Corporate Presentation


  
	

	 


Corporate Presentation

March  2012

1

Exhibit 10.2
 







  
	

	 


The

presentation

may

contain

“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. Reference is made in particular to 

the description of our plans and objectives for future operations, 

assumptions underlying such plans and objectives and other forward-

looking terminology such as “may,”

“expects,”

“believes,”

“anticipates,”

“intends,”

“expects,”

“projects,”

or similar terms, 

variations of such terms or the negative of such terms.  Forward-looking

 statements are based on management’s current expectations. Actual 

results

could

differ

materially

from

those

currently

anticipated

due

to

a 

number of factors, including but not limited to, uncertainties relating to 

financing and strategic agreements and relationships; difficulties or 

delays in the regulatory approval process; uncertainties relating to 

sales, marketing and distribution of the Company's drug candidates that 

may be successfully developed and approved for commercialization; 

adverse side effects or inadequate therapeutic efficacy of the 

Company's drug candidates that could slow or prevent product 

development or commercialization; dependence on third party 

suppliers; the uncertainty of protection for the Company's patents and 

other intellectual property or trade secrets; and competition. 

Safe Harbor

2
 







  
	

	 


•

Titan Pharmaceuticals Highlights

•

Probuphine Development

•

Probuphine Market Opportunity

•

Financial Summary

•

Summary

Presentation Content

3
 







  
	

	 


•

Specialty pharmaceutical company focused in CNS with an NDA 

submission

for

ProbuphineTM

expected

in

Q3,

2012

•

Probuphine has the potential to be the first long acting therapeutic 

on the market for the treatment of opioid dependence

–

Six month controlled release formulation of an approved drug, buprenorphine

–

Clinical development completed 

–

Addresses U.S. market of over $1B and growing

–

Significant unmet needs continue to exist in the market place

–

Potential peak sales of $300m –

$500m

–

U.S. patent life to 2024

–

Probuphine has the potential to be developed for treating chronic pain

•

ProNeuraTM

–

unique long term drug delivery system can provide 

around the clock medication and has potential in additional 

applications

•

Near term value-creating milestones

•

Lean and capital efficient organization

Titan Pharmaceuticals: Highlights

4
 







  
	

	 


Probuphine Development

5
 







  
	

	 


•

Addiction is a primary, chronic disease of brain reward, 

motivation, memory and related neurobiological circuitry* 

•

inability to consistently abstain 

•

impairment in behavioral control

•

craving 

•

diminished recognition of significant problems with one’s behaviors

•

Addiction involves cycles of relapse and remission 

•

Without treatment or engagement in recovery activities, addiction 

is progressive and can result in disability or premature death

*American Society of Addiction Medicine, Inc., 2011

Disease Overview

6
 







  
	

	 


•

In the U.S. buprenorphine has replaced methadone as the gold standard in treating

 opioid dependence

•

Buprenorphine is a mixed partial agonist at the mu receptor and an antagonist at

 the kappa receptor

•

Ceiling effect

•

Improved safety profile

•

Lack of euphoria

Ceiling

Effect

of

Buprenorphine

Disease Treatment Overview

7
 







  
	

	 


Launched in 2003 

Global sales exceed 

$1.2B in 2010 (U.S. 

sales of $1B)

Source: EvaluatePharma; Reckitt Benckiser 2010 Annual Report

Suboxone

®

Franchise WW Sales

0

200

400

600

800

1000

1200

1400

2003

2004

2005

2006

2007

2008

2009

2010

58% CAGR for

the last 4 years

Suboxone has grown rapidly  

Incremental Treatment Improvements Have Driven 

Conversion and Growth of the Market

8
 







  
	

	 


•

Efficacy

•

Medication compliance 

•

Retention of patients

•

Reduction in the use of opioids and other substances 

•

Safety and tolerability

•

Risks of misuse, abuse, diversion

•

Risk of precipitating withdrawal

•

Risk of overdose 

Significant Unmet Medical Needs in the Treatment of 

Opioid Dependence

9
 







  
	

	 


