COMPANY PRESENTATION

Transcription

1 COMPANY PRESENTATION

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3 LEADER IN PEPTIDES SINCE THE 1970 s Dedicated to peptides since its establishment in 1971 Working on a global scale Public company since 1998 (Swiss Stock Exchange) Nr.

4 OUR BUSINESS PARTNERS % of Sales 4

5 OUR BUSINESS SALES REVENUES IN 2014: MILLION CHF Research Chemicals Custom synthesis Catalog products APIs Generic peptide and small molecule APIs, development and manufacturing of NCEs 5

6 HIGHLY TRAINED EMPLOYEES STRONG COMMITMENT TO TRAINING Over 790 employees 6

7 BACHEM LOCATIONS SUNNYVALE (CA) VISTA (CA) THE BACHEM GROUP Bachem Europe Bubendorf, CH Vionnaz, CH St. Helens, UK Weil am Rhein, DE Bachem Americas Torrance, US (CA) King of Prussia, US (PA) American Peptide Company Sunnyvale, US (CA) Vista, US (CA) GMP sites 7

8 BACHEM AG BUBENDORF, SWITZERLAND API development and manufacturing (cgmp) & production of research chemicals (catalog products, custom synthesis) by solid-phase peptide synthesis (SPPS) and solution phase chemistry For SPPS Annual capacity of over 500 kg 1000L (stainless steel) and 75L / 150L (glass) reactors For solution phase Annual capacity of hundreds of kg 100 L / 250 L / 630 L reactors and 1000 L reactor 9

9 BACHEM IS YOUR TRUSTED PARTNER Research & Development: Catalog peptides and custom synthesis services Custom Manufacturing Process development and validation Production of peptides for preclinical and clinical phases Commercial supply Supply of (multi-) kilograms to tons of cgmp API (launch quantities, manufacturing of API for marketed drugs) peptide and small molecule generics 16

10 PIONEERING THROUGH CONTINUED INNOVATION No. of amino acids BACHEM founded in Thymopentin 1989 Goserelin 1993 Calcitonin 2003 Aprotinin 2013 Interferon β-1a Year 17

11 OUR PORTFOLIO OF PRODUCTS AND SERVICES BACHEM PIONEERING PARTNER FOR PEPTIDES 18

12 CATALOG PRODUCTS RESEARCH INSTITUTES, UNIVERSITIES AND INDUSTRIAL R&D Product portfolio of over 6500 catalog peptides and biochemicals at shop.bachem.com Easy ordering & fast delivery Research and bulk quantities available from stock (mg to kg) Peptides, amino acid derivatives, inhibitors, substrates, resins, linkers, reagents 19

13 CUSTOM SYNTHESIS HEALTHCARE, BIOTECH, AND PHARMACEUTICAL COMPANIES Dedicated site for Custom Synthesis Peptide synthesis from mg/g to kg scale Development of synthetic routes for scale up Cosmetic & diagnostic peptides High quality and timely delivery 20

14 OUR TEAM IS EXPERIENCED IN A LARGE SELECTION OF MODIFICATIONS N- and C-terminal Modifications Backbone Modifications Non-natural Amino Acids Glycosylation Lipidation Methylation Phosphorylation and Sulfation Cyclic Peptides Multiple Disulfide Bond Formation Maleimido and Clickable Peptides Hydrocarbon-Stapled Peptides Branched Peptides MAP Peptides Depsipeptides Peptidomimetics We re very pleased with Bachem s services. Their employees are extremely knowledgeable. LABELING AND CONJUGATION Biotinylated Peptides Dye Labeling Heavy Isotope Labeling FRET or TR-FRET Peptides Pegylated Peptides Conjugation to Imaging Agents Conjugation to Proteins (BSA, KLH) Conjugation to Oligonucleotides 21

15 CUSTOM DEVELOPMENT AND MANUFACTURING OF NCEs BIOTECHS AND PHARMACEUTICAL COMPANIES Our project team is your proactive partner Development and manufacturing of APIs from early clinical trials to commercialization Process development, optimization and validation Quality by design Sterile fill & finish for clinical trials (Clinalfa ) Production of launch quantities 22

