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8/6/2019 Strategic Implications of Clinical Research for Generic Companies Dr Sohail Manzoor
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Dr Sohail ManzoorDirector Medical & Regulatory Affairs
Hilton Pharma
Strategic Implications of Clinical
Research for Generic Companies
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In all affairs it is a healthy thingnow and then to hang a question
mark on the things you have longtaken for granted.
-Bertrand Russell
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Pakistan 664 Pharma Companies
634 National companies
30 MNCs
212 national Pharma companies arerepresented by the PakistanPharmaceutical manufacturersAssociation (PPMA).
400 Pharmaceutical Manufacturingplants 370 national Pharma Companies
30 MNCs
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86 Billion PKR Market
84%
16%
Top 50 Companies
Others
84% market share = 72 billion PKR
Among top 50 companies 30 are National companies
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86 Billion PKR Market
94%
6%
Top 100 Companies
Others
94% market share = 80 Billion PKRAmong top 100 companies 70 are National Companies
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Market ShareMNCs vsNational
0
10
20
30
40
50
60
70
1999 2000 2001 2002 2003 2004 2005 2006
MNC's National
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Pakistan
Per Capita drug spending is 8 US $ (488 PKR).
Pakistans population is 2.4 % of worlds Population
Share of the Global Pharmaceutical market is 0.31 %
40,000 brand names are registered comprising of1,400 molecules. 28 : 1
Diclofenac sodium 98 Brands
Omerprazole capsule 86 Brands
Ciprofloxacin tablet 84 Brands
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Generic Market (Gx) A REALITY
The quality of generics manufacturers production has improved
dramatically, and these companies are far larger moresophisticated
The rise in health-care costs means that even in developedmarkets, generic drugs will become increasingly popular andthat in emerging markets they will be a key to gaining a broaderpresence.
Finally Rx companies are facing a well-known shortfall ininnovation as Gx companies are beginning to expand intoinnovative activities cost-effectively.
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Generic Market (Gx) ---- A REALITY
Of the 3.5 billion prescriptions written inthe U.S. in 2004 56% were for generic
drugs a fourfold increase in last 20years .
Worldwide, $45.2 billion of genericdrugs were sold in 2004.
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Why The Need
According to the WHO 14 million people dieeach year from communicable diseases
Malaria TB
Sleeping sickness
kala azar
For which treatment options are inadequateor do not exist, and for which R&D isinsufficient
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Why the NEED
About 97 % of deaths from communicable diseasesoccur in developing countries.
Infectious and parasitic diseases account for 25 % ofthe disease burden in low- and middle-incomecountries compared to only 3 % in high-incomecountries.
Eliminating communicable diseases would close themortality gap between the richest 20 % of the worldpopulation and the poorest 20 % ( World Bank report)
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Market Failures
Over the last few decades major progress inmolecular biology and biotechnology has enabled thedevelopment of increasingly sophisticated medicines
to cure a wide variety of diseases.
Meanwhile, global expenditures on health R&D hasincreased dramatically, R&D funds are focused on
diseases of the rich. Only 10 % of global health research is devoted to
conditions that account for 90 % of the global diseaseburden -- an imbalance that has been referred to asthe 10/90 disequilibrium.
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80/20
People in developing countries, who make upabout 80 % of the world Population, only
represent about 20 % of worldwide medicinesales.
All of sub-Saharan Africa totals less than 2percent of the global pharmaceutical market.
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Possible Issues !!
Current reality is majority of registration trials arefocused on the United States and Europe.
Pattern of disease in our population is different from
that of the US / European population !! Disease characteristics in Asian patients may be
different from those seen in white patients!!
This is particularly evident in breast cancer.
In Singapore Women Peak incidence of breast cancer in their40s In United States, the peak incidence is in women in their60s.
Postmenopausal patients in Singapore 47%
Postmenopausal patients in USA 80%
Less hormone-receptor-positive tumors in Asian women
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Differe P r k k ine ics !!!!
How the body handles drugs may be different inAsian patients compared with white patients !!!
different metabolic rates and geneticvariations
The acetylation of drugs 80% of Asians are Fast acetylators
60% of Whites are Slow acetylators.
Body size difference
Difference in diet/alcohol P450 Enzymes
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Dose Difference !!!???
This study demonstrated interethnicdifferences in myelotoxicity with doxorubicin
and cyclophosphamide in breast cancerpatients. Higher portion of Singaporean patients 55%
experienced severe myelotoxicity vs. 20 %Australian patients.
Beith JM, Goh BC, Yeo W, et al. Inter-ethnic differences in the
myelotoxicity of adriamycin/cylophosphamide (AC) for adjuvant breastcancer.of the American Society of ClinicalOncology 38th Annual Meeting, May 18-21, 2002; Orlando, Florida.
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Local Normal Ranges !!!
Do we know what is the average HB ornormal range of HB is among our population.
We follow 12-15 Mg HB range of westernfemale population
Where they have a birth rate ranging from 0to 2 per women as compared 5.4 births perwomen in our country !!!
Can the HB range be SAME !!!!! ?????
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Regulatory Requirement
Now Our regulatory authorities haveadvised for all new product
registrations--- to submit Post MarketingSurveillance (PMS) report.
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Export Potential
Central Asian states, Africa and middle east hasnumber of requirements for registration eg PSUR,Bioeqvilance & PMS.
Pakistan Medicine exports are about 60 million US $
India Medicine Exports are
570 Million US$
Clinical Trials with Generic products will makeregistration FASTER in export market.
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HCV -Pakistan
Approx.10 million HCV patients
Treated with Interferon Alfa TIW with Ribavirin for sixmonths.
Interferon alfa half life of 6 hours given TIW withweekend OFF---- Effective Drug levels notMAINTAINED to supress HCV virus.
Peg interferon once a week maintains DRUG LEVEL
through out the week. Cost difference 312000 PKR vs 60000 PKR ( 5 : 1)
A study with DAILY DOSE of standard interferonshowed a better response of 94% as compared to
78 % with Peg interferon.
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Clinicalstudies Benefits !!
Usually Peg interferon alfa 2 a180 microgramis used--- some Gastroentrologists suggest
its 90 Microgram also gives SAME result withHalf the cost.
Daily Dose standard Interferon study for OurHCV patients -- if positive can save money
and along with giving a better result for ourpatients.
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Clinicaltrials
Phase 4 studies with a generic moleculewill help to DIFFERENTIATE , More
EVIDENCE BASED Proof of QUALITY& EFFICACY confidence to theprescriber.
A Generic drug with ITS OWN clinicaldata will be EASY to Sell.
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Need
Now most doctors ask for LOCAL data
Now more doctors WANT to do Clinicalstudies.
Now More National companies haveMEDICAL departments
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Business & Science
Actually Business RULES the Science inreality.
But GOOD Strategic science if thought &implemented properly can make the Businessto INVEST in science to get more business.
National Companies should INVEST more in
local studies to Find answers for betterlogical,quality and economical treatment---allthis will definitely Increase Business---due toLocal evidence based science
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Clinical studies
Clinical studies will find out about
Hb ranges
Dose requirements
Side effects profiles Based on such information NATIONAL TREATMENT
GUIDELINES for various diseases can be made forbetter patient care.
This can be the most Ethical WINNING MedicalMarketing toolfor the national Pharma companies.
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