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Company profile

Company profile. LISAPHARMA at a glance. Fully owned by Italian capital Family-ruled business from its foundation to today Manufacturing plant of dosage forms in full GMP compliance, including β -lactam ceph derivatives dedicated line

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Company profile

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  1. May 2007 Lisapharma – Confidential

  2. Company profile May 2007 Lisapharma – Confidential

  3. LISAPHARMA at a glance • Fully owned by Italian capital • Family-ruled business from its foundation to today • Manufacturing plant of dosage forms in full GMP compliance, including β-lactam ceph derivatives dedicated line • Driven to technological developments throughout strong liaisons with different university bodies • Operative on the Italian and international markets through a portfolio of proprietary medicines May 2007 Lisapharma – Confidential

  4. Milestones • 1925: Lisapharma is established in Bologna • 1949: HHQQ and plant moved to actual site of Erba (Co) • 1968: first export business to Taiwan • 1970: establishment of international production units in Nicaragua & Costarica • 1993: first manufacturing activity as toll manufacturer with Novartis • 2000: start of phase-out of production of oral solid non-sterile products • 2002: establishment of the j.-v. with Omicron for the manufacture of oral solid non-sterile products May 2007 Lisapharma – Confidential

  5. Key facts & figures • Fully owned Italian manufacturing plant for sterile injection products, non-sterile liquids, semisolids • J.-V. participation in Omicron plant (Italy) for oral solid non-sterile production • 148 total headcounts, out of which 80reps • International customers portfolio of 81 accounts • International sales in 32 different countries worldwide • Intellectual property of 18 patents covering original technologies • Development & RA expenditure up to 5.60% of company revenues May 2007 Lisapharma – Confidential

  6. Organization chart May 2007 Lisapharma – Confidential

  7. Goals • To consolidate the presence in the Italian market • To improve the penetration in existing countries outside Italy and to expand to further new markets its business partneriships • To enlarge the toll manufacturing activities for renowned international companies BY……………………….. May 2007 Lisapharma – Confidential

  8. Strategy • In-house development of generic registration dossiers focusing on niche products (injectable class,…) • Partnering and/or tightening strategic alliances allowing the best exploitation of the in-house developed patented technologies (Sucralfate Gel, Dome Matrix™, Patch-non-Patch™, Chimerical Agglomerates™) • Diversification of the product portfolio to include additional non-RX compounds “dedicated” to specialists (food supplements, medical devices,…) • Strengthening the existing collaborations through the proven high standard of quality and service provided, by doing so attracting new potential customers too May 2007 Lisapharma – Confidential

  9. Sales trend – comparable* +7.9 -0.8 +15.9 +1.0 +6.7 t.over *using Y03 €/$ rate for all years Source: historical company data May 2007 Lisapharma – Confidential

  10. Sales breakdown by business type 5.8% 34.4% 23.8% 35.9% Source: company data 2006 May 2007 Lisapharma – Confidential

  11. Sales breakdown by geographical area 4.6% 6.7% 14.0% 26.0% 48.7% Source: company data 2006 May 2007 Lisapharma – Confidential

  12. KPI • Robust sales growth in the last triennium, expected to similarily continue in the coming years • Revenues generated by three well balanced business sectors • International sales spread in many countries and areas, excellent contribution represented by fast growing markets (Asia), good room for increase the European-stable markets (development of the proprietary technologies) • Good existing network of partners either local or MNs’ companies May 2007 Lisapharma – Confidential

  13. Product list May 2007 Lisapharma – Confidential

  14. Product list May 2007 Lisapharma – Confidential

  15. Product list May 2007 Lisapharma – Confidential

  16. Product list May 2007 Lisapharma – Confidential

  17. Product list May 2007 Lisapharma – Confidential

  18. Products under development May 2007 Lisapharma – Confidential

  19. Products under development May 2007 Lisapharma – Confidential

  20. Operation – key data • Manufacturing plant and warehouse cover a surface of 6,000 sqm • Workforce of 35 people • Handling in excess of 2,500 references corresponding to 650+ presentations • Production capacity expanded up to 43 mio units • Production lines for: • Injection products - liquids in ampoules and vials, powder in vials • Non-sterile liquids • Semisolids for topical use May 2007 Lisapharma – Confidential

  21. Operation – plant map May 2007 Lisapharma – Confidential

  22. Operation – main equipments • W.F.I. loop distribution system • Purified water loop distribution system • Compressed air distribution system • Nitrogen distribution system • HVAC systems • Continuous particle monitoring system May 2007 Lisapharma – Confidential

  23. Operation – plant overview • Steriles • Liquids in ampoules and vials • Solutions • Suspensions • Aseptic filled and terminally sterilized • Powders in vials • Aseptically filled sterile powders May 2007 Lisapharma – Confidential

