Company profile

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Company profile
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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 ß-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

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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

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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

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Organization chart
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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..

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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

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Sales trend comparable
23.1
7.9
15.9
-0.8
1.0
6.7
t.over
using Y03 / rate for all years
Source historical company data
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Sales breakdown by business type
5.7
34.1
22.7
39.8
Source company data 2007
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Sales breakdown by geographical area
10.1
5.1
11.7
32.7
40.2
Source company data 2007
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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

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Product list
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Product list
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Product list
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Product list
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Product list
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Products under development
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Products under development
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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

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Operation plant map
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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

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Operation plant overview

• Steriles
• Liquids in ampoules and vials
• Solutions
• Suspensions
• Aseptic filled and terminally sterilized
• Powders in vials
• Aseptically filled sterile powders

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Operation plant overview

• Non-steriles
• Liquids
• Semisolids

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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

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Operation - production lines

• Sterile powder dept.
• Sterile 3 - sterile powder dept.
• Sterile 4 high activity (cephs derivatives)
  sterile powder dept.

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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

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Operation - production equipments

• Ampoule vial automatically inspection dept.
• Automatic inspection machine
• Packaging dept.
• Labelling of ampoules vials
• Secondary packaging dept.
• Weighing rooms
• Weighing rooms A (API and excipients)
• Weighing rooms B (High activity API)

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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)

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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

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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 Fischers 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

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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

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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

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Manufacturing authorization
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Manufacturing authorization
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Manufacturing authorization
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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

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Proprietary technologies
FOUR PLATFORMS

• 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

The technologies are covered by patents and
available for discussions
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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