Abbott Files for Registration of Innovative Formulation for the Treatment of HIV In South Africa

Abbott Files for Registration of Innovative Formulation for the Treatment of HIV In South Africa

April 04, 2006

- Abbott to Maintain Current Lopinavir/Ritonavir Pricing for New Non-Refrigerated Formulation Throughout Africa and the Least Developed Countries -

    JOHANNESBURG, South Africa, April 4 /Xinhua-PRNewswire/
-- Abbott today announced that it has filed for registration
of the new tablet formulation of its HIV medicine,
lopinavir/ritonavir, in South Africa.  The Government of
South Africa has granted fast track review of the new
tablet formulation.  This filing marks a key milestone in
Abbott's ongoing efforts to expand availability of the new
formulation for patients with HIV in developing countries.

 
    Abbott plans to maintain its current
lopinavir/ritonavir price of $500 per patient, per year in
Africa and the Least Developed Countries (LDCs) for the new
formulation.  By maintaining this price, lopinavir/ritonavir
will continue to be one of the lowest-priced protease
inhibitors (branded and generic) in Africa and the LDCs.  

    Investing in Meeting the Needs of HIV Patients in
Developing Countries

    Abbott has made a significant investment in advanced
technologies to bring the new formulation to HIV patients,
including expanding manufacturing capacity to meet the
growing demand for second-line HIV treatment when
first-line treatment has failed in developing countries,
and developing the innovative and complex Meltrex
technology for the new tablet formulation. With this novel,
breakthrough technology, the more convenient
lopinavir/ritonavir tablet formulation will allow adult
patients to take fewer pills with or without food as part
of their treatment regimen, and do not require
refrigeration -- an important advance for patients in
developing countries.  Efforts are underway to register
this new formulation in developing and developed countries
around the world.

    Abbott has taken extensive steps to make the capsule
formulations of its HIV medicines, lopinavir/ritonavir and
ritonavir, available throughout the world, including in
developing countries.  This includes the liquid
formulations of both medicines that have demonstrated
safety and efficacy in pediatric HIV treatment. All current
formulations of Abbott's HIV medicines are available in
Africa and the LDCs at $500 per patient, per year.  

    Developing New Formulations

    Abbott is applying the Meltrex technology to develop
additional new formulations of its HIV medicines to benefit
patients around the world.  Initiatives include a new
lower-dose pediatric tablet being developed with the goals
of eliminating the need for refrigeration and providing
dosing option flexibility.  Abbott also is developing a
tablet formulation of its protease inhibitor ritonavir that
does not require refrigeration.

    Delivering Results in the Fight Against HIV/AIDS
Through Philanthropy 
    Abbott and the Abbott Fund are investing $100 million
to address fundamental barriers to testing, treatment and
support services for people living with HIV in developing
countries; results to date include:

    * Pioneering a new pediatric treatment model -- The
Abbott Fund supported 
      Baylor College of Medicine in establishing a
treatment program in 
      Constanta, Romania, that reduced the death rate for
children with HIV 
      by more than 90 percent in three years. This model
program is now 
      being replicated by Baylor across Africa, providing
treatment for more 
      than 4,000 children with HIV. In partnership with
Baylor and the 
      Government of Malawi, the Abbott Fund is supporting
the opening of the 
      first pediatric treatment center in Malawi in
mid-2006.    

    * Supporting orphans and vulnerable children impacted
by HIV/AIDS -- The 
      Abbott Fund provides care and support for children
through innovative 
      model programs that address specific community needs,
including HIV 
      testing, legal assistance for women and children,
child-focused 
      counseling and support groups, and vocational
training. Since 2001 more 
      than 500,000 children and families have received
services in Burkina 
      Faso, India, Malawi, Romania and Tanzania.

    * Helping prevent mother-to-child transmission of HIV
-- The transmission 
      of HIV from mother to child has been virtually
eliminated in the U.S., 
      but remains a significant problem in developing
countries. Testing is 
      the first step toward achieving prevention, and
Abbott is donating rapid 
      HIV tests to programs for the prevention of
mother-to-child transmission 
      of HIV in Africa and the LDCs.  To date, Abbott has
provided more than 
      3.4 million free HIV tests through the program.

