1. 24 November 2011 1 note

    First ever ATV/r combination pill improves treatment options for second-line

    On 18 Novermber 2011, the US Food and Drug Administration granted tentative approval for Matrix’s atazanavir sulfate and ritonavir fixed-dose combination (FDC) tablets, 300/100 mg.

    MSF has long advocated for generic manufacturers to develop a heat-stable FDC of atazanavir/ritonavir (ATV/r). This is the first such FDC to receive approval from a stringent regulatory authority or the WHO prequalification programme.

    Atazanavir – which needs to be boosted with ritonavir - is one of the two protease inhibitors drugs recommended by WHO in its 2010 ARV treatment guidelines for adults and adolescents as backbone for second-line regimens, in combination with two Nucleoside Reverse Transcriptase Inhibitors.

    The introduction of this heat-stable formulation represents a step forward for access to second-line ARVs, as it provides the first FDC alternative to heat-stable lopinavir/ritonavir (LPV/r).  It also has the added benefit of reducing the pill burden for patients – down from four pills a day for heat-stable LPV/r, to one pill a day for ATV/r.

    However, unlike first-line HIV regimens which now come as one or two pills per day, as of now no three-in-one FDC exists that covers the full second-line regimen as per WHO recommendations. 

    Matrix has communicated to MSF the price of this new tablet.  At US$ 25 per pack of 30 tablets (FCA Mumbai. Freight & Insurance charges are additional), this means a price of $307 per patient per year (0.84 per unit).

  2. 10 November 2011

    Brazilians demand greater access to crucial HIV drug

    Brazilian civil society will oppose a patent application today for the key HIV drug lopinavir/ritonavir (LPV/r), in an effort to allow access to more affordable generic versions of the medicine. The move is part of efforts to use all available public health provisions within international trade rules to increase access to the drug for people living with HIV/AIDS. The international medical humanitarian organisation Médecins Sans Frontières (MSF) welcomes this action.

    — excerpt from today’s MSF press release on Brazilian civil society’s move to oppose a patent application by Abbott on lopinavir/ritonavir in order to ensure greater access to affordable generic versions of the medicine 

    More than 40,000 people in Brazil today take LPV/r, and this number is only expected to increase. 

    (Full statement here) 

  3. 18 July 2011 3 notes

    14th Edition of Untangling the Web Launches at International AIDS Conference in Rome

    MSF launched the 14th edition of Untangling the Web at the International AIDS Conference in Rome on Sunday, 17 July 2011.

    The big news this year is that several pharmaceutical companies have abandoned HIV drug discount programmes in middle-income countries.

    From MSF’s press release:

    “While there is continued progress to reduce prices for the poorest countries, a significant number of people with HIV/AIDS live in countries that are now excluded from price reductions,” said Nathan Ford, medical director of MSF’s Campaign for Access to Affordable Medicines. 

    Tibotec/ Johnson & Johnson exclude all countries classified as ‘middle-income’ from their price reductions; Abbott excludes low-income and lower middle-income countries from discounts for one of its drugs; and ViiV (Pfizer + GlaxoSmithKline) no longer offers reduced prices to middle-income countries, even when programmes are fully funded by the Global Fund to fight AIDS, TB and Malaria or the US-government’s PEPFAR programme.

    In a reversal, Merck has now announced that it will no longer issue price discounts for 49 middle-income countries for its new drug raltegravir.  This move leaves out countries with large numbers of people living with HIV/AIDS, such as India, Indonesia, Thailand, Viet Nam, Ukraine, Colombia and Brazil.  Today, Brazil is paying $5,870 per patient per year (ppy) for just this one HIV drug; in least-developed countries, Merck charges $675 ppy for the drug, which is already four times the price of the recommended triple first-line combination (TDF/3TC/EFV).

    This development comes on the heels of a number of developing countries being excluded from last week’s agreement between drug company Gilead and the new Medicines Patent Pool, which aims to increase access to affordable ARVs by negotiating licencing that can be used by generic manufacturers. 

    Access this year’s edition of UTW online at utw.msfaccess.org

  4. 13 April 2011 1 note

    Driving a decade of change: HIV/AIDS, patents and access to medicines for all

    From Journal of the International AIDS Society:

    Driving a decade of change: HIV/AIDS, patents and access to medicines for all

    Authors: Ellen ‘t Hoen, Jonathan Berger, Alexandra Calmy and Suerie Moon

    ABSTRACT

    Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization’s Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a “treatment timebomb” awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health.

    To download and access the full report, please visit the JIA website.

  5. 5 April 2011 57 notes

    Cipla applies to Merck for a voluntary licence for raltegravir

    Pharma major Cipla has applied for a “voluntary license” for Merck’s anti-HIV drug Isentress saying the drug is exorbitantly priced and is inaccessible to needy patients in India.

    What this means is that Cipla is asking Merck to share the technical know-how for making the drug, so that Cipla can make and sell a generic version in India, and in turn pay a royalty to Merck.

