New Abbott Kaletra(R) (lopinavir/ritonavir) Lower-Strength Tablet for Pediatric Use Approved in Europe

Abbott Park, Illinois (ots/PRNewswire) -

- Lopinavir/ritonavir Tablet is the First and Only Co-Formulated
Protease Inhibitor Tablet Approved for Use in Children with HIV

Abbott announced today that it has received marketing
authorization from the European Commission for the new,
lower-strength tablet formulation of the company's leading HIV
protease inhibitor, Kaletra(R) (lopinavir/ritonavir). The Kaletra
tablet can be taken with or without food and does not require
refrigeration. Lopinavir/ritonavir is marketed as Aluvia(R) in
developing countries.

European approval is a critical step in Abbott's efforts to
expedite registration filings for the lower-strength tablet
formulation in countries around the world, including in developing
countries where more than 2 million of the estimated 2.3 million
children worldwide with HIV/AIDS live. In Europe, there are
approximately 4,000 children living with HIV.

Currently, the lower-strength tablet is available or approved in
53 countries in Europe, Africa, Asia, Latin America and in North
America, and is filed in an additional 11 countries. European
Commission approval is significant for many developing countries
because they require documentation of the marketing authorization to
obtain a Certificate of Pharmaceutical Product (CPP) -- often a
prerequisite for regulatory filing in developing countries. In order
to expedite review in developing countries, Abbott is working with
regulatory agencies on a country-by-country basis to negotiate
submissions before the CPP is available. Abbott intends to make the
lower-strength tablet available or approved in 155 countries around
the world, just as it has done with the adult tablet.

"The lower-strength Kaletra formulation is the first and only
co-formulated protease inhibitor tablet that can be used in children
of appropriate age, weight or body surface area, representing a
significant breakthrough for clinicians treating children with HIV in
both developed and developing countries," said Carlo Giaquinto, M.D.,
Department of Pediatrics, University of Padua, Italy, chair of PENTA
(Pediatric European Network for Treatment of AIDS).

The lower-strength Kaletra tablet offers HIV-positive children
new benefits not available with the current soft capsules or oral
solution, enhancing the dosing convenience without compromising
efficacy.

-- Simple tablet form -- the lower-strength tablet is more convenient to
administer than the oral solution.
-- Dosing is with or without food, providing patients greater
flexibility -- the current soft capsule formulation should be taken
with food.
-- No required refrigeration -- unlike the current soft capsule
formulation or oral solution, which require refrigeration, the new
Kaletra tablet can be stored at room temperature.

"HIV/AIDS continues to have a devastating effect on millions of
children around the world, especially those patients living in
resource-limited settings," said Scott Brun, M.D., divisional vice
president, infectious diseases, Global Pharmaceutical Research and
Development, Abbott. "The new lower-strength Kaletra formulation is
another example of Abbott's continued commitment to advancing
treatment and care for the HIV community."

Kaletra Lower-Strength Tablet Availability

Based on the U.S. Food and Drug Administration (FDA) approval on
Nov. 9, 2007, Abbott is shipping the lower-strength tablets to
countries that have issued approved waiver orders. On Dec. 1, 2007,
Uganda, the first country to issue such a waiver order, was one of
the first countries in the world -- and the first country in Africa
-- to receive the lower-strength tablets. According to the Joint
United Nations Programme on HIV/AIDS (UNAIDS), an estimated 110,000
Ugandan children were living with HIV in 2005. Other African
governments are now also talking to Abbott about the possibility of
waiver shipments.

The World Health Organization recommends lopinavir/ritonavir as
the preferred treatment for children who no longer respond to
first-line HIV medicine. The U.S. Department of Health and Human
Service recommends lopinavir/ritonavir for the initial treatment of
children with HIV.

Kaletra Lower-Strength Tablets

The new tablet formulation will complement Kaletra oral solution,
which has been available for pediatric use since its U.S. approval in
September 2000. For pediatric patients, lower-strength Kaletra
tablets will offer more dosing flexibility. The tablets contain 100mg
of lopinavir and 25mg of ritonavir, compared with the original tablet
strength of 200mg of lopinavir and 50mg of ritonavir, most commonly
used by adults.

