Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients

Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients

November 13, 2007

Abbott Will Register and Make the New Lower-Strength
lopinavir/ritonavir Tablet Available in More Than 150
Countries to Support Broad Access for the More Than 2
Million Children Living with HIV Worldwide

    ABBOTT PARK, Ill., Nov. 13 /Xinhua-PRNewswire / -- 

    Abbott today announced that it has received U.S. Food
and Drug Administration (FDA) approval for a new
lower-strength tablet formulation of its leading HIV
protease inhibitor, Kaletra(R) (lopinavir/ritonavir), which
is also marketed as Aluvia(R) (lopinavir/ritonavir) in
developing countries.  The lower-strength Kaletra tablets
will be available in the U.S. this month. 

    Abbott is awaiting EMEA marketing authorization for the
Kaletra/Aluvia lower-strength tablets.  Upon EMEA marketing
authorization, Abbott intends to register this new tablet
formulation in more than 150 countries.  The soft gel
capsule formulation of LPV/r is the most widely registered
protease inhibitor in the world. The original tablet
formulation is already available in 93 countries and Abbott
is awaiting approval in an additional 45 countries for this
formulation.

    Approval of this lower-strength Kaletra tablet
represents an important step in Abbott's ongoing commitment
to the global fight against HIV because:

    --  The tablets do not require refrigeration and can be
taken with or 
        without a meal -- an important advance in
delivering HIV medicine to 
        children in developing countries. 

    --  The World Health Organization (WHO) estimates 2
million children were 
        living with HIV/AIDS in sub-Saharan Africa at the
end of 2006.

    --  The new lower-strength tablets are smaller in size
than original 
        Kaletra tablets and contain the same proven active
ingredients as 
        Abbott's Kaletra oral solution. The lower-strength
Kaletra tablet is 
        approved for children weighing 15kg or more who are
able to swallow 
        the intact tablet.

    --  The FDA approval expands available options for
using the first and 
        only co-formulated protease inhibitor tablet to
treat children with 
        HIV. 


    "HIV/AIDS continues to have a devastating impact
globally, especially among the more than two million
children living with the disease throughout the
world," said Scott Brun, M.D., divisional vice
president, infectious diseases and renal development,
Global Pharmaceutical Research and Development, Abbott. 
"Abbott developed a lower-strength tablet formulation
of Kaletra to give physicians an innovative treatment
option to help curb the impact of HIV infection in
children."  

    The price of the recently approved lower-strength
tablet will be half the price of the original tablet in the
developing world.

    About 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.  

    About 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 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
$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 Abbott Fund are investing more than $100
million in developing countries through the Abbott Global
AIDS Care programs focusing on four areas:  strengthening
health care systems; helping children affected by HIV/AIDS;
preventing mother-to-child transmission of HIV; and
expanding access to testing and treatment.  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 $12 million
in grants and product donations this year.  

    Background on HIV in Children

    According to the WHO, an estimated 2.3 million children
under the age of 15 worldwide were living with HIV/AIDS in
2006; a vast majority -- 2 million children with HIV/AIDS
-- was living in Africa.  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. The U.S.
Department of Health & Human Services (HHS) and the WHO
recommend lopinavir/ritonavir for the treatment of children
with HIV.  

    Indication

    KALETRA(R) (lopinavir/ritonavir) is a human
immunodeficiency virus-1 (HIV-1) protease inhibitor. 
KALETRA is always used in combination with other anti-HIV-1
medicines for the treatment of HIV-1 infection.  KALETRA is
a combination of two medicines, lopinavir and ritonavir. 
KALETRA is for adults and for children age 6 months and
older.

    Important Safety Information

    KALETRA does not cure HIV-1 infection or AIDS and does
not reduce the risk of passing HIV-1 to others.  

    KALETRA must not be taken by patients who have had an
allergic reaction to KALETRA or any of its ingredients. 

