Transcript Introduction to Pfizer CentreSource

Introduction to Pfizer CentreSource
October, 2013
Pfizer Today
$59
175
BILLION
revenue
in 2012
manufacturing
sites worldwide
markets
in which Pfizer
sells products
OVER
$3.1
R&D partner
institutions across
the globe
products with sales
greater than
$1 billion in 2012
90,000
BILLION
cash and products
donated from U.S.
and Puerto Rico
in 2011 globally
Primary Care and
Specialty Care
businesses
worldwide
colleagues around
the world
Who We Are and Where We Want to Be
Our Purpose:
Innovate to bring therapies to patients that significantly improve their
lives….
….we will deliver on Our Mission:
To be the premier, innovative biopharmaceutical company
Guided by the Four Imperatives…
3
1
2
3
4
Fix the innovative core and
generate medicines that
profoundly impact health
Make the right capital
allocation decisions to
maximize value and
enhance shareholder
return
Earn greater respect from
society
Create an ownership
culture
3
New Global Commercial Organization
Structure
Vaccines, Oncology &
Consumer Healthcare
Innovative Products Group
Geno Germano, Group President
Value Products Group
John Young, Group President
Amy Schulman, Group President
●
Inflammation/Immunology
●
Vaccines
●
LOE Products
●
CV/Metabolic
●
Oncology
●
Biosimilars
●
Neuroscience
●
Consumer Healthcare
●
EP/EM Collaborations
●
Pain
 Mylan in Japan
●
Rare Diseases
 Hisun in China
●
Men’s/Women’s Health
Will generally include products that
have exclusivity beyond 2015
 Teuto in Brazil
Will include businesses with
different operating models and
distinct specializations
Will include LOE products and generally the
patent-protected products that are expected
to lose exclusivity through 2015
● Emerging Markets will be integrated into each segment
● Will begin operating in the new commercial structure at the start of fiscal 2014
● Will provide greater financial transparency for each business segment starting with the Q1
2014 earnings release
New Commercial Structure Better Positions Pfizer for Long-Term Success
Pfizer Global Supply
(PGS)
The World Premiere Pharmaceutical Supply Organization
PGS covers all aspects of
Pfizer product supply
Our Network
• 58 internal manuf. sites
• 188 logistics centers
• 400+ supply partners
• 30,000+ colleagues
Products and Formulations
• 600+ major product groups
• 35,000+ SKUs
• 3,000+ formulations
• 40+
technologies/platforms
Key Activities
• Site and Logistics network
• Operational/Supply/
Technical support
• Product co-development,
launch, and process
optimization
• External partnerships
>175
>50
Markets
Languages
PGS Purpose and Mission
Pfizer Global Supply:
Purpose
We supply quality products to patients that
significantly improve their lives
Mission
To be the premier, innovative
biopharmaceutical global supply
organization delivering recognized value
7
Pfizer CentreSource
(PCS)
Pfizer CentreSource Profile
• Commercial operations experience since 1970
• Lean Global Team (45 FTEs)
• Two Business Units
9
14
– Contract Manufacturing
– Fine Chemicals
• Management of Manufacturing &
Supply Agreements (MSAs)
• Dedicated Technical Service and Regulatory
Support
77
PCS Leadership Team
Michael J. Kosko
President
Pfizer CentreSource
Brenda G. Saylor
Admin. Assistant
Brian R. Boyer
Kevin Chng
Finance Manager
Vice President
Asia Pacific
Bindert Vriesema
Vice President
Europe/Middle East/Africa
James A. Carr
Jeffery W. Frazier
Cristin Grove
Vice President
North/South America
Vice President
Fine Chemicals
Director, Marketing
Contract Mfg.
Steven E. Grieve
Director, Tech. Dev.
& Regulatory Affairs
Brigita Holley
Joan L. Root
Sr. Manager
Divested Products
Sr. Corporate Counsel
Kathy G. Amrhein
Director, Human Resources
Sales & Business
Development Team Leaders
Business Leaders
Global reach….
