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  1. 1. Hybrid-Nanoengineering™ Opportunity To beat Multi Billion Dollar Patent Cliff Using A New Patented Technology Hybrid-Nanoengineering™ Concept to Bench to Clinic and More……. Dr. Mewa Singh 609-902-7128
  2. 2. Simple to collaborate • Since I know it is very hard for big pharmaceutical to review and come up with a decision for collaboration, so we have a very simple risk free process at our end. We offer a free of cost one drug proof-of-concept for our technology. Either you select a drug from our list of solubility resolved drugs or you provide us with your drug to resolve the solubility issue using our Hybrid Nanoengineering platform. • We will just take three weeks to inform you results.
  3. 3. What is new • New concept and new approach • There have never been used two active molecule in nanomedicines • There have never been developed a hybrid nanomedicine • There have never been used an active molecule to developed a water soluble drug formulation • Two water insoluble drugs have never been used to developed a water soluble formulation, at least without changing the chemistry • Chemistry of individual drugs remains unchanged • IT IS NOT JUST SOLUBILITY BUT A BETTER TREATMENT
  4. 4. What has been accomplished or we have in our basket • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Drugs List (Resolved solubility problem) 5-aminosalicylic acid Aspirin Artemisinin Aripiprazole, 99% Azacitidine (Vidaza) Azathioprine Bexarotene, Free Acid (4) Budesonide, 98% Camptothecin Capecitabine Carbenicillin disodium salt Celecoxib Cisplatin Clopidogrel Sulfate Combrestastatin A4 Curcumin (2cc.) for injection Cyclosporin A Daunorubicin hydrochloride Dexamethasone Dihydroergotamine Mesylate Digooxin Docetaxel Epothilone A Erlotinib Monohydrochloride β-Estradiol Fexofenadine hcl Griseofulvin • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Ibuprofen Itraconazole Ivermectin Lenalidomide Leucovorin Calcium Loperamide HCL Loratadine Magestrol Acetate Methotrexate Mevastatin, Minimum 95% HPLC Nystatin mycostatin Nimodipine Ofloxacin Olanzapine Paclitaxel from Taxus Brevifolia Paliperidone Pomalidomide Pravastatin Sodium (2) Prednisone Quinine Rapamycin Resveratrol Retinonic acid 97% Rifampin Rlaxifene hcl Statine Sidenafil Citrate >99% Sulfasalazine Tadalafil (Cialis) (2) • • • • • • • Telaprevir Thalidomide Valsartan 99% Vardenafil hydrocholoride trihydrate Variconazole Zidovudine Ziprasidone hydrocholoride 1. Provisional patent filed in May, 2012 and final is on its way this year. 2. There is no common solubility which cover 63 drugs using one procedure. 3.A simple and inexpensive technology to resolve solubility problem of 63 drugs should deserve some respect.
  5. 5. Practical progress • 86 drugs have tested at lab. scale • Five drugs have been tested at pilot scale production • Three drugs have been tested in dogs • Two drugs have been tested in dogs and humans. The technology is not at early stages of proof of concept or R&D
  6. 6. Technology • Typical existing nanotechnology involved the use of phosphophilipids, detergents, surfactants, polymers and copolymers, PEGylation and other multistep procedures to manufacture a nanomedicine. • We have discovered a new system and a new molecules to manufacture nanomedicines or to generate nano-particles.
  7. 7. New System and Molecule for NanoTechnology • The new molecule discovered is drug that has its own mode of action to treat the disease. • The new molecule has its own properties to be a part of the process to make nanoparticles • This new molecule of discovery is the integral part of the whole formulation or nanomedicine (Hybrid-Nanoengineering™)
  8. 8. Experimetal results-1 ( Paclitaxel) Microscopy Paclitaxel in water Paclitaxel in water Using Hybrid nanoengineering
  9. 9. Experimental Results-2 Solubility in water Paclitaxel in water Paclitaxel in water Using Hybrid nanoengineering
  10. 10. Passive Targeting Longer circulation by evading scavenging by the mononuclear phagocytic system And Bypassing inter-endothelial cells 600-800 nm Size Charge Hydrophobicity Enhanced Permeability and Retention (EPR) Effect
  11. 11. Experimental reuslts-4 (POTENCY) 10000000 8000000 6000000 4000000 2000000 0 Plate 1 Concentration (µg) 0.015625 0.03125 0.0625 0.125 0.25 1 P average 0.5 Live Cells MewTaxel is Potent at 1.1 nM ( ic50 is 30nM) MewTaxel is potent at 5nm ( ic50 is >60nM) Much lower than taxol
  12. 12. Experimental Results-5 • In Mewtaxol ( Paclitaxel) Hypothesis is that our Hybrid partner shut down the pumps , hence incremental in drug concentration leads to overcome the drug resistance. • Our Mewtaxol demonstrate the above mentioned mechanism by killing the paclitaxel drug resistance cell lines.
