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127.01.2015
PROBLEM
“Half of the $383 billion-worth patented drugs to be sold in the World this year will lose patent protection within five years.”
The Economist – Aug 6th 2009
• National Health Services demand lower costs
• Generic drug market share is on the rise.
• Drug manufacturing costs are becoming significant to the Pharma Industry.
The Patent Cliff:
227.01.2015
“The global Pharmaceutical industry has long been plagued by fears of the “patent cliff”—the looming expiration of patents on drugs accounting for about $90 billion in annual sales between 2010 and 2015” – www.marketminder.com - 22.07.2011
SOLUTION – HPE PLATFORMnon-animal derived, natural fermentation products
HPE-1 Chitin-Glucan ComplexHPE-1 Chitin-Glucan Complex (CGC)HPE-2 ExoPolysaccharide HPE-2 ExoPolysaccharide (EPS)High functionality excipients with tunable characteristics
Higher Stability
Better compactability
Higher binding capacity
Lower friability
Polyfunctionality
Lower raw materials dependence
Lower energy consumption327.01.2015
Semi-solid forms
Liquid forms
Solid forms
FIRST PRODUCT – HPE-1
HPE1 Features & Production Steps:Natural BiocompositeYeast FermentationExtractionWashing & ClarificationConcentrationDryingFinal Product - Dry powder
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HPE1- BINDER & FILLER EXCCIPIENT USED IN TABLET MANUFACTURE
•FILLERS - Used to dilute the API in the final mixture.
•BINDERS – Used to increase the hardness of tablets.
HPE-1 – COMPARATIVE STUDY.
5
PARAMETER HPE-1 AVICEL PH 302Particle Size (Average) 100 µm 100 µm
Bulk Density 0,92 0,46Tapped Density 1,03 0,70Hausner Ratio 0,88 (Excellent) 1,56 (very Bad)
Carr’s Index 11,53 34,28Compressibility Index 1,06 12,5
Mass Flow 142,78 70,62
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>100% HIGHER BULK DENSITY THAN THE BEST AVICEL
HPE-1 FINAL BULK DENSITY
6
HIGH BULK DENSITY - GOOD POWDER FLOWABILITY - INCREASES SPEED OF TABLETING MACHINE
COMPRESSION CYCLE
POWDER FLOWABILITY
POWDER FLOWABILITY IS A CRITICAL ISSUE IN TABLET PRODUCTION
POWDER FLOWABILITY IS A CRITICAL ISSUE IN TABLET PRODUCTION 7
INCREASING BULK DENSITY FROM 0,33 TO 0,45 > INCREASES SPEED MACHINE> HIGHER PRODUCTIVITY
BULK DENSITY IMPACT
AN INCREASE OF 33% IN POWDER BULK DENSITY ENABLE THE MANUFACTURER TO INCREASE OUTPUT BY 20%
AN INCREASE OF 33% IN POWDER BULK DENSITY ENABLE THE MANUFACTURER TO INCREASE OUTPUT BY 20% 8
HIGH PERFORMANCE EXCIPIENTS
The Excipients that will boost
the Industry bottom line927.01.2015
EXCIPIENT MARKET DYNAMICS
Source: BCC Research
The CAGR of the global excipient market has been in the order of 3-4%/Year, and immune to crisis effects. It is expected to keep
growing in the next 10 years
The CAGR of the global excipient market has been in the order of 3-4%/Year, and immune to crisis effects. It is expected to keep
growing in the next 10 years
Values in billion USD
1027.01.2015
EXCIPIENT MARKET SIZE
Binders & Fillers – approx. 3,25 Billions USDBinders & Fillers – approx. 3,25 Billions USD
3%4%
5%
7%
13%
20%
48% *
*
*
Flavours & Colorants
*
**
Source: Frost & Sullivan
1127.01.2015
SALES ENTRY STRATEGY
HPE1 pillsHPE1 pills
HPE1 - Binder & Filler for Direct Compression Production of solid pills outstanding bulk density
Largest market segment
Quickest time-to-market
High technical advantage
Largely exceeds current reference excipient’s features
HPE1 addresses the largest market segment and has a quick time to market.
HPE1 addresses the largest market segment and has a quick time to market.
1227.01.2015
Industry •Formulation Services – Provide Problem Solving approach for problematic APIs, to be solved with HPE-1; • Develop Showcase for Blockbuster API with HPE-1;• Practical Courses, Brochures & Samples for industrials;DistributorsEstablish distribution agreements with regional operatorsScientific Community• Publish Excipient Performance Studies in Reference Scientific publications;• Participation in Specialty Fairs and Conferences;
MARKETING STRATEGY
1327.01.2015
Pedro Vilarinho – CEO – 55 – PhD Industrial Management, 30 Yrs experience in Industry consulting
Filipe Aguiar, 35 – Graduate Biotechnology, 10 yrs Project Management experience
Filomena Freitas, 42 – PhD Biological Engineering– 14 Yrs experience in Microbial Fermentation
Luís Pedro Correia, 46 – Graduate Management – 17 Yrs Experience Accounting, Finance, Project Management
Fernando Cruz, 53 – MsC Biotechnology/MsC Pharmaceutical Technology – 22 Yrs Exerience in the Pharmaceutical Industry;
Inês Farinha – 26 - PhD student in Biotechnology – 4 Yrs experience in Biochemical Engineering and Fermentation;
TEAM
1427.01.2015
1527.01.2015