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

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

April 10, 2007

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


    ABBOTT PARK, Ill., April 10 /Xinhua-PRNewswire/ --
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 exist.

    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 price.

    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
glucocorticoids.
 
    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 erection. 

    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 reported.  

    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
http://www.abbott.com . 






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