  13. 13. Mechanism of action For our Cancer Hybrid formulations • Control inflammation • ABCG2 control • While keeping the parent drug unaltered
  14. 14. Overall Summary • Taxanes are a key first-line component of BC therapy • The majority of patients treated with a taxane develop resistance • To date, most therapies developed to overcome resistance are inadequate • Epothilones have shown activity against taxaneresistant tumors – Poor substrates for P-gp – May be unaffected by taxane-resistant tubulin mutations – Positive results in clinical trials
  15. 15. Limitations of Conventional, Solvent-based Taxane Therapy • Taxanes, like many cancer drugs, are hydrophobic and require solvents • Solvents cause hypersensitivity reactions that necessitate – Corticosteroid premedication – Prolonged infusion • Solvents leach plasticizers, requiring specialized IV tubing • Solvents alter the bioavailability of the active drug van Zuylen L, et al. Invest New Drugs. 2001;19:125-141; van Tellingen O, et al. Clin Cancer Res. 1999;5:2918-2924; Ellis AG, et al. Cancer Chemother Pharmacol. 1996;38:81-87; LoRusso PM, Pilat MJ. ONS News. 2004;19:75-76.
  16. 16. Alternative Approaches to Taxane Drug Development Strategy Example Stage Reference HAS-Paclitaxel Pre-clinical Dosio (2001) Emulsions Tocosol paclitaxel Clinical (Phase III) Spigel (2002) Liposomes LEP-ETU Clinical (Phase I/II) Soepenberg (2004) Cyclodextrins PTX-CYD Pre-clinical Alcaro (2002) Nanoparticles nab-paclitaxel Approved Gradishar (2005) Microspheres Paclimer Clinical (Phase I) Armstrong (2006) Analogs BMS-184476; RPR 109881 Clinical (Phase II) Hildago (2001) Prodrugs DHA-Paclitaxel Clinical (Phase II) Harries (2004) Prodrugs Paclitaxel polyglumex Clinical (Phase III) Albain (2006) Paclitaxel + cyclosporine Clinical (Phase II) Kruijtzer (2002) Pharmaceutical Co-solvents Chemical Biological Oral administration Adapted from ten Tije AJ, et al. Clin Pharmacokinet. 2003;42:665-685. There is no reported technology like our’s Hybrid-Nanoengineering™
  17. 17. Properties For Business Success Hybrid Nanoengineering™ One Platform fit for more than 80 Drugs No No Platform Patent Protection Simplicity and Cost of production No No No need to change any Existing manufacturing Setup For Generic or new Drug Need facility change Simplicity Synergistic Or Potentiating Of Material used No No No No No No ? ? Yes Just filed in 2013 Old Technology ? Fit for 87 Drugs List is Growing ? ? A new way to make use of Nanomedicine One step POC in 3-weeks POC for your Drug Free
  18. 18. Nanotechnology Hybrid-Nanoengineering™ 10-200nm
  19. 19. Parameters
  20. 20. Time to discover More • Nanotechnology is used for pharmaceutical products since many years • It has solved many problems • It will solve even more problems in the future: mainly solubility and bioavailability • Hybrid-Nanoengineering™ is the newest invention in Nanotechnology. We need you join us
  21. 21. Nanomedicine ~200 Companies are involved in nanomedicine R&D • ~40 Nanomedicine products registered • – Active US clinical trials using nano-based drug delivery systems in september 2009 Emulsion 127 Liposomes 392 Micelle 5 Microemulsion 44 Hybrid-Nanoengineering™ Nanoemulsion 1 2013 IND Nanoparticle 73 Nanocrystal 8 Nanosuspension 1 ( – – – – – – – –
  22. 22. To Beat Generic And Patent Cliff • An inventory of 67 drugs covered by our patent • These drugs covered multi billion dollar market • Using our technology ,we can avoid the metoo concept in generic market • Using our technology ,we can beat the competition.
