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Drug delivery technology that could make a drug more effective and less harmful to patients. …

Drug delivery technology that could make a drug more effective and less harmful to patients.
Currently, about 30% of drugs that appear on the World Health Organization (WHO) Essential Drug List were reported to be poorly water-soluble, based on the Biopharmaceutics Classification System (BCS) .
Over 40% of newly developed pharmaceutically active substances have solubility issues.
The poor dissolution and/or permeability of these drugs often result in low and highly variable bioavailability.
The major obstacle of successfully commercializing these compounds is the difficulty of enhancing their dissolution rate and extent of dissolution
.In a word: bioavailability. As much as $40 billion is invested annually in drug discovery. Unfortunately, many of the drug leads that result exhibit poor water solubility and an inability to deliver therapeutic agents in vivo. In fact, it's estimated that 40-50 percent of these new chemical entities are poorly water soluble. (which leads to a number of otherwise promising technologies to be abandoned)
Despite the solubility issue, worldwide sales of poorly soluble drugs are about $108 billion and it is going to increase further. It is reasonably expected that improving water solubility would only increase this number.
The result is inefficiency in the R&D process. Due to the challenges of evaluating efficacy in biologic models for a poorly bio-available compound, these compounds are often shelved with no further development activity—even if they show promising therapeutic activity in cell culture.
Meda’s hybrid formulation technology addresses this problem by improving water solubility, bioavailability, effectiveness and efficiency.
Poor water solubility for many drugs and drug candidates remains a major obstacle to their development and clinical application. Conventional formulations to improve solubility suffer from low bioavailability and poor pharmacokinetics, with some carriers rendering systemic toxicities (e.g. Cremophor1 EL).
Scale. The process has been specifically developed to achieve commercial manufacturing scale.
Simplicity. The technology is unique in its simplicity as the process can be performed using normal manufacturing equipment that is present in most development and manufacturing facilities.
Cost & Increased Profitability. Because the development costs for new chemical entities are so high, many companies are instead working to optimize existing marketed molecules – this saves R&D expenses and should also have decreased drug approval costs.
This is perhaps the only available technology that delivers a synergistic and potentiating partnership with a soluble formulation.
Technology-Patented
Experience –More than 40 drugs
Creativity – A new approach from our discovery
Combining technology, experience, and creativity, Meda Biotech would like to explore the opportunities with you.

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  • 1. Meda Biotech LLc.Water Soluble HybridDrug Delivery Systems A straight-forward technology aimed at reducing dosage (frequency & total amount) requirements and side effects Mewa Singh 609-902-7128 mewasinghsandhu@hotmail.com
  • 2. Water Soluble Drug Delivery Systems - Approach Hybridize the drug to achieve (increase) water solubility Maintain basic chemistry of active molecules Potentiate efficacy of the drug Synergistic effects Copyright: Meda Biotech/Mewa Singh 2
  • 3. WHO Report Currently, about 30% of drugs that appear on the World Health Organization (WHO) Essential Drug List were reported to be poorly water- soluble, based on the Biopharmaceutics Classification System (BCS) . Over 40% of newly developed pharmaceutically active substances have solubility issues. The poor dissolution and/or permeability of these drugs often result in low and highly variable bioavailability. The major obstacle of successfully commercializing these compounds is the difficulty of enhancing their dissolution rate and extent of dissolution Copyright: Meda Biotech/Mewa Singh 3
  • 4. Technology Platform-Drug Delivery Synergistic /Potentiating HybridsInsoluble Hybrid Formulation Technology Soluble Copyright: Meda Biotech/Mewa Singh 4
  • 5. Impact of Drug Delivery: Summary Drug delivery provides measurable value Utilized in some capacity in 40% of Top 20 pharmaceutical products with sales of 51 billion USD worldwide. Drug delivery increases revenues via patent protection and life cycle products Delays generic introduction in some cases and provides additional franchise revenues. Drug delivery has to make sense Does not provide inherent value to all programs. Must be product/market driven. Copyright: Meda Biotech/Mewa Singh 5
  • 6. Impact of DD Technology on Products Emend Solubilization technology enabled product to reach market. Sales of $380 million USD in 2010. MegaceES Eliminated food effect and reduced dose size. Important for patient population that has difficulties eating/swallowing. Sales of approx. $70 million USD. Intelence Solubilization technology enabled product to reach market Invega OROS and Nano-crystal technologies created products with good safety/efficacy profiles. May be difficult for Generics to copy. Sales of $424 million USD in 2010. TriCor Reduced dose, eliminate food effect, LCM delayed Generic introduction. Sales of $1.6 billion USD in 2010. Geoden Allowed for an injectable form to reach market. Franchise sales of over $1 billion USD in 2010 Copyright: Meda Biotech/Mewa Singh 6
