Apr 12th - Increasing Access to Essential Medicines in Developing ...


Apr 12th - Increasing Access to Essential Medicines in Developing ...

Solutions to the AccessGapSonja BabovicApril 12th 2010

Types of solutions• Bridging the “Access Gap”•• The role of universitiesNew drugs to treat neglected diseases

Bridging the “access gap”- a few examples

Tiered pricing of antiretrovirals


Gilead: voluntary licensingUpdated February 11, 2010PartnershipsGilead has established partnerships with 13 Indian companies, providinga full technology transfer to enable them to produce and distributequality, low-cost generic versions of Gilead’s HIV medications in 95developing countries.These companies have extensive expertise in achieving efficiencies inmanufacturing and distributing HIV medicines in the developing world.Our partners have the freedom to establish pricing for their products,while Gilead receives a 5 percent royalty on finished product sales.Several partners have already received World Health Organizationprequalification for generic Viread and U.S. Food and DrugAdministration tentative approval through the U.S. President’sEmergency Plan for AIDS Relief (PEPFAR) program for generic Viread,generic Truvada, generic Atripla®(efavirenz, emtricitabine and tenofovir disoproxil fumarate) and othertenofovir-based fixed-dose combinations, thereby significantlyincreasing patient access to high-quality HIV treatment.http://www.gilead.com/pdf/access_fact_sheet.pdf

GSK will:GSK• Cut its prices for all drugs in the 50 least developed countries to nomore than 25% of the levels in the UK and US – and less if possible – andmake drugs more affordable in middle-income countries such as Braziland India.• Put any chemicals or processes over which it has intellectual propertyrights that are relevant to finding drugs for neglected diseases into a"patent pool", so they can be explored by other researchers.• Reinvest 20% of any profits it makes in the least developed countries inhospitals, clinics and staff.• Invite scientists from other companies, NGOs or governments to jointhe hunt for tropical disease treatments at its dedicated institute at TresCantos, Spain.Andrew Witty, CEO of GSK:“We work like crazy to come up with the next great medicine, knowingthat it's likely to get used an awful lot in developed countries, but wecould do something for developing countries. Are we working as hard onthat? I want to be able to say yes we are, and that's what this is all about –trying to make sure we are even-handed in terms of our efforts tofind solutions not just for developed but for developing countries,” hesaid.http://www.guardian.co.uk/business/2009/feb/13/glaxo-smith-kline-cheap-medicine

Clinton HIV/AIDS initiativeAccess Programs* 2.0 million people are benefiting from medicines purchased underCHAI agreements, representing nearly half of all people living with HIVand on treatment in developing countries.* 70 countries have access to CHAI's negotiated prices for ARV drugsand diagnostics, representing more than 92% of people living with HIVglobally.* CHAI has negotiated breakthrough ARV price reductions with 8suppliers on over 40 formulations and negotiated significant pricereductions with 12 suppliers for 16 HIV/AIDS diagnostic tests. CHAI'ssuccessive agreements have reduced the price of first-line treatments by50%, pediatric medicines by 90%, and second-line HIV/AIDS medicinesby a cumulative reduction of 30% in low income countries.* CHAI's first malaria price negotiations reduced the price of one ACT,an effective malaria drug, by 30% and reduced price volatility ofartmesinin, the plant extract in ACTs, by 70%.* CHAI initiated a pilot subsidy on ACTs in Tanzania which reduced theprice in targeted areas by 95% and increased uptake by approximately45% for people of all ages - 62% for children under 5.http://www.clintonfoundation.org/what-we-do/clinton-hiv-aids-initiative/what-we-ve-accomplished

UNITAID patent poolhttp://www.unitaid.eu/en/20091215237/News/UNITAID-APPROVES-PATENT-POOL.htmlAlso visit: http://www.scripnews.com/home/AIDS-patent-pool-gets-green-light-but-some-countries-could-be-left-out-185204

New drugs to treatneglected diseases

DNDi: Drugs for Neglected DiseasesinitiativeDNDi’s primary objective is to deliver 6 - 8 new treatments by 2014 for VL, HAT, Chagas disease and malariaSuccesses to date:* ASAQ, the new fixed-dose combination (FDC) of artesunate (AS) and amodiaquine (AQ), was the first drug to bemade available by DNDi in an innovative partnership with sanofi–aventis, in 2007.* ASMQ, the new co-formulation of artesunate (AS) and mefloquine (MQ) manufacturedby Farmanguinhos/Fiocruz, was developed by a worldwide public partnership coordinated by DNDi.* NECT, a simplified combination of oral nifurtimox co-administered with intravenous eflornithine, has successfullyshowed excellent efficacy and safety profiles, and is a new therapeutic option in the treatment of second-stagesleeping sickness.http://www.dndi.org/index.php

The role of universities


Drug Discovery Unit at University ofDundeeN-myristoyltransferase inhibitors as new leads to treat sleeping sicknessNature 464, 728-732 (1 April 2010) |Julie A. Frearson et al.African sleeping sickness or human African trypanosomiasis, caused by Trypanosoma brucei spp., is responsiblefor ~30,000 deaths each year. Available treatments for this disease are poor, with unacceptable efficacy andsafety profiles, particularly in the late stage of the disease when the parasite has infected the central nervoussystem. Here we report the validation of a molecular target and the discovery of associatedlead compounds with the potential to address this lack of suitable treatments. Inhibition of this target—T.brucei N-myristoyltransferase—leads to rapid killing of trypanosomes both in vitro and in vivo and curestrypanosomiasis in mice. These high-affinity inhibitors bind into the peptide substrate pocket of the enzymeand inhibit protein N-myristoylation in trypanosomes. The compounds identified have promisingpharmaceutical properties and represent an opportunity to develop oral drugs to treat this devastatingdisease. Our studies validate T. brucei N-myristoyltransferase as a promising therapeutic target for humanAfrican trypanosomiasis.

2009: Statement of Principles and StrategiesWritten by Harvard, Yale, Brown, UPenn, BU (14)Sign-ons: 16 universities and counting!

Statement of Principles and Strategies: keypoints Part 11. Efforts to develop creative and effective licensing strategies that help topromote global access to health-related technologies2. “Our intellectual property should not become a barrier to essentialhealth-related technologies needed by patients in developing countries”- Not patent in developing countries- File and abandon patents- May patent in “special circumstances” e.g. in India, China or Brazil3. In cases where patent rights are pursued, license agreements will besought to promote broad access to health-related technologies- Reserved or ‘march-in’ rights, termination of license as penalty- Tiered, subsidized, at-cost or no-cost pricing

Statement of Principles and Strategies: keypoints Part 24. Preserve institutions’ future rights to negotiate global access terms5. Further support the development of new health-related technologiesaimed at diseases that disproportionately burden individuals in the developingworld6. Apply meaningful metrics to measure success7. Maintain flexibility and creativity; share experiences from working withlicensees in implementing these principles- Compendium of best practices, tools and techniques- Educate others- Revisit principles on biennial basis

Glimmers of Hopehttp://essentialmedicine.org/glimmers-hope

Key Point• The pharmaceutical industry is a key partnerin moving forward the access to medicinesmovement

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