march 2008 lisapharma – confidential 1. 2 company introduction & proprietary technologies
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March 2008 Lisapharma – Confidential 1
March 2008 Lisapharma – Confidential 2
Company Introduction
&
Proprietary Technologies
March 2008 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
March 2008 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
March 2008 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
March 2008 Lisapharma – Confidential 6
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………………………..
March 2008 Lisapharma – Confidential 7
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
March 2008 Lisapharma – Confidential 8
PROPRIETARY TECHNOLOGIES
March 2008 Lisapharma – Confidential 9
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 LED TO
March 2008 Lisapharma – Confidential 10
Proprietary technologies
Dome Matrix™, oral platform
Patch-non-Patch™, transdermal platform
Chimerical Agglomerates™, inhalation nasal platform
Sucralfate Gel, as unti-ulcer for GI tract and skin wounds
FOUR PLATFORMS
The technologies are covered by patents and available for discussions
March 2008 Lisapharma – Confidential 11
The Platform Concept in DDS
• More than 15% of the total pharma market – in excess of U$ 80 billion - is covered by drug delivery technolgies
• Future belongs to biotech drugs, to old drugs to be revaluated, to new drugs offered with appropriate dds, and to generics
• The systems invented shall posses not only versatility in delivery, but also adaptability to different drugs
• The term platform indicates a delivery system capable to be adapted to various drugs, strenghts, mechanisms of delivery, in order to control not only the time but also the site of delivery
March 2008 Lisapharma – Confidential 12
DOME MATRIX®
March 2008 Lisapharma – Confidential 13
Dome Matrix®
• The system is based on tablets (modules) with a peculiar shape made of swellable polymer for controlling the release rate
• The typical shape of the module is a cylindrical tablet having one concave and one convex base designed to allow the convex base to be inserted in the concave
• The shape permits to put together several modules to create different assembled release systems
March 2008 Lisapharma – Confidential 14
Dome Matrix®
March 2008 Lisapharma – Confidential 15
Dome Matrix®
• A peculiar assembly can be obtained by fitting the concave base of two modules allowing the construction of a floating system able to keep the release of the substance into the stomach
March 2008 Lisapharma – Confidential 16
Dome Matrix®
• Piled configurations can be obtained by staking the modules convex face into concave face
March 2008 Lisapharma – Confidential 17
Dome Matrix®
• Dome Matrix® finds its ideal application whenever there is a need for:
a prolonged release of solid dosage forms and it may represent an effective answer to the need to have versatility in the substance release kinetics
modulation of dose administered
association of different substances in one modular system
improving the efficacy of the substance delivered, providing a time-and-space controlled release system
March 2008 Lisapharma – Confidential 18
Dome Matrix®
• Dome Matrix® technology can be applied
To “old” products presented in innovative dosage forms
New compounds combined with an original and innovative delivery route
• Dome Matrix® industrial development is in progress
• Dome Matrix® is covered by patent, license or transfer could be considered
March 2008 Lisapharma – Confidential 19
Patch-non-Patch®
March 2008 Lisapharma – Confidential 20
Patch-non-Patch®
Patches vs. Traditional Systemic Formulations
• Constant plasma levels
• Lower incidence of side effectsvs Injection vs Oral
Non invasive Increased bioavailability
More acceptable Reduced dosing frequency
No need of specialized No drug interaction
personnel
• Limitation
Low skin permeability (daily dosing < 10 mg)
March 2008 Lisapharma – Confidential 21
Patch-non-Patch®
Patches vs. Traditional Systemic Formulations
• Topical formulations (solutions, creams, gels,…) can:−Be accidentally removed – contact time
−Applied at the wrong dose
−Stick to cloths
• Patches guarantee control in:−Dose applied
−Area of application
−Contact time
−Release kinetics
March 2008 Lisapharma – Confidential 22
Patch-non-Patch®
The Typical Structure of a Patch
• Multi-layer structures composed of:
−Backing
−Deposit of the active (solid/liquid)
−(Membrane)
−Adhesive
−Release linerBackingDepositMembraneAdhesiveLiner
Minitran®
March 2008 Lisapharma – Confidential 23
Patch-non-Patch®
The Typical Structure of a Patch
• Plasters
−Backing (woven-non-woven)
−Thick adhesive hydrogel
containing the active
−Liner
• Gauzes soaked in gel/oil formulations
Lidoderm®
Medicell Patch®
March 2008 Lisapharma – Confidential 24
Patch-non-Patch®: the Novelty
Backing
Active+Adhesive
Liner
Backing
Active+Adhesive
Liner Patch-non-Patch®
SEM Image
March 2008 Lisapharma – Confidential 25
Patch-non-Patch®: Characteristics
• Dry
• Not self-adhesive
• Flexible, transparent
• Water permeable
• Electrically conductive
• Organic solvents not required
• Adhesive only on wet skin
• Washeable with water
March 2008 Lisapharma – Confidential 26
Patch-non-Patch®
March 2008 Lisapharma – Confidential 27
Patch-non-Patch®: Case Studies
Lidocaine Estradiol Hydrocortisone
Caffeine Nitroglycerin Herbal extracts
Thiocolchicoside Progesterone Rutin derivatives
Ibuprofen lysine Nicotine&Bupropion Ketoconazole
Diclofenac Sumatripan Clindamycin
Acyclovir
Clorexidine
Nicotinamide&Salicylic ac.
