ANATOMY AND PHYSIOLOGY OF REPRODUCTIVE SYSTEM.pptx
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New approach to treat cancer
1. The technology can reduce dose frequency requirements and side effects
INNOVATION
&
DISCOVERY
Water Soluble Hybrids
DD System
Hybridize the active drug and made it water soluble
No change in chemistry of active molecules
Synergistic and potentiating the efficacy for their action
Mewa Singh, 609-902-7128,
mewasinghsandhu@hotmail.com
2. WHO Report
ā¢ 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
4. Goal
ā¢ Our main focus to improve existing drug to make a better product
portfolio using our Synergistic Hybrid Technology for solubiliy
and DD
ā¢ Water Solubility improving itās effectiveness
ā¢ Water Solubility reducing itās toxicity
ā¢ Our technology improving itās cost of manufacturing
ā¢ Added value to end user for ease and convenience.
ā¢ Of course IP to protect our business
6. Problem
Effectiveness of the drug is directly proportional to the amount of drug reached at disease site
ā¢ 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.
ā¢ 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.
ā¢ 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 activityāeven if
they show promising therapeutic activity in cell culture. Medaās hybrid formulation technology addresses this problem
by improving water solubility, bioavailability, effectiveness and efficiency.
ā¢ 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).
7. Hybrid Technology
ā¢ How does Meda differ from other nanoformulation and
solubility technology on the market?
ā¢ The problem with existing techniques, they use multiple expensive
steps and almost everyone use just polymers or proteins to make
these drugs more soluble.
ā¢ Medaās 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.
8. What is good about our Technology
ā¢ It is one of the few new technologies that have been specifically
developed to achieve commercial manufacturing scale.
ā¢ 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.
ā¢ Because the development costs for new chemical entities are so
high, many companies are instead working to optimize existing
marketed molecules.
ā¢ This is only technology I am aware of having a synergistic and
potentiating partnership leads to soluble formulation.
9. Collaboration
ā¢ How can I work with Meda Hybrid Technology?
ā¢ 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
10. Our Strength
ā¢ Technology-Patented
ā¢ Experience āMore than 30 drugs
ā¢ Creativity ā A new approach from our discovery
ā¢ Combining technology, experience, and creativity, Meda Biotech
would like to explore the opportunities with you.
11. Oral, Injectable and Transdermal
ā¢Specialty Pharma is a growing sector
ā¢Drug Delivery has a large, measurable role in successful
products and franchises
ā¢Water solubility of NME pipeline programs usually not
publicly available ( Big pharma)
ā¢Technology approaches also not usually available until
later phases or until registration/approval.
12. Product and Technology Deals
ā¢ Need to understand past and current deal terms
ā¢ Upfront Payments
ā¢ Royalties
ā¢ Milestones
ā¢ Development Fees
ā¢ Phase Deal Signed
ā¢ Therapeutic Category
ā¢ Route
ā¢ Technologies licensed (DD, Discovery)
13. Impact of Drug Delivery: Summary
ā¢ Drug delivery provides measurable value
ā¢ Utilized in some capacity in 40% of Top 20 pharmaceutical products
with sales of 51 billion USD worldwide.
ā¢ Drug delivery increases revenues via patent protection and life
cycle products
ā¢ Delays generic introduction in some cases and provides additional
franchise revenues.
ā¢ Drug delivery has to make sense
ā¢ Does not provide inherent value to all programs. Must be
product/market driven.
14. Impact of DD Technology on Products
ā¢ ā¢Emend
ā¢ ā«Solubilizationtechnology enabled product to reach market. Sales of $380 million USD in 2010.
ā¢ ā¢MegaceES
ā¢ ā«Eliminated food effect and reduced dose size. Important for patient population that has difficulties eating/swallowing. Sales of
approx. $70 million USD.
ā¢ ā¢Intelence
ā¢ ā«Solubilizationtechnology enabled product to reach market
ā¢ ā¢Invega
ā¢ ā«OROS and Nanocrystaltechnologies created products with good safety/efficacy profiles. May be difficult for Generics to copy.
Sales of $424 millionUSDin 2010.
ā¢ ā¢TriCor
ā¢ ā«Reduced dose, eliminate food effect, LCM delayed Generic introduction. Sales of $1.6 billion USD in 2010.
ā¢ ā¢Geoden
ā¢ ā«Allowed for an injectableform to reach market. Franchise sales of over $1 billion USD in 2010