Solid Matrix Long-Term Delivery

•

Non-biodegradable

•

Inserted subcutaneously

•

Stable non-fluctuating blood levels of drug maintained for over 6 months

Probuphine is a subcutaneous implant capable of delivering continuous and 

persistent around the clock blood levels of buprenorphine for 6 months 

following a single treatment, enhancing patient compliance and retention

Probuphine

10
 







  
	

	 

 EVA
polymer
 Buprenorphine

Each implant contains 80 mg of buprenorphine HCl which has been blended and 

extruded with ethylene vinyl acetate (EVA) co-polymer

Probuphine

Probuphine

11

26 mm long,

2.5 mm 

diameter

Inert component of 

several 

approved products

Approved for treatment of 

opioid addiction, and

acute and chronic pain

Blended

&

Extruded
 







  
	

	 


PRO-810

Pharmacokinetics

Pharmacokinetics

PRO-806

U.S. Efficacy 2

U.S. Efficacy 2

Pre-NDA meeting

U.S. Retreatment 2 

U.S. Retreatment 2 

2007

2008

2009

2010

2011

2012

Q

1

Q

2

Q

3

Q

4

Q

1

Q

2

Q

3

Q

4

Q

1

Q

2

Q

3

Q

4

Q

1

Q

2

Q

3

Q

4

Q

1

Q

2

Q

3

Q

4

Q

1

Q

2

Q

3

Q

4

PRO-805

U.S. Efficacy 1

U.S. Efficacy 1

PRO-807

U.S. Retreatment 1 

U.S. Retreatment 1 

n = 163

n = 163

n = 62

n = 62

n = 9

n = 9

n = 287

n = 287

n = 85

n = 85

Probuphine: Clinical Development Program

NDA 

NDA 

submission

submission

12

PRO-811
 







  
	

	 

 PRO
810 –
 Mean Plasma Buprenorphine AUC (0-24 h)

2.29

2.13

0.82

0

0.5

1

1.5

2

2.5

3

Suboxone (Day -2)

Suboxone (Day -1)

Probuphine 

(Steady State)

Probuphine: Plasma Pharmacokinetics

13

Continuous, around the clock medication maintaining a 

Continuous, around the clock medication maintaining a 

stable level of buprenorphine in the patient

stable level of buprenorphine in the patient

Weeks on Study

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

4.50

0

4

8

12

16

20

24

Phase 1/2 (4 implants, n=6)

PRO

805 (4 or 5 Implants, n=104)

PRO

807 (4 or 5 Implants, n=61)

PRO

810 (4 Implants, n=9)

PRO

806 (4 or 5 Implants, n=113)

-

-

-

-
 







  
	

	 


Study 2 (PRO-806):

•

n = 287; 20 sites

•

Three-arm: Double-blind 

randomized, placebo-controlled 

and open-label active 

(Suboxone)

Study 1 (PRO-805):

•

n = 163; 18 sites

•

Two-arm: Double-blind 

randomized, placebo-

controlled

(Urine Toxicology Three Times Per Week)

Probuphine: Two Phase 3 Controlled Studies

14

Up to 16 days

SL BPN Dose

12

16 mg/day

3 Days

6-month Treatment Phase

Telephone

Call

Implant Removal

End of Treatment /

Induction

Follow-up

Screening

Baseline

Implant 

Visit

Randomize/

-

Post

Implant

Treatment and

x/

week Urine Visits

3

(Weeks 1 –

24)

Week 

24

Week 

26

Week 

25

-
 







  
	

	 


•

Urine toxicology (blinded to sites and patients)

•

Tests for presence of opioids (heroin, methadone, prescription pain medications,

 etc.)