  23. 23. Example: 1.Lipitor Cholesterol fighter Lipitor held the title "best-selling drug" for a few years, and had been a major source of income for the world's biggest drug company, Pfizer. Lipitor (atorvastatin) was released in 1998, and by 2006 it had reached worldwide peak sales of $12.9 billion, accounting for 27% of the company's revenue. In 2010, with $10.8 billion in sales, Lipitor still accounted for 15.8% of Pfizer’s total revenue. Unfortunately, Lipitor lost its patent protection and cut Pfizer's total net income by 50%. Pfizer's CEO Ian Read stated on January 31, 2012, in USA TODAY: "Patent losses cost the company 5 Billion Dollars." 2.Paclitaxel and Docetaxel The cumulative sales of paclitaxel have exceeded $ 20 billion so far since 1992. It is estimated that its total global sales were approximately $ 4.5 billion last year. Docetaxel is considered the largest oncology product ever developed with global market value at $3 billion in 2009. Patent and generic cliff can be taken care with our technology. Hybrid Nanoengineering™ can rejuvenate ageing pharmaceutical assets to counteract generic threats and preserve market share and income streams—it could become one of the more successful specialty pharmaceutical companies in memory. Pharmaceutical companies desperately need to protect their revenue streams especially towards the end of their patent life as this is when their products are most profitable. For that reason, upfront and milestone payments should be significant and commensurate to the perceived value brought to the project by adopting Hybrid Nanoengineering™ technology. In addition to milestone payments, royalties would continue for the life of the newly patented product. For drug delivery companies, royalty rates are generally accepted to be in the 7% to 12% range depending on the time and expense of adopting the extended release mechanism. Crown’s Strong patent estate and low development costs for new formulations appears to provide for the least expensive and expedient method for preserving patents and revenue streams. We see a long term share price in the 30.00 to 40.00 range. Strong Buy. Mewa Singh, PhD, Meda Biotech,, 609-902-7128,
  24. 24. Nano Companies • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Abraxis (USA) The company's nab™ drug delivery technology uses albumin nanoparticles to deliver drugs into tumors. Access Pharmaceuticals (USA) Access' lead anticancer program is ProLindac™ applies the principals of nanoparticulate prodrugs to enhance the delivery of a platinum drug to tumors. AcryMed (USA) Manufacturer of SilvaGard, a silver nanoparticle antimicrobial surface treatment for medical devices. ActiVery (Spain) The basic technology platform of Activery™ is a nanoparticle production method using supercritical fluids (SCF). Based on SCF the company intends to create new medicines and modified active ingredients for pharmaceutical and cosmetic use. Acusphere (USA) The company has developed a proprietary formulation technology called HDDS that converts drugs that do not dissolve well in water, or hydrophobic drugs, into microparticles or nanoparticles of the drug embedded in small microspheres, such that the drug can more rapidly dissolve in water. AparnaBio (USA) The company develops biomedical nanoparticle technology and products for research and treatment of human disease. They are developing NanoElectroPlex™, a proprietary tissue selective nanoparticle platform technology based on biodegradable macromolecular carriers. Aphios (USA) The company has developed enabling nanotechnologies for the production of protein nanoparticles, polymer nanospheres and phospholipid nanosomes for the enhanced delivery of drugs Aquanova (Germany) Develops and manufactures micelle-like nanoparticulate encapsulation technology for applications in food, cosmetics, pharmaceuticals and biotechnology. Asklepios BioPharmaceuticals (USA) A biotechnology company engaged in the development and delivery of novel protein and cellular based therapies through design of proprietary Biological Nano Particles. Azaya Therapeutics (USA) A specialty pharmaceutical company with a novel drug delivery system. Its proprietary Protein Stabilized Liposomes nanotechnology platform addresses the significant problems associated with delivery of water insoluble drugs. BIND Biosciences (USA) BIND Biosciences, Inc. is a biopharmaceutical company developing therapeutic targeted nanoparticles. Bio Delivery Sciences International (USA) The company's he Bioral® drug delivery technology encapsulates the selected drug in a nanocrystalline structure termed a "cochleate" cylinder. BioAlliance Pharma (France) Manufactures a nanoparticle-based drug delivery platform. BioCure (USA) Develops amphiphilic self-assembling nanocapsules and planar membranes for drug delivery. Bionostra (Spain) The company's technology is based on the large scale production of nanometric particles known as VLPs (virus like particles). The most advanced application of this technology is the production of viral vector derived vaccines for human and animal health. Biophan Technologies (USA) Develops nanotechnology drug delivery systems based on novel nanomaterials that provide precise control over location and timing of drug delivery. Biosante Pharmaceuticals (USA) The company is developing its proprietary calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. BioSpectrum (South Korea) A life sciences R&D company with a special focus on skin cell biology. The company has established proprietary technologies for nano-liposomal formulation techniques.
