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Transdermal T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary. Transdermal T herapies and Medicaments Dr. Zoltán DÁRDAI h.c. Technology Description .

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Transdermal T herapies and Medicaments Dr. Zoltán DÁRDAI h.c.

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  1. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Transdermal Therapies and MedicamentsDr. Zoltán DÁRDAI h.c.

  2. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary This is the normal structure of the skin, this needs to be changed if we want to apply transdermal technology.

  3. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary The main points of this technology: Solubilisation of the medically active molecule How to dissolve the barrier in a reversible way?

  4. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary In order to change the barrier we need to apply amfipathic tenside (=surfce active molecule). This tensid has to ensure the solubilisation of the active molecule.

  5. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Tenside molecules in solvent

  6. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Opening the pores with using the van de Waals effect

  7. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Dissolving the barrier opens up the following problem: How to prevent harmful materials from entering the body?

  8. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Harmful material (i.e. bacteria, chemicals)

  9. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Enlarging the harmful agents

  10. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Insulin is mostly an association

  11. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Linearisation of the associated insulins with tenside

  12. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Bio-colloidical chemistry = Bio-nano-technology

  13. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary 3D representation

  14. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary

  15. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary

  16. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary The effect of selective tenside adsorpion on the barrier and antibarrier (only for medicaments) function

  17. Technology Description Transdermal Technologies and Medicaments Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Barrier and antibarrier in practice

  18. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status

  19. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status Insulin Patch: All in vitro and in vivo preclinical experiments were ready before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed. Phasis I. research: self testing Missing: Phasis II and Phasis III trials Esimated time until application: If using permited insulin: cca. 1 years

  20. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status Aspirin Patch: All in vitro and in vivo preclinical experiments were ready before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed. Phasis I. research: self testing Missing: Phasis II and Phasis III trials Esimated time until application: cca. 6-8 months

  21. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status Myocardial Infarct Prevention Patch : Preclinical in vitro experiments are ready. In vivo animal experiments could begin at university level this year. In this case results would be available within one year. Phasis I. research: self testing Missing: Phasis I, II, III trials Esimated time until application: cca. 1-2 years

  22. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status

  23. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status Gels, Creams, Emulsions Mobilis Gel Curative therapy for rheumatic problems. All in vitro and in vivo clinical experiments were ready with a significant result of 97% before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed. Estimated time until application: 6 months.

  24. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status

  25. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status Gels, Creams, Emulsions Osteoporosis Cream All in vitro and in vivo clinical experiments were ready with a significant result of 90% before the agreement between EU and Hungary. That is why now GLP, GMP and GCP are needed. Estimated time until application: 4-5 months.

  26. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status

  27. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Technology Status Gels, Creams, Emulsions: Hepa Mix Emulsion Anti Fet emulsion Divertic Emulsion Psori Crem family All permissions available. Missing: capital.

  28. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Potential Market Opportunities • The pains and problems that application of transdermal technology can address: • consertative approach of administring medicaments • competitive companies applying per os, intramuscular • or subcutan drug administration • Services enabled by transdermal technology: • improving the patients’ quality of life (i.e. no fridge needed; indicates the time of new administration-colour coded) • Benefits: • administration of the drug is more human • less side effects because doses can be lower

  29. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Potential Market Opportunities • Scientific merit: • - new pharmaco-chemical and medical view • - re-evaluating the function of the skin • Market: • all patients • Chanels to customer: • - education of doctors and pharmacologists • - informing the health insurance system about this more • economical solution • - informing the patients • Barriers to market: • competitive companies • lack of information