Thyroxine
March 2008 Lisapharma – Confidential 28
Patch-non-Patch®: Production
• Solution (suspension) of all components in water
• Lamination on the release liner at predetermined time
• Oven drying (60-80°C)
• Cutting
• Thickness of 40-200 µm
• Different shapes/patterns possible
March 2008 Lisapharma – Confidential 29
Patch-non-Patch®: The Cosmetic difference
March 2008 Lisapharma – Confidential 30
Patch-non-Patch®: The Cosmetic advantage
March 2008 Lisapharma – Confidential 31
Patch-non-Patch®: Advantages vs Competitors
FeatureFeature P-n-PP-n-P®® PatchPatch PlasterPlaster GelGel
% of active released High Low Low Low
Time lag No Yes Yes No
Duration of activity Long Long LongShort
Adaptation to skin surf. Yes No No ?
Occlusive No Yes Yes/No No
Water soluble Yes No ? Yes
Electrically conductive Yes No ? Yes/No
Cosmetically acceptableYes Yes/No No ?
Easy to be removed Yes No Yes/No Yes
March 2008 Lisapharma – Confidential 32
Patch-non-Patch®: Advantages vs Competitors
FeatureFeature P-n-PP-n-P®® PatchPatch PlasterPlaster GelGel
Preservatives needed No No Yes Yes
Organic solvents requ. No Yes Yes/No No
Drying step critical No Yes Yes -
Active crystalliz.critical No Yes Yes Yes
Cost of production ++ ++++ +++ ++
March 2008 Lisapharma – Confidential 33
Patch-non-Patch ®
Patch-non-Patch® is meant for pharmaceutical, cosmetic, medical device and medical industries
Patch-non-Patch® feasibility studies with different actives/prototypes are available and further can be added
Patch-non-Patch ® allows several potential applications including smoking cessation products, analgesic patches, caffeine-based cellulite treatments, among the others
Patch-non-Patch ® is covered by patent, license or transfer can be considered
March 2008 Lisapharma – Confidential 34
Chimerical Agglomerates™
March 2008 Lisapharma – Confidential 35
Chimerical Agglomerates™
• Inhalation nasal platform
• A new nasal form as powder able to satisfy different technological requirements related to preparation and administration of powders through non-invasive routes such as oral, buccal and nasal ones
• The powder is made of agglomerates of micro-particles obtained by spray-drying process of an aqueous or hydro-alcoholic solution containing the substance and excipients
March 2008 Lisapharma – Confidential 36
Chimerical Agglomerates™
• In case of insufflation, the agglomerates dimension are useful for the dose metering of the powder into the insufflation device
• After insufflation, due to turbolence of air flow, agglomerates are broken into fragments of appropriate dimension for nasal or buccal administration which are rapidly deaggreagated in the primary micro-particles by water
March 2008 Lisapharma – Confidential 37
Chimerical Agglomerates™
20 µm20 µm
Prepared by spray drying
Ø 5-10 µm
Primary microparticles
200µm
Roundish shape Free flowing
Ø 106-850 µm
They break up into fragments during
insufflation
Chimeral Agglomerates
200µm
Fragments
Suitable size for nasal deposition
Prepared by spray drying
Ø 5-10 µm
Primary microparticles
200µm
Roundish shape Free flowing
Ø 106-850 µm
They break up into fragments during
insufflation
Chimeral Agglomerates
200µm200µm
Roundish shape Free flowing
Ø 106-850 µm
They break up into fragments during
insufflation
Chimeral Agglomerates
200µm
Fragments
Suitable size for nasal deposition
200µm200µm
Fragments
Suitable size for nasal deposition
March 2008 Lisapharma – Confidential 38
Chimerical Agglomerates™
• Chimerical Agglomerates™ is very versatile system since it is possible to prepare formulations of different substances by varying the composition of the micro-particles
• Chimerical Agglomerates™ scale of development is laboratory tested – scale up phase
• Chimerical Agglomerates™ is covered by patent, license or transfer could be considered
March 2008 Lisapharma – Confidential 39
Chimerical Agglomerates™
• Highly respirable insulin case study
