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May 2007 Lisapharma – Confidential 1. 2 Company profile.

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Presentation on theme: "May 2007 Lisapharma – Confidential 1. 2 Company profile."— Presentation transcript:

1 May 2007 Lisapharma – Confidential 1

2 2 Company profile

3 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

4 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

5 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 80 reps  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

6 May 2007 Lisapharma – Confidential 6 Organization chart MANAGING DIRECTOR FINANCE & CONTROLHUMAN RESOURCESQUALITY ASSURANCEOPERATION MARKETING & SALES ITALY INTERNATIONAL SALES & LICENSING PURCHASINGPHARMACOVIGILANCESCIENTIFIC 6 RA

7 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………………………..

8 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

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

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

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

12 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

13 May 2007 Lisapharma – Confidential 13 Product list

14 May 2007 Lisapharma – Confidential 14 Product list

15 May 2007 Lisapharma – Confidential 15 Product list

16 May 2007 Lisapharma – Confidential 16 Product list

17 May 2007 Lisapharma – Confidential 17 Product list

18 May 2007 Lisapharma – Confidential 18 Products under development

19 May 2007 Lisapharma – Confidential 19 Products under development

20 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

21 May 2007 Lisapharma – Confidential 21 Operation – plant map

22 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

23 May 2007 Lisapharma – Confidential 23 Operation – plant overview  Steriles  Liquids in ampoules and vials oSolutions oSuspensions oAseptic filled and terminally sterilized  Powders in vials oAseptically filled sterile powders

24 May 2007 Lisapharma – Confidential 24 Operation – plant overview  Non-steriles  Liquids  Semisolids

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

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

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

28 May 2007 Lisapharma – Confidential 28 Operation - production equipments  Ampoule & vial automatically inspection dept. oAutomatic inspection machine  Packaging dept. oLabelling of ampoules & vials oSecondary packaging dept.  Weighing rooms oWeighing rooms A (API and excipients) oWeighing rooms B (High activity API)

29 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)

30 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

31 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

32 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

33 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

34 May 2007 Lisapharma – Confidential 34 Manufacturing authorization

35 May 2007 Lisapharma – Confidential 35 Manufacturing authorization

36 May 2007 Lisapharma – Confidential 36 Manufacturing authorization

37 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

38 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

39 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

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


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