Meda biotech l lc.pptx final

Meda Biotech LLc. Water Soluble Hybrid

Drug Delivery Systems

Mewa Singh609-902-7128

[email protected]

A straight-forward technology aimed at reducing dosage (frequency & total amount) requirements and side effects

Copyright: Meda Biotech/Mewa Singh

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Water Soluble Drug Delivery Systems - Approach

Hybridize the drug to achieve (increase) water solubility

Maintain basic chemistry of active molecules

Potentiate efficacy of the drugSynergistic effects


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WHO ReportCurrently, 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

Technology Platform-Drug Delivery

Hybrid Formulation TechnologyInsoluble Soluble

Synergistic /Potentiating Hybrids

4Copyright: Meda Biotech/Mewa Singh

http://en.wikipedia.org/wiki/File:Paclitaxel_JMolBiol_2001_1045.jpg

http://www.biomedcentral.com/1471-2407/5/97/figure/F1?highres=y


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Impact of Drug Delivery: Summary

Drug delivery provides measurable valueUtilized 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 senseDoes not provide inherent value to all

programs. Must be product/market driven.


Impact of DD Technology on Products

EmendSolubilization technology enabled product to reach market. Sales of $380 million USD in 2010.

MegaceESEliminated food effect and reduced dose size. Important for patient population that has difficulties eating/swallowing. Sales of approx. $70 million USD.

IntelenceSolubilization technology enabled product to reach market

InvegaOROS 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.

TriCorReduced dose, eliminate food effect, LCM delayed Generic introduction. Sales of $1.6 billion USD in 2010.

GeodenAllowed for an injectable form to reach market. Franchise sales of over $1 billion USD in 2010



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.



Successfully improved Hybrid Drugs for solubility

Paclitaxel Tadalafil Rapamycin

Bexarotene verdenafil 5-aminosalicylic acid

Aspirin Celecoxib Docetaxel

Combretastatin Ibuprofen Epothione A

Prednisone Quinine Itraconazole

Azathioprine Artemisinin Cyclosporin

Nimesulide Rapamycin Tadalafil

Sildenafil Camptothecin StatinAripiprazole Paliperidone Megastrol

Carbenicillin verdenafil 5-aminosalicylic acid

Ofloxacin Budesonide Tamoxifen

Finofibrate Clopidogrel ValsartanList is growing


Problem

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).

Effectiveness of the drug is directly proportional to the amount of drug reached

at disease site




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Meda: Hybrid Technology

Q: 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.



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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.



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CollaborationHow 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.



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Meda: Our Strengths

Technology-PatentedExperience –More than 40 drugsCreativity – A new approach from our

discoveryCombining technology, experience,

and creativity, Meda Biotech would like to explore the opportunities with you.


Need to understand past and current deal terms

Upfront PaymentsRoyaltiesMilestonesDevelopment FeesPhase Deal SignedTherapeutic CategoryRouteTechnologies licensed (DD, Discovery)

Product and Technology Deals



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)

Proof of Concept



Meda biotech l lc.pptx final

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