  25. 25. Nano companies • • • • • • • • Capsulution (Germany) Develops nanotechnology-based advanced drug delivery carriers, medical devices and diagnostic particles. Celator Pharmaceuticals (USA) The company develops new treatments for cancer based on a portfolio of delivery technologies including liposomes, polymers and nanotechnologies. Cornerstone Pharmaceuticals (USA) Develops the Emulsiphan™ nanoparticle tumor targeting technology. Dabur Pharma (India) One of the company's delivery systems in the most advanced stages of clinical development is a novel drug delivery system for Paclitaxel. Because of the better safety and pharmacokinetic profile, the polymeric nanoparticle delivery system is seen as a potential super generic. • • • • Debiopharm Group (Switzerland) Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. Delpor (USA) Delpor develops the next generation Drug Delivery Systems that improve the clinical and commercial value of drugs and biopharmaceuticals. The company also has developed a microfabricated nanopore device for the sustained release of therapeutic agents. • • • • dermaCM (USA) The company's NLP technology produces a generation of particles which retains the strength of the Dermazone Solutions' (SDMC) technologies, but includes the ability to produce particles of 60 nanometers to 150 nanometers which are optically clear. The use of this generation of lipid-based particle delivery system provides the ability to control the size of the final particle by controlling the number of NLPs used to assemble the finished particle. This system maintains very high loading capacity of passenger molecules and uses only safe, all natural ingredients to form both the NLPs and the final delivery system. Dune Sciences (USA) Dune Sciences is an emerging technology company specializing in products and services that will facilitate the development and commercialization of nano-enabled products. The company employs several patented and patent-pending technologies to engineer interfaces for the integration of new materials and devices in medicine, bionanotechnology, energy technologies, and nanoscience. • • • • • • • • • • Elan (Ireland) The company's proprietary NanoCrystal® technology can enable formulation and improve compound activity and final product characteristics for poorly water-soluble compounds. Endor Nanotechnologies (Spain) The company's mission is to develop and license R&D projects in Nanotechnology applied to Life Sciences. Endor is also developing pioneer in-house projects in novel Nanomaterials. Eqalix (USA) The company is in the Regenerative Medicine space. The backbone of Eqalix's technology resides in development of a plant-based protein nanofiber structure. Eugene Science (South Korea) Develops food additives with specially formulated nanoparticles which improve bioavailability. Exilica (UK) The company develops unique molecular delivery systems. Its spherical micrometer sizes polymer particles act like micro sponges and absorb molecules while the sub-micrometer sized Hollow silica shells have an internal void space and act much like a standard container.
  26. 26. Nano Companies • • GeneSegues (USA) The company's targeted nanocapsule technology is designed using a flexible formulation process and can carry large or small molecules, custom target delivery to different organs, tissues and cells, and be applied several ways including topically, intravenously, or via devices or tablets. • • • • iCeutica (USA) iCeutica has developed the Encapsulated Organic Nanoparticles (EON™) Platform to produce consistent nano-sized drug particles. Intezyn Technologies (USA) The foundation of the company's IVEC™ drug delivery platform is based on polymer micelle technology, spherical nanosized capsules formed by the assembly of block copolymers in water. • • • • Introgen Therapeutics (USA) Develops and markets a nanoparticle vector technology that combines DNA with the lipids DOTAP and cholesterol to create a synthetic gene delivery vehicle. Keystone Nano (USA) Keystone Nano has an exclusive license to Penn State patented technology that allows the creation of stable, non-toxic, 5 to 50 nm-composite particles that they call Molecular Dots (MDs). These Molecular Dots can encapsulate drugs and/or fluorescent molecules. • • • • Labopharm (Canada) Develops novel polymeric, nano-delivery systems for delivery of water-insoluble and poorly bio-available drugs. LiPlasome Pharma (Denmark) The combination of a protected blood transporting nanocarrier system and a tumor specific activation technology makes LiPlasome Pharma very competitive in a commercially attractive and dynamic anticancer market, where drug delivery systems will gain increasing importance over the coming years. • • Lipoxen (UK) Lipoxen is a leading biopharmaceutical company operating from the UK that develops high-value, differentiated pharmaceutical products in the fields of protein drugs, vaccines and anticancer drugs. • • Lumera (USA) Develops proprietary nanoengineered polymer materials and products based on these materials for a broad range of applications.