•

Clinical Global Improvement

•

Clinician-rated

•

Patient-rated

•

Symptoms of opioid withdrawal and craving

•

Clinician-rated (COWS)

•

Patient-rated (SOWS and craving VAS)

•

Patient-reported illicit drug use

•

Mood

•

Beck Depression Inventory II

Study Assessments

15
 







  
	

	 


Outcome Measures

Outcome Measures

Probuphine

Probuphine

> Placebo

> Placebo

CDF of % Negative Urines

(24 weeks)

p = 0.0117 (primary)

Treatment Retention

(24 weeks)

p < 0.0001

Global Severity of Opioid Addiction

(Patient Rated)

(24 Weeks)

p < 0.0021

Global Severity of Opioid Addiction

(Physician Rated)

(24 Weeks)

p < 0.0086

Patient-rated opioid withdrawal

(24 weeks)

p = 0.0005

Clinician-rated opioid withdrawal

(24 weeks)

p = 0.0008

Opioid craving

(24 weeks)

p = 0.0006

Study 1: Efficacy Results –

Probuphine vs Placebo

16
 







  
	

	 


Outcome Measures

Outcome Measures

Probuphine > Placebo

Probuphine > Placebo

p < 0.0001 (primary)

p < 0.0001 (primary)

p = 0.0002

p = 0.005

p = 0.031

p = 0.0003

p = 0.0002

p < 0.0001

p < 0.0001

p < 0.0001

Study 2: Efficacy Results –

Probuphine vs Placebo

17

CDF of % Negative Urines

(24 weeks)

CDF of % Negative Urines Incorporating Patient 

Self Report (24 weeks)

Treatment Retention

(24 weeks)

Patient-Rated Global Severity

Global Improvement

(24 Weeks)

Clinician-Rated Global Severity

Global Improvement

(24 Weeks)

Patient-rated opioid withdrawal

(24 weeks)

Clinician-rated opioid withdrawal

(24 weeks)

Opioid craving

(24 weeks)
 







  
	

	 


Probuphine vs. Suboxone: Percentage of Urine Samples

Probuphine vs. Suboxone: Percentage of Urine Samples

Negative for Illicit Opioids in Weeks 1-24

Negative for Illicit Opioids in Weeks 1-24

•

Non-Inferiority Comparison (-15% Margin):

•

31% Probuphine vs. 33% Suboxone

•

95% Confidence Interval for Difference:
-10.8, 5.9 

•

Least-Squared Means Comparison:

•

36% Probuphine vs. 35% Suboxone

Study 2: Efficacy Results –

Probuphine vs Suboxone

18
 







  
	

	 


PRO-805

End

of

Treatment

/

PRO-807

Baseline

Start

SL

BPN

Induction

Implant

Visit

/

4

Probuphine

Implants

Post-

Implant

Visit

Wk

1

Wk

24

Wk

25

Wk

26

Wk

8

Wk

12

Wk

16

Wk

20

Wk

4

Implants Removed

Stop Sublingual Buprenorphine

12-24 Hours

Prior to

Implantation

End of 

Treatment/

Implant

Removal

Follow-Up

Visit

Telephone

Call

24 Hours

Up to 14 Days

Six-Month, Open-Label, Multicenter Retreatment Trials in 

Patients Completing the Controlled Studies

PRO -

807

•

14 study sites in the U.S.

•

62 patients who completed PRO-805

received 4 initial Probuphine implants

•

6 patients received a 5

th

implant

PRO -

811

•

20 study sites in the U.S. 

•

85 patients who completed PRO-806 

received 4 initial Probuphine implants 

•

Study completed end of Dec 2011 and initial      

 results released in Feb 2012

19
 







  
	

	 


•

Probuphine was clinically and statistically superior to placebo in the 

treatment of opioid-addicted patients, and demonstrated non-inferiority to

 Suboxone.

•

Adverse events were mild to moderate in severity and generally consistent 

with the patient population and the known safety profile of buprenorphine in 

all studies.

•

Early termination due to adverse events was low in all studies.

•

The number and profile of serious adverse events was low in all studies and 

similar to placebo.

•

The implant procedure was generally well tolerated in all studies and there 

was no evidence of implant diversion or misuse.

•

Probuphine delivers an efficacious, low level of buprenorphine continuously 

for six months.

