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

Slides:



Advertisements
Similar presentations
1 CTI Life Sciences Fund Introduction January 2008.
Advertisements

Life Science Cluster in Krakow
Knowledge intensive companies, IC readiness and Seed Capital New and Improved Activities, Outreach and Support Programs on IP Financing WIPO Forum on intellectual.
PLIVA, a Member of the Teva Group Tihomir Oreskovic
CONTRACT RESEARCH SERVICES 1537 NW 65th Avenue Plantation, FL USA Phone: (954) Fax: (954)
ObjectWin Confidential ObjectWin Corporate Presentation.
Bioprocess Pilot Facility
Confidential and Proprietary Information © 2011 Express Scripts, Inc. All Rights Reserved 1 The State of New Mexico Prescription Drug Program 2013.
Confidential Presentation ©2013 The University of Texas at El Paso Business Plan Guidelines.
2014 Annual Meeting of Stockholders Dan Moore, President & Chief Executive Officer September 18, 2014.
Targeted Cancer Therapeutics, LLC Investor Presentation.
1 Pharmaceutical Challenges for the Semantic Web.
US Pharmaceutical/Medical Device Regulatory and Product Development Overview Tom Gardner.
+ Drug Development and Review Process. + Objectives Learn the processes involved in drug discovery and development Define the phases involved in FDA drug.
Cancer Nanotechnology: New Opportunities for Targeted Therapies FDA Public Meeting October 10, 2006 Piotr Grodzinski, Ph.D. Director, Nanotechnology for.
DRIVING INNOVATION AND ABILITY TO COMPETE THROUGH OUTSOURCING Anthony (Tony) C. Bernardo, Alloy Polymers Inc. NPE 2003 bernardo:
SUCCESS FACTORS IN THE PHARMACEUTICAL MARKETPLACE
Career Opportunities for PharmDs in the Pharmaceutical Industry: Research & Development.
Overview  Founded in 2008  Privately held technology development company  Reorganized under new ownership as Tamarisk Technologies Group in 2014 About.
Growth and Success through Partnering & Outsourcing.
PHRM 8660 PHARMACEUTICAL MARKETING RIAN MARIE EXTAVOUR; APRIL 11 TH 2013 TRACKING PROJECT: IMS HEALTH.
Sponsored by Organized by The Thailand International Development Cooperation Agency The Mekong Institute Khon Kaen in Thailand Development of SME Clusters.
Control Components, Inc A wholly owned subsidiary of IMI, plc.
Company Overview NZFMA Seminar March 2013
1 Michael V. Novinski President and Chief Executive Officer November 6, 2008 Third Quarter 2008 Earnings Conference Call.
Veiovis LifeSciences Pvt Ltd
Capital Increase of Electricity Company of Montenegro (EPCG) Vujica Lazovic, PhD Investment Conference Podgorica, January 13, 2009 The Government of Montenegro.
Questcor Pharmaceuticals, Inc
Method of Administering Medication Kevin Murphy. Administration Methods One way to administer a drug is to taking it orally either by pills, capsules,
Social Pharmacy Lecture no. 6 Rational use of drugs Dr. Padma GM Rao
ONTARIO CENTRES OF EXCELLENCE Briefing for the York Boot Camp July 19, 2012.
Developing medicines for the future and why it is challenging Angela Milne.
DELIVERY OF PROTEINS USING BIODEGRADABLE POLYMERS Mahesh V. Chaubal Guilford Pharmaceuticals Inc. Baltimore, MD 21224
CHEE 4401 Definitions drug - any substance that affects the structure or functioning of an organism pharmaceutics - the area of study concerned with the.
The Pharmaceutical Composition Methodology described in this presentation has been developed to improve controlled drug delivery through site specific.
ICU MEDICAL, INC.. 1 FORWARD LOOKING INFORMATION Any statement concerning Management’s expectation with respect to future results is a forward looking.
Visit us at: us at: Talk to us: Partnering Connecting channel partners.
Opiate Analgesic Use in Pediatric Patients Bob Rappaport, M.D. Deputy Division Director Division of Anesthetic, Critical Care and Addiction Drug Products,
1Technology Transfer Tactics
 TECHNOLOGIA is a startup company in Bangalore in 2007 which is completely owned by emirates telecommunication corporation- ETISALAT.  It has helped.
Introduction to Carilex Medical. Overview  Manufacturer and designer of OEM and Carilex-branded wound care products o Specializing in therapeutic support.
Targeted Drug Therapeutics An overview of our technologies and their potential 505(b)(2) applications Sino-American Regulatory Consulting Alliance Yongtian.
BioTrinity April 2016 soloMER Biologics:
BUSINESS STRATEGY AND PLAN 2010 Emerging Energy Solutions 1.
Andy Passey September 23rd 2003 Advanced Wound Management in Europe: Market Overview and Critical Success Factors © 2003 Frost & Sullivan. All rights reserved.
© 2014 GS1 US ALL RIGHTS RESERVED Making a Difference 1.
Innovation Manager SPECIFIC DUTIES AND RESPONSIBILITIES Manage new product projects from concept through commercialization. Partner with Brand Teams to.
© 2016 Global Market Insights, Inc. USA. All Rights Reserved Fuel Cell Market size worth $25.5bn by 2024Low Power Wide Area Network.
Success Stories of Globalization in Korean Pharma
VxP Biologics The Biologics Service Company
Atlantic Bridge Dr Helen McBreen, INVESTMENT DIRECTOR
Part of Suyog Dye Chemie, In Business Since 1983
“Running On Empty” Safe Medication Practices
KJ Hansen, JK Simons, TA Peterson
The Dealy Strategy Group LLC Presentation to Health TechNet
VxP Pharma The Pharmaceutical Services Company
Gestora brasileiro focada exclusivamente na área da saúde.
Global Auto-Injectors Market to Witness 18.6% CAGR during 2017 – 2023.
1888 Press Release - Next Generation Spinal Decompression Technology Enterprise Launched
1888 Press Release - Spine Care Technologies Inc. and mdi Consultants Inc. Announce Strategic Alliance
Non-PEGylated Liposome Production Non-PEGylated Liposome Production —Creative Biostructure.
From Bench to Clinical Applications: Money Talks
AHS Laboratory Supplies
Drug Delivery Systems Pharmaceutical technology Petra University.
Bertelsmann Education Strategy
Life Sciences Solutions
MAZARS’ CONSULTING PRACTICE Helping your Business Venture Further
Proactive One2One Healthcare Forum July 11th 2019
An Enabling Business Environment and A Strategic Collaborative Approach for Sustainable Quality Local Production Africa Pharma Conference 4-5 June 2019,
An Enabling Business Environment and A Strategy and Collaborative Approach for Sustainable Quality Local Production Africa Pharma Conference 4-5 June 2019,
Presentation transcript:

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

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 Toxic Level Sustained-Release Formulation Free Bolus Minimum Therapeutic Level Time Drug Concentration

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 - 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

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) 40% AGR over last three years

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

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

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