our locations in europe

22
Headquarters Affiliates Plant sites Brussels Zurich Vienna Munich London Amsterdam Pfaffenhofen Paris Altkirch Madrid Lisbon Rome Istanbul Dublin Our Locations in Europe 1

Upload: lola

Post on 23-Feb-2016

35 views

Category:

Documents


0 download

DESCRIPTION

Our Locations in Europe. Headquarters Affiliates Plant sites. Dublin. London. Amsterdam. Brussels. Pfaffenhofen. Paris. Altkirch. Vienna. Munich. Zurich. Madrid. Rome. Lisbon. Istanbul. European Production Sites. Altkirch , France. Pfaffenhofen, Germany. - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: Our Locations in Europe

HeadquartersAffiliatesPlant sites

Brussels

ZurichViennaMunich

London Amsterdam

PfaffenhofenParis

Altkirch

Madrid

Lisbon RomeIstanbul

Dublin

Our Locations in Europe

1

Page 2: Our Locations in Europe

European Production Sites

Altkirch, France

About 40 employees

Manufacturing of active pharmaceutical ingredients for traditional Luitpold products

Main products: MPS/PSGAG (mucopolysaccharides for topical or veterinary applications)

Pfaffenhofen, Germany

About 400 employees

Pharmaceutical development

Pharmaceutical services

Pharmaceutical and biotech manufacturing: 900 stock items, shipped out to 50 countries

2

Page 3: Our Locations in Europe

Facts and Figures of Our Pfaffenhofen Plant

• Pharmaceutical manufacturing activities established at the current site as part of Luitpold-Werk in 1962

• Additional state-of-the-art facilities for solids manufacturing/packaging inaugurated in 2007

• Only DAIICHI SANKYO plant in Europe producing bulk and finished pharmaceutical goods

• Approved by local and international authorities such as the U.S. FDA

• Approximately 70 per cent of DAIICHI SANKYO EUROPE’s turnover is produced or handled via the Pfaffenhofen plant

• Toll manufacturing for USA and Asian markets• Successful development and launch site for

new products, such as OLMETEC PLUS®, SEVIKAR®/AZOR®, and CS-8635

3

Page 4: Our Locations in Europe

Sales of Global Products

FY 2008 (in € m.) FY 2009 (in € m.)

Olmesartan 1,471 1,816

OLMETEC® (JP) 448 588

BENICAR®/BENICAR HTC® (US) 609 677

AZOR® (US) 61 97

OLMETEC®/OLMETEC PLUS® (EU) 261 304

SEVIKAR® (EU) 15 48

Others & exports 76 99

Levofloxacin 680 664

CRAVIT® (JP) 299 332

Export 216 162

Royalty 112 111

Others 52 59

Pravastatin 423 419

MEVALOTIN® (JP) 353 352

Export 22 18

European subsidiaries 27 24

Others 20 25

Prasugrel 0.2 3Exchange rates: (FY 2008) ¥143.5=€1 / (FY 2009) ¥131.2=€1 These figures do not include out-licensing sales.

4

Page 5: Our Locations in Europe

Main Products in Europe

Trade name Active ingredient Indication areaEFIENT® prasugrel prevention of

atherothrombotic events

SEVIKAR® olmesartan medoxomil + amlodipine besilate

hypertension

OLMETEC® olmesartan medoxomil hypertension

OLMETEC PLUS® olmesartan medoxomil + hydrochlorotiazide

hypertension

EVISTA® raloxifene osteoporosis

MEVALOTIN® pravastatin sodium hypercholesterolaemia

PODOMEXEF® cefpodoxime proxetil bacterial infections

LOPRESOR® metroprolol extended release hypertension

LOMIR® / ICAZ® isradipine hypertension

5

Page 6: Our Locations in Europe

EFIENT®

• Potential blockbuster in cardiovascular care• Antiplatelet agent to prevent atherothrombotic

events• Discovered by DAIICHI SANKYO and its Japanese

research partner Ube Industries, co-developed and co-promoted with Eli Lilly and Company

• European launch sequence started in Spring 2009• Key contributor to company sales over the next

years

6

Page 7: Our Locations in Europe

The Olmesartan Success Story

*As of February 2010

• Leading angiotensin receptor blocker (ARB) with excellent blood pressure lowering efficacy

• Launched in 2002 as 7th product in the ARB market, still showing high growth rates

• OLMETEC® launched in 58 countries worldwide*, including the majority of European markets

• Co-marketing agreements with Menarini Group, Pfizer, Nycomed

• OLMETEC PLUS® launched in majority of European countries, launch sequence for additionaldosage comprising 40 milligrams olmesartan startedin Spring 2010

• SEVIKAR® launched in several European countriesin 2009

• Singel pill combination containing olmesartan, hydrochlorotiazide and amlodipine in approval process

7

Page 8: Our Locations in Europe

SEVIKAR®

• Fixed dose combination of olmesartan and amlodipine• Significantly lowers blood pressure and was well

tolerated in clinical trials• Effective treatment option: Most hypertensive

patients need two or more medications to normalise their blood pressure

• Approval for majority of European countries achieved, launch started in January 2009

• In the U.S. the combination was already approved in September 2007 under the name of AZOR®, sales have been successful since launch in October 2007

8

Page 9: Our Locations in Europe

EVISTA®

• In 2006, DAIICHI SANKYO bought the co-marketing and distribution rights for the osteoporosis brand EVISTA® (raloxifene) for six European countries from Eli Lilly: Germany, Austria, Switzerland, Italy, Belgium, the Netherlands.

