Letter to Abbott Laboratories regarding access to heat stable LPV/r in developing countries

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Dear Colleagues,

Pasted below please find a sign-on letter addressed to Abbott Laboratories

CEO Miles White. Thanks for the support with this. Please contact me if

you would like a formatted version.

Sincerely,

Kate

Kate

U.S. Coordinator, Campaign for Access to Essential Medicines

Doctors Without Borders/Médecins Sans Frontières (MSF)

333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA

Tel: +1-212-655-3762

Cell: +917-331-9077

Fax: +1-212-679-7016

E-mail: kate.evans@...

__________________________________________________________________________

March 15, 2006

Miles White

Chairman and CEO

Abbott Laboratories

100 Abbott Park Road

Abbott Park, IL 60064

Dear Mr. White,

We are writing to you to express our concern about the lack of availability

in developing countries of the new melt extrusion (Meltrex) formulation of

lopinavir/ritonavir (LPV/r), marketed as Kaletra (200/50mg tablets).

LPV/r has been recognized as an essential medicine by the WHO and will be

included in its revised antiretroviral treatment guidelines, in which

boosted protease inhibitors represent the cornerstone of second-line

therapy. As you know, the tablet formulation of LPV/r, approved by the US

Food and Drug Administration in October 2005, has critically important

advantages for patients in developing countries: no dietary restrictions,

lower pill burden, and most importantly, storage without refrigeration.

Due to the storage requirements of the old formulation, there is the risk

that some patients in tropical climates are currently using degraded LPV/r

capsules. In short, there is an urgent need in developing countries for

access to the new heat-stable formulation of LPV/r, as no other boosted

protease inhibitors are practical to use in the hot climates of many of

these countries.

We urge Abbott to take the following actions to make this crucial

second-line option accessible in developing countries:

1. Immediately file for registration of the new LPV/r formulation in all

countries where the old formulation was registered or pending, as well as

in other developing countries.

According to the WHO/AMDS registration database published in October 2005,

the old formulation of LPV/r (133/33.3 mg soft gel capsules) is registered

in 55 countries and registration is pending in 13 others, covering 68 of

the 69 countries eligible in Abbott’s Access Program. But the new

formulation of the drug has not been registered in any country except for

the US. We urge you to immediately file for registration of the new

formulation of LPV/r (200/50mg tablets) in developing countries, so that

the old formulation can be replaced by the new one, as was done in the US.

2. Communicate the countries and the filing dates where registration of

the new formulation of LPV/r is pending and a timeline for submissions to

remaining countries.

We ask that Abbott communicate the countries and the filing dates where

registration of the new formulation of LPV/r is pending so that health

advocates in these countries can work with national drug regulatory

authorities to overcome any delays and provide a timeline for submitting

remaining registration requests.

3. Publish a price for the new formulation of LPV/r for least-developed

and middle-income countries.

Since May 2002, Abbott has been selling the old formulation of LPV/r in

Africa and Least Developed Countries for $500 per patient per year on an

FOB basis (freight, insurance, customs handling, taxes and duties paid by

purchaser). Abbott has not yet made public any price for the new

formulation of LPV/r in developing countries. We ask that Abbott establish

a price that is at least as low as the price for the old formulation in

least-developed countries.

Abbott’s Access Program for the old formulation of LPV/r excludes

middle-income countries, resulting in prices up to 12 times more than in

least-developed African countries. We urge you to make the new formulation

available at an affordable price in middle-income countries where millions

live on less than US $2 per day.

4. Develop a heat-stable formulation of RTV and make it accessible in

developing countries.

A separate, heat-stable formulation of ritonavir (RTV), marketed as Norvir,

is also needed in developing countries so that care-providers can implement

the forthcoming WHO guidelines and pair RTV with other available and

affordable, heat-stable protease-inhibitors.

5. Develop a pediatric formulation of the new formulation of LPV/r.

WHO draft pediatric guidelines recommend LPV/r for use in children if there

is cold-chain access. While this new formulation overcomes the storage

challenges presented by the old formulation, care-providers would not be

able to cut or crush tablets because the new LPV/r is a coated tablet.

Therefore, care-providers need a pediatric version of this formulation so

that they can provide adequate second-line regimens for children as well as

adults.