    Taking KALETRA with certain drugs can cause serious
problems or death.  KALETRA must not be taken with
dihydro-ergotamine, ergonovine, ergotamine, or
methylergonovines such as Cafergot(R), Migranal(R), D.H.E.
45(R), ergotrate maleate, and methergine, as well as
Halcion(R) (triazolam), Orap(R) (pimozide), Propulsid(R)
(cisapride), or Versed(R) (midazolam).  

    KALETRA must not be taken with rifampin, also known as
Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R); St.
John's wort (Hypericum perforatum); Mevacor(R)
(lovastatin), or Zocor(R) (simvastatin). 

    There are drug-drug interactions with the potential for
risk of serious or life-threatening side effects. 
Alterations in dose, increased monitoring of drug levels in
the blood, or increased observations for side effects may be
recommended when KALETRA is taken with: Lipitor(R)
(atorvastatin), Crestor(R) (rosuvastatin), Viagra(R)
(sildenafil), Cialis(R) (tadalafil), Levitra(R)
(vardenafil), oral contraceptives ("the pill") or
the contraceptive patch, Mycobutin(R) (rifabutin), inhaled
Flonase(R)  (fluticasone), metronidazole, or disulfiram.
Patients should talk with their doctor about all medicines
they are taking or planning to take, including those
without a prescription and herbal products. 

    KALETRA should not be given once-daily in combination
with Sustiva(R) (efavirenz), Viramune(R) (nevirapine),
Agenerase(R) (amprenavir), fosamprenavir, Viracept(R)
(nelfinavir), phenobarbital, phenytoin (Dilantin(R)) or
carbamazepine (Tegretol(R)).

    Patients and/or their care providers should pay special
attention to accurate administration of the KALETRA dose to
reduce the risk of accidentally giving too much or too
little medicine.

    The most commonly reported side effects of moderate
severity that are thought to be drug related are abdominal
pain, abnormal bowel movements, diarrhea, feeling
weak/tired, headache, and nausea.  Children taking KALETRA
may sometimes get a skin rash.  Other side effects may
occur.  

    Pancreatitis and liver problems, which can be fatal,
have been reported in patients receiving KALETRA.  Patients
should tell their doctor if they have nausea, vomiting, or
abdominal pain, which may be signs of pancreatitis, or if
they have or have had liver disease such as Hepatitis B or
C. 

    Some patients have had large increases in triglycerides
and cholesterol.  Changes in body fat have been seen in some
patients taking anti-HIV therapy.  The long-term health
effects of these conditions are not known at this time. 
Diabetes and high blood sugar have occurred in patients
taking protease inhibitors such as KALETRA. 

    Some patients with hemophilia have increased bleeding
with protease inhibitors.  

    The effects of KALETRA on pregnant women or their
unborn babies are not known.  Mothers taking KALETRA should
not breast-feed.

    All strengths of KALETRA tablets should be swallowed
whole and not chewed, broken, or crushed.

    KALETRA tablets should be stored at room temperature. 
Exposure of this product to high humidity outside the
pharmacy container for longer than 2 weeks is not
recommended.

    Refrigerated KALETRA oral solution remains stable until
the expiration date printed on the label.  If stored at room
temperature up to 77¡ãF (25¡ãC), KALETRA oral solution
should be used within 2 months.  

    Avoid exposure to excessive heat.  For full prescribing
information visit http://www.kaletra.com.

    Abbott and HIV

    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.


    Expanding on its scientific contributions, Abbott and
Abbott Fund have invested more than $100 million in
developing countries to improve the lives of people
affected by HIV/AIDS through programs targeting critical
areas of need, including strengthening health care systems
and supporting children affected by HIV/AIDS and advancing
HIV testing and treatment. For more information on Abbott's
HIV/AIDS programs, please visit
http://www.abbott.com/HIVAIDS and
http://www.abbottglobalcare.org.

    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, please contact:

    Abbott

     U.S. Media:

     Laureen Cassidy
     Tel:  [phone]

     Julie Herlocker
     Tel:  [phone]

     International:

     Jennifer Smoter, 
     Tel:  [phone]