Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA

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 (NYSE: ABT) announced today that the European Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency (EMEA), has issued a positive opinion
recommending approval of a new, lower-strength tablet formulation of
the company's leading HIV protease inhibitor, Kaletra(R)
(lopinavir/ritonavir). In addition, the CHMP has adopted a positive
opinion, in coordination with the World Health Organization (WHO),
for Aluvia(R) (lopinavir/ritonavir), the tradename of the same
lower-strength tablet formulation in developing countries.

The new lower-strength formulation is suitable for pediatric use
and represents a significant breakthrough for clinicians and patients
in developing countries, where more than 2 million of the estimated
2.3 million children worldwide with HIV/AIDS live. The first and only
co-formulated protease inhibitor tablet that can be used in children,
the tablets do not require refrigeration and can be taken with or
without a meal -- an important advance in delivering HIV medicine in
developing countries.

"EMEA approval is an essential first step to registering the
tablet in Europe and most developing countries and it is welcome news
for physicians and caregivers of children with HIV," said Mark Kline,
M.D., professor of pediatrics, chief of Retrovirology, director, AIDS
International Training and Research Program, and director, Baylor-CDC
Global AIDS Technical Assistance Project, Baylor College of Medicine.
"The development of this product, which does not require
refrigeration, is not only a scientific development tailored to the
needs of patients, especially children, but also is a huge advance in
the care of patients in resource-limited settings." Kline is also
president of the Baylor International Pediatric AIDS Initiative at
Texas Children's Hospital, which has opened six pediatric centers of
excellence throughout Africa and in Romania. Together, these clinics
are providing HIV care and treatment to more than 20,000 children.

Next Steps for Making Lower-Strength Pediatric Tablets Broadly
Available

The European Commission will review the CHMP's positive opinion
for Kaletra and is expected to issue a final decision for marketing
authorization for the lower-strength Kaletra in the European Union
within the next 60-90 days.

The regulatory review processes in many developing countries
require products to receive positive opinion from the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of
the EMEA. The positive opinion is necessary for obtaining 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.

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

Based on the U.S. Food and Drug Administration (FDA) approval on
November 9, 2007, Abbott is shipping the lower-strength tablets to
countries that have issued approved waiver orders. On December 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. The Ugandan
Government's early approval of the waiver allowed Dr. Victor Musiime
of the Joint Clinical Research Centre in Kampala to write the first
prescription for the lower-strength tablet just days after the
product received marketing authorization in the United States. Other
African governments are now also talking to Abbott about the
possibility of waiver shipments. According to UNAIDS, an estimated
110,000 Ugandan children were living with HIV in 2005.

The WHO 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 approval in
September 2000 in the United States. For pediatric patients,
lower-strength Kaletra tablets will offer more dosing flexibility and
contains 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.

"Abbott has kept the needs of children living in the developing
world firmly in mind when making decisions about the development,
manufacturing and delivery of our innovative product," said Scott
Brun, M.D., divisional vice president, infectious diseases, Global
Pharmaceutical Research and Development, Abbott. "We have been
addressing the growing epidemic of HIV in children for more than a
decade and will continue to for years to come."

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 civil society to expand access to HIV/AIDS
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 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 600,000 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 and Abbott Fund have also 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.

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

Background on HIV in Children

According to the Joint United Nations Programme on HIV/AIDS
(UNAIDS), in 2006, an estimated 2.3 million children under the age of
15 were living with HIV/AIDS worldwide; a vast majority -- 2 million
children with HIV/AIDS -- was living in Africa. Last year alone, an
estimated 530,000 children were infected with HIV, and 380,000
children died of AIDS.

Based on 2004 Centers for Disease Control and Prevention (CDC)
data for 33 states, an estimated 3,336 children under the age of 13
were living with HIV/AIDS in the United States. While the number of
pediatric AIDS cases has decreased overall in the U.S., the risk
among African-American and Hispanic infants and children is of
special concern. Among U.S. children living with AIDS, 63 percent are
African-American, 21.6 percent are Hispanic, and 14.2 percent are
Caucasian.

For more information about our commitment to fighting HIV/AIDS,
please visit our Web site at http://www.abbott.com/hiv.

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 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

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. 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

ots Originaltext: Abbott Laboratories
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