    From MoneyControl.com, “Cipla Tells Merck your anti-AIDS drug too costly in India” (4 April 2011)

  6. 17 February 2011 1 note

    Medicines Patent Pool Releases Status of Negotiations with HIV Medicines Patent Holders

    Four pharmaceutical companies have stated their intent to enter into formal negotiations with the Medicines Patent Pool – but five companies that hold patents on important AIDS medicines have yet to agree to do so. [See full details here]

    “We welcome the fact that that Gilead, ViiV, Roche and Sequoia have sent a clear signal that they wish to seriously engage with the MMP,” said Michelle Childs, Director of Policy Advocacy at MSF’s Campaign for Access to Essential Medicines.  “Which begs the question: why won’t Merck, Abbott, Johnson & Johnson/Tibotec, Bristol-Myers Squibb and Boehringer Ingelheim get on board?   They have given different reasons for not doing so. Some have said that that they do not wish to do so because they want more specifics, but any questions cannot be resolved if they refuse to negotiate.  Given the strong backing that has been given to the pool, these companies and their shareholders need to consider the message their present position sends to governments, donors and treatment providers about their true willingness to support a voluntary approach. ”

    Several companies have recently entered into voluntary license agreements with generic manufacturers.  However, most agreements so far are overly restrictive in terms of which regions they cover, and leave out too many people living with HIV and do not include enough generic companies to create the level of competition needed to sufficiently drive prices down.  

    “The needs are not going away any time soon,” said Dr. von Schoen-Angerer.  “There are five million people on AIDS treatment in developing countries today but another 10 million are in urgent need and will die within the next few years without it.  We need a collective response on the part of companies and governments.”

    MORE INFORMATION

  7. 10 February 2011 5 notes

    India rejects patent for atazanavir

    In December 2010 the Indian Patent Office denied Bristol-Myers Squibb a patent for the atazanavir bisulphate because it ‘lacked inventive ingenuity’. However the company has filed other patent applications in relation to this drug which are still pending.

    Atazanavir is recommended by the World Health Organization for second-line AIDS therapy. 

    MORE INFORMATION

  8. 9 February 2011 3 notes

    New voluntary licences for rilpivirine

    Tibotec, owned by Johnson & Johnson, has agreed to licence rilpivirine, a promising new AIDS medicine, to three generic manufacturers, however geographic limitations will keep the medicine out of the hands of many patients across the developing world.

    Aspen (South Africa), Hetero (India) and Matrix (India) have received licences from Tibotec to produce rilviripine. But the benefits will not be felt in Latin America, Central Asia and most Caribbean and South East Asian countries as they are ineligible to receive generic versions of the medicine under Tibotec’s agreement.

    “While it’s encouraging to see Tibotec is thinking about access to this drug for patients in sub-Saharan Africa, it’s very unfortunate that the company has chosen to be restrictive and discriminatory by issuing licenses that look more like a franchise than actual generic competition,” said Dr. Tido von Schoen-Angerer, Executive Director of MSF’s Campaign for Access to Essential Medicines.

    MSF has written to the CEOs of Johnson & Johnson and other companies that produce AIDS medicines, asking them to put their patents in to the newly-established Medicines Patent Pool. The Patent Pool mechanism would allow generic manufacturers to produce more affordable versions and fixed-dose combinations that combine two or more medicines into one pill.

    “It is easy to make voluntary licenses work for commercial interests - the challenge is making them work for both commercial and public health needs so we can tackle the AIDS epidemic,” said von Schoen-Angerer.  “We urge Johnson & Johnson to establish better license conditions and include its patents in the Patent Pool.”

    MORE INFORMATION

  9. 6 January 2011 26 notes

    India rejects patent for AIDS drug lopinavir/ritonavir

    On 30 December 2010, the Indian Patent Office decided that the AIDS combination medicine lopinavir/ritonavir does not merit a patent.  The decision marks a major victory for public health, and keeps the door open for generic production of the drug, that health providers such as Médecins Sans Frontières (MSF) rely on to treat patients across the developing world.

    Lopinavir/ritonavir (LPV/r) is a boosted protease inhibitor and is primarily used for people on second-line AIDS therapy, when patients have become resistant to their first combination of medicines. It is also used in certain instances as first-line therapy for infants born with HIV.

    The US drug company Abbott Laboratories, which markets the medicine under the brand names Kaletra or Aluvia, applied for a patent on the combination LPV/r in India which was opposed by civil society organisations in 2006. The same year, MSF led a campaign to access LPV/r in the face of Abbott’s refusal to market or provide discounted prices on an improved version of the medicine in many developing countries.

    This latest decision by the Mumbai Patent Office means that generic manufacturers can continue to produce affordable versions of LPV/r and export them to countries where Abbott has no patent or where local patent barriers have been overcome.

    “This is a great victory for access to medicines,” said Dr. Tido von Schoen-Angerer, Executive Director of MSF’s Campaign for Access to Essential Medicines.  “Many patients rely on LPV/r as a frontline drug to keep them alive, and the drug will increasingly be important in the future, as more and more people on AIDS treatment need to shift to second-line medicines. But the company has filed other patent applications, so the fight for affordable sources of this drug is by no means over.”

    MORE INFORMATION

Web Updates

Regularly updated news feed of updates to the online version of Untangling the Web as well as related news articles.

Latest Tweets