6. Work with countries to make the new formulation of LPV/r easily

available while registration applications are being considered.

Because the drug registration process can take months if not years to

complete, we ask that Abbott establish a reliable interim system to

distribute this new formulation to treatment programs in developing

countries while registration is pending.

Sincerely,

, United Nations Secretary General’s Special Envoy for

HIV/AIDS in Africa

Craig McClure, Executive Director, The International AIDS Society

Médecins Sans Frontières / Doctors Without Borders (MSF)

European AIDS Treatment Group

American Academy of HIV Medicine (AAHIVM), USA

AIDS Treatment Activist Coalition (ATAC), USA

The Drug Development Committee of AIDS Treatment Activist Coalition (ATAC),

USA

Elaine J. Abrams, MD, Professor of Pediatrics & Epidemiology, Director,

MTCT-Plus, International Center of AIDS Care and Treatment Programs,

Mailman School of Public Health, Columbia University, USA

Hirschhorn MD MPH, Associate Director, Office of International

Programs,

Harvard Medical School Division of AIDS, USA

Joia S. Mukherjee, MD, MPH, Medical Director, Partners In Health, USA

Hoos, MD, MPH , Director Multicountry Antiretroviral Program (MCAP)

Mailman School of Public Health, Columbia University, USA

Wafaa El-Sadr, MD, MPH, Columbia University, USA

Mark Mirochnick, MD, Associate Professor of Pediatrics, Boston University

School of Medicine, USA

Ruby Faysey, MD, MPH, Pediatric Clinical Advisor, ICAP, Columbia University

School of Public Health, USA

Gay Men’s Health Crisis (GMHC), USA

Global AIDS Alliance, USA

The Center for AIDS Information & Advocacy, USA

Treatment Action Group (TAG), USA

Student Global AIDS Campaign, USA

Health Global Access Project (GAP), USA

Gottfried Mernyi, Managing Director, Protestant Association for World

Mission, Austria

Sonja Hauser, Assoc. AIDS Life, Production, Austria

Anton Mair, Head of Dept. for Evaluation, Development Policy and

Strategies, Federal Ministry of Foreign Affairs, Austria

Birgit Habermann, Coordinating Committee for Development Issues (KEF) at

the Academy of Sciences, Austria

Dr. Florian Breitenecker, General Practioner, Detention Centre fstadt,

Austria

Stephan Neuhäuser, International Research ation, Federal Ministry for

Education, Science and Culture, Austria

Dr. Norbert Kohrgruber (MD), Medical University of Vienna, Dept. of

Dermatology, Austria

Dr. Öllinger, Dermatologist/Spezialist HIV/Aids, General Hospital

Linz (AKH), Austria

Dr. Harald Schopper, Head of the Detention Centre fstadt, Austria

Univ. Prof. Dr. Christoph Wenisch, President of the Austrian Society of

Infectious Diseases, Kaiser Franz f Hospital, Austria

Dr. N. Vetter, Head of the Lung Dept. Otto-Wagner Hospital, Austria

Dr. Steuer, Otto-Wagner Hospital, Austria

Dr. Brigitte Schmied, Otto-Wagner Hospital, Austria

Dr. Wolfgang Steflitsch, Otto-Wagner Hospital, Austria

Dr. Heinrich Haber, Otto-Wagner Hospital, Austria

Dr. Manfred Gartner, Otto-Wagner Hospital, Austria