The price of the lower-strength tablet will be half the price of
the original-strength tablet everywhere it is available.

Abbott's Commitment to Fighting HIV/AIDS

HIV/AIDS is a global problem that demands shared commitment and
shared responsibility. Abbott is committed to working with
governments, multilateral organizations, nongovernmental
organizations (NGOs) and patient groups to expand access to HIV
treatments around the world. Abbott has also made significant
investments in expanding manufacturing capacity to meet the growing
demand for HIV treatment in developing countries.

Abbott's lopinavir/ritonavir formulations are among the
lowest-priced protease inhibitors in the developing world. Abbott has
been providing its HIV medicines at a price of US$500 per adult
patient per year in all African and least developed countries (LDCs)
since 2002, making these medicines more affordable than any generic
copies.

Abbott and the company's philanthropic foundation Abbott Fund
have invested more than US$100 million in the fight against HIV/AIDS
in Africa and the developing world. Abbott Fund-supported programs
have served more than 700,000 children and families. In addition,
more than 250,000 patients have been tested through Abbott
Fund-supported voluntary counseling and testing programs, with
thousands being referred to treatment programs. Abbott also has
donated more than 8 million rapid HIV tests to help prevent
mother-to-child HIV transmission.

Abbott and Abbott Fund also have announced several efforts to
expand access to treatment and care for children living with
HIV/AIDS, including an additional investment of US$12 million in
grants and product donations this year.

Background on HIV in Children

According to UNAIDS, in 2007, an estimated 2.5 million children
under the age of 15 were living with HIV worldwide; a vast majority
-- almost 90 percent of children with HIV -- were living in
sub-Saharan Africa. Last year alone, an estimated 420,000 children
under age 15 were newly infected with HIV, and 330,000 children under
age 15 died of AIDS.

About Kaletra

Indication and Important Safety Information for
lopinavir/ritonavir

Indication

Kaletra is indicated for the treatment of HIV-1 infected adults
and children above the age of two years. It is used in combination
with other antiretroviral agents. Kaletra does not cure HIV infection
or AIDS and does not reduce the risk of passing HIV to others.

Kaletra Important Safety Information

Globally, prescribing information varies; refer to the individual
country product label for complete information. For U.S. safety
information visit http://www.KALETRA.com. Kaletra should not be taken
by patients who have had an allergic reaction to any of its
ingredients, including lopinavir or ritonavir, or any of the
excipients, or by patients with severe liver problems.

Taking certain medications with Kaletra could cause serious side
effects that could be life threatening. Do not take Kaletra with
astemizole, terfenadine, midazolam, triazolam, pimozide, cisapride,
ergotamine, dihydroergotamine, ergonovine, and methylergonovine,
rifampicin, amiodarone, vardenafil and products containing St. John's
Wort (Hypericum perforatum).

Medical advice and approval must be sought before Kaletra is
taken with medicines that lower blood cholesterol (e.g. lovastatinor
simvastatin), some medicines affecting the immune system (e.g.,
cyclosporin, sirolimus [rapamycin], tacrolimus), various steroids
(e.g., dexamethasone, fluticasone propionate, ethinyl oestradiol),
other protease inhibitors, certain heart medicines such as calcium
channel antagonists (e.g., felodipine, nifedipine, nicardipine), and
medicines used to correct heart rhythm (e.g., bepridil, systemic
lidocaine, quinidine), antifungals (e.g., ketoconazole,
itraconazole), morphine-like medicines (e.g., methadone)
anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital),
warfarin, certain antibiotics (i.e., rifabutin, clarithromycin),
certain antidepressants (e.g., trazodone) and voriconazole. Kaletra
may interact with erectile dysfunction agents (e.g., sildenafil or
tadalafil). Lower doses of these medicines should be prescribed in
patients taking Kaletra. Kaletra may interact with digoxin (heart
medicine); monitoring by a physician is recommended.

Taking Kaletra with certain medicines can cause increased levels
of these other medicines in the body. This could increase or prolong
their effects and/or adverse reactions, which may result in serious
or life-threatening problems. Because of this, patients must tell
their doctor about all medicines they are taking or planning to take,
including those medicines that can be bought without a prescription
and herbal preparations.

