DAVID HARDINGMARCH 12, 2008DCAT WEEK

PERCEPTIONS vs. REALITYFacts and Figures on the Generic Industry

2

Agenda

• History of Thomson Scientific, API Intelligence

• ANDA Trends

• Trends in Paragraph IV filings

• Availability of High-Quality API

• Trends in Regulatory Filings and FDA Inspections

TS API Intelligence is the leading supplier of strategic competitive intelligence and product targeting systems to the generic industry• Newport Strategies was founded in 1990 and acquired by

Thomson Scientific in 2004

• Industry pioneer in research and analysis of how global API development drives competition in launched pharmaceutical products

• Horizon Global and Vision CI are used by professionals in– Product Targeting and Evaluation– Business Development & Licensing– Corporate Development and M&A– R&D, Market Research– Competitive and Business Intelligence– API Sourcing

• In use at more than 150 companies including 8 of the world’s Top 10 innovators and 38 of the Top 50 generic companies

What are the Combined US Sales of Products Losing Patent Protection in 2008?

$0 - $5Billion

$5 - $10Billion

$10 - $15Billion

$15 - $20Billion

>$20Billion

7%

21% 21%

7%

43%1. $0 - $5 Billion

2. $5 - $10 Billion

3. $10 - $15 Billion

4. $15 - $20 Billion

5. >$20 Billion

Generic Opportunities in the U.S.

• Over 150 products, including 20 blockbusters, with $77 Billion in total branded drug sales in the US are coming off patent in the next 5 years

Source: Newport Horizon Global™

0

5000

10000

15000

20000

25000

2008 2009 2010 2011 2012

Sal

es B

illi

on

s U

SD

0

5

10

15

20

25

30

35

40

# D

rug

s L

osi

ng

Exc

lusi

vity

Non-Blockbuster

Blockbuster

Drugs losing Exclusivity

What Country had the Most ANDA Approvals in 2007?

GERM

ANY

INDIA

USA

CHIN

A

ISRAEL

25% 25%

17%17%17%

1. GERMANY

2. INDIA

3. USA

4. CHINA

5. ISRAEL

2007 Final ANDA Approvals by Country

USA; 169; 38%

India; 132; 29%

Israel; 40; 9%

Germany; 25; 5%

Other; 25; 5%

Jordan; 11; 2%Iceland; 14; 3%

Switzerland; 19; 4%

Canada; 24; 5%

Source: FDA, Newport Horizon Global™

Total ANDA Approvals by Indian Generics

0

20

40

60

80

100

120

140

160

180

200

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

# A

ND

As

0

2

4

6

8

10

12

14

16

18

20

# H

old

ers Tentative

Final

Holders

Source: Newport Horizon Global™

Top 10 Companies by Number of Final ANDA Approvals: 1998 – 2007

Source: Newport Horizon Global ™

Group Country NumberTeva Pharmaceutical Industries Ltd Israel 427Novartis AG SwitzerlandApotex Inc Canada 219Ranbaxy Laboratories Ltd India 180Mylan Laboratories USA 168Barr Laboratories Inc USA 121Watson Pharmaceuticals Inc USA 120Vintage Pharmaceuticals Inc USA 116Taro Pharmaceutical USA Inc Israel 115Boehringer Ingelheim KG Germany 113

280

Major New Generic Launches - 2007

• Of the 29 products that witnessed first ANDA approval in 2007, 15 of them were considered blockbusters

• Some major new generic launches of 2007 include:– Ceterizine HCl

– Carvedilol

– Pantoprazole Sodium

– Zolpidem Tartrate

– Risedronate Sodium

– Valacyclovir HCl

Source: FDA, Newport Horizon Global™

Anticipated 2008 Generic Launches

• 25 products will lose patent protection in 2008 in the US and see generic competition

• Some anticipated generic launches of 2008 include:– Memantine HCl

– Topiramate

– Risperidone

– Levetiracetam

– Ropinirole HCl

– Alfuzolin HCl

– Eplerenone

– Rocuronium Bromide Source: FDA, Newport Horizon Global™

How Many Unique Molecules/Combinations Received First ANDA filings with Paragraph IV Certification in 2007?

0-1

0

10-

20

20-

30

30-

40 >

40

17% 17%

25%25%

17%

1. 0-10

2. 10-20

3. 20-30

4. 30-40

5. >40

Paragraph IV Patent Challenges - 2007

• 27 unique molecules or molecule combinations saw first Paragraph IV Patent challenge in 2007

• Some Examples (RLD):– Abilify

– Boniva

– Crestor

– Opana

– Strattera

– Zanaflex

Source: Newport Horizon Global™

Patent Challenges by Country

USA; 200; 37%

India; 113; 21%

Israel; 89; 17%

Canada; 43; 8%

Switzerland; 34; 6%

Iceland; 17; 3%

Germany; 10; 2%

Other; 32; 6%

Source: Newport Horizon Global™

Top 10 Companies by Number of Patent Challenges

Source: Newport Horizon Global™

Group Country NumberTeva Pharmaceutical Industries Ltd Israel 78Apotex Inc Canada 36Mylan Laboratories Inc USA 35Barr Laboratories Inc USA 34Novartis AG Switzerland 31Dr Reddy’s Group India 29Ranbaxy Laboratories Ltd India 26Sun Pharmaceutical Industries Ltd India 24Watson Pharmaceuticals Inc USA 20Par Pharmaceutical Companies Inc USA 19

Paragraph IV Patent Challenges - 2008

• There are 29 molecules with New Chemical Entity exclusivity expiring in 2009, so therefore are exposed to Paragraph IV Patent Challenge in 2008

• So far in 2008, 5 molecules (or combinations) have seen their first patent challenges

• Some major products that will likely see a Patent Challenge include: – Duloxetine HCl

– Pregabalin

– Tiotropium Bromide

Source: FDA, Newport Horizon Global™, data as of 2/29/2008

Availability of High-Quality API for India, China and Rest of World

Source: Newport Horizon Global™

0

20

40

60

80

100

120

140

160

Established Less Established Potential Future

Nu

mb

er o

f C

orp

ora

te G

rou

ps

India

China

ROW

US DMF Filings by Indian, Chinese and Rest of World API Manufacturers: 1998 - 2007

Source: Newport Horizon Global™

257

167 159185 189

226250

312

115

160

233

267 274

5547

3332 26

920

7870

2519

90

6627

292282

0

50

100

150

200

250

300

350

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Nu

mb

er o

f T

ype

II D

MF

s

India

China

ROW

Number of Plants Inspected by US FDA: 2001 – 2007

USA; 173; 32%

India; 71; 13%

Italy; 65; 12%

China; 57; 11%

England; 22; 4%

Spain; 19; 4%Ireland; 16; 3%

Switzerland; 20; 4%

Japan; 30; 6%

Germany; 30; 6%

France; 26; 5%

Source: Newport Horizon Global™

Thank you!

David Harding

Sales Support Specialist, API Intelligence

Pharmaceutical and Chemical Markets

Thomson Reuters

215 Commercial Street

Portland, Maine 04101

USA

+ 1 (207) 871-9700 x27

david.harding@thomsonreuters.com