Clinical Summary

20
 







  
	

	 


•

Pre-NDA meeting completed with the FDA on October 25, 2011

•

Clinical

data

on

safety

and

efficacy

of

Probuphine

considered

to

be 

sufficient for NDA submission

•

Manufacturing scale up plans are acceptable to the FDA, however,

additional data on the characterization of the EVA and Probuphine is 

required to complete the Chemistry, Manufacturing and Controls 

section

•

FDA provided guidance on the requirements for a Priority Review 

designation and suggested that appropriate information should be

included with the NDA submission

•

NDA submission is targeted for Q3, 2012

•

CMC section related analytical testing underway at two vendors

•

Electronic NDA document preparation commenced at CRO

•

Manufacturing facility expansion and production scale-up in process

NDA Preparation Status

21
 







  
	

	 


•

Buprenorphine has several advantages over other opioids used for

chronic pain

•

Safer than other opioids

–

ceiling effect for respiratory depression, relatively long half-life, minimal

 euphoric effect

•

Buprenorphine transdermal patch (3-7 days) is approved in U.S., 

Europe and Australia for the treatment of moderate to severe chronic 

pain

•

Therapeutic window of 0.1 –

0.5 ng/ml plasma level can be delivered with   

1 to 2 Probuphine implants

•

Probuphine value proposition for treating chronic pain

•

Around the clock non-fluctuating therapeutic levels, no on/off therapy 

cycling, enhances compliance and increases patient convenience

Sources: NEJM 2003;349:1943-53

Sittl, Expert Rev. Neurotherapeutics 2005;5(3): 315-323

Probuphine for the Treatment of Chronic Pain

22
 







  
	

	 


Probuphine Market Opportunity

23
 







  
	

	 


•

Prevalence is large and growing rapidly

•

Worldwide: > 6m persons addicted to opioids

•

U.S.  > 2m, range varies between 2-4m depending on source

•

Opioid addiction is a chronic long term illness

•

Patients who stop all medically-assisted therapy (MAT) are highly 

susceptible to relapse

•

Opioid addiction market is now >$1.2B globally

•

Opioid prescriptions have grown 400% from 1997-2007

•

Hospitalizations have increased 500% over the last 10 years

•

Treatment for abuse of pain relievers increased at a 13% CAGR 

from 2002-2009

Sources: EPIDEMIC: RESPONDING TO AMERICA’S PRESCRIPTION DRUG ABUSE CRISIS,
Executive Office of the President of the United States (2011); 2009 National Survey on 

Drug Use and Health (NSDUH); “A Wave of Addiction and Crime, with the Medicine
Cabinet to Blame”, New York Times (Sept 23, 2010); Drug Abuse Warning Network (DAWN), 

SAMHSA, HHS; “A General in the Drug War”, New York Times (Jun 14,
2011)
 Market Overview

24
 







  
	

	 


•

Methadone tablets mainstay for opioid addition in U.S. from late

1960’s to 2002

•

Strong

restrictions

regarding

patient

access

and

administration

access

in

U.S.

•

Can be lethal and has high potential for misuse, abuse and diversion

•

Subutex

®

and Suboxone

®

oral formulations approved in 2002 

•

Safer than methadone and other opioids

•

Buprenorphine can occupy opioid receptors but produces ”ceiling
effect”
 •

Mitigates euphoric effect and respiratory depression

•

Fewer restrictions on patient access

•

Enabled treatment in office-based setting

•

Misuse, abuse and diversion problematic

•

Naltrexone

•

Opioid antagonist

•

Must be completely detoxified before initiating therapy

•

Minority of opioid addicted patients succeed

Competitors: Few and Well Established with no New 

Innovations on Immediate Horizon 

25
 







  
	

	 


•

Launched in 2003 

•

Global sales exceed $1.2B in 2010 (U.S. sales of $1B)

Source: EvaluatePharma; Reckitt Benckiser 2010 Annual Report

Suboxone

®

Franchise WW Sales

0

200

400

600

800

1000

1200

1400

2003

2004

2005

2006

2007

2008

2009

2010

58% CAGR for

the last 4 years

90% of prescriptions 

were written by 5,037 

physicians

Suboxone

®

Sales 

Exceed $1B a Year in 

the U.S.

