May 2007                                    Lisapharma – Confidential
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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

May 2007 Lisapharma – Confidential


Company profile

Company profile

May 2007 Lisapharma – Confidential


Lisapharma at a glance

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


Milestones

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


Key facts figures

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


Organization chart

Organization chart

May 2007 Lisapharma – Confidential


Goals

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


Strategy

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


Sales trend comparable

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


Sales breakdown by business type

Sales breakdown by business type

5.8%

34.4%

23.8%

35.9%

Source: company data 2006

May 2007 Lisapharma – Confidential


Sales breakdown by geographical area

Sales breakdown by geographical area

4.6%

6.7%

14.0%

26.0%

48.7%

Source: company data 2006

May 2007 Lisapharma – Confidential


Company profile

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


Product list

Product list

May 2007 Lisapharma – Confidential


Product list1

Product list

May 2007 Lisapharma – Confidential


Product list2

Product list

May 2007 Lisapharma – Confidential


Product list3

Product list

May 2007 Lisapharma – Confidential


Product list4

Product list

May 2007 Lisapharma – Confidential


Products under development

Products under development

May 2007 Lisapharma – Confidential


Products under development1

Products under development

May 2007 Lisapharma – Confidential


Operation key data

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


Operation plant map

Operation – plant map

May 2007 Lisapharma – Confidential


Operation main equipments

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


Operation plant overview

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


Operation plant overview1

Operation – plant overview

  • Non-steriles

    • Liquids

    • Semisolids

May 2007 Lisapharma – Confidential


Operation production lines

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


Operation production lines1

Operation - production lines

  • Sterile powder dept.

    • Sterile 3 - sterile powder dept.

    • Sterile 4 – high activity (cephs derivatives) sterile powder dept.

May 2007 Lisapharma – Confidential


Operation production lines2

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


Operation production equipments

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


Quality area

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


Quality control

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


Qc departments

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


Quality assurance

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


Regulatory inspections

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


Manufacturing authorization

Manufacturing authorization

May 2007 Lisapharma – Confidential


Manufacturing authorization1

Manufacturing authorization

May 2007 Lisapharma – Confidential


Manufacturing authorization2

Manufacturing authorization

May 2007 Lisapharma – Confidential


Proprietary technologies

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


Proprietary technologies1

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


Good tips to partnering with lisapharma

…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


Company profile

Thank you

Alessandro Cescut

International Sales and Licensing Director

p. +39.031.641257-412

@: [email protected]

May 2007 Lisapharma – Confidential


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