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©2013 Waters Corporation 1
Pharmaceutical Trends
Warren B Potts III
Senior Director, Waters Corporation
Confidential
©2013 Waters Corporation 2
Pharmaceutical Industry What lies ahead
Continuing challenges caused by patent cliff
– Big pharma companies exposed to generic competition
– Growth of the biopharmaceuticals industry
Stricter regulations
– More emphasis on tighter quality control (QC)
– Demands for international harmonization
Increasing demands for profitability
– Demands for low price drug with high quality
The surge of rapidly growing markets
– Quality control is an increasingly critical topic
Confidential
©2013 Waters Corporation 3
Patent Cliff – an Example
Year Brand Name Manufacturer Generic Name
Sales ($m US)
2011 Lipitor Zyprexa
Pfizer Lilly
Atorvastatin Olanzapine
5,804 2,114
2012 Plavix Singulair Seroquel Actos Lexapro Diovan
SA/BMS Merck AZ Takeda Forest Novartis
Clopidogrel Montelukast Quetiapine Pioglitazone Escitalopram valsartan
5,020 3,824 3,549 2,914 2,591 1,585
2013 Cymbalta Lilly duloxetine 2,891
2014 Celebrex Nexium
Pfizer AZ
Celexocib esomeprazole
1,497 5,586
2015 Abilify BMS/Otsuka Aripirazole 4,077
2016 Crestor AZ Rosuvastatin 3,277
2019 Lyrica Pfizer pregabalin 1,571
Total $46,300
Confidential
©2013 Waters Corporation 4
Generics Industry
Grew to $84.8Bn [7.9%] in 2009
Represents worldwide
– 70% of prescriptions written
– 12% of sales revenue
Grow to $207.1B by 2025
– Growth outside mature markets
– >$150B losing patent protection
Difficult regulatory environment
– US Hatch-Waxman
o Can start before patent expires
o 180 days exclusivity
– ROW
o Start after patents expire
o No exclusivity period
46.4%
Confidential
©2013 Waters Corporation 5
Generic Penetration 2000 - 2009
0
10
20
30
40
50
60
70
80
% Revenue
% Rx Written
Visiongain: World Generic Drug Market Outlook 2010-2025
70% prescriptions written account for 12% of the total revenue
Confidential
©2013 Waters Corporation 6
Global Generic Pharma Growth
0
50
100
150
200
250
An
nu
al
Sale
s (
$b
n)
CAGR 5.7%
Generic Pharma industry continues to sustain its growth Visiongain: World Generic Drug Market Outlook 2010-2025
Confidential
©2013 Waters Corporation 7
Generic Growth Driven Outside Traditional Markets
Traditional markets slowing
– US and Germany saturated
– Western EU and Japan slowing
Rapidly growing markets drive growth
– Latin America
– Russia
– India
– China
– Turkey
Opportunity for local companies as well as multi-nationals
Confidential
©2013 Waters Corporation 8
Market Comparison
Visiongain: World Generic Drug Market Outlook 2010-2025
Confidential
©2013 Waters Corporation 9
Trends in Generic Pharmaceuticals
Competitive pressures
– Reducing time to market
– Consistently manufacturing quality product
– Pricing pressures
Fiscal responsibility
– Manage expenses in increasingly competitive environment
– Differentiate on more than price
Global harmonization
– Drive to platform strategy
– Standardization on WW basis
– Consistent supply and technical support WW
Confidential
©2013 Waters Corporation 10
Trends in Generic Pharmaceuticals
Compliance and quality
– Risk based approaches
Focusing on innovation
– Drug delivery
– Diversifying portfolio through biosimilars
Continuous improvement philosophy
– Shorten development time/reduce time to market
– Operational excellence and quality product
Looking at new ways to engage value chain
– Vendor relationships focused on financial terms to partnership
Confidential
©2013 Waters Corporation 11
The Generic Drug Development Process
“Discover” Develop Manufacture Commercialize
Target Drug Selected
“Reverse-engineer” or
“deformulate” brand drug
Distribute and sell
ANDA submitted to FDA
ANDA approved by FDA
Impurity Profile
Formulation Development
Specifications
Route Optimization
Final Formulation
Scale-up
Bioequivalence Bioavailability
Confidential
©2013 Waters Corporation 12
QC Analysis Workflow Typical Tests
Finished Dosage
Form
Raw material
Intermediate and API
Assay
Content Uniformity
Dissolution
Impurities
Sterility
Preservatives
Physical tests
