Our Locations in Europe
description
Transcript of Our Locations in Europe
HeadquartersAffiliatesPlant sites
Brussels
ZurichViennaMunich
London Amsterdam
PfaffenhofenParis
Altkirch
Madrid
Lisbon RomeIstanbul
Dublin
Our Locations in Europe
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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
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
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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
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)
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
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Our R&D Focus
Research and early stage
development
• Oncology
• Cardiovascular-
metabolics
Late-stage development
• Thrombotic
disorders
Life cycle management
• Hypertension
• Bacterial
infections
• Hyperlipidemia
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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
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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.
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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
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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*
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
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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
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