Dr. Gunvor Koitz, Otto-Wagner Hospital, Austria

Dr. Herbert Keller, Otto-Wagner Hospital, Austria

Dr. Wolfgang Scholz, Otto-Wagner Hospital, Austria

Dr. Aichelburg, Otto-Wagner Hospital, Austria

Dirk Pyck, Directeur, Sensoa (Dutch speaking platform of AIDS NGOs),

Belgium

Professor Colebunders, Medical Tropical Institute, Antwerpen,

Belgium

Mr. Thierry , Director, Prevention SIDA, Belgium

GESTOS - Soropositividade, Comunicação e Gênero, Brazil

ABIA - Associação Brasileira Interdisciplinar de AIDS, Brazil

CONECTAS Direitos Humanos, Brazil

Grupo Pela Vidda São o, Brazil

DAWN Brasil, Brazil

GAPA/São o, Brazil

LACCASO - Consejo Latinoamericano y del Caribe de ONGs con Servicio en

VIH/SIDA, Brazil

Canadian HIV/AIDS Legal Network, Canada

Interagency Coalition on AIDS and Development, Canada

Canadian Harm Reduction Network, Canada

Yiming Shao, M.D., Ph.D., Chief Expert on AIDS, Chinese Center for Disease

Control and Prevention (China CDC), National Center for AIDS/STD Control

and Prevention (NCAIDS), China CDC, Director, Division of Research on

Virology and Immunology, NCAIDS, Chairman, Committee on Virology,

Chinese Society for Microbiology, China

Odilon Couzin, Executive Director, China AIDS Info, China

Nina Friss-Moleer, MD, PhD, Clinical Research Associate, Copenhaged HIV

Programme, Hvidovre University Hospital, Denmark

Darío Abarca, Ecuadorian Coalition of PLWHA, Ecuador

Asociación Atlacat, El Salvador

Pr. Delaporte, UMR 145 L'Institut de recherche pour le developpement

(IRD)/ Université de Montpellier, France

Pr. t Mandelbrot, Hôpital Louis Mourier, France

Pr. Jean-Michel Molina, Chef de Service, Maladies Infectieuses, Hôpital

Saint Louis, France

Dr. Suna Balkan, Service de Maladies Infecieuses, Hôpital Saint Louis,

France

Dr. Jean-Baptiste Guiard Schmidt, Service des Maladies Infecieuses et

Tropicales, Hôpital Tenon, France

Pr. Yeni, Chef de Service, Maladies Infectieuses, Hôpital Bichat,

France

Dr. François Bourdillon, Président de la Société de Santé Publique, France

Pr. François Dabis, Unité INSERM 593, Institut de Santé Publique,

Epidémiologie et Développement (ISPED), France

Dr. Xavier Anglare, ISPED, France

Dr. Seyler, ISPED, France

Dr. Danel, ISPED, France

Dr. Besigin Tonwe-Gold, ISPED, France

Dr. Valériane Leroy, ISPED, France

Dr. Elise Klement, Service de Maladies Infectieuses, Hôpital

Pitié-Salpêtrière, France

Fleutelot, Head of International Programs, Sidaction, France

Albert sen, Chair of the Ecumenical Pharmaceutical Network Nairobi,

Germany

Günther Schmutz, Arzt für Innere Medizin, Hamatologie und Internistische

Onkologie, HIV-Schwerpunktpraxis, Germany

Dr. med. Stefan Esser, Leiter der HIV-Ambulanz am Universitatsklinkum

Essen, Klinki für Dermatologie und Venerologie, Germany

Bernd Pastors, Managing Director and Member of the Board, German Medical

Organization, Action Medeor, Germany

Dr. med. Albrecht Ulmer, Gemeinschaftspraxis, Germany

Dr. med. s Carganico, Facharzt für Allgemeinmedizin,

Gemeinschaftspraxis, Germany

