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International Partnership for Microbicides

Introduction to Microbicides
Dr. Zeda Rosenberg, CEO

XVII International AIDS Conference


Mexico City, 1 August 2008
Presentation outline

„ WHAT are microbicides?

„ WHY do we need them?

„ HOW would microbicides work?

„ HOW are microbicides developed?

„ WHERE are microbicides being researched?

„ WHAT is a PDP?

„ Key messages

„ Q&A
The face of HIV is increasingly…
increasingly…

„ Female

„ Young

„ Married and monogamous

„ A mother

World Bank Photo


Women and men with HIV in 2007
What are microbicides?

„ Products that prevent or reduce HIV transmission


„ Not yet available — research ongoing
„ Ideally safe, effective, low cost and user-friendly

„ Could take many forms — gels, vaginal rings, tablets or


films

Gel applicator Vaginal ring


Why do we need microbicides?

„ Current prevention options are not enough:

• ABC (Abstain, Be faithful, use Condoms)


• Male circumcision (protection for men)
• Treatment of sexually transmitted infections
• Prevention of mother-to-child transmission

„ Possible new prevention options:


• Microbicides
• Oral prevention pills (PrEP)
• HIV vaccines
How HIV attacks the body

HIV virus HIV virus approaches cell

Virus attaches to cell


Virus enters cell

Virus joins with cell


and begins to replicate Human cell

New viruses form inside the cell

New virus leaves the cell…

… and goes on to infect other cells in the body


How would microbicides work?

HIV cannot approach cell

Virus cannot attach itself to cell


Virus cannot enter cell

Virus cannot replicate


inside the cell
Early generation microbicides

„ Products that non-specifically block HIV


from interacting with target cells

„ Two remain in efficacy trials

„ Partial, low or no effectiveness

„ Short-acting (used near time of sex) and


“coitally dependent”
Next generation microbicides

„ Based on successful HIV treatment drugs


— antiretrovirals (ARVs)

„ Prophylaxis — using treatment drugs for


prevention is well established (malaria, TB,
meningitis)

„ Daily or monthly use offering longer term


protection
Early & next generation microbicides

Early Generation Next Generation

• First microbicides tested, • Newer products in different stages


some still in efficacy trials of preclinical and clinical research

• Non-specific to HIV • Specific to HIV (ARV-based)

• Gel formulations • Various forms: gel, ring, film, tablet

• To be applied vaginally • Longer duration of action:


within a few hours before sex daily gels, monthly rings, etc.

• No concern about potential • ARV resistance needs to be


resistance to ARVs later investigated
How are microbicides developed?

Research & Site Regulatory Launch &


Clinical Trials
Development Development Approval Access

• Formulation • Community engagement • Safety • Clinical trials • Manufacturing


• Lab safety • Capacity building • Efficacy • Licensure • Service delivery
• Incidence studies • Acceptability • Post-licensure studies • Marketing
Partnerships with industry

Compound License Year Type/Stage Development Status

Dapivirine Tibotec 2004 NNRTI Phase I/II (vaginal gel, ring)

M167, Merck 2005 CCR5 Pre-clinical


M872, M882 blockers

BMS793 BMS 2005 gp120 binder Early pre-clinical

Tenofovir Gilead 2006 NRTI Phase I PK (CONRAD / IPM)


Phase IIB (CONRAD / CAPRISA)
Phase IIB (MTN, planned)

Maraviroc Pfizer 2008 CCR5 blocker Pre-clinical

L’644 peptide Merck 2008 gp41 binder Early pre-clinical


Intellectual property rights

„ Non-exclusive royalty-free licenses to


develop, manufacture and distribute
antiviral compounds as microbicides
in developing countries

„ Ongoing technical support from industry


• Drug synthesis
• Site evaluation
• New compounds
Clinical development process

Lab studies Human safety Expanded safety Efficacy & safety


Several years Days or weeks Weeks or months Several years

Pre-clinical Phase I Phase I / II Phase III

Tens Hundreds Thousands


Drug discovery, development
and review process
Stage 4
Stage 1 Stage 2 Stage 3 Regulatory
Drug discovery Pre-clinical Clinical trials review