  24. Operation – plant overview • Non-steriles • Liquids • Semisolids May 2007 Lisapharma – Confidential

  25. Operation- production lines • Sterile liquids dept. • Sterile 1 - high activity sterile liquid dept – ampoules & vials • Sterile 2 – sterile liquids dept. - ampoules & vials • Sterile 5 - high activity sterile liquid dept. – ampoules & vials May 2007 Lisapharma – Confidential

  26. Operation - production lines • Sterile powder dept. • Sterile 3 - sterile powder dept. • Sterile 4 – high activity (cephs derivatives) sterile powder dept. May 2007 Lisapharma – Confidential

  27. Operation - production lines • Non-sterile liquids dept. • Preparation and packaging of non sterile liquids • Semisolids for topical use • Preparation and packaging of semisolids • Preparation and packaging of high-activity semisolids May 2007 Lisapharma – Confidential

  28. Operation - production equipments • Ampoule & vial automatically inspection dept. • Automaticinspection machine • Packaging dept. • Labelling of ampoules & vials • Secondary packaging dept. • Weighing rooms • Weighing rooms A (API and excipients) • Weighing rooms B (High activity API) May 2007 Lisapharma – Confidential

  29. Quality area • QC & QA account for 13 people • 38% university degree, 38% high school degree • Year 2006 quality performance: • 800+ batches • 2,500+ analysis • Handling of 14 product defects with average time of solution and definition of corrective actions, if any requested, of 21 days in accordance to what defined in the relevant SOP (solution required within 30 days from receipt of product defect notice) May 2007 Lisapharma – Confidential

  30. Quality Control • QC activities • Acceptance of incoming goods • Release of finished products • Performance of analytical validation • Performance of the stabilities • Analytical support for process & environmental validation May 2007 Lisapharma – Confidential

  31. QC departments • Chemical department • HPLC assays, UV/VIS spectrophotometric analyses, GLC and TLC analyses, IR spectrophotometric analyses, potentiometric and redox titration, TOC assays, dissolution test, viscometric tests, conductivity and pH analysis, Karl Fischer’s test • Microbiological department • sterility testing of obligatory sterile products, determination of the microbial loading of products non-obligatory sterile, qualitative and quantitative LAL test (gel cloth and chromogenic test), microbiological assays, bacterial identification, challenge test, microbiological and particle controls of controlled contamination environments • Classified goods department • weight and volume control, primary and secondary packaging material control, finished product control May 2007 Lisapharma – Confidential

  32. Quality Assurance • QA activities • Quality system management • SOP management • Validation protocols of production processes performance • Oversee the installation and operating qualification of new equipments and performance qualification of the existing equipments • Product defects management • APR performance May 2007 Lisapharma – Confidential

  33. Regulatory inspections • Lisapharma plant has a very outstanding record of successful inspections, the most recent carried out by Official Authorities with no observation received, comprises the following: • May 18-20, 2005: Taiwan MoH • April 26-28, 2006: Italian MoH • Audits by customers including MNs’ companies are also regularly performed and successfully passed May 2007 Lisapharma – Confidential

  34. Manufacturing authorization May 2007 Lisapharma – Confidential

  35. Manufacturing authorization May 2007 Lisapharma – Confidential

  36. Manufacturing authorization May 2007 Lisapharma – Confidential

  37. Proprietary technologies • Long-lasting cooperation between Lisapharma and well reputable Universities in Italy • Focusing in the development of novel delivery systems, due to the increased market demand for drug delivery technology • Aiming to develop versatility in drug delivery, as much as adaptability to different drugs to inhance patient compliance ALL THIS HAS LED TO May 2007 Lisapharma – Confidential

  38. Proprietary technologies • Sucralfate Gel, as unti-ulcer for GI tract and skin wounds • Dome Matrix™, oral platform • Patch-non-Patch™, transdermal platform • Chimerical Agglomerates™, inhalation nasal platform FOUR PLATFORMS The technologies are covered by patents and available for discussions May 2007 Lisapharma – Confidential

  39. …Good tips to partnering with Lisapharma • Small though efficient and dedicated team group allowing quick decision process • Flexibility combined to first class service • Quick adaptation to market changes • Fast reacting to customers’ demands and needs • Commitment to innovation • Very promising tech package portfolio • Excellent expertise and know how in manufacturing of injection products • Independent company not belonging to any group May 2007 Lisapharma – Confidential

  40. Thank you Alessandro Cescut International Sales and Licensing Director p. +39.031.641257-412 @: acescut@lisapharma.it May 2007 Lisapharma – Confidential

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