Dr. med. Ansgar Rieke, Arzt für Innere Medizin / Nephrologie /

Infektiologie (DGI), Immunologische Ambulanz, II. Medizinische Klinik,

Klinikum Kemperhof, Koblenz, Germany

Dr. med. Bernd Buchhoz, HIV-Ambulanz der Universitätsklinik Mannheim,

Germany

Dr. med. Christoph Mayr, Arzt, Praxis MVZ Ärzteforum Seestrasse, Germany

Dr. med. Gundula Notheis, Oberärztin und Leiterin der Immundefekt-Ambulanz,

Germany

Dr. von Haunerschen Kinderspital, Germany

Dr. med. Hans Jäger, Gemeinschaftspraxis München, Germany

Dr. med. Holger Flick, DTMPH, Arzt, Medizinische Klinik mit Schwerpunkt

Infektiologie und Pneumologie Charité Universitätsmedizin, Germany

Dr. med. Jan- Siedentopf, Infektionsambulanz, Klinik für

Geburtsmedizin, Campus Virchow-Klinikum, Charité – Universitätsklinikum,

Germany

Dr. med. Jörg Gölz, Praxiszentrum Kaiserdamm Berlin, Germany

Dr. med. Katharina von Weizsäcker, Infektionsambulanz, Klinik für

Geburtsmedizin, Campus Virchow-Klinikum, Charité – Universitätsklinikum,

Germany

Dr. Rainward Bastian, Director, German Institute for Medical Mission

(DIfÄM), Germany

Olaf Hirschmann, MPH, Advisor HIV/AIDS in Development Policy, Brot für die

Welt, Diakonisches Werk der EKD, Germany

P.D. Dr. med. Keikawus Arastéh, Direktor der Klinik für Innere Medizin

Infektiologie / Gastroenterologie, Vivantes Auguste-Viktoria-Klinikum,

Germany

Prof. Dr. med. Gerd Fätkenheuer, Klinik I für Innere Medizin, Klinische

Infektiologie Universitätsklinikum, Germany

Prof. Dr. med. Hartwig Klinker, Leiter des Schwerpunktes Infektiologie,

Medizinische Klinik und Poliklinik II Klinikum der Universität, Germany

Prof. Dr. med. Jürgen Lohmeyer, Infektiologie-Ambulanz

Universitätsklinikum, Gießen, Germany

Prof. Dr. med. Norbert Suttorp, Director, Charité-Universitätsmedizin

Berlin Department of, Infectious Diseases, Germany

Marwin Meier, Co-ordinator HIV and AIDS, World Vision Germany, Germany

Chrisoula Botsi, MD, ''s Sigros'' Hospital, Greece

Hadjichristodoulou Christos,MD,PhD, Ass.Professor of Epidemiology and

Infectious Diseases, Medical School of Larissa, University of Larissa,

Greece

s Vasiloyiannakopoulos ,MD,PhD, Head of 1st Infectious Diseases

Department, ''Erricos Dunant'' Hospital, Vice President of the Hellenic

Association of Tropical,Geographical and Travelling Medicine, Greece

Gatsiou Hariklea ,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Koutsouri Natassa,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Kirpoglou Panagiotis,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Amanatidou Konstantina,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Rapti Rena ,MD, Internal Medicine, ''Erricos Dunant'' Hospital, Greece

Dimou Evangelini,MD, Internal Medicine, ''Erricos Dunant'' Hospital, Greece

Kanelopoulos Petros,MD,PhD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Vassilopoulou Adamantia,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Palamarou ,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Sevastianos Vassilios,MD, Internal Medicine, ''Erricos Dunant'' Hospital,

