meeting with commission on intellectual property rights ... · eliminate kala azar 2010 eliminate...

Indian Council of Medical Research

Meeting withCommission on Intellectual Property Rights, Innovation and Public Health

Prof N K GangulyDirector General

Indian Council of Medical ResearchNew Delhi, India


The ‘India Advantage’

150

350

15 20 40

400

050

100150200250300350400450

IND Clinical trials Discovering singledrug molecule and

further dev

US

$ m

illio

n

Global India


Cost savings by stage in India

70%45%40%

290260250

Drug Discoveryand Pre-Clinical

Clinical Trials Others

R&D spend/NDA in USD million

TOTAL USD 800 Million

SAVING USD 400 Million


Drugs Patents Filed in IPO1995-2001

433 465

8641089

1550

1015

1729

0200400600800

100012001400160018002000

1995 1996 1997 1998 1999 2000 2001

No.

of p

aten

ts fi

led

Annual Report, Deptt S&T, Min S&T, Govt of India, 2002-03


Drugs in Pipe-line

2853 31023278

5387

0

1000

2000

3000

4000

5000

6000

No.

of d

rugs

1996 1997 1998 2002

>250 clinical trials in progress, 2003


“India promises to become a world center for testing new medicines”

The Economist, London, 29th January 2000

“India can capture approx $1.0 billion worth of global clinical research spending by 2010”

“India can capture approx $1.0 billion worth of global clinical research spending by 2010”

McKinsey 2002

“Today India is identified as a major resource center for conducting clinical trials and data management services” -

Applied Clinical Trials, February 2003’


Indian Industries Engaged in New Drug Discovery

Ranbaxy (Malaria)Dr. Reddy’s Research FoundationLupin (TB)Astra Zeneca (TB)Zydus CadillaWochardtOrchidGlenmark


Goals to be achieved by 2000-2015

2010Reduce IMR to 30/100 and MMR to 100/lakh

2010Reduce Mortality by 50% on account of TB, Malaria and other vector and water borne diseases

2007Achieve Zero level growth of HIV/AIDS2015Eliminate Lymphatic Filariasis2010Eliminate Kala Azar2005Eliminate Leprosy2005Eradicate Polio and Yaws


HIV/AIDSVaccines

Division of Epidemiology and Communicable Diseases

Role of Partners in HIV Vaccine Development

HIV/AIDSVaccine

IAVIMin Health & F W

ICMR

Design, develop and evaluate candidate vaccines appropriate for India

Capacity building, advocacy, training for vaccine trials

Transfer of technology for manufacture of vaccine in India

Facilitate permissions and permitsHarmonization of goals

Selection of Indian manufacturer

Select appropriate HIV strainProvide technical expertise

Collaborate in pre-clinical trials Cohort developmentCommunity preparednessConduct clinical trials

NACO


Objective

Participate in development of one or more AIDS vaccine programmes aimed at developing safe and effective AIDS vaccine(s) suitable for IndiaForesaw IPR issues and that of access and equityStarted with MVA based vaccine


Types of agreements

Overall project agreement between ICMR (GOI) and IAVIPatent and technology transfer agreement between ICMR and IAVIIPR and confidentiality agreement between ICMR and Therion Biologics


Patent and IP Decisions

All new IP generated will be jointly held by IAVI and ICMRGOI shall have exclusive right to use all patent and other new IP rights to inventions arising out of the program in India and neighboring (SAARC) countries


Patent and IP Decisions

ICMR grants non-excusive, world-wide, royalty-free, sub-licensable license to all new patent and other IP arising out of the project to permit IAVI or third parties selected by IAVI to make, use, sell offer for sale and import HIV/AIDS vaccine in countries other than those indicated in the agreement (to the extent ICMR has the right) to permit the use of the same


Key lessons learnt

That only through strategic public-private partnership ventures as this can we succeed in providing effective and affordable vaccines to the peoplePrivate sector’s interests need to consideredRecognition of the crucial role of international NGOs like IAVI that can play the role of honest broker which is vital for the success of such projects


Value addition to MVA

Indian scientist worked with US biotech firm TherionCompleted three constructs in MVA expression vectorsModified the MVA vector to accept 6 genes of India HIV strain C strainProto-type vaccine developed, undergoing pre-clinical toxicity studies


Track-II

Simultaneously continued to scan HIV vaccine development around worldHave had top-level science reviews in India in which national experts met international researchers and evaluated other components


Short-listed vaccines

VectorsAdeno Associated VirusAdeno 5Semliki Forest Virus


HIV/AIDSMicrobicides

Trends in Microbicide Research and Development, 1996-2003


Number of Microbicides under trial worldwide

Over 60 candidate Microbicide leads in the world20 tested in Phase I clinical trails3 in Phase II trails4 in Phase III effectiveness studies 6 Products shortly undergoing Phase III testing


Number of Microbicides trials in India

Phase I studies on Buffer Gel, Pro 2000/5, Cellulose Sulphate

International collaboration with NIH, CONRAD and other agencies.Proposed Phase II studies with

Pro 2000/5, Buffer Gel and Polystyriene Sulphate (PSS)


Indigenous Microbicides trials on Praneem Polyherbal

Patented in IndiaPhase I (safety) studies completed at NARIPhase II studies therapeutic against common RTIs completed through HRRCs.


