Abbott Agrees With World Health Organization (WHO) Director-General to Expand Access to Kaletra/Aluvia (lopinavir/ritonavir)

    Abbott Reduces Price of Kaletra/Aluvia in Low and Low-Middle Income
    Countries to $1,000

    ABBOTT PARK, Ill., April 10 /CNW/ -- Abbott (NYSE:   ABT) and World Health
Organization (WHO) Director-General, Margaret Chan, have agreed on a balanced
approach to provide Kaletra/Aluvia (lopinavir/ritonavir) capsules and tablets
to more patients in the developing world, while supporting continued long-term
biopharmaceutical research and development. In the interest of international
public health, Director-General Chan approached Abbott to discuss how to
improve affordability and access while maintaining incentives to support
developing new medicines.
    To meet the needs of countries committed to expanding HIV/AIDS treatment,
Abbott will offer the governments of more than 40 low and low-middle income
countries (as defined by World Bank criteria) and NGOs a new price of $1,000
per patient per year. This price is lower than any generic price available in
the world today for this medicine and is approximately 55 percent less than
the average current price for these countries.
    Abbott will immediately begin discussions with individual countries where
Abbott's patents are respected to maximize the number of patients that can be
provided Kaletra/Aluvia capsules and tablets at this new price.
    Abbott is taking this action in order to further increase access and
address the debate around pricing of HIV medicines: by increasing
affordability while preserving the system that enables the discovery of new
medicines. The patents of scientists and inventors must exist so that there
are incentives for sustained research and development. Without this system,
the miracle drugs the world enjoys today, including HIV medicines, would not
    Specifically, with regard to Thailand, Abbott appreciates and fully
respects the suggestion of Director-General Chan that more work needs to be
done with the government of Thailand to achieve a positive outcome. Meanwhile,
Kaletra capsules remain available in Thailand and will be eligible for the new
    Today, Kaletra capsules are registered in 118 countries, making it the
most widely registered HIV medicine. Kaletra/Aluvia tablets will be registered
in more than 150 countries at the completion of the registration process.

    About Kaletra/Aluvia

    Kaletra (lopinavir/ritonavir) is indicated for the treatment of HIV-1
infected adults and children above the age of 2 years, in combination with
other antiretroviral agents.
    Most experience with Kaletra is derived from the use of the product in
antiretroviral therapy naive patients. Data in heavily pretreated protease
inhibitor experienced patients are limited. There are limited data on salvage
therapy on patients who have failed therapy with Kaletra.
    The choice of Kaletra to treat protease inhibitor experienced HIV-1
infected patients should be based on individual viral resistance testing and
treatment history of patients. Kaletra is not recommended for use in children
below 2 years of age due to insufficient data on safety and efficacy.

    Important Safety Information

    Kaletra should not be given to patients who have had an allergic reaction
to the active substances or any of the excipients, or by patients with severe
hepatic insufficiency.
    Kaletra is contraindicated with astemizole, terfenadine, midazolam,
triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e.g., ergotamine,
dihydroergotamine, ergonovine and methylergonovine), products containing St.
John's wort (Hypericum perforatum) and vardenafil. Kaletra should not be
co-administered with lovastatin, simvastatin, rifampicin, fluticasone or other
    Co-administration of efavirenz, nevirapine, nelfinavir or amprenavir with
Kaletra tablets 400/100 mg is not recommended. If co-administration of these
products with Kaletra is clinically indicated, a dose increase of Kaletra
tablets to 600/150 mg twice daily may be considered. However, as the safety of
high doses of Kaletra has not been established, safety should be closely
monitored when Kaletra tablets 600/150 mg twice daily is administered.
    Particular caution must be used when prescribing sildenafil or tadalafil
in patients receiving Kaletra. Concomitant use of Kaletra with tadalafil or
sildenafil is expected to substantially increase PDE5 inhibitor associated
adverse reactions including hypotension, syncope, visual changes and prolonged
    Particular caution must be used when prescribing Kaletra and medicinal
products known to induce QT interval prolongation such as chlorpheniramine,
quinidine, erythromycin, or clarithromycin.
    Levels of ethinyl estradiol may decrease when estrogen-based oral
contraceptives are co-administered with Kaletra; alternative or additional
contraceptive measures are to be used.
    Please consult your local prescribing information for any additional
country specific prescribing recommendations.
    Cases of pancreatitis have been reported in patients receiving Kaletra,
including those who developed hypertriglyceridemia.
    Kaletra is contraindicated in patients with severe liver impairment.
Patients with chronic hepatitis B or C and treated with combination
antiretroviral therapy are at an increased risk for severe and potentially
fatal hepatic adverse events. Patients should be monitored, and if there is
evidence of worsening liver disease in such patients, interruption or
discontinuation of treatment should be considered. In patients receiving
protease inhibitors, increased bleeding (in patients with hemophilia), new
onset or exacerbation of diabetes mellitus and hyperglycemia have been
    Combination antiretroviral therapy has been associated with
redistribution of body fat (lipodystrophy) in HIV patients. The long-term
consequences of these events are currently unknown.
    Treatment with Kaletra has resulted in increases, sometimes marked, in
total cholesterol and triglycerides, which should be monitored before and
during therapy. Immune reactivation syndrome has been reported in HIV-
infected patients with severe immune deficiency at the time of institution of
combination antiretroviral therapy. Although the etiology is considered
multifactorial (including corticosteroid use, alcohol consumption, severe
immunosuppression, higher body mass index), cases of osteonecrosis have been
reported particularly in patients with advanced HIV-disease and/or long-term
exposure to combination antiretroviral therapy.
    At this stage of development, little information is available on the
cross-resistance of viruses selected during therapy with Kaletra.
    In Kaletra clinical trials, adverse reactions of moderate to severe
intensity with possible or probable relationship to Kaletra were diarrhea,
nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence,
gastrointestinal disorder, insomnia, headache, rash, lipodystrophy, and
asthenia. In children 2 years of age and older, the nature of the safety
profile is similar to that seen in adults.

    About Abbott

    Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs 65,000 people and markets its products in more than 130 countries.

    Abbott's news releases and other information are available on the
company's Web site at

For further information:

For further information: Melissa Brotz, office, (847) 935-3456, mobile,
(847) 772-2761; or Jennifer Smoter, office, (847) 935-8865, mobile, (847)
772-4631; or financial community, Larry Peepo, (847) 935-6722, all of Abbott
Web Site:

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