Dry insulin powders have been prepared by using spray-drying process starting from suspensions or aqueous solutions of the active ingredient in acetic acid
As metering device has been used a commercial device able to administer 2 mg of insulin powder when activated by an air flow of 60 l/min
Stability study has been carried out for 12 months during which the powders have been kept in two different conditions: 25°C-60% RU and 2-8°C
March 2008 Lisapharma – Confidential 40
Chimerical Agglomerates™
• Highly respirable insulin case studyPowders obtained form insulin suspensions showed lower values
of FPF (10-30%) compared to those obtained by drying of solutions of insulin (60-80%)
Particles obtained applying this latter option have corrugated surface characteristics, when examined through SEM analysis
All powders showed a median volume diameter below 5 µm, therefore suitable for inhalatory administration
The chemical and physical stabilities of powders obtained starting from acetic acid solutions were the best one and the hydrolytic degradation products, the related substances as well as the covalent aggregation products remain within the spec limits described in EP, also when the powders were stored at 25°C up to 24 months
March 2008 Lisapharma – Confidential 41
Chimerical Agglomerates™
• Highly respirable insulin case study
By spray-drying process therefore is possible to obtain dry insulin powders characterized by high stability and suitable particle shape able to make the powders highly breathable and manageable for manufacturing
These powders show good flow properties which allow them to be easily charged in a adevice for insufflation
By this approach insulin crystals are transformed in micro-particles
The product does not contain excipients, so reducing the potential side effects associated to them
The room temperature stability of these pwders allows the product to be stored in non-refrigerated conditions
March 2008 Lisapharma – Confidential 42
Sucralfate Gel
March 2008 Lisapharma – Confidential 43
Sucralfate Gel
• Sucralfate is a safe and active antiulcer drug
• A new physical form of Sucralfate, named Sucralfate Gel, has been patented and developed and possesses colloidal properties due to the reduced particle size
• The material is a humid solid since the drying of the sucralfate gel causes the lost of the gel properties
• It has been demonstrated that sucralfate gel superior activity is due to a demonstrated strong bio-adhesion towards the oral and gastrointestinal mucosa, which allows the product to persist in contact with the tissue to be healed
March 2008 Lisapharma – Confidential 44
Sucralfate Gel
• Other than the development of Sucralfate Gel as oral suspension for the treatment of GI ulcers, the peculiarity of this new material has suggested a series of further development.
• One of this has been the topical use of Sucralfate Gel for the treatment of the skin ulcers of various origin, which has got the CE approval as Medical Device
• This was made possible again by the bio-adhesion properties of the Sucralfate humid gel that allowed the preparation of a simplified and self-adherent topical preparation
• The topical preparation can be used also as a carrier for topical substances and it is patented
March 2008 Lisapharma – Confidential 45
Sucralfate Gel
March 2008 Lisapharma – Confidential 46
Sucralfate Gel
• There are already on the market in many countries various products based on the Sucralfate Gel technology including:
• Sucralfate gel topical 25% for the treatment of skin ulcers of various origin (Medical Device)
• Sucralfate gel oral suspension 1g/5ml sachet
• Sucralfate gel oral suspension 2g/10ml sachet
• Dried sucralfate gel tablets 1g (under registration)
• Dried sucralfate gel sequential tablets + ketoprofen
• Dried Sucralfate gel sequential tablets + aspirin
March 2008 Lisapharma – Confidential 47
…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
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