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Innovative Pharmaceutical Composition for Controlled Drug Release

A cutting-edge pharmaceutical composition deploying new technology for controlled drug release from the formulation, addressing the issues of uncontrolled drug administration and concentration-related side effects. The patented solution features a unique particle model with distinct layers for controlled and site-specific drug release, offering improved therapeutic effects and cost efficiency. The platform is adaptable for various drugs, accentuating the potential for better treatments and economic benefits. Developed by a seasoned team with extensive experience, the project represents a significant advancement in drug delivery technology.

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Innovative Pharmaceutical Composition for Controlled Drug Release

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  1. PHARMACEUTICAL COMPOSITION New GenerationofMedicines Technology whichenables controlled releaseof drug fromformulation. Croatia, Zagreb, September 4, 2018 Ljiljana Sović Brkičić

  2. Problem – Uncontrolled administration of drugs Concentration of drug RESULT too high that causes side effects therapeutic window ideal concentration of drug too low that it is not effective Time

  3. 3 – enteric layer 2 – bioadhesive layer 1 – CR layer 0 – DRC diameter 100-500 µm Model of particle (DRC + layers) Solution– Controlled releasing of drug from formulation Patent application WO2012136816 (at national phases – 90 countries) Novelty – number and the order of coatings RESULT • Formulation – a lot of particles • DRC / drug resin complex + layers • Pharmaceutical composition - • enables controlled and site specific release of drug from forumulaton • Technology – spray granulation • modification – number / order of coatings

  4. Patent application – WO201236816 • EPO application • PCT application • national applications • 90 countries • 4 patent unions, others • granted – 45 countries • covered – 3 billion….

  5. Competition Example - novel levodopa (antiparkisonic) Competitors Duodopa Existing oral formulations Novel formulation Price per year 50,000 Euros or more 1,000 Euros 3,000 - 5,000 Euros Administration parenteral oral oral Features unacceptable application causes side effects well controlled release Rating of CR excellent bad very good Expensive Very inconvenient Highly effective Low cost Convenient Ineffective Price acceptable Convenient Very Effective Evaluation

  6. The Platform - Usable for drugs with N Duodopa Hypertension morphine Depression Viagra olanzapine sildenafil Parkinson`s disease Sinemet tramadole Epilepsy risperidone levodopa

  7. Value Proposition Users Benefits Patients • better drug treatments • better therapy • better quality of life  • therapeutic – lower side effects • economic – saving money • business – staying on job / working Health insurances / payers • will ensure better treatments • rationalisation of costs • lower costs  • therapeutic – better healthcare • economic - saving money (long-term) • business – better results Pharmaceutical company • will produce better products • good business opportunity • higher market share  • added value – higher profit • revenues in billion / blockbusters • The Platform

  8. Market Opportunity & Risks Market European and global Blockbusters (past and future) Revenues in billion / Large PH company The Platform Usable to all drugs containing N (nitrogen)

  9. Business Model Licensing (Model 1 of commercialization) • cooperation with large pharmaceutical company • resources, fast model, high revenues § Production (Model 2 ofcommercialization) • outsourced production, laterownproduction • higher costs, slower realization, longerexploitation Next proceedings • completing of package for commercialization / licensing • smalltrials (knownmainandadditonalsubstances)

  10. Commercialization & Marketing …to large PH company • crisis in PH industry • lack of good inventions • need for novel products • large PH likes „Platforms” • commercialization – 3st year …outsourced production • need for better therapy • finalization of R&D • small trials • registration of medicines • commercialization – 3rd year Licensing (Model 1)… Production (Model 2)…

  11. Financial Projections Large PH (Model 1) • revenues in billion • blockbusters • resources • networking • files… SME (Model 2) • need partnering • need funding • slower realization • less revenues • less profit Licensing… Production…

  12. Who we are? ? Zdravko Dokuzović, PhD Researcher, inventor, technologist, earlier patents Ljiljana Sović Brkičić Researcher, inventor, patent applicant, idea, business strategy Cvjetko Brkičić Patent applicant, business experience, investment - 1,000,000 € Team – 95 years of experience; 9 years on this project;36,500 hours ofwork (this project) BLC pharmaceutica d.o.o. Croatia, Zagreb, Kralja Zvonimira 82 http://www.pharmaceutica.blc.hr/ • Ljiljana Sović Brkičić • ljiljana.sovic@gmail.com • pharmaceutica@blc.hr

  13. Conclusion We have a solution which will improve the lives of patients. We have the best innovative project in Europe.

  14. Points Novel technology • developed • granted patents ThePlatform • usable to differentdrugs • usable to alldrugscontainingnitrogen (N) Important / noveltechnolgoyisapplicable • generics - addedvalue, newgenerationofmedicines • noveldrugs – to prolong patent protection

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