Water Soluble HybridsDD System

Hybridize the active drug and made it water solubleNo change in chemistry of active molecules

Synergistic and potentiating the efficacy for their action Mewa Singh, 609-902-7128, mewasinghsandhu@hotmail.com

The technology can reduce dose frequency requirements and side effects

INNOVATION&DISCOVERY

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

Technology Platform-Drug Dlivery

Hybrid Formulation TechnologyInsoluble Soluble

Synergistic /Potentiating Hybrids

Goal

• Our main focus to improve existing drug to make a better product portfolio using our Synergistic Hybrid Technology for solubiliy and DD

• Water Solubility improving it’s effectiveness

• Water Solubility reducing it’s toxicity

• Our technology improving it’s cost of manufacturing

• Added value to end user for ease and convenience.

• Of course IP to protect our business

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 Statin

Aripiprazole Paliperidone Megastrol

Carbenicillin verdenafil 5-aminosalicylic acid

Ofloxacin Budesonide Tamoxifen

Finofibrate Clopidogrel Valsartan

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.

• Worldwide sales of poorly soluble drugs are about $108 billion and it is going to increase further. So there is a large growing demand exists for technology that improve the solubility.

• 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

Hybrid Technology

• How does Meda differ from other nanoformulation and solubility technology on the market?

• The problem with 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 use a partner molecule for solubility, which also provides synergistic and potentiating effects to parent drug.

What is good about our Technology

• It is one of the few new technologies that have been specifically developed to achieve commercial manufacturing scale.

• The technology is unique in its simplicity because the process can be performed using normal manufacturing equipment that is present in most development and manufacturing facilities.

• Because the development costs for new chemical entities are so high, many companies are instead working to optimize existing marketed molecules.

• This is only technology I am aware of having a synergistic and potentiating partnership leads to soluble formulation.

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

Our Strength

• Technology-Patented

• Experience –More than 30 drugs

• Creativity – A new approach from our discovery

• Combining technology, experience, and creativity, Meda Biotech would like to explore the opportunities with you.

Oral, Injectable and Transdermal

•Specialty Pharma is a growing sector•Drug Delivery has a large, measurable role in successful products and franchises•Water solubility of NME pipeline programs usually not publicly available ( Big pharma)•Technology approaches also not usually available until later phases or until registration/approval.

• Need to understand past and current deal terms

• Upfront Payments

• Royalties

• Milestones

• Development Fees

• Phase Deal Signed

• Therapeutic Category

• Route

• Technologies licensed (DD, Discovery)

Product and Technology Deals

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.

Impact of DD Technology on Products

• •Emend

• ▫Solubilizationtechnology 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

• ▫Solubilizationtechnology enabled product to reach market

• •Invega

• ▫OROS and Nanocrystaltechnologies created products with good safety/efficacy profiles. May be difficult for Generics to copy. Sales of $424 millionUSDin 2010.

• •TriCor

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

• •Geoden

• ▫Allowed for an injectableform to reach market. Franchise sales of over $1 billion USD in 2010