Suboxone

®

sales

have 

grown at a 58% CAGR 

over the last 4 years

Extremely Concentrated Prescriber Base

26
 







  
	

	 


Suboxone Prescribing Physicians

27

Breakdown of Suboxone Prescribing Physicians

Other 

12%

Pain/Neuro 

5%

Psych

32%

IM/FP/GP

51%

Source: IMS Health
 







  
	

	 


•

Efficacy

•

Reduction in the use of opioids

•

Retention of patients and their treatment on therapy  

•

Reduction in the use of other substances 

•

Safety and tolerability

•

Risk of overdose 

•

Risk of misuse, abuse, diversion

•

Risk of precipitating withdrawal 

•

Accessibility / cost 

•

Delivery 

•

Onset of action

•

Restrictions on administration

Source: Decision Resources 2011 

Top Unmet Needs Defined by Physicians

28
 







  
	

	 


Efficacy

Effective in reducing illicit opioid use 

Enhanced compliance may lead to superior outcomes

Safety

Lower drug exposure may provide superior safety and tolerability

Ease of Use

Unique delivery system dosed once every six months

Continuous buprenorphine delivery

•

Non-fluctuating blood levels, around-the clock medication

•

Potential 100% compliance

Diversion

Limited access to implants

•

Subcutaneous placement

•

Specific distribution (non-retail)

Probuphine Value Proposition

Probuphine is the first and only potential treatment for opioid dependence 

that can provide continuous and persistent around the clock blood levels 

of buprenorphine for six months, enhancing patient compliance and 

retention and preventing diversion

29
 







  
	

	 


•

Billion dollar market large and growing

•

Significant unmet needs continue to exist in the market 

place

•

Excellent margins due to small, target prescriber population 

•

5,037

physicians

wrote

90%

of

buprenorphine

prescriptions

in

the

U.S.

in 

2010

•

Sales Force of 50 reps can cover majority of prescribers

•

Controlled distribution facilitates efficiency and maintenance of accounts

•

Unique value proposition for Probuphine better addresses 

unmet needs and has the potential to become the new gold 

standard

of

treatment

–

Peak

sales

$300-500m

Market Opportunity Ideal as Specialty Pharma Stand-

alone or as an Addition to Existing CNS Franchise

30
 







  
	

	 


•

Patent applications are for method-of-use claims

•

Method-of-use and similar claims provide strong protection of commercial
product:  
 •

Alternate device or alternate indication would require de novo clinical
trials
 Country

Opioid Dependence

U.S.

Granted (to 2024)

Pending

Europe

Pending

Pending

Japan

Granted (to 2023)

Granted (to 2023)

Canada

Pending

Pending

Mexico

Granted (to 2023)

Granted (to 2023)

Australia

Granted (to 2023)

Granted (to 2023)

New Zealand

Granted (to 2023)

Granted (to 2023)

Hong Kong

Pending

Pending

India

Pending

Pending

Probuphine Intellectual Property

31

Pain Treatment
 







  
	

	 


•

Equity

•

Common Stock Outstanding

59.4m

•

Stock Options/ Restricted Stock

5.6m

–

weighted-average exercise price of $1.56 per share

•

Warrants

13.0m

–

weighted-average exercise price of $1.78 per share

•

December 30, 2011

•

Cash

$   5.4m

•

Debt

$ 12.3m 

–

Principal $10m + Present Value of Interest $2.3m

Financial Summary

32
 







  
	

	 


Probuphine

•

Billion dollar opioid dependence market is large and growing

•

Worldwide: > 6m people addicted to opioids

•

Addresses significant unmet needs that exist in the market place

•

Reduction in the use of opioids 

•

Retention of patients on therapy (persistence and compliance)

•

Diversion, abuse

•

Probuphine has the potential to be the first long acting therapeutic on the 

market for the treatment of opioid dependence

•

Six month controlled release formulation of buprenorphine has key advantages in

 patient compliance to treatment, and avoidance of diversion/abuse

•

$300-500m potential annual peak sales in opioid dependence

•

Potential application in treating chronic pain

•

Goal to establish U.S. commercialization partnership by the time

of NDA filing

ProNeura

•

Possible applications of technology for long term drug delivery in other 

chronic illnesses, e.g. Parkinson’s Disease

Titan Pharmaceuticals Summary

33
 







  
	

	 


Marc Rubin, M.D.    