Patients using an oral contraceptive or using a patch
contraceptive to prevent pregnancy should use an additional or
alternative type of contraception since Kaletra may reduce the
effectiveness of these products.

Pregnant or nursing mothers should not take Kaletra unless
specifically directed by their doctor.

Kaletra oral solution contains 42 percent alcohol. While taking
Kaletra oral solution, patients should not take any medicines that
may cause a reaction with alcohol such as disulfiram.

It is important that Kaletra oral solution is taken with food.
Kaletra tablets may be taken with or without food.

Cases of pancreatitis have been reported in patients taking
Kaletra. Liver problems, which can be fatal, have also been reported.
Patients should tell their doctor if they have had liver disease such
as chronic hepatitis B or C as they are at increased risk for severe
and potentially fatal liver adverse events. These patients may
require blood tests for control of liver function.

Redistribution, accumulation or loss of body fat may occur in
patients receiving combination antiretroviral therapy. Patients
should contact their doctor if they notice changes in body fat.

In patients taking protease inhibitors, increased bleeding (in
patients with hemophilia type A and B) has been reported.

Combination antiretroviral therapy may cause new cases of
diabetes and high blood sugar or worsening of existing diabetes, as
well as increased fats and raised lactic acid in the blood. The
long-term risks for complications due to increases in triglycerides
and cholesterol are not known at this time. In addition, large
amounts of triglycerides have been considered a risk factor for
pancreatitis.

In some patients with advanced HIV infection and a history of
opportunistic infection, signs and symptoms of inflammation from
previous infections may occur soon after anti-HIV treatment is
started. Symptoms of infection should be reported to a doctor
immediately.

Some patients taking combination antiretroviral therapy may
develop a bone disease called osteonecrosis. Signs and symptoms are
joint stiffness, aches and pains (especially in the hip, knee and
shoulder) and difficulty in movement. These symptoms require that
patients contact their doctor.

In lopinavir/ritonavir adult clinical trials, the very commonly
reported (>1 out of 10 persons treated) and commonly reported (less
than 1 out of 10 but more than 1 out of 100 persons treated) side
effects of moderate to severe intensity were diarrhea, insomnia,
headache, nausea, vomiting, abdominal pain, abnormal stools,
dyspepsia, flatulence, gastrointestinal disorder, rash,
lipodystrophy, weakness and abnormal liver enzymes. This is not a
complete list of reported side effects.

In children two years of age and older, the safety profile is
similar to that seen in adults.

For more information about Kaletra, please consult your local
prescribing information.

Storage Conditions

Kaletra tablets do not require any special storage conditions.

Kaletra oral solution: Store in a refrigerator (2 degrees - 8
degrees C). If kept outside of the refrigerator, do not store above
25 degrees C and discard any unused contents after 42 days (6 weeks).
Avoid exposure to excessive heat.

Abbott and HIV/AIDS

Abbott has been a leader in HIV/AIDS research since the early
years of the epidemic. In 1985, the company developed the first
licensed test to detect HIV antibodies in the blood and remains a
leader in HIV diagnostics. Abbott retroviral and hepatitis tests are
used to screen more than half of the world's donated blood supply.
Abbott has developed two protease inhibitors for the treatment of
HIV.

About Abbott and Abbott Fund

Abbott (NYSE: ABT) 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 more than 68,000 people and
markets its products in more than 130 countries.

Abbott Fund is a philanthropic foundation established by Abbott
in 1951. Abbott Fund's mission is to create healthier global
communities by investing in creative ideas that promote science,
expand health care and strengthen communities worldwide.

Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com. For more information on
Abbott's HIV/AIDS programs, please visit
http://www.abbott.com/HIVAIDS and http://www.abbottglobalcare.org.

Web site: http://www.abbott.com
http://www.KALETRA.com
http://www.abbott.com/HIVAIDS
http://www.abbottglobalcare.org

ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Asia, North America and Latin America, Susan Beverly,
+1-847-935-9096, or Europe and Africa, Dirk van Eeden,
+1-847-224-1828, both of Abbott