Greece

Peros Ioannis, MD,PhD, Dermatologist, ''Erricos Dunant'' Hospital, Greece

Hellenic Association of Tropical,Geographical and Travelling Medicine,

Greece

ACT UP Hellas, Greece

Greek Committee of Feeding Minds,Fighting Hunger, Greece

Igisipolis,Club for Dialogue and Activism, Greece

Hellenic Branch of Feminist net, Greece

Antigoni: European Watch Against Racism and Xenophobia, Greece

Albert Adalsteinsson, HIV+ Group Iceland, Iceland

Italian League for Fighting AIDS (LILA), Italy

Persia+, Iran

Gideaon Hirsh, MD, Executive Director, Israel AIDS Task Force, Israel

Aleksandrs Molokovskis, Board Chair, Association HIV. LV, Latvia

Marcel van Soest, Executive Director, World AIDS Campaign, The Netherlands

Sjoera Dikkers,Director, Stop AIDS Now!, The Netherlands

Mauro Guarinieri, Global Network of People living with HIV/AIDS (GNP+), The

Netherlands

Asociación Nicaraguense de Personas Vivendo con VIH y SIDA, Nicaragua

Asociación Lazos de Vida – Iquitos, Peru

Sipho Mthathi, General Secretary, Treatment Action Campaign, South Africa

Prof. Andy Gray, Centre for the AIDS Programme of Research in South Africa

(CAPRISA), South Africa

Dr , Department of Medicine, Edendale Hospital, University of

KwaZuluNatal, South Africa

Dr Boulle, Infectious Diseases Epidemiology unit, University of Cape

Town, South Africa

Dr Elma de Vries, Rural Doctors Association of South Africa (RuDASA), South

Africa

Acquet, Service Comptabilité, Bayer Crop Science SA Lyon, Barcelona,

Spain

Gatell MD.Infectious Diseases and HIV Unit.Hospital Clinic Barcelona,

Vice President European HIV Society, Spain

Carles Campuzano I Canades, Member of Parliament, Spain

Espinosa, Red Cross, Spain

Tenemos SIDA, Spain

GobalSIDA, Spain

A+MAS, Spain

Anesvad, Spain

Acción contra el SIDA, Spain

IAVI, Spain

Fundación Ecología y desarrollo, Spain

Fundación Triángulo, Spain

Más+Madrid, Spain

RED 2002, Spain

Save the Children, Spain

World Aids Campaign, Spain

Gerhard Bärtschi , CEO TearFund Switzerland, Switzerland

Praphan Phanuphak MD, Professor of Medicine, Department of Medicine,

Faculty of Medicine, Chulalongkorn University; and Deputy Director of

HIV Netherlands Australia Thailand, Thai Red Cross AIDS Research Centre,

Thailand

Kiat Ruxrungtham, M.D., Associate Professor of Medicine, Head, Division of

Allergy and Clinical Immunology, Department of Medicine, Faculty of

Medicine, Chulalongkorn University; andDeputy Director of HIV

Netherlands Australia Thailand, Thai Red Cross AIDS Research Centre,

Thailand

Jintanat Ananworanich MD, Chief, South East Asia Research with Hawaii

(SEARCH) Consultant, The HIV Netherlands, Australia, Thailand Research

Collaboration (HIV-NAT), Thailand

Duncombe MD, Senior Staff Physician, The HIV Netherlands, Australia,

Thailand Research Collaboration (HIV-NAT), Thailand

Kulkanya Chokephaibulkit MD, Senior Pediatrician, Department of

Paediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University,

Thailand

Ploenchan Chetchotisakd MD, Professor of Medicine, Department of Medicine,

Faculty of Medicine, Khon Kaen University, Thailand

Pope Kosalaraksa, MD, Associate Professor of Paediatrics, Department of

Paediatrics, Faculty of Medicine, Khon Kaen University, Thailand

Pranee Moungnoi MD, Consultant Psychiatrist, Department of Child and

Adolescent Psychiatry, Institute of Child Health, Thailand

Manop Srisuphanthavorn MD, Chief Medical Officer, Bangkwang Central Prison,

Thailand

Witaya Petdachai MD, Hospital Deputy Director and Head of Paediatrics,

Phrachomklao Hospital, Thailand

Chureeratna Bowon MD, Senior Physician, Chonburi Regional Hospital,

Thailand

Jon Ungphakorn, Senator and member of Public Health Committee, The Senate,

Parliament House, Thailand

Sureerat Thimakkra, Representative, National Economic and Social Advisory

Council, Thailand

Vithaya Kulsomboon PhD, MPHM, Chair of Social Pharmacy Department ,

Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand

Niyada Kiatying-Angsulee, Ph.D, Faculty of Pharmaceutical Sciences,

Chulalongkorn University, Thailand

Jiraporn Limpananont, Faculty of Pharmaceutical Sciences, Chulalongkorn

University, Thailand

Sumlee Jaidee, Faculty of Pharmaceutical Sciences, Chulalongkorn

University, Thailand

Kamon Uppakaew, Chairman, Thai Network for People With HIV/AIDS, Thailand

Nimit Tienudom, Director, AIDS Access Foundation, Thailand

Paisan Suwannawong, Director, Thai AIDS Treatment Action Group (TTAG),

Thailand

Karyn Kaplan, Director, Policy and Development, Thai AIDS Treatment Action

Group (TTAG), Thailand

Christian Aid, United Kingdom

International Planned Parenthood Federation, United Kingdom

DHIVERSE, United Kingdom

The UWESO UK Trust (Uganda Women’s Effort to Save Orphans), United Kingdom

National AIDS Trust, United Kingdom

International HIV/AIDS Alliance, United Kingdom

UK Coalition of People Living with HIV and AIDS, United Kingdom

Andria Efthimiou, Mordaunt Trust,C/O Drugscope, United Kingdom

Dr. Ed Wilkins, Specialist in HIV/AIDS and WHO Consultant, North Manchester

Hospital, United Kingdom

Fiona Pettitt, International Community of Women living with HIV/AIDS (ICW),

London, United Kingdom

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