (2009)

47.9M

Addressable

>25M

Ambulatory procedures

Total procedures (2006)

53.3M

Addressable

>25M

Note: Addressable includes procedures expected to

utilize pain medication.

Source: National Center for Health Statistics and

management estimates.

(1) GBI Research, 2010 sales.

Limited Pain Relief Options for Patients

Pain

Severity

Class

Compounds

Advantages

Disadvantages

Mild

Acetaminophen

Antipyretic properties;

Oral; no opioid AEs

Only effective for mild pain

NSAIDs

Ketorolac,

ibuprofen, aspirin

Mild to moderate

analgesia; oral; no

opioid AEs

Bleeding risk; GI and renal

complications

Moderate

Sodium channel

blockers

Bupivacaine,

lidocaine

Use directly at pain

site; mostly peri-

operative

Limited duration of action; some are

concerned about local tissue impact

Moderate to

Severe

Alpha 2 agonists

Dexmedetomidine

(Recro Pharma)

Good pain relief;

anxiolytic properties;

no respiratory

depression, impaired GI

or addictive properties

In development –

potential for first in

class to be approved for post-

operative pain

Opioids

Morphine,

hydrocodone,

oxycodone, fentanyl

Good pain relief

Respiratory depression, impaired GI

motility after even one dose;

frequent nausea and vomiting;

abuse/addiction potential

Note: Pain severity based upon market research / physician feedback

Dexmedetomidine (“Dex”)

Dex Has Demonstrated Analgesia & Safety

•

Alpha 2 agonist (non-opioid)

–

Injectable form (Precedex) marketed by Hospira in US as sedative

–

Multiple studies demonstrating analgesia of alpha 2 agonists

•

Intranasal formulation in clinical development for acute pain

–

In-licensed non-IV rights from Orion

–

Worldwide rights except Europe, Turkey, and CIS

•

Multiple studies demonstrate Dex pain relief and safe profile

–

Including our completed placebo controlled trials

•

Expect strong IP position

–

Pending IP coverage could run through 2030

•

Expect to file 505(b)(2) NDA shortly after completion of Ph III

Dex Efficacy and Safety in Multiple Studies

Beneficial effects

Source

Approved sedative and safe profile

NDA filing / pivotal trials -

Abbott/Hospira, Orion

Morphine sparing

NDA studies plus Literature

Analgesia by IV route

Chan, 2010; Grosu, 2010; Lin, 2009, Arain,

2010

Demonstration of pain relief (VAS)

Placebo controlled trials; L. Webster, MD

(Utah) CLBP study (Recro sponsored)

Positive PK/PD plasma levels

demonstrating analgesic potential

Clinical trials run by Recro

Relieves morphine “Max”

(‘hyperalgesia’)

University of Minnesota; M. Belgrade, MD

Significant Advantages Over Opioids

Dex

Fast-acting Opioids

Non-opioid (Not controlled substance)

Opioid -

DEA scheduled product

No habituation effects

Addictive

Does not cause respiratory depression

Respiratory depression

Not associated with constipation,

nausea, or vomiting

Unwanted side-effects of constipation,

nausea and vomiting

Enhances morphine effectiveness

without morphine dose increase

Additive effect requires higher dose

More cognitively intact

Frequently “Foggy”/ may be confused

Anxiolytic properties

Not anxiolytic

Effective Analgesic

Dex Has Been Well Studied by Recro

•

Evaluated proprietary formulations of Dex in 9 trials

Trial

Form

Design

Outcome

REC-13-012

Dex-IN

Acute pain following

bunionectomy surgery

(n=85 evaluable)

Within a subset of patients (n=42), with

baseline pain intensity of 6 or below,

there was a trend towards analgesia in

50 mcg and reduced opioid use versus

placebo

REC-11-010

Dex-IN

Chronic lower back

pain POC study (n=24)

