2008 future leaders conference march 27 th, 2008 millennium hotel – new york

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2008 Future Leaders Conference March 27 th , 2008 Millennium Hotel – New York

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Page 1: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

2008 Future Leaders ConferenceMarch 27th, 2008

Millennium Hotel – New York

Page 2: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Pharmaceuticals, Inc.Acute Care Specialty Pharmaceutical Company

• Established March 2007 – SkyePharma Injectable Business• Syndicate Investors

– HBM Bioventures (Cayman) Ltd.– MPM Capital – OrbiMed Advisors, LLC– Sanderling Ventures

• Series A tranched investment of $85 million• Pacira Pharmaceuticals – moving from drug delivery to an

acute care specialty pharmaceutical company

Page 3: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Introduction and Overview

Page 4: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Pharmaceuticals, Inc. Unique Technology and Team Create Value

Acute Care Specialty Pharmaceutical Company Model • Value creation based on understanding of institutional

markets and acute care medical needs• Technology provides advantages over existing therapies

to create high end innovative products– Currently developing products with significant market potential

for Pacira and Partners

• Experienced management team with a strong knowledge of developing, manufacturing, marketing, and delivering products to the acute care market

• Capable and passionate people dedicated to delivering to our customers

Page 5: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Pharmaceuticals, Inc.Unique Technology Creates Value

Acute Care Specialty Pharmaceutical Company Growth

• DepoFoam® delivery technology – highly flexible technology platform– Products approved utilizing DepoFoam® with regulatory agencies

in multiple markets – US, EU, Australia, Brazil

– Epidural and Intrathecal delivery of approved products provide efficacy and safety pathways

• Two GMP approved manufacturing facilities provide global manufacturing requirements– Best in class capabilities to extend the stability of labile

compounds including peptides and proteins

– Aseptic manufacture and filling

Page 6: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Pharmaceuticals Inc.Unique Team Creates Value

Acute Care Specialty Pharmaceutical Company Model

• Company Management experienced in development and delivery of acute care products– Multiple game changing product introductions – Zantac/IV,

Rocephin, Versed, Angiomax, Seroquel, Oxycontin

– DepoFoam® Products improve patient care utilizing well characterized molecules

• Create value efficiently utilizing our knowledge and understanding of the acute care market and customer partnerships to develop high value added products– Commercialize DepoBupivacaine™ in the United States

Page 7: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Unique Proprietary Technology

Page 8: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoFoam® Technology Optimizes Pharmacokinetics and Pharmacodynamics

Toxic Level Sustained-Release Formulation

Free Bolus

Minimum Therapeutic Level

Time

Dru

g C

on

cen

trat

ion

Page 9: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoFoam® Proven Technology Platform

Non-Traditional (multivesicular) Liposomes

•Sustained release delivery technology proven for a wide range of administration strategies developed over 15 years– Ready-to-use aqueous suspension, works with narrow

gauge needles and pen systems (29 & 31 gauge)– Aseptic manufacture and fill– Water-soluble, water-stable drugs– Small molecules, macromolecules– Commercialized manufacture in place– IP to 2018 with significant “know how”

Page 10: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoFoam® Releases Product From 1-30 Days

• Multivesicular, non-classical liposome

• 10–30 µm diameter

• Particle suspension in e.g., saline injected with fine-gauge needles

• >97% water & drug, <3% lipid

• Lipids naturally occurring, biocompatible, biodegradable

• Release: 1 to 30 days

• Delivery: µg to mg/day

• FDA, EMEA, Australian and South American regulatory approvals

FF-SEM image of DepoFoam particle

Page 11: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoFoam® Permits Both Systemic and Local Delivery

- Subcutaneous- Intramuscular

- Intrathecal- Intra-articular- Intraperitoneal

- Subcutaneous- Epidural- Intraocular

Systemic Delivery Local Site DeliveryDepoFoam® can release drug into thebloodstream via the interstitial space

DepoFoam® can release drug into abody compartment, such as a joint

Page 12: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Products and Pipeline

Page 13: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoDur® Provides Effective Pain Relief for up to 48 Hours After Surgery

• Sustained–release, injectable (epidural) morphine for relief of post-surgical pain

– Provides effective relief of pain for up to 48 hours with a single injection– Avoids catheter-related problems with conventional short-acting morphine– Potential to replace conventional infusion pumps (equipment failure and med errors)

• USA – Approved by FDA May 2004 (first-cycle approval)– Launched Dec 2004 – now marketed by EKR Therapeutics– Significant commercial opportunity

• Europe– Filed Nov 2003 (EU mutual recognition procedure with UK as reference country)– UK marketing authorization 2006 – Licensed by Flynn Pharma– Approvals in other EU countries to follow over next 12 months

• Australia– Approved and sold by Orphan Australia

Page 14: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoCyt(e)® – Improves Response Rates and Dosing Regimen

• Intrathecal, injectable cytarabine for lymphomatous meningitis– Severe complication of lymphoma

– DepoFoam® formulation extends period between injections from 1–2 days to 2 weeks and allows treatment on an outpatient basis