16 OUR PIPELINE OF CUSTOMER NCE PROJECTS Over 150 NCE projects DEVELOPMENT & VALIDATION Product characterization Development and validation of analytical methods Stability studies Identification of impurities cgmp SYNTHESIS OF APIs For all phases of clinical trials Commercial supply 23

17 REGULATORY AFFAIRS SUPPORT Consultation with customers Compilation of CMC documentation for IMPD/IND Support for regulatory requests Global submission experience: preparation, filing, updating of s Numerous CMCs have been submitted in support of successful applications of our partners 24

18 PROJECT MANAGEMENT Coordinates project activities Monitors project objectives and progress Facilitates direct customer interactions with Bachem experts Provides regular and timely project updates We manage your project in close collaboration with you 25

19 CLINALFA STERILE PEPTIDES FOR CLINICAL RESEARCH Clinalfa Basic Vials of sterile freeze-dried products Used as controls when investigating new peptide drugs, particularly for metabolic, neurologic, and cardiac indications Clinalfa Plus NCEs supplied as sterile freeze-dried or ready-to-use liquid formulation vials for clinical trials Clinalfa products are released by a Qualified Person. 26

20 GLYCOSYLATION OUR NEW SERVICE Advantages of Glycosylation of Peptide Drugs Increased half-life, providing extended dosing duration Better solubility, enabling improved formulation properties Improved response to therapy Increased drug tolerance Human follicle-stimulating hormone, a 92 amino acid glycopeptide. PDB: 1FL7 Fox, K.M., Dias, J.A., Van Roey, P. (2001) Three dimensional structure of human follicle-stimulating hormone, Mol. Endocrinol.15:

21 BACHEM AND GLYTECH The complex chemical synthesis of Interferon β-1a was adapted to costeffective industrial-scale manufacturing. Two pioneers in their respective fields collaborating to advance innovation in drug development Interferon β-1a is a glycosylated 166 amino acid protein and an approved drug substance to treat multiple sclerosis with a world market of more than $ 4 billion. There are currently three recombinant products on the market which are mixtures of at least 10 glycoforms. 28

22 PIONEERING PARTNERSHIP BACHEM AND GLYTECH The partnership between Bachem and GlyTech is focused on the chemical development and manufacturing of glycosylated peptides. Bachem has the proven expertise to scale up and manufacture kilogram scale peptides. GlyTech is capable of producing glycans in kg amounts by a proprietary technology. «The selective chemical glycosylation at large scale has the potential to be applied to a variety of peptides, where we can pioneer the concept of improving current and future drugs via chemical glycosylation.» Dr. José de Chastonay, CMO Bachem 29

23 GLYCOPEPTIDE APIs BY CHEMICAL SYNTHESIS The goal is to improve physicochemical properties of peptides through selective glycosylation Both chemical structure and position of glycosyl moieties can markedly improve the biological activity of a peptide. A comprehensive library of glycans, containing human glycoproteins linked to asparagine, has been created. Well-defined glycosylated structures can be generated through chemical synthesis, which allows optimal choice of the glycosyl moiety and its position. 30

24 GENERIC APIs BIOTECHS AND PHARMACEUTICAL COMPANIES Peptide & Small Molecule Generics Trusted supplier Strong reputation for sustained quality & supply Long term collaborative partnerships Generic APIs are available from stock in commercial quantities 31

25 WE ARE YOUR TRUSTED PARTNER LONG-TERM RELATIONS PRODUCT Goserelin Triptorelin Nitisinone SUPPLY AGREEMENT WITH AstraZeneca (Great Britain) Debiopharm (Switzerland) Swedish Orphan (Sweden) 32

26 REGULATORY AFFAIRS SUPPORT OVER 80 ACTIVE s AND 15 CEPS WORLDWIDE Active s worldwide* It has been a great experience working with Bachem. They offer a large collection of products with consistent high quality and have been a very responsive and engaged partner. Big Pharma Company *Please inquire for country specific information 33