• Since 2008, DAIICHI SANKYO is the marketing authorisation holder for 34 countries (Europe and further countries).

Background

• Treatment and prevention of osteoporosis in postmenopausal women• Only selective estrogen receptor modulator (SERM) in the osteoporosis market,

available as a once daily tablet • Estrogen agonist in bone tissue, and an estrogen antogonist in breast and

uterine

Product description

• Provides a significant contribution to increasing net sales• Significant revenue enhancement in all major countries • “Vehicle” for European expansion e.g. to Turkey and Ireland

Strategic implications

9

Page 10: Our Locations in Europe

DAIICHI SANKYO EUROPE GmbH 10

€1.5 billion20.7% of net sales

Creating first-in-class, best-in-class, high-value-added products

Kazunori HirokawaHead of R&D Division

R&D Expenditures in the Fiscal Year 2009

Page 11: Our Locations in Europe

DAIICHI SANKYO is Investing Heavily into R&D

2006 2007 2008 2009 2010*0

200

400

600

800

1000

1200

1400

1600

1168 10181285

1500 1600

Investment in €m.

* Forecast

18.5%

21.4%21.9% 20.7%

18.3%

Percentage of net sales

Page 12: Our Locations in Europe

R&D Today: Overview

• “First-in-class“ or “best-in-class” products

Philosophy

• Tokyo, Japan: Two sites for basic research, preclinical research, clinical development for Japan and Southeast Asia

• Edison/New Jersey, USA: Global clinical research centre• London, United Kingdom: Clinical development coordination for Europe• Martinsried/Munich/Pfaffenhofen, Germany: Preclinical research for

monoclonal antibodies by U3 Pharma, pharmaceutical development by DAIICHI SANKYO EUROPE

Main locations

• R&D budget FY2009: €1.5 bn. / 20.7% of net sales (Industry average 15-17%)• Global research teams: About 4,500 researchers for active ingredients and

develop new pharmaceuticals

Support

12

Page 13: Our Locations in Europe

The Global R&D Network

As of 31 March 2010 13

DAIICHI SANKYO R&D ~ 1,500 peoplePharmaceutical technology~ 400 People

Asubio Pharma~ 300 people

DAIICHI SANKYO RD Associe~150 people

Asia, South & Central America~ 80 people

DAIICHI SANKYO DEVELOPMENT (London)~ 50 people

DAIICHI SANKYO EUROPE (Munich)~ 130 people

U3 Pharma (Munich)~ 28 people

DAIICHI SANKYO (Edison, NJ)~ 300 people

Luitpold Pharmaceuticals(Shirley, NY)~ 40 people

Ranbaxy Laboratories~ 1,400 people

Page 14: Our Locations in Europe

The European R&D Network

As of 31 March 2010 14

DAIICHI SANKYODEVELOPMENT LTD.London

50 people(development)

DAIICHI SANKYOEUROPE GmbH Munich

130 people(development, pharmaceutical technology)

U3 Pharma GmbH Martinsried

28 people(research)

Page 15: Our Locations in Europe

R&D Highlights

• Invention of the statin class• Invention of insulin sensitizer class (TZDs)• Invention of the oral factor Xa class• Leading quinolones (levofloxacin, ofloxacin)• Best-in-class angiotensin II receptor blocker (olmesartan)• Standard colon cancer treatment developed (irinotecan)

DAIICHI SANKYO invents and develops globally leading products

15

Page 16: Our Locations in Europe

Our R&D Focus

Research and early stage

development

• Oncology

• Cardiovascular-

metabolics

Late-stage development

• Thrombotic

disorders

Life cycle management

• Hypertension

• Bacterial

infections

• Hyperlipidemia

16

Page 17: Our Locations in Europe

Cardiovascular Pipeline

Hypertension: olmesartan

• 2002 – Launch of mono indication

• 2005 – Launch of hydrochlorotiazide fixed dose combination

• 2009 – Launch of amlodipine fixed dose combination

• Triple combination in the approval process

Anti-platelet aggregation: prasugrel• More effective than

clopidogrel• Basically same safety

profile as clopidogrel • 2009 – Launch of PCI

indication in Europe

Anticoagulation: edoxaban

• Oral factor Xa inhibitor expected to have better safety and similar efficacy profile than vitamin K antagonists

• Once daily tablet without monitoring

• Pivotal phase III study in patients with atrial fibrillation and venous thromboembolism ongoing

“Best-in-Class” ARB, increasing blockbuster

sales

“Best-in-Class“ anti-platelet with blockbuster

potential

“Best-in-Class” oral factor Xa inhibitor with

blockbuster potential

17

Page 18: Our Locations in Europe

Development of Factor Xa Inhibitor Edoxaban

• Edoxaban is a direct factor Xa inhibitor and a member of a new class of oral anticoagulants.