    * Expanding access to HIV testing -- Abbott has
provided more than 42 
      million rapid HIV tests at no profit in Africa and
the LDCs to expand 
      access to testing services.

    * Training health care workers -- Abbott has trained
more than 15,000 
      health care staff in developing countries in HIV
care, including 
      testing, counseling and treatment.  These efforts
include a partnership 
      between Baylor and the Abbott Fund to establish the
Baylor Children's 
      Clinical Centers of Excellence Network and the
International Pediatric 
      HIV/AIDS Fellowship program to train health
professionals and share best 
      practices in HIV care.

    * Strengthening health care systems -- Abbott has
partnered with the 
      Government of Tanzania to implement a nationwide
program to scale-up HIV 
      testing and treatment in Tanzania.  Key results to
date include the 
      dedication of a new outpatient center and modern
clinical laboratories 
      at Muhimbili National Hospital serving up to 1,000
patients a day, and 
      the expansion of testing and treatment services at 82
hospitals and 
      health centers across the country.

    Lopinavir/Ritonavir Safety Information

    Lopinavir/ritonavir is always used in combination with
other anti-HIV medicines to treat people with HIV
infection.  Lopinavir/ritonavir should not be taken by
patients who have had an allergic reaction to any of its
ingredients, including lopinavir or ritonavir.

    Taking certain medications with lopinavir/ritonavir
could create the potential for serious side effects that
could be life threatening.  Lopinavir/ritonavir should not
be taken with astemizole, cisapride, dihydroergotamine,
ergonovine, ergotamine, methylergonovine, midazolam,
pimozide, terfenadine or triazolam.

    In addition, lopinavir/ritonavir should not be taken
with fluticasone propionate, lovastatin, rifampin,
simvastatin, or products containing St. John's Wort
(Hypericum perforatum).  Particular caution should be used
when taking lopinavir/ritonavir with sildenafil, tadalafil,
or vardenafil.  Please consult your local prescribing
information for country specific recommendations.  Discuss
all medicines, including those without a prescription and
herbal preparations you are taking or plan to take, with
your doctor or pharmacist.

    Pancreatitis and liver problems, which can be fatal,
have been reported.  Patients should tell their doctor if
they have had liver disease such as hepatitis. In patients
taking protease inhibitors, increased bleeding (in patients
with hemophilia) and diabetes/high blood sugar have
occurred.  Changes in body fat have been seen in some
patients receiving antiretroviral therapy.  

    Some patients receiving lopinavir/ritonavir have had
large increases in triglycerides and cholesterol.  Varying
degrees of cross-resistance among protease inhibitors have
been observed.

    In lopinavir/ritonavir clinical trials, the most
commonly reported side effects of moderate-to-severe
intensity were abdominal pain, abnormal bowel movements,
diarrhea, feeling weak or tired, headache, nausea and
vomiting.  Children taking lopinavir/ritonavir may
sometimes get a skin rash. This is not a complete list of
reported side effects. Lopinavir/ritonavir oral solution
contains alcohol.

    Lopinavir/ritonavir does not cure HIV infection or AIDS
and does not reduce the risk of passing HIV to others. 

    Ritonavir Safety Information 

    Ritonavir is indicated in combination with other
antiretroviral agents for the treatment of HIV infection.

    Ritonavir should not be taken if you have had a serious
allergic reaction to ritonavir or any of its ingredients.

    Taking ritonavir with certain drugs could create
potential for serious and/or life-threatening side effects.
 Do not use ritonavir with Cafergot(R), Cordaron(R), D.H.E.
45(R), Halcion(R), Hismanal(R), Mevacor(R), Migranal(R),
Orap(R), Propulsid(R), Quinidine(R), Rythmol(R),
Seldane(R), Tambocor(TM), Vascor(R), Versed(R), Zocor(R) or
products containing St. John's Wort (Hypericum perforatum).
Discuss all medicines, including those without a
prescription and herbal preparations you are taking or plan
to take, with your doctor or pharmacist. 

    Pancreatitis and liver problems, which may cause death,
have been reported in patients receiving ritonavir. Tell
your doctor if you have or have had liver disease such as
hepatitis. In patients taking protease inhibitors,
increased bleeding (in patients with hemophilia) and
diabetes/high blood sugar have occurred. Some patients have
reported allergic reactions ranging from mild