Highly Potent APIs Made by Heraeus Dr. Friedrich Wissmann Pharmaforum, Frankfurt, Nov. 3rd, 2009
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1 Highly Potent APIs Made by Heraeus Dr. Friedrich Wissmann Pharmaforum, Frankfurt, Nov. 3rd, 2009 Page 1
2 The Heraeus Group at a Glance
3 Key financial indicators 2008 Heraeus Product revenue Precious metal trading revenue Employees at year-end 2,920 million 12,994 million 12,830 Precious Metals W. C. Heraeus Sensors Heraeus Electro-Nite Dental and Medical Products Heraeus Kulzer Quartz Glass Heraeus Quarzglas Specialty Lighting Sources Heraeus Noblelight Product revenue in million 1, Employees 4,824 3,462 1,656 1, Seite 3
4 Organization Structure W. C. Heraeus GmbH Divisionsi i Chemicals CHD Contact Materials CMD Engineered Materials EMD Medical Components MCD Thick Film Materials TFD Thin Film Materials TMD Trading TRD Business Units CA Catalysts AM Assembly Materials ET Electro Technology AC Assemblies & Coiling CC Ceramic Colours ELC Electronics CP Chemical Products BW Bonding Wires FM Functional Materials MM Materials & Machining PV Photovoltaic LAC Large Area Coating PI Pharma- ceutical Ingredients PT Packaging Technology WP Wire Processing TH Thick Film MDS Magnetic Data Storage RC Recycling PM Precious Metals Technology ST Special Metals Technology Page 4
5 W. C. Heraeus Locations Worldwide USA: Chandler Newark / New York Santa Fe Springs St. Paul West Conshohocken Wartburg Puerto Rico: Dorado Brazil: São Paulo Production Facility Sales Facility Great Britain: Hertfordshire Stoke-on-Trent Ireland: Shannon Switzerland: Yverdon Thalwil Mendrisio France: Courtaboeuf Grésy-sur-Aix Spain: Madrid Germany: Hanau Potsdam Austria: Vienna Italy: Milan South Africa: Dunswart Port Elizabeth Hungary: Gödöllö Croatia: Zagreb Sweden: Sollentuna Denmark: Hilleroed Romania: Bucharest Bulgaria: Sofia Varna Czech Republic: Prague Russia: Moscow St. Petersburg Ukraine: Kiev Belarus: Minsk Poland: Warsaw Turkey: Izmir India: Udaipur Indonesia: Tangerang Serang The Philippines: Cavite Singapore: Singapore Kazakhstan: Almaty China: Changshu Danyang Hong Kong Shanghai Shenzen Zhaoyuan Taiwan: Taipei Japan: Tokyo Tsukuba Korea: Incheon Page 5
6 Heraeus Core Competencies in highly hl potent t API synthesis Business Unit Pharmaceutical Ingredients
7 Our Business Activities Generic hapis Branded hapis Expertise in anti- cancer APIs Global services Process Development Seite 7
8 Generic hapis Cisplatin Carboplatin Oxaliplatin Dacarbazin Thiotepa Epirubicin Idarubicin Seite 8
9 Branded hapis Full support through all preclinical and clinical phases Exclusive R&D Scale-up and pilot-scale under full cgmp CMC-section filing Exclusive commercial production Strict protection of customer IP Seite 9
10 Global services Worldwide sales network and professional logistics DMFs and CEPs filed in Europe, USA, Japan, Australia and further regions Consultancy services for EU, USA and Japan All product releases by Qualified Person Strong Regulatory Affairs group Seite 10
11 Development services All R&D in fully glove boxed systems Working range from ml to 70 L in R&D for chemical and mircobiological processes All R&D under full cgmp Analytical development and validation inhouse Qualification of reference standards Seite 11
12 Technology platforms Precious metal chemistry Organic chemistry Expertise in anti- cancer APIs Fermentation Downstream processing Seite 12
13 Heraeus Expertise in hapi Synthesis Technology Portfolio Beg 70s Cisplatin (tech.) Production Pt based Anticancer hapi Production Organic Anticancer hapi Manufacturing Fermentation Based hapi Manufacturing Page 13
14 Precious metal chemistry Worldwide leader for generic platinum APIs Production capacities exceeds ton-scale All production in class D cleanrooms Safe supply by multiple production facilities Professional precious metal handling incl. internal refining services Seite 14
15 Organic chemistry Fully closed reactor trains to meet highest safety standards Production capacities from 20 L to 2 cbm; all glass-lined equipment Capable to handle chlorinated solvents and highly corrosive reagents Equipment designed to be combined with fermentation up- or/and downstream Seite 15
16 Fermentation Handling of modified d organisms (class S2) Master cell banks from our biotech cooperation partners indvidually stored (-70 C) at multiple utpelocations o Fermenter volumes ranging from 10 L to 3000L (total: > 6000 L) Development and testing laboratory up to Risk Class S2 Herstellerlaubnis issued by the RP Darmstadt in 2009 Seite 16
17 Downstream proccesing All handling in closed systems or glove boxes to meet highest protection requirements Fermentation products purified by extraction, cristallization, and reverse osmosis GL equipment for chemical modification of intermediates Preparative HPLC for polishing intermediates or final product (30 cm columns) Working permit for chlorinated solvents Seite 17
18 Overall Summary Heraeus is the expert for the synthesis of highly potent APIs by chemical or microbial pathways. We meet the industries needs for gram amounts as well as for full scale commercial supply. All work is performed under full cgmp. We perform chemical / microbial process development under highesth safety and cgmp requirements. Analytical development is done inhouse. We back our products by support in all technical, regulatory and IP matters. All our products are well accepted in EU, USA, Japan and Australia. We are FDA approved since Seite 18
19 Thanks for your attention! W.C. Heraeus GmbH Chemicals Division Business Unit Pharmaceutical Ingredients Heraeusstr Hanau / Germany Phone: Mail: pharma@heraeus.com Page 19
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