  • 7. Proprietary Synergistic Hybrid Technology Main focus: improve an existing or new drug to make a better product Increased Water Solubility improves effectiveness Increased Water Solubility indirectly reduces toxicity Added bonus: potentially decreased cost of manufacturing Overall great increases in ease and convenience. Copyright: Meda Biotech/Mewa Singh 7
  • 8. Successfully improved Hybrid Drugs for solubilityPaclitaxel Tadalafil RapamycinBexarotene verdenafil 5-aminosalicylic acidAspirin Celecoxib DocetaxelCombretastatin Ibuprofen Epothione APrednisone Quinine ItraconazoleAzathioprine Artemisinin CyclosporinNimesulide Rapamycin TadalafilSildenafil Camptothecin StatinAripiprazole Paliperidone MegastrolCarbenicillin verdenafil 5-aminosalicylic acidOfloxacin Budesonide TamoxifenFinofibrate Clopidogrel ValsartanList is growing Copyright: Meda Biotech/Mewa Singh 8
  • 9. Problem Effectiveness of the drug is directly proportional to the amount of drug reached at disease site In a word: bioavailability. As much as $40 billion is invested annually in drug discovery. Unfortunately, many of the drug leads that result exhibit poor water solubility and an inability to deliver therapeutic agents in vivo. In fact, its estimated that 40-50 percent of these new chemical entities are poorly water soluble. (which leads to a number of otherwise promising technologies to be abandoned) Despite the solubility issue, worldwide sales of poorly soluble drugs are about $108 billion and it is going to increase further. It is reasonably expected that improving water solubility would only increase this number. The result is inefficiency in the R&D process. Due to the challenges of evaluating efficacy in biologic models for a poorly bio-available compound, these compounds are often shelved with no further development activity—even if they show promising therapeutic activity in cell culture. Meda’s hybrid formulation technology addresses this problem by improving water solubility, bioavailability, effectiveness and efficiency. Poor water solubility for many drugs and drug candidates remains a major obstacle to their development and clinical application. Conventional formulations to improve solubility suffer from low bioavailability and poor pharmacokinetics, with some carriers rendering systemic toxicities (e.g. Cremophor1 EL). Copyright: Meda Biotech/Mewa Singh 9
  • 10. Meda: Hybrid TechnologyQ: How does Meda differ from other nanoformulation and solubility technology on the market? Existing techniques, they use multiple expensive steps and almost everyone use just polymers or proteins to make these drugs more soluble. Meda’s hybrid formulation technology is simple and cost effective to achieve required solubility. Meda uses a partner molecule for solubility, which also provides synergistic and potentiating effects to parent drug. Copyright: Meda Biotech/Mewa Singh 10
  • 11. Meda Advantages Scale. The process has been specifically developed to achieve commercial manufacturing scale. Simplicity. The technology is unique in its simplicity as the process can be performed using normal manufacturing equipment that is present in most development and manufacturing facilities. Cost & Increased Profitability. Because the development costs for new chemical entities are so high, many companies are instead working to optimize existing marketed molecules – this saves R&D expenses and should also have decreased drug approval costs. This is perhaps the only available technology that delivers a synergistic and potentiating partnership with a soluble formulation. Copyright: Meda Biotech/Mewa Singh 11
  • 12. Collaboration How can I work with Meda Hybrid Technology? Meda is targeting commercial activity in drug discovery and development as a formulation resource for industry and academic researchers. We can work with you to create an efficient and effective way to leverage existing libraries of compounds with known solubility issues but with great commercial potential. Copyright: Meda Biotech/Mewa Singh 12
  • 13. Meda: Our Strengths Technology-Patented Experience –More than 40 drugs Creativity – A new approach from our discovery Combining technology, experience, and creativity, Meda Biotech would like to explore the opportunities with you. Copyright: Meda Biotech/Mewa Singh 13
  • 14. Product and Technology Deals Need to understand past and current deal terms Upfront Payments Royalties Milestones Development Fees Phase Deal Signed Therapeutic Category Route Technologies licensed (DD, Discovery) Copyright: Meda Biotech/Mewa Singh 14
  • 15. Proof of Concept We are currently working on furthering a water- soluble version of Taxol that is garnering substantial interest We are so confident in our technology and it’s cost/manufacturing efficiency that we are willing to discuss a proof-of-concept proposal: from your product portfolio we will work with you to select a candidate to adapt into a new, water-soluble form that can then be evaluated for various characteristics. ◦ Our process is fairly quick and cost efficient so the expenses related to this should be minimal (and probably close to nothing except for provision of the starting molecule) Copyright: Meda Biotech/Mewa Singh 15