27 Atosiban Aviptadil Bivalirudin* Buserelin Calcitonin (salmon) CRF Trifluoroacetate (human, rat) Desmopressin Acetate Exenatide* Glucagon Gonadorelin Acetate Goserelin Acetate GRF Acetate (human) Histrelin Acetate Leuprolide Acetate Octreotide Acetate Teriparatide Acetate, pth (1-34) (human) Secretin Hydrochloride (porcine) Somatostatin Tetracosactide Triptorelin Acetate Triptorelin Pamoate CEP, CEP, CEP, CEP, CEP, CEP, 34 *All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.

28 PEPTIDE GENERIC APIs COMING SOON Products under development & potential candidates Lanreotide* Liraglutide* Lixisenatide* Pasireotide Acetate* 35 *All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.

29 SMALL MOLECULE GENERICS Antazoline Hydrochloride Antazoline Phosphate Antazoline Sulfate Carbidopa L-Cysteine Hydrochloride Monohydrate Econazole Sulfosalicylate Etomidate L-Ornithine α-ketoglutarate Monohydrate Pergolide Mesylate Perindopril Erbumine Propofol Trimetazidine Dihydrochloride Xipamide Zolpidem Tartrate CEP, CEP, CEP, CEP, CEP, CEP CEP coming soon 36 *All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.

30 LARGE SCALE MANUFACTURING AT BACHEM 37

31 MANUFACTURING CAPABILITIES SOLID PHASE PEPTIDE SYNTHESIS MEDIUM SCALE 75 / 150 L SPPS reactor LARGE SCALE 1000 L SPPS reactor Scale: Mol SPPS Scale: 8-35 Mol SPPS 38

32 MANUFACTURING CAPABILITIES CLEAVAGE (I) Three story cleavage unit, especially designed for peptide resin cleavage 250 L vessels for cleavage Filters to filter off polystyrene resin 1000 L precipitation vessel 39

33 MANUFACTURING CAPABILITIES CLEAVAGE (II) CLOSED & CONTAINED PEPTIDE ISOLATION Fully contained operation Improved filtration Inverting filter centrifuge Heinkel HF

34 MANUFACTURING CAPABILITIES PURIFICATION (I) PREPARATIVE HPLC Columns 5, 20, 30, 59 cm (diameter) Scalable processes 41 20cm Ø HPLC 59cm Ø HPLC

35 MANUFACTURING CAPABILITIES PURIFICATION (II) ELUENT BUFFER TANK FARM Equipped with weighing cells for automated buffer preparation Jacketed for temperature control Control unit guarantees optimal operation: expiration date, minimal volume, etc L stainless steel tanks 42

36 MANUFACTURING CAPABILITIES PRODUCT ISOLATION BATCH LYOPHILIZATION 6 freeze dryers with 4.6 m 2 (49.5 ft 2 ) shelf area 150 kg (39.6 gal) ice condenser capacity 9 freeze dryers with 2.3 m 2 (24.8 ft 2 ) shelf area 100 kg (26.4 gal) ice condenser capacity Located in clean rooms All equipment qualified (cgmp) 43

37 MANUFACTURING CAPABILITIES ANALYTICAL TECHNIQUES TECHNIQUES AVAILABLE Amino Acid Analysis Bioburden Endotoxins Ion Exchange HPLC Mass Spec RP-(U)-HPLC SCX-HPLC.and much more Ultra-High-Performance Liquid Chromatography (rapid HPLC, UHPLC) is used as the standard analytical LC method for IPC and release testing 44

38 BACHEM PIONEERING PARTNER FOR PEPTIDES SINCE 1971 Independent CMO with >40 years proven track record of peptide innovation and manufacturing expertise Our products and services support our partners through all stages of drug development Highest industry standard for quality assurance, control, and regulatory compliance Excellent project management record with the world s leading pharmaceutical and biotechnology companies Sustainable long-term partnership with all stakeholders 45

39 46 Thank you for your attention