Abbott Receives U.S. Food and Drug Administration Approval for New Patients



    
    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. 12 /CNW/ -- 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 77A0F (25A0C),
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 further information:

For further information: U.S. Media, Laureen Cassidy, +1-847-938-7743,
or  Julie Herlocker, +1-847-936-6116, or International, Jennifer Smoter, 
+1-847-935-8865, all of Abbott Web Site: http://www.abbott.com

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