• Marketed by Enzon in US as DepoCyt® and Mundipharma in Europe and most other ROW countries (Ex-Japan)

40% AGR over last three years

0

5

10

15

20

25

30

2004 2005 2006 2007

Global DepoCyte Sales

Sa

les

in

$M

M

0

5

10

15

20

25

30

2004 2005 2006 2007

Global DepoCyte Sales

Sa

les

in

$M

M

40% AGR over last three years

Page 15: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoBupivacaine™ 72 Hour Post-surgical Pain Relief

• Approximately 45 million annual US in-patient and out-patient surgical procedures – 7.2 million utilize bupivacaine

• Non-opioid therapy for post-surgical pain is a significant unmet medical need

• Bupivacaine is the most commonly used local anesthetic for significant surgical procedures and is considered the gold standard– Bupivacaine is effective but duration of action is 6-8 hours

Source: Thomson Medical Data 2007

Page 16: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoBupivacaine™ Offers Important Customer and Patient Benefits

• Simplified post-operative pain management after various surgical procedures

– Post-op pain control for 72 hours following surgery, part of multi-modal pain control strategy

• Significant reduction of supplemental opioid pain medications– Fewer narcotic related issues and side effects

• Easy to use– Infiltration of wound site at closure– No need for catheters, pumps, or devices– Simple dilution with saline solutions for a wide range of volumes

• Likely pharmacoeconomic benefits– Improved patient management, earlier discharge, faster rehabilitation– Reduced opioid related costs and enhanced patient satisfaction

Page 17: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoBupivacaine™ Clinical Development and Regulatory Strategy

• Phase II complete, effective pain control in soft tissue surgery and bone surgery, four surgical models

• No safety issues at highest doses studied for pain control

• Phase III trials, completed as planned support a NDA/EMEA in 1H 2009– Japan – Partner (Maruho) developing for intra-articular use

– Additional clinical opportunity in nerve block and epidurals

• 505(b)(2) Regulatory Strategy– Bupivacaine is a well-characterized molecule

– DepoFoam® successful in multiple global regulatory approvals

– IP for DepoFoam® through 2018

Page 18: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoBupivacaine™ Manufacturing Strategy is Solid

• Pacira manufactures DepoDur® and DepoCyte® in our San Diego facility to meet global requirements

• Pacira produces material to meet the needs of our multiple R&D partnerships in San Diego facility

• DepoBupivacaine™ strategy is to manufacture product for the US and the EU launch at scale on equipment currently producing clinical material

• Two GMP commercial manufacturing facilities in San Diego

Page 19: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoBupivacaine™ Commercial Strategy is On Track

• Launch in the US with Pacira Commercial Resources– Extensive clinical and commercial experience in acute care

markets, history of success including many blockbuster brands –Versed, Zantac/IV, Rocephin, Angiomax, Seroquel, Oxycontin

– Marketing and Sales Team who launched Angiomax vs Heparin in percutaneous coronary angioplasty

– Concentrated market <1,000 hospitals perform 70% of targeted surgical procedures

• In-patient and out-patient opportunity to replace opioid therapy (IV and PCA) for enhanced patient care and improved economics

• Partner in the European Union and ROW– Currently partnered with Maruho in Japan

Page 20: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Partners and Bio-

Improvement Opportunities

Page 21: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

DepoFoam® Research and Development

• Improved dosing and administration – weekly and monthly profiles to improve PK/PD

• Three active partnerships for multiple products and combinations of products – subcutaneous dosing

• DepoFoam® provides a novel opportunity for long acting intrathecal injection for multiple sclerosis, alzheimer's, metabolic proteins or enzymes

• DepoFoam® provides the opportunity for long acting injection into body compartments beyond SQ dosing

Page 22: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Pharmaceuticals Inc Bio-lmprovement Utilizing DepoFoam®

• Pacira sponsored enhanced biosimilars/bioimprovements– Product feasibility demonstrated for IFN-α, EPO, G-CSF, FSH

– Products could be further developed for out-licensing or Pacira commercialization

0 1 2 3 4 5 6 7 8 90

1,000

2,000

3,000

4,000

20,000

40,000

60,000

80,000

Seru

m IF

Na-2

b C

onc,

pg/m

L

Time, days

DepoIFN-a Rat, sc

DepoFoam®-encapsulated IFNα-2B (160 mcg dose)

unencapsulated IFNα-2B (100 mcg dose)

Δ

Page 23: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Pacira Pharmaceuticals, Inc.Acute Care Specialty Pharmaceutical Company

• Blue Chip Venture Investors and Board of Directors

• Management Team with world class experience and expertise in product delivery and acute care commercialization

• DepoBupivacaine™ – a significant product opportunity, Pacira launch in the US and partner in EU and ROW

• DepoFoam® Technology platform provides opportunity

– Rapid, low risk clinical and regulatory development programs

– Improve product dosing profiles and therapeutic options

• Multiple Partnerships provide short term milestone revenue and longer term royalty revenue

– 2 international product approvals – DepoDur® and DepoCyt®

– R&D initiatives around blockbuster brands

Page 24: 2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York

Thank You