  27. 27. Nano Companies • • • • Magforce Nanotechnologies (Germany) Provides integrated systems for nanotechnology-based cancer therapy Mersana Therapeutics (USA) The company utilizes its proprietary nanotechnology platform to transform existing and experimental anti-cancer agents into new, patentable drugs with superior pharmaceutical properties. • • • • • • • • • • • • Midatech Group (UK) Design, synthesis and manufacture of biocompatible nanoparticles called nanocells. NanoBio Corporation (USA) A biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines, based on its nanotechnology platform. Nanocarrier (Japan) Applies the manufacturing technology of ultrafine particles termed 'micellar nanoparticles' to use them as carriers for drugs, such as anticancer agents. NanoMedica (USA) The company's core technology includes a suite of proprietary drug discovery and drug delivery tools referred to as the NanoDiscovery™ platform. Nanospectra Biosciences (USA) Develops a therapeutic medical device which incorporates a new class of microparticles/nano-shells to selectively destroy solid tumors. Nanotherapeutics (USA) Uses nanotechnology to create novel drug delivery systems.
  28. 28. Nano companies • • • • Oasmia (Sweden) Oasmia Pharmaceutical AB develops next generation cancer drugs based on nanotechnology for human and veterinary use. Particle Sciences (USA) Particle Sciences is an integrated provider of both standard and nanotechnology approaches to drug development and delivery. The company originally pioneered use of encapsulated ingredients and nanoparticles for sunscreens and personal care. In 1999 the company licensed a portion of its nanotechnology portfolio to BASF and focused its efforts on providing services to Life Sciences companies. Now, through a full range of formulation, analytic, and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution designed to minimize the time and risk between discovery and the clinic. • • PDS Biotechnology (USA) PDS Biotechnology Corporation is a biopharmaceutical company applying the company's platform Versamune nanotechnology to a new class of safe, simple, potent and targeted immunotherapies for the treatment of cancer and infectious diseases. • • • • • • • • • • • • • • • • PharmaIN (USA) Develops a Protected Graft Copolymer (PGC™) nano-carrier drug delivery system. PharmaNova (USA) PharmaNova Inc. is a privately held, specialty drug development company founded on the re-purposing and enhancement of known drugs using our proprietary nanoparticle technology platform and other complementary formulation and drug delivery technologies. orthopaedics markets. PolyMicrospheres (USA) The company is specialized in developing cutting-edge nanoparticle technologies for the development of targeted drug delivery systems. pSivida (Australia) A nanobiotechnology company developing commercializing drug delivery products and new nanostructured biomaterials. Rexahn Pharmaceuticals (USA) Rexahn and the University of Maryland, Baltimore (UMB) Center for Nanomedicine & Cellular Delivery (CNCD), are jointly pursuing the development of water-soluble nano-polymers for targeted delivery of anticancer drugs. Starpharma (Australia) Starpharma Holdings Limited is a world leader in the development of dendrimer nanotechnology products for pharmaceutical, life-science and other applications. Tempo Pharmaceuticals (USA) Tempo is focused on significantly improving the efficacy and safety profile of existing and new drugs employing advances in nanotechnology. The Company utilizes its proprietary Nanocell™ technology to develop multi-compartmental, nanoparticle-based therapeutics in which two drugs with varied release rates are packaged within a single nanoparticle. • • Uluru (USA) Developed and manufactures a novel, biomaterial which utilizes hydrogel nanoparticles which aggregate to form a material of varying strength and elasticity which has extensive medical application including wound management and burn care, tissue regeneration and drug delivery devices.
  29. 29. • None of the existing companies has any technology close to our unique platform. • A recent report by Cientifica, a leading global emerging technology consulting firm predicts: Nanotech-enabled drug delivery therapeutics is set to grow from a current value of $2.3 billion to $136 billion by the year 2021. Nano Nano Nano Nano Nano Nano Nano Nano Nano Hybrid-Nanoengineering™ Nano Nano Nano Nano Nano