Purity
Identity
Impurities
Crystal form
Water content
Residual solvents
Prepare Samples
Acquire Data
Generate Report
Samples & Info
Product Release Confidential
©2013 Waters Corporation 13
QC Laboratory Challenges
Flexibility
Complexity
Instrument Robustness
Long Term reliability of Methods
Method transfer
Ease of Use
Right First Time
Removing Waste and variability
Interface with Manufacturing
Incorporating technology advances
– While maintaining workflow
Confidential
©2013 Waters Corporation 14
Resource Driven Challenges
People are are your most important assets
– Significant investment needed
Training
Using Multiple platforms
New technology
Ease of Use
New Molecules
– Emergence of Large Molecules
Institutional memory
– Staff Turnover
Avoiding Human Error
Limited Space
Confidential
©2013 Waters Corporation 15
Business Driven Challenges
Productivity
Asset Utilization
Reducing the cost of quality
Profitability
– Eliminate weekend work, OT, 3rd shift
Data processing/results crunching
– Excel?
Timeliness of results
– Releasing product
– Release manufacturing facilities
Documentation/data tracking/audit
Compliance
Confidential
©2013 Waters Corporation 16
Turning Challenges into Winning Strategy How to sustain growth and protect profitability
Take advantage of technology innovation and advances
– Enhance asset utilization and return of investment (ROI)
Make informatics a facilitating factor for productivity
Proactively work with regulatory organizations
– Compliance is a natural result of an effective streamlined workflow
– Should not burden productivity
Emphasis on efficient/effective QC strategies to enhance
productivity
Confidential
©2013 Waters Corporation 17
Why we built the ACQUITY UPLC H-Class
Designed for the QC Lab
Robustness and Reliability
Ease of Use
HPLC/UPLC capability
Smooth method transfer across existing LC platform
Solvent selection capability (up to 9)
Column switching capability (up to 6)
Different column temperature zones
Acquire Data Samples
Preparation Report
Release
Confidential
©2013 Waters Corporation 18
Managing your Laboratory Data
Comprehensive laboratory workflow and documentation solution
Integration of business and laboratory systems
Supports entire product lifecycle from research to manufacturing
Laboratory Instruments
Business Systems
Research QC Development
Sampling Testing Evaluation Release Reporting Request Manage Data
Confidential
©2013 Waters Corporation 19
Technology Adoption Barriers
Pharmaceutical companies risk adverse
– Highly regulated
o Is technology recognized by regulators and standard setters?
– Cost of change
o Investment in technology and potential cost to change filings
– How easy is it to migrate organizationally?
o Acceptance and usage
Many companies, many approaches
– Is there a monograph?
– Start in development
– Prioritize marketed products by volume
– Focus on areas with lower regulatory hurdles
Confidential
©2013 Waters Corporation 20
New Technology Batch Release of Polypellets
Background
– Polypellet (MUPS) manufacturing for Omeprazole
Production
o Three stages of HPLC analysis
• Assay of individual polypellet batches
• Assay of blended polypellets
• Finished product
New technology
– UPLC reduced from 25 mins per run to 2 mins per run
(same resolution)
– Solvent consumption reduced significantly
– HPLC total wait time for a single in-process was 5 hours!
– UPLC total wait time is 30 minutes
Impact
– Release 6 batches in 6 hours, instead of 2 batches per day
– Production of Omeprazole capsules increased from 25
million per month to 40 million per month
Confidential
©2013 Waters Corporation 21
QC Analysis Workflow How Can Waters Help?
Global Service and Support
Prepare Samples
Acquire Data
Generate Report
Samples & Info
Product Release
Confidential
©2013 Waters Corporation 22
Summary
Generic business will continue to grow
Regulations, quality, margins will continue to put pressure on business
Technology adoption will be required for business efficiency
Picking the right company to partner with will make the attainment of the business goals easier
Confidential
