Transcript Slide 1
2008 Future Leaders Conference
March 27th, 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
Introduction and Overview
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
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
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
Unique Proprietary Technology
DepoFoam® Technology Optimizes
Pharmacokinetics and Pharmacodynamics
Drug Concentration
Free Bolus
Sustained-Release Formulation
Toxic Level
Minimum Therapeutic Level
Time
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”
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
DepoFoam®
Permits Both Systemic and Local Delivery
Systemic Delivery
Local 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
- Subcutaneous
- Intramuscular
- Intrathecal
- Intra-articular
- Intraperitoneal
- Subcutaneous
- Epidural
- Intraocular
Products and Pipeline
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
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)
Sales in $MM
Global DepoCyte Sales
30
25
20
15
40% AGR over last three years
40% AGR over last three years
10
5
0
2004
2005
2006
2007
DepoBupivacaine™
72 Hour Post-surgical Pain Relief
• Approximately 45 million annual US in-patient and outpatient 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
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
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
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
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
Pacira Partners and
Bio-Improvement
Opportunities
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
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-a
80,000
60,000
Rat, sc
40,000
Δ
Serum IFNa-2b Conc, pg/mL
20,000
4,000
●
3,000
DepoFoam®-encapsulated IFNα2B (160 mcg dose)
unencapsulated IFNα-2B
(100 mcg dose)
2,000
1,000
0
0
1
2
3
4
5
Time, days
6
7
8
9
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
Thank You