First clinical trial application submitted


Phase I Phase II Phase III

Marketing application submitted


250 compounds
5 compounds 1
10,000 approved
compounds drug

6.5 years 7 years 1.5 years

Adapted from: Pharmaceutical Research and Manufacturers of America, 2006


Ethical guidelines for clinical trials

ƒ Community engagement
ƒ Monitoring social harms
ƒ Informed consent process
ƒ Risk reduction counseling
ƒ Male/female condoms
ƒ Family planning
ƒ Managing pregnancy
ƒ STI screening and treatment
ƒ Testing positive at screening
ƒ Counseling and Rx referrals
ƒ Participants who seroconvert ƒ Treatment for physical harms
ƒ Counseling and Rx referrals ƒ Services for study staff
ƒ Follow-up study protocol
ƒ Partnerships/dedicated financing ƒ Post-trial access to products
Where are microbicides being tested?

„ Belgium „ Tanzania
„ Cameroon „ Thailand
„ Dominican „ Uganda
Republic „ United Kingdom
„ Kenya „ United States
„ Malawi „ Zambia
„ Puerto Rico „ Zimbabwe
„ South Africa
Why test in developing countries?

„ Test in countries with greatest need for new HIV


prevention options
¾ Communities with high HIV incidence
¾ Risk-benefit can be determined only where
disease in question is endemic

„ Test in contexts in which they will be used


¾ Effectiveness, risk, acceptability and adverse
events must be studied in relevant populations
¾ Clinical and regulatory implications

„ Build understanding and support towards future


access
Microbicides advance global development

„ Improvement in health

„ Local capacity building

„ Gender equality

„ Millennium Development Goals


Microbicide donors

„ Belgium „ Sweden
„ Canada „ United Kingdom
„ Denmark „ USA
„ France „ European Commission
„ Germany „ World Bank
„ Ireland „ UNFPA
„ Netherlands „ Rockefeller Foundation
„ Norway „ Gates Foundation
„ South Africa
What is a PDP?

Product development partnerships are


nonprofit organizations that bridge the public
and private sectors to accelerate product
development and speed access to effective
products for the people who need them most.
Key messages
Microbicides & HIV prevention

„ Biology and culture make women especially


vulnerable to HIV

„ Today, most HIV prevention options depend


on the consent of male partners

„ Microbicides are among the most promising


products being developed for HIV prevention

„ Microbicides would give women a powerful


new way to protect their own health
Next generation microbicides

„ Since its founding, IPM has been


committed to developing “next generation,”
ARV-based microbicides

„ Next generation products are in safety and


early efficacy studies by IPM and others

„ IPM’s most advanced candidate, dapivirine,


is on track to enter Phase III clinical trials in
2010
Importance of continued research

„ Drug development is difficult and unpredictable, especially


for first-of-a-kind drugs like microbicides

„ Developing ARVs to treat HIV/AIDS took over a decade

„ Perseverance is essential if we are to


help women protect themselves against
HIV

„ When success does occur, millions will


benefit
Lessons from HIV/AIDS treatment

1981 1987 1997 2003

1983 1995 2002 2006

Three-drug Drug combinations/


First AIDS AZT therapy: HAART reducing pill burden
case reported mono-therapy
in the US approved for Brazil offers free “3 by 5” Initiative &
use universal access PEPFAR launched
to treatment
HIV virus Global Fund 26 FDA-approved
Two-drug
identified established drugs and research
therapy becomes
continues
available
For more on HIV prevention …

“Vaccines and Microbicides: Where Do


We Go from Here?”

When: Mon., 4 August, 11:00 – 13:00

Where: Session Room 1

Join senior scientists and advocacy leaders


for an in-depth and candid exploration of
HIV prevention research — where we
stand and where we’re headed.
Media inquiries

For more information about microbicides, or to interview


experts in the field or use IPM as a source, contact:

IPM’s Director of Communication,


Steve Taravella

¾ staravella@ipm-microbicides.org
¾ +1-301-312-3473 (in Mexico)
¾ +1-301-495-4188 (permanent)
Q&A

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