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March 2008 Lisapharma – Confidential 1. 2 Company Introduction & Proprietary Technologies.

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Presentation on theme: "March 2008 Lisapharma – Confidential 1. 2 Company Introduction & Proprietary Technologies."— Presentation transcript:

1 March 2008 Lisapharma – Confidential 1

2 2 Company Introduction & Proprietary Technologies

3 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

4 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

5 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

6 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………………………..

7 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

8 March 2008 Lisapharma – Confidential 8 PROPRIETARY TECHNOLOGIES

9 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

10 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

11 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

12 March 2008 Lisapharma – Confidential 12 DOME MATRIX ®

13 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

14 March 2008 Lisapharma – Confidential 14 Dome Matrix ®

15 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

16 March 2008 Lisapharma – Confidential 16 Dome Matrix ® Piled configurations can be obtained by staking the modules convex face into concave face

17 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

18 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

19 March 2008 Lisapharma – Confidential 19 Patch-non-Patch®

20 March 2008 Lisapharma – Confidential 20 Patch-non-Patch ® Patches vs. Traditional Systemic Formulations Constant plasma levels Lower incidence of side effects vs Injectionvs Oral Non invasive Increased bioavailability More acceptableReduced dosing frequency No need of specialized No drug interaction personnel Limitation Low skin permeability (daily dosing < 10 mg)

21 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

22 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 liner Backing Deposit Membrane Adhesive Liner Minitran ®

23 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 ®

24 March 2008 Lisapharma – Confidential 24 Patch-non-Patch ® : the Novelty Patch-non-Patch ® SEM Image

25 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

26 March 2008 Lisapharma – Confidential 26 Patch-non-Patch ®

27 March 2008 Lisapharma – Confidential 27 Patch-non-Patch ®: Case Studies LidocaineEstradiolHydrocortisone CaffeineNitroglycerinHerbal extracts ThiocolchicosideProgesteroneRutin derivatives Ibuprofen lysineNicotine&BupropionKetoconazole Diclofenac SumatripanClindamycin Acyclovir Clorexidine Nicotinamide&Salicylic ac. Thyroxine

28 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

29 March 2008 Lisapharma – Confidential 29 Patch-non-Patch ®: The Cosmetic difference

30 March 2008 Lisapharma – Confidential 30 Patch-non-Patch ®: The Cosmetic advantage

31 March 2008 Lisapharma – Confidential 31 Patch-non-Patch ® : Advantages vs Competitors FeatureP-n-P ® PatchPlasterGel % of active releasedHighLowLowLow Time lagNoYesYesNo Duration of activityLongLongLongShort Adaptation to skin surf.YesNoNo? OcclusiveNoYesYes/NoNo Water solubleYesNo?Yes Electrically conductiveYesNo? Yes/No Cosmetically acceptableYesYes/NoNo? Easy to be removedYesNoYes/NoYes

32 March 2008 Lisapharma – Confidential 32 Patch-non-Patch ® : Advantages vs Competitors FeatureP-n-P ® PatchPlaster Gel Preservatives neededNoNoYesYes Organic solvents requ.NoYesYes/No No Drying step criticalNoYesYes - Active crystalliz.criticalNoYesYes Yes Cost of production+++++++++ ++

33 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

34 March 2008 Lisapharma – Confidential 34 Chimerical Agglomerates™

35 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

36 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

37 March 2008 Lisapharma – Confidential 37 Chimerical Agglomerates™

38 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

39 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

40 March 2008 Lisapharma – Confidential 40 Chimerical Agglomerates™ Highly respirable insulin case study  Powders 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

41 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

42 March 2008 Lisapharma – Confidential 42 Sucralfate Gel

43 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

44 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

45 March 2008 Lisapharma – Confidential 45 Sucralfate Gel

46 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

47 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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