  30. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Intellectual Property Status All intellectual properties are either under PCT, Hungarian licence, or secret know-how of Dr. Zolán DÁRDAI h.c. Development partners: Eötvös Lóránd Tudomány Egyetem: Prof. Dr. Nagy Miklós, Állatorvos Tudományi Egyetem: Prof. Dr. Rudas Péter, Prof. Dr. Sótonyi Péter, Debreceni Egyetem: Prof. Dr.Tosaky Árpád, Kaposvári Mezőgazdasági Egyetem: Prof.Dr. Szendrő Zsolt, Semmelweis Egyetem:Prof. Dr. Sótonyi Péter II., Prof.Dr. Pogácsa Gábor, Prof. Dr. Kéry Ágnes, Magyar Honvédség Egészségügyi Intézet: Prof. Dr. Fűrész József, Gyógyszeripari Minőségellenőrző Intézet: Dr.Financsek István, Dr.Horváth Katalin, Állategészségügyi Intézet: Dr.Sályi Gábor. Roche Diagnostics: Dr.Békésy Mariann, Országos Élelmiszeripari és Táplálkozástudományi Intézet: Dr.Kontraszti Mariann, Országos Tiszti Főorvos: Dr.Bujdosó László, Szent László Kórház, Prof. Dr.Mészmer Zsófia, ITW Dynatech GmbH: Kishonti Attila, ICI National Adhesives AG: Zsíros Viktor. Partners: Egészségügyi Minisztérium Prof.Dr.Huszár András Főosztályvezető, Gazdasági Minisztérium Egyed Géza államtitkár, Dr.Balogh Tamás Főosztályvezető, Nemzetvédelmi Minisztérium: Prof.Dr.Fűrész József, Miniszterelnöki Hivatal: Dr.Angelusz Róbert főtanácsadó.

  31. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Resource Requirements • Economical data • Inzulin patch (piece) • 5 UI 10 UI 20 UI • Price of main materials • 30 HUF 60 HUF 120 HUF • Price of production • 95 HUF 175 HUF 200 HUF • Market value 150 HUF 240 HUF 280 HUF

  32. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Resource Requirements • MOBILIS OSTEOPOROSIS HEPAMIX PSORI Crem • gel cream emulsion cream • Price of main materials, HUF/100g 600 400 500 600 • Price of production 1400 1100 1300 1400 • Market value 2100 1800 2000 2100 • Hungary’s population is 10.000.000. Counting maximally 20% economic participation the expected result is: • Nr of patients 20 % of this Result, HUF/year • Diabetes mellitus 700.000 140.000 1,5 milliard HUF 3,2 M.EUR • Infarctus prevention 3.500.000 700.000 1,5 milliard HUF 3,2 M.EUR • Aspirin patch 3.000.000 600.000 1,5 milliard HUF 3,2 M.EUR • Rheumatology 1.300.000 260.000 0,7 milliard HUF 1.7 M.EUR • Osteoporosis 600.000 120.000 0,6 milliard HUF 1,6 M.EUR • Hepatology 500.000 100.000 0.5 milliard HUF 1.3 M.EUR • Psoriasis 350.000 70.000 0.3 milliard HUF 1 M.EUR • Total amount of income only after one year of sale just in Hungary: • 6.100.000.000 HUF, 16 M.EUR • At the EU market we have to consider the population of 320.000.000, the export counting only 5% of the whole market, the yearly result is 50.000.000 EUR.

  33. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Resource Requirements • Estimated amount of grand capital for finishing researches and starting production: • Laboratory instruments 400 MHUF • Personal 20 persons • Brutto salary 250 MHUF • Material costs 100 MHUF • Regie 150 MHUF • Extern research costs 100 MHUF • Total costs 1.000 MHUF • Starting costs for production • Patches factory 15 M Euro • Gel, cream, emulsion factory 15 M Euro • Laboratory, clinic 10 M Euro • Laboratory of nano-technology 5 M Euro • Total investment 45 M Euro • PR, promotion 15 M Euro • The new firm is profitable after one year.

  34. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Potential Challenges Market: The big pharmaceutical companies are not interested in heeling, but in keeping the potential customers. Our goal is heeling. Our partners are the insurance companies and the govermental health organisations. Technology: changing the traditional production of medicaments both qualitatively and quantitatively. Political: improvement of health level especially in the developing countries.

  35. Name of the Technology Technology Description Technology Status Potential Market Opportunities Intellectual Property Status Stakeholder Support Resource Requirements Potential Challenges Summary Summary We solved our main aim with solubilisation of the medical agents by using nano-technology with bio-colloidics. Applying this technique we developed transdermal technology to a level where we can lower the amount of medicine needed for a treatment and reduce the number of side effects at the same time.

  36. Thank you for your kind attention.

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