Regionally Organized to be Closer to our Partners
Kalamazoo, MI
Headquarters
Brussels,
Belgium
Singapore
North &
South America
•
•
Europe,
Mid. East & Africa
Asia
Pacific
Regional Sales & Business Development teams with customer service support (order
processing, financial & logistics services)
Local warehousing facilities supporting the region
11
Contract Manufacturing
Liquids
and SemiSolids
Sterile
Injectable
Specialized
Technology
Global
Pfizer
Network
Solid Oral
Dose
High
Containment
Solid Oral
Dose
Manufacturing Network for HighContainment Solid Dose Forms
Development
Newbridge, Ireland
Freiburg (PPD), Germany
High-containment development
Supply of clinical batches phase I-IV
Batch size: 1-50 kg
High-containment development
Supply of clinical batches phase I-IV
DevCON batch size: 5-150 kg
Integrated resources for solid dose contract manufacturing
Commercial
Newbridge, Ireland
Ascoli, Italy
Commercial production in segregated
areas
(batch size from 50 kg to 1000 kg)
Product lines: low-dose and highly–
potent products, cytotoxics, sex
hormones
Freiburg (PGS), Germany
Medium-scale commercial production in
segregated areas (batch size from 10 kg
to 400 kg depending on technology)
Product lines: low-dose and highly–
potent products, cytotoxics, sex
hormones
Commercial production in segregated
areas
(Batch size from up to 150kg)Product
lines: low-dose and highly–potent
products, immunosuppressant,
cytotoxics,
Fine Chemical
• Portfolio of steroid & hormone products (intermediates
& APIs)
• Biologic drug substance contract manufacturing
services (proteins, biologics, vaccine components, …)
• 3rd Party Heparin Sodium supply (injectable grade)
• Sales & Marketing of selective API’s (antibiotics,
prostaglandins…)
• Emphasis on IP protection, quality and GMP
compliance
Selected Sites
Kalamazoo, MI
Andover, MA
Sanford NC
North &
South America
Strängnäs, SE
Ringaskiddy, IE
Freiburg, Gr
Ascoli ,IT
Europe,
Mid. East & Africa
Pfizer Kalamazoo
16
Pfizer Ringaskiddy
OSP1
1972 &
1980
OSP2
1984
Ringaskiddy Site Facts
Size:
Volume:
People:
APIs:
Markets:
200 acres
499,000 litres
475
17 (commercial)
Global
(closed)
OSP3
1995&
1999
OSP4
2001
Strategic Role: Multi-product API Manufacturing Facility &
New Product Introduction
Waste
Water
Treatment
Andover – A Biotechnology Facility
Founded in 1980



Clinical and commercial Drug
Substance (DS) and Drug Substance
Intermediate (DSI) production
Strong focus on lifecycle
management
Products
 rFvIII (Recombinate)
 rFIX (BeneFIX)
 rhBMP-2 (InductOs/Infuse)
 rhIL-11 (Neumega)
 polysaccharides (Prevnar 13v)
 Herceptin
 Clinical manufacture of over 80
candidates
Strangnas Sweden: Fast facts
• Modern GMP Licensed Drug Substance
Biotech facility operating to Pfizer Quality
Standards
• ISO certified
– 9 001
– 14 001
– 18 001
•
•
•
•
Facility with attractive scale
Designed for flexibility
Low CO2 footprint
Possibilities to continuously optimize
processes with support from small scale
lab
Fragmin
for thrombosis prevention;
haemodialysis
Somavert
GH-receptor antagonist
•
•
•
•
Genotropin
Biosynthetic growth
hormone
89 000 m² total site
20 000 m² plant facilities
Approx. 220 full time
employees
Up to 300 production batches
a year in a 3000 l fermentation
scale
Sanford, NC
Quick Facts:
1.
2.
3.
4.
Microbial platform production with
fermentation and conjugation capabilities
Multi-product capable facilities
Designed for BSL 3 operations
CDC select agent production registration
Drug substance for microbial / conjugate products:
Clinical trial materials
Commercial launch / production
Global CRM197 carrier protein production
Pfizer Ascoli
Total Area
164,000sm
Floored Area
42,000sm
Expansion Area
60,000sm
Pharma Forms
Oral Solids
Recipes
# 125
Families (API’s)
# 42
SKU’s
1700
Supplied Countries
100 +
Volume (Packs)
manufacturing expertise in high
containment (OEB4-5),
cytotoxic, central nervous system (CNS)
& sex hormones products
Approx 100MM
Pfizer Manufacturing Deutschland, Standort
Freiburg
 Located in South-West Germany in
Baden-Württemberg
 Founded 1866 (Leipzig), since 1962 in
Freiburg
 Total site area: 155.000 m²
 Pharmaceutical production of tablets and
capsules
 Main Products: Lipitor, Valoron, Lyrica
 1,000 Employees in Production, PPD and
other functions
Pfizer Freiburg:
Launch Site for
New Solid Dosage
Form Products
 Production volume A2009:
3.4 Billion tablets/capsules,
228 Million packs (8.3 Billion tablets and
capsules packaged)
 More than 1,800 different presentations for
150 countries (Europe, USA, Japan, ...)
 Highly automated and state-of-the-art
pharmaceutical facility