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The GS Gene Expression System ™

The GS Gene Expression System ™. The GS System™ is a widely accepted, industry-leading expression system . Industry-Leading Expression System Owned and licensed by Lonza A mammalian gene expression system For therapeutic proteins and monoclonal antibodies GS-CHO and GS-NS0 cell lines

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The GS Gene Expression System ™

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  1. The GS Gene Expression System™

  2. The GS System™ is a widely accepted, industry-leading expression system Industry-Leading Expression System • Owned and licensed by Lonza • A mammalian gene expression system • For therapeutic proteins and monoclonal antibodies • GS-CHO and GS-NS0 cell lines Widely Accepted • Over 110 companies, 75 academic institutions • Over 95 products in the clinic • 100s of high-yielding cell lines created (last 15 years)

  3. Principles of the Glutamine Synthetase (GS) System ATP ADP + Pi NH4+ + glutamate glutamine methionine sulphoximine (MSX) MSX = a glutamate analogue that binds to GS irreversibly

  4. GS vector & cell line construction GS vector & cell line construction cGMPcell banking cGMPcell banking process development & scale up process development & scale up cGMPproduction cGMPproduction regulatorysupport regulatorysupport The GS Gene Expression System™ is accessible at all stages of production Discovery Development Manufacture Distribution basicresearch diseasediscovery drugdiscovery drugdevelopment clinicaltrials production packaging marketingsalesdistribution Lonza Development Services & Manufacturing Customer In-Licensing Lonza’s GS Technology

  5. Using the GS System™ is proven to improve yields and speed

  6. Using the GS System™ leads to higher product concentrations Product concentrations for GS-CHO cell lines making different antibodies in Lonza’s cGMP manufacturing bioreactors Product Concentration (g/L)

  7. The majority of products will achieve more then 2g/L using the GS System™ Product concentrations for GS-CHO cell lines making different antibodies in Lonza’s cGMP manufacturing bioreactors Number of Cell Lines(Each Making a Different Product) Product Concentration (g/L)

  8. Increasing productivity with the GS System™ lowers relative cost Assumptions Product Requirement: 35kg/yr 65% yield across purification

  9. The GS System™ is used for a number of well-known commercial products Zenapax™ • Roche - humanized antibody • Treatment of prophylaxis of acute organ rejection in kidney transplant rejection patients Synagis™ • MedImmune - humanized antibody • Prevention of serious lower tract disease caused by RSV (Respiratory Syncytial Virus) 4 additional mAbs: Alexion’s Soliris® and 3 non-disclosed

  10. The GS System™ and out-licensing team ensures your needs are meet Qingyu Cao • Licensing and Technology Manager • +33 3 20 26 8738 • qingyu.cao@lonza.com General • 228 Bath Road, Slough SL1 4DX, Great Britain • +44 1753 777 000 • GSLonza@lonza.com Online • www.lonza.com • Arun NatarajDirector of Licensing & Technology Sales • +1 201 316 9485 • arun.nataraj@lonza.com Isabella SharrattSales & Business Development Administrator • +44 1753 716 676 • isabella.sharratt@lonza.com

  11. The GS out-licensing package provides timely, comprehensive support • Patents Materials • Standard 0.4 series GS vectors • Host cell lines from cGMP cell banks • NSO • CHOK1SV • Transfection Medium System

  12. Our GS out-licensing package offers access to years of specific know-how • GS manuals: methodologies, equipment • Vector sequences • Regulatory support • Vector information • Characterization and testing status of host cell banks • Support for media and feeds in regulatory submissions • Working with Lonza’s proprietary media and feeds • Technical updates; Support: GSLonza@lonza.com

  13. GS System Optional Packages / Updates and Improvements 2011: GS-CHO Chemically Defined Animal Component Free (CDACF) Live Version 8 Media System 2011: Light Path™ Discovery Material Supply 2011: Epibase™ Server for Immunogenicity Risk Mitigation 2010: Genetic Characterisation Service 2010: pConPlus vectors 2010:Potelligent® CHOK1SV Cell Line Technology 2007: GS-NS0 and GS-CHOK1 Host Cell Protein ELISA assay reagents and know-how 2006: GS-NS0 and GS-CHOK1SV Host Cell Protein Western Blotting assay reagents and know-how

  14. Lonza also offers the GS System™to customers for research purposes Research Evaluation Agreement (REA) • Commerical Customers • any product – research use only • Annual fee: £35K

  15. The GS System™ license is designed with a user’s needs in mind Per Product Required before start of clinical trials for therapeutics Commercial terms linked to manufacturing source • 3rd Party manufacturing (CMO) • £300k per annum and 2% royalties on net sales • Customer or Strategic Partner manufacturing • £75k per annum due from Phase 2, 1.5% royalties on net sales • Lonza manufacturing • License fees waived, 1.5% royalties on net sales Term • Royalties to patent expiry then 50% reduction to cover know-how. Multi-product Licenses for using GS as a platform technology

  16. The GS System™ has been adopted for licensed therapeutics at every stage Notes Total active licensed products: over 240 Total in active human trials / pre-registration: 100 Total approved: 9

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