July 30, 2008

34
 







  
	

	 


Buprenorphine Implant

35
 







  
	

	 


Insertion Applicator

36
 







  
	

	 


Insertion Location

37
 







  
	

	 


Removal Clamp

38
 







  
	

	 


Summary of Non-Implant Site Adverse Events 

Frequency (

10% in Any Treatment Group) 

PRO-805

PRO-807

Probuphine

(n = 108)

Placebo

(n = 55)

Probuphine

(n = 62)

System Organ Class

n

%

n

%

n

%

Any Adverse Events

85

78.7

41

74.5

43

69.4

Gastrointestinal

Constipation

15

13.9

3

5.5

8

12.9

Diarrhea

6

5.6

7

12.7

2

3.2

Nausea

15

13.9

7

12.7

2

3.2

Toothache

12

11.1

3

5.5

3

4.8

Infections

Nasopharyngitis

15

13.9

3

5.5

2

3.2

Upper Respiratory

14

13.0

6

10.9

3

4.8

Musculoskeletal

Back Pain

13

12.0

3

5.5

5

8.1

Nervous System

Headache

27

25.0

10

18.2

11

17.7

Psychiatric

Anxiety

11

10.2

5

9.1

2

3.2

Insomnia

23

21.3

12

21.8

8

12.9

39
 







  
	

	 


PRO-806

PRO-811

Probuphine

(n = 114)

Placebo

(n = 54)

Suboxone

(n = 119)

Probuphine

(n = 85)

System Organ Class

n

%

n

%

n

%

n

%

Any Adverse Events

77

67.5

33

61.1

85

71.4

57

67.1

Gastrointestinal

Constipation

5

4.4

1

1.9

5

4.2

2

2.4

Diarrhea

2

1.8

3

5.6

2

1.7

2

2.4

Nausea

7

6.1

1

1.9

8

6.7

3

3.5

Toothache

4

3.5

1

1.9

5

4.2

3

3.5

Infections

Nasopharyngitis

6

5.3

3

5.6

12

10.1

2

2.4

Upper Respiratory

10

8.8

4

7.4

11

9.2

7

8.2

Musculoskeletal

Back Pain

6

5.3

3

5.6

7

5.9

5

5.9

Nervous System

Headache

15

13.2

5

9.3

19

16.0

10

11.8

Psychiatric

Anxiety

2

1.8

3

5.6

6

5.0

3

3.5

Insomnia

9

7.9

8

14.8

16

13.4

2

2.4

Summary of Non-Implant Site Adverse Events 

Frequency (   10% in Any Treatment Group) 

40
 







  
	

	 


Summary of Implant Site Adverse Events Frequency 

(

10%

in

Any

Treatment

Group) 

PRO-805

PRO-807

PRO-806

PRO-811

Probuphine

(n = 108)

Placebo

(n = 55)

Probuphine

(n = 62)

Probuphine

(n = 114)

Placebo

(n = 54)

Probuphine

(n = 85)

Erythema

25.0%

21.8%

25.8%

3.5%

0%

1.2%

Edema

13.0%

9.1%

12.9%

1.8%

0%

0.0%

Itching

25.0%

14.5%

19.4%

4.4%

3.7%

1.2%

Pain

22.2%

10.9%

19.4%

8.8%

9.3%

0.0%

Bleeding

12.0%

12.7%

16.1%

1.8%

3.7%

3.5%

Bruising

5.6%

14.5%

9.7%

7.9%

11.1%

3.6%

Scar

9.3%

12.7%

1.6%

0%

0%

1.6%

41