• It is given once daily and has been investigated in phase II trials in patients undergoing orthopedic surgery and in patients with atrial fibrillation.

• It is developed solely by DAIICHI SANKYO as a new treatment for the prevention of both arterial and venous thromboembolism.

Edoxaban is tested in two phase III clinical studies• ENGAGE AF-TIMI 48 with about 16,500 patients

focuses on prevention of thromboembolic stroke in atrial fibrillation.

• HOKUSAI-VTE with about 7,500 patients focuses on the treatment and recurrence-prevention of venous thromboembolism.

18

Page 19: Our Locations in Europe

Oncology Pipeline

• “First-in-class“ death receptor 5 antibody with high sales potential • Administered concomitant with established anti-tumour therapy• Efficacy and safety in therapy of several cancer types observed

Tigatuzumab (CS -1008) – Phase II

• “First-in-class“ PPAR γ agonist in oncology • Concomitant with established anti-tumour therapy• Attractive sales potential

CS-7017 – Phase II

• c-Met inhibitor suppressing the c-Met pathway of cancer cells• Target indications: c-Met associated sarcoma, non-small cell lung cancer, pancreatic

adenocarcinoma, hepatocellular carcinoma (HCC)

ARQ-197 - Phase II

• HER-3 human antibody• Target indications: tumours associated with over-expression of HRE-3

U3 1287 – Phase I

19

Page 20: Our Locations in Europe

Key Projects from our Development Pipeline

*Only developed in Japan / **Only developed in the US / As of March 2010 20

Area Phase I Phase II Phase III Application for approval

Cardiovascular disease

DB-772dedoxaban (AF/VTE)

prasugrel (ACS-MM)

CS-8635,edoxaban*

Metabolic disorders

CS-1036

Infectious disease

CS-4771 levofloxacin inj.*, laninamivir

Malignant neoplasm

U3 -1287

nimotuzumab*, tigatuzumab,

CS-7017, ARQ-197

Immunological allergic disease

CS-0777 SUN 13834**

Bone/joint disease

denosumab* loxonin gel*

Page 21: Our Locations in Europe

Acknowledged Research Pipeline

• Renowned R&D Directions magazine selected DAIICHI SANKYO in 2009 to have the “Best Cardiovascular Pipeline”

• Great potential of EFIENT® and edoxaban acknowledged

• More than 25 years experience with anticoagulants and anti-thrombotics

21

Page 22: Our Locations in Europe

Major Group Companies

Japan India The Netherlands

DAIICHI SANKYO PROPHARMA CO., LTD. DAIICHI SANKYO INDIA PHARMA PRIVATE LIMITED DAIICHI SANKYO NEDERLAND B.V.

DAIICHI SANKYO RD ASSOCIE CO., LTD. Ranbaxy Laboratories Limited Belgium

DAIICHI SANKYO BUSINESS ASSOCIE CO., LTD. Brazil DAIICHI SANKYO BELGIUM N.V.-S.A.

DAIICHI SANKYO HAPPINESS CO., LTD. DAIICHI SANKYO BRASIL FARMACÉUTICAL LTDA. France

DAIICHI SANKYO LOGISTICS CO., LTD. Venezuela DAIICHI SANKYO ALTKIRCH SARL

DAIICHI SANKYO HEALTHCARE CO., LTD. DAIICHI SANKYO VENEZUELA, S.A. DAIICHI SANKYO FRANCE SAS

ASUBIO PHARMA CO., LTD. Puerto Rico Italy

DAIICHI SANKYO CHEMICAL PHARMA CO., LTD. DAIICHI SANKYO PUERTO RICO, INC. DAIICHI SANKYO ITALIA S.p.A.

DAIICHI SANKYO ESPHA LTD. U.S.A. Spain

China DAIICHI SANKYO, INC. DAIICHI SANKYO ESPAÑA, S.A.

Shanghai Sankyo Pharmaceuticals Co., Ltd. Luitpold Pharmaceuticals, Inc. Portugal

Daiichi Pharmaceutical (Beijing) Co., Ltd. United Kingdom DAIICHI SANKYO PORTUGAL LDA.

DAIICHI SANKYO HONG KONG LTD. DAIICHI SANKYO UK LTD. Turkey

Taiwan DAIICHI SANKYO DEVELOPMENT LTD. DAIICHI SANKYO İLAÇ TİCARET Ltd., Sti.

DAIICHI SANKYO TAIWAN LTD. Germany Switzerland

Korea DAIICHI SANKYO EUROPE GmbH DAIICHI SANKYO (SCHWEIZ) AG

DAIICHI SANKYO KOREA CO., LTD. DAIICHI SANKYO DEUTSCHLAND GmbH Ireland

Thailand U3 Pharma GmbH DAIICHI SANKYO IRELAND LTD.

DAIICHI SANKYO (THAILAND) LTD. Austria

DAIICHI SANKYO AUSTRIA GmbH

22