Agreement with Conrad

Signed in 2004Major components

Drug discovery and formulationPre clinical screeningPreparation of clinical sites to conduct Microbicide researchProvide opportunity for testing in India microbicides developed elsewhere; and tested Indian products elsewhere


Leishmaniasis


Drugs for Visceral Leishmaniasis

Problems with existing drugsHigh costDifficulty in administeringDrug unresponsivenessToxicity


First effective oral remedy against VLSide-effects negligiblePhase-III success rates: 98%Simple chemical structureCan be produced in large quantities easilyEconomicalCan be stored indefinitely at 0-40 deg CCan control epidemic

Miltefosine

Miltefosine


Cure rate of VL after MILTEFOSINE in Relation to Prior Therapy

MILTEFOSINE - equally effective in newly diagnosed VL and those unresponsive to prior standard therapy

Final parasitological cure (ITT) missing/ n.a. no yes all

Treatment / Status of VL n % n % n % n

newly diagnosed 8 2.1 21 5.6 349 92.3 378Miltefosine previously treated 2 1.0 8 2.7 199 95.2 209

Miltefosine all patients 10 1.7 29 4.9 548 93.4 587newly diagnosed 1 1.4 0 0 70 98.6 71Ampho B previously treated 2 7.1 0 0 26 92.9 28

all patients 13 1.9 29 4.2 644 93.9 686

Integrated Analysis for VL


Going GlobalOutcome

Tackled IPR issuesStrengthened Public Private Partnership Led to the formulation of elimination programme by the GoI; but not inducted in ProgrammeGave a boost to development and evaluation of other anti-leishmaniasis drugs e.g. ParamomycinImproving regional access to the drug by including elimination of leishmaniasis for discussion during Ministers’ meeting at Regional ACHR meetingHas potentials for making global impact in countries which have leishmaniasis-HIV co-infectionNegotiating with other funding agencies (Bill & Melinda Gates)


Acute Respiratory Infections


Causes of 1.5 million vaccineCauses of 1.5 million vaccine--preventable preventable deaths among children < 5 years, 2001deaths among children < 5 years, 2001

Diphtheria0.3%

Measles36.6%

Tetanus13.3%

Pertussis18.8%

Hepatitis B0.2%

Yellow fever1.0%

Hib29.8%

Poliomyelitis0.0%

Source: WHO estimatesSource: WHO estimates


Current vaccine is excellent!

Over 40 years since it was licensedExcellent safety recordProved effectiveness when recommended strategies are implementedGood stability before reconstitutionLow cost

Approx US$ 0.26 (vaccine and safety equipment)


Why do we need a Why do we need a new delivery system ?new delivery system ?

EASIER ADMINISTRATIONEASIER ADMINISTRATIONTo facilitate the administration, thus reducing the challenges of reaching every child

SAFETY CONCERNSSAFETY CONCERNSTo further address issues related to safe administration and reduce the burden of ensuring safe disposal of used sharps

SUPPLY AND POTENTIAL COST SAVINGSSUPPLY AND POTENTIAL COST SAVINGSTo help ensure sufficient vaccine supply and benefit from potential reductions in the cost per child vaccinated

Demand and availability of MCV to UNICEF, 1995-2003

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100

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300

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1995 1996 1997 1998 1999 2000 2001 2002 2003

Mill

ion

dose

s

Availability

Demand


no serious AEFIs, fewer than SC route

induced >80% response among infants < 9 months of age86-100% response in studies (1961-2002) among > 9 months & school-aged childrengood response with rubella vaccinegood response with rubella vaccine

lower attack rate (outbreak Mexico 1988-90):- immunized with aerosol (0.8%)(0.8%)- immunized with s-c (14%)(14%)- unvaccinated group (26%)(26%)

Measles aerosol immunizationMeasles aerosol immunization

SAFESAFE

IMMUNOGENICIMMUNOGENIC

EFFECTIVEEFFECTIVE


Ultrasonic Ultrasonic nebulizersnebulizersCDC-Creare

Nasal spray systemsNasal spray systems

Current optionsCurrent options

Jet Jet nebulizersnebulizers

Mexico-INSP


Investigational New Drugs


Investigational New Drugs

2002-0413 compounds screened

Antimicrobial agents: 3Migraine: 1Anti-hyperglycaemic agents: 2Urinary system 2Psoriasis 1Anti-ulcer drug 1Anti-histaminic agent 1Others 2


Facilitating Clinical Trials

Currently available preparations for clot management: streptokinase, urokinase, tissue plasminogen activator, anistreplase, reteplaseThrombinase acts via different pathway; directly acts on fibrin without involving plasminogenFaster dissolution of blood clot and restoration of blood flowPatented in US and India

meeting with commission on intellectual property rights ... · eliminate kala azar 2010 eliminate...

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