Statistically significant pain relief within

30 minutes demonstrated in placebo

controlled trial –

single use device

REC-09-003

Dex-SL

Chronic lower back

pain POC study (n=21)

Statistically

significant reduction in pain

intensity demonstrated in placebo

controlled trial

REC-11-008

Dex-IN

Multi-dose PK study

(n=12)

Safety & tolerability of IN dosage form

Dex-IN Study REC-13-012

(US placebo controlled trial)

•

Phase II bunionectomy study in approx. 150-200 pts

•

Three dosing groups –

50 mcg, 35 mcg and placebo

•

Preplanned interim analysis

–

Randomized, placebo controlled study

•

Primary endpoint –

summed pain intensity difference (SPID) over 48 hours

•

Rescue therapy allowed

•

Post Op Day 0 dosing

–

Scheduled after half of patients enrolled

–

Allowed for possible sample size adjustment

–

85 pts evaluable in interim analysis –

approx. 28 pts per group

Results of Phase II Interim Analysis

•

Analgesia and opioid reduction seen in subset of

patients

–

Patients with baseline pain score equal to 6 or lower

–

Approximately half of patients enrolled

•

However, trial was not expected to reach statistical

significance with current design

–

Post Op Day 0 dosing

•

Revised trial design –

Post Op Day 1 dosing

–

Stable / declining pain trajectory

Summary of Key Safety Data –

No SAEs

Event

Dex-IN 50 mcg arm

Placebo arm

Drowsiness

17 (53%)

Nausea

8 (25%)

14 (44%)

Vomiting

2 (6%)

6 (19%)

Dizziness

3 (9%)

5 (16%)

Nasal Irritation

2 (6%)

3 (9%)

Epistaxis

2 (6%)

3 (9%)

•

4 patients discontinued due to symptomatic hypotension (3 in

50 mcg arm, 1 in 35 mcg), 1 due to fever (35 mcg) and 1 due to

nausea and vomiting (placebo)

•

Adverse event of asymptomatic “BP decrease”

in 10 Dex-IN

patients (6 in 50 mcg arm)

•

1 patient in 50 mcg arm and 2 patients in placebo arm had heart

rate below 50 bpm and notable change from baseline

Select Opioid Clinical Trials Side Effects

Source: Stegmann et. al. (2008). The efficacy and tolerability of multiple-dose tapentadol immediate release

for the relief of acute pain following orthopedic (bunionectomy)

surgery. Current Medical Research and Opinion

Placebo

Tapentadol IR

50mg

Tapentadol IR

100mg

Oxycodone IR

10mg

Event

n = 67

n = 68

n = 67

Nausea

17.9%

46.3%

66.2%

71.6%

Dizziness

14.9%

32.8%

64.7%

56.7%

Somnolence

7.5%

28.4%

36.8%

26.9%

Vomiting

1.5%

16.4%

35.3%

38.8%

Headache

10.4%

17.9%

22.1%

20.9%

Pruritus generalized

0.0%

7.5%

13.2%

10.4%

Hyperhidrosis

1.5%

6.0%

8.8%

10.4%

Constipation

1.5%

6.0%

7.4%

17.9%

Pruritus

3.0%

7.5%

7.4%

11.9%

Feeling Hot

4.5%

7.5%

2.9%

10.4%

Dex-IN Next Steps –

REC-14-013

(US placebo controlled trial)

•

Phase II bunionectomy study in approx. 200 –

250pts

•

Post Op Day 1 dosing (previous trial Post Op Day 0)

•

Interim analysis for sample size adjustment planned

•

Top line results expected mid 2015

–

Randomized, placebo controlled study

–

Primary endpoint –

SPID over 48 hours

–

Rescue therapy allowed

–

Pain trajectory stable / declining

–

approximately half of the evaluable patients enrolled

Dex-IN Study REC-11-010

(US placebo controlled POC trial)

•

24 chronic lower back pain (CLBP) patients

–

Chronic opioid users & non-opioid users

•

PBO controlled, cross-over to evaluate:

–

Analgesia –

Standard VAS for Pain Intensity and Pain Relief at multiple

timepoints

–

Safety –

Adverse Events, Vital Signs, Sedation

•

Single doses in a 3-way cross-over

–

PBO

–

Dex-IN 25 µg

–

Dex-IN 50 µg

•

Pain intensity measurements focused on 1 hour with

patients monitored for up to 24 hours

Fast Onset Of and Prolonged Action

(Clinical trial REC-11-010 –

Dex-IN pharmacokinetics)

Note: Administered with single unit device

Statistically Significant Pain Relief

(Dex-IN –

REC-11-010)

Scale: 0 = No Relief, 4 = Complete Relief

* p < 0.05

** p < 0.01

Significant Pain Relief Over Time

(Dex-IN –

REC-11-010 –

Summed Pain Intensity Difference)

* p < 0.05

Dex-IN Well Tolerated

(Clinical trial REC-11-010 -

Adverse events†)

Placebo

(n=24)

DEX-IN 25 µg

(n=24)

DEX-IN 50 µg

(n=24)

Dry Mouth

Nausea

Vomiting

Feeling Abnormal

BP Decrease

Dizziness

Headache

Paraesthesia

Sinus Headache

Somnolence

Nasal Congestion

Nasal Discomfort

Hypotension

†Reported by more than one subject

Dex-IN Repeat Dosing Well Tolerated

(Clinical trial REC-11-008)

•

7 consecutive doses of 35 mcg Dex-IN every 6 hours

•

Evaluated heart rate, blood pressure and BP upon

standing every 5 minutes for two hours after dosing

–

Transient effect after initial dosing

•

None of the above effects categorized by

investigators as AEs

Well Tolerated Profile –

Repeated Dosing

(Study REC-11-008 –

35 mcg Dex-IN formulation)

Period 1

n = 12

Period 2

n = 10

Term

Total

7am

1pm

7am

1pm

7pm

1am

7am

1pm

7pm

Back Pain

Muscle Spasms

Dizziness

Headache

Anxiety

Nasal Discomfort

Nasal Dryness

Rhinalgia

Rinorrhea

Number of Subjects

Fadolmidine (“Fado”)

Fado Effective in Phase II for Pain Relief

•

Alpha 2 agonist

–

more potent at the alpha 2c receptor than Dex

–

>20 fold less potent at the alpha 1b receptor than clonidine

•

Fado has demonstrated analgesia in multiple animal models

•

Positive Phase II analgesia study in bunionectomy patients

–

Intrathecal route of administration

•

Formulation work underway for topical prototype

–

Potential in regional neuropathies

•

WW rights to all human uses except Europe, Turkey and CIS

•

NCE patent w/ expected extension to 2021 / pursuing add’l IP

Corporate Overview

Intellectual Property

•

Dex applications for methods for treating/preventing

pain through intranasal, sublingual and transdermal

formulations without sedation

•

Dex composition of oral transmucosal (SL)

formulation and dispensing devices

•

Fado IP in-licensed from Orion

–

Composition of matter

–

Method of administration for analgesia

–

Treatment and prevention of hypotension and shock

•

Regulatory exclusivity

–

505(b)(2) –

3 years (Dex-IN, Dex-SL)

–

505(b)(1) –

NCE, 5 years (Fado)

Company Highlights

•

Dex-IN –

intranasal, non-opioid in Phase II for acute

pain following surgery -

significant market opp’y

•

Multiple clinical studies demonstrate analgesic

effect, fast onset of action and well tolerated

•

Phase II post op pain trial ongoing –

Day 1 dosing

•

Multiple clinical and regulatory milestones over next

few years

•

Experienced team with significant development,

regulatory and commercial experience

Recro Pharma, Inc. - FORM 8-K - EX-99.2 - November 10, 2014

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Recro Pharma, Inc. Reports