Dear colleagues …

Sign-on letter to Abbott Laboratories re
unavailability of Kaletra in developing countries
Miles White
Chairman and CEO
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
March 15, 2006

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.

    Abbottb'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,

Stephen Lewis, 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
Lisa 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
David 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 Josefstadt, Austria
Stephan NeuhC$user, International Research Cooperation, Federal Ministry for Education, Science and Culture, Austria
Dr. Norbert Kohrgruber (MD), Medical University of Vienna, Dept. of Dermatology, Austria
Dr. Angela Cllinger, Dermatologist/Spezialist HIV/Aids, General Hospital Linz (AKH), Austria
Dr. Harald Schopper, Head of the Detention Centre Josefstadt, Austria
Univ. Prof. Dr. Christoph Wenisch, President of the Austrian Society of Infectious Diseases, Kaiser Franz Josef Hospital, Austria
Dr. N. Vetter, Head of the Lung Dept. Otto-Wagner Hospital, Austria
Dr. Andrea 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. Alexander Aichelburg, Otto-Wagner Hospital, Austria
Dirk Pyck, Directeur, Sensoa (Dutch speaking platform of AIDS NGOs), Belgium
Professor Robert Colebunders, Medical Tropical Institute, Antwerpen, Belgium
Mr. Thierry Martin, Director, Prevention SIDA, Belgium
GESTOS - Soropositividade, ComunicaçC#o e Género, Brazil
ABIA - AssociaçC#o Brasileira Interdisciplinar de AIDS, Brazil
CONECTAS Direitos Humanos, Brazil
Grupo Pela Vidda SC#o Paulo, Brazil
DAWN Brasil, Brazil
GAPA/SC#o Paulo, 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
Daríco Abarca, Ecuadorian Coalition of PLWHA, Ecuador
Asociaciòn Atlacat, El Salvador
Pr. Eric Delaporte, UMR 145 L'Institut de recherche pour le developpement (IRD)/ Université de Montpellier, France
Pr. Laurent Mandelbrot, Hõpital Louis Mourier, France
Pr. Jean-Michel Molina, Chef de Service, Maladies Infectieuses, Hõpital Saint Louis, France
Dr. Suna Balkan, Service de Maladies Infecieuses, Hõpital Saint Louis, France
Dr. Jean-Baptiste Guiard Schmidt, Service des Maladies Infecieuses et Tropicales, Hõpital Tenon, France
Pr. Patrick Yeni, Chef de Service, Maladies Infectieuses, Hõpital 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. Catherine Seyler, ISPED, France
Dr. Christine Danel, ISPED, France
Dr. Besigin Tonwe-Gold, ISPED, France
Dr. Valériane Leroy, ISPED, France
Dr. Elise Klement, Service de Maladies Infectieuses, Hõpital
Pitié-Salpétrière, France
Eric Fleutelot, Head of International Programs, Sidaction, France
Albert Petersen, Chair of the Ecumenical Pharmaceutical Network Nairobi, Germany
GC< und Hamatologie Medizin, Innere fC Onkologie, HIV-Schwerpunktpraxis, Germany
Dr. med. Stefan Esser, Leiter der HIV-Ambulanz am Universitatsklinkum Essen, Klinki fC< Venerologie, Dermatologie>
Bernd Pastors, Managing Director and Member of the Board, German Medical Organization, Action Medeor, Germany
Dr. med. Albrecht Ulmer, Gemeinschaftspraxis, Germany
Dr. med. Andreas Carganico, Facharzt fC<> Gemeinschaftspraxis, Germany
Dr. med. Ansgar Rieke, Arzt fC< Nephrologie Medizin> Infektiologie (DGI), Immunologische Ambulanz, II. Medizinische Klinik, Klinikum Kemperhof, Koblenz, Germany
Dr. med. Bernd Buchhoz, HIV-Ambulanz der Université–klinik Mannheim, Germany
Dr. med. Christoph Mayr, Arzt, Praxis MVZ C rzteforum Seestrasse, Germany
Dr. med. Gundula Notheis, OberC$rztin und Leiterin der Immundefekt-Ambulanz, Germany
Dr. von Haunerschen Kinderspital, Germany
Dr. med. Hans JC$ger, Gemeinschaftspraxis MC<>
Dr. med. Holger Flick, DTMPH, Arzt, Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie Charité Université–medizin, Germany
Dr. med. Jan-Peter Siedentopf, Infektionsambulanz, Klinik fC Geburtsmedizin, Campus Virchow-Klinikum, Charité Universitté–klinikum, Germany
Dr. med. JC6rg GC6lz, Praxiszentrum Kaiserdamm Berlin, Germany
Dr. med. Katharina von WeizsC$cker, Infektionsambulanz, Klinik fC Geburtsmedizin, Campus Virchow-Klinikum, Charité Universitté–klinikum, Germany
Dr. Rainward Bastian, Director, German Institute for Medical Mission (DIfC M), Germany
Olaf Hirschmann, MPH, Advisor HIV/AIDS in Development Policy, Brot fC<> Welt, Diakonisches Werk der EKD, Germany
P.D. Dr. med. Keikawus Arastéh, Direktor der Klinik fC<> Infektiologie / Gastroenterologie, Vivantes Auguste-Viktoria-Klinikum, Germany
Prof. Dr. med. Gerd FC$tkenheuer, Klinik I fC<> Infektiologie Université–klinikum, Germany
Prof. Dr. med. Hartwig Klinker, Leiter des Schwerpunktes Infektiologie, Medizinische Klinik und Poliklinik II Klinikum der UniversitC$t, Germany
Prof. Dr. med. JC< Lohmeyer,> Université–klinikum, GieCen, Germany
Prof. Dr. med. Norbert Suttorp, Director, Charité-Université–medizin Berlin Department of, Infectious Diseases, Germany
Marwin Meier, Co-ordinator HIV and AIDS, World Vision Germany, Germany
Chrisoula Botsi, MD, ''Andreas Sigros'' Hospital, Greece
Hadjichristodoulou Christos,MD,PhD, Ass.Professor of Epidemiology and Infectious Diseases, Medical School of Larissa, University of Larissa, Greece
Antonios 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 Christina,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
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
Asociaciòn Nicaraguense de Personas Vivendo con VIH y SIDA, Nicaragua
Asociaciòn 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 Douglas Wilson, Department of Medicine, Edendale Hospital, University of KwaZuluNatal, South Africa
Dr Andrew Boulle, Infectious Diseases Epidemiology unit, University of Cape Town, South Africa
Dr Elma de Vries, Rural Doctors Association of South Africa (RuDASA), South Africa
Robert Acquet, Service Comptabilité, Bayer Crop Science SA Lyon, Barcelona, Spain
Jose Gatell MD.Infectious Diseases and HIV Unit.Hospital Clinic Barcelona, Vice President European HIV Society, Spain
Carles Campuzano I Canades, Member of Parliament, Spain
Jose Javier Sanchez Espinosa, Red Cross, Spain
Tenemos SIDA, Spain
GobalSIDA, Spain
A+MAS, Spain
Anesvad, Spain
Acciòn contra el SIDA, Spain
IAVI, Spain
Fundaciòn Ecologíca y desarrollo, Spain
Fundaciòn TriC!ngulo, Spain
MC!s+Madrid, Spain
RED 2002, Spain
Save the Children, Spain
World Aids Campaign, Spain
Gerhard Bürtschi , 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
Chris 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,John 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
ACCSI - Acciòn Ciudadana Contra el SIDA, Venezuela

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