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

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Presentation on theme: "2008 Future Leaders Conference March 27 th, 2008 Millennium Hotel – New York."— Presentation transcript:

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

2 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

3 Introduction and Overview

4 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

5 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

6 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

7 Unique Proprietary Technology

8 DepoFoam ® Technology Optimizes Pharmacokinetics and Pharmacodynamics Toxic Level Sustained-Release Formulation Free Bolus Minimum Therapeutic Level Time Drug Concentration

9 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

10 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

11 DepoFoam ® Permits Both Systemic and Local Delivery - Subcutaneous - Intramuscular - Intrathecal - Intra-articular - Intraperitoneal - Subcutaneous - Epidural - Intraocular Systemic DeliveryLocal Site Delivery DepoFoam® can release drug into the bloodstream via the interstitial space DepoFoam® can release drug into a body compartment, such as a joint

12 Products and Pipeline

13 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

14 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

15 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

16 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

17 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

18 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

19 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

20 Pacira Partners and Bio-Improvement Opportunities

21 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

22 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 DepoIFN- Rat, sc DepoFoam®-encapsulated IFNα- 2B (160 mcg dose) unencapsulated IFNα-2B (100 mcg dose) Δ

23 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

24 Thank You

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