GLOBAL PHARMA PRIMER

GEOGRAPHIC CONSIDERATIONS IN PHARMACEUTICAL INDUSTRY

SUPPORTING MATERIALS

BIG PHARMA HQ - USA

BIG PHARMA HQ – US West Coast

BIG PHARMA HQ – US East Coast

BIG PHARMA HQ – Europe & Israel

BIG PHARMA HQ – EUROPE

BIG PHARMA HQ – Japan

Inhaled insulin failed to convince patients and doctors and was withdrawn by Pfizer because it did not sell. The main reason was the need to involve another group of specialists in patient care – pulmonologists – in the care of diabetes patients. The practice was expensive and inconvenient for the patients as well as for the practitioners. The device itself failed to meet customers’ expectations because of its design features: too big and indiscrete to carry around. Investors as well as financial analysts had high expectations for inhaled insulin and predicted Exubera to become a blockbuster.

EXUBERA

EXUBERA … WILL KNOCK YOUR SOCKS OFF

Exubera became a topic for in popular culture due to its design which resembled a bong, exposing its legitimate users to public ridicule .

CLINICAL TRIALS: INTERVENTIONAL & OBSERVATIONAL

CLINICAL TRIALS: INTERVENTIONAL

Country Region Number of clinical trials

United States of America NORAM 86,784 United Kingdom EU 21,677 Japan APAC 20,764 Germany EU 20,719 Canada NORAM 14,936 France EU 14,557 Netherlands EU 13,372 Italy EU 12,467 Australia APAC 12,403 China APAC 11,955 Spain EU 11,331 Iran ME 8,162 Belgium EU 7,850 India SEA 7,623

CLINICAL RESEARCH – GEOGRAPHICAL DISTRIBUTION

86,784

0

5000

10000

15000

20000

25000

CLINICAL RESEARCH BY COUNTRY – TOP 25

LATAM 17,724

NORAM 101,720

Country Number of trials

USA 86,784

Canada 14,936

Brazil 5,557

Mexico 2,764

Argentina 2,311

Puerto Rico 1,760

Chile 1,308

Colombia 1,097

Peru 1,093

CLINICAL RESEARCH GEOGRAPHICAL DISTRIBUTION

EUROPE 175,603

EU 153,761

ROE 21,842

Country Number of trials

UK 21677

Germany 20719

France 14557

Netherlands 13372 Italy 12467 Spain 11331

Belgium 7850

Denmark 6481

Sweden 6165

Israel 5423

Austria 5412

Poland 4828

Czech Republic 4609

Switzerland 4454

Hungary 4401

Russia 3499

Finland 3398

CLINICAL RESEARCH GEOGRAPHICAL DISTRIBUTION

AFRICA 5,480

ME 11,211

Country Number of

trials South Africa 2,449 Uganda 399

Kenya 369

Tanzania 291

Malawi 187

Zambia 164

Ghana 152

Nigeria 133 Burkina Faso 128

Mali 111

Zimbabwe 103

Country Number of trials

Iran 8,162

Egypt 1,066

Saudi Arabia 444 Pakistan 385 Lebanon 297 Tunisia 209 Jordan 147 United Arab Emirates 137 Morocco 101

CLINICAL RESEARCH GEOGRAPHICAL DISTRIBUTION

APAC 65,051

SEA 10,784

Country Number of trials

India 7,623

Thailand 2,204

Indonesia 329

Bangladesh 242

Sri Lanka 220

Nepal 87

Korea 54

Myanmar 25

Country Number of trials

Japan 20,764

Australia 12,403

China 11,955

Republic of Korea 7,577

Taiwan 4,171

New Zealand 2,917

Singapore 1,667

Hong Kong 1,338

Malaysia 969

Philippines 900

CLINICAL RESEARCH GEOGRAPHICAL DISTRIBUTION

EXTRATERRITORIAL FDA

CHINESE FDA

The deputy director of the Chinese State Food and Drug Administration Zhang Jingli has been dismissed and is now under investigation for “disciplinary violations.” The move comes after the former head of the drug agency Zheng Xiaoyu was executed in 2007 for taking bribes to approve faulty medicine that was blamed for several deaths.

FOREIGN SOURCED APIs v. IMPORTED DRUGS

GLOBAL PHARMA PRIMER

Source: Sanofi website

Source: Novartis website http://www.novartis.com/about-novartis/company-history/

Pfizer abandoned bid on AstraZeneca, May 2014

PFIZER BID ON ASTREZENECA

Source: Techalive

MAIN SHIPPING ROUTES STRAITS, PASSAGES AND CHOKEPOINTS

SHIPPING ROUTES: India to East Coast

STRAITS: Bob el Mandab, Suez Canal, Gibraltar

SHIPPING ROUTES: India to West Coast

STRAITS: Malacca, Windward Passage

SHIPPING ROUTES: China to East Coast

STRAITS: Tsugaru, Panama Canal

SHIPPING ROUTES: China to the UK

STRAITS: Malacca, Bob el Mandab, Suez Canal, Gibraltar

SHIPPING ROUTES: India to the UK

STRAITS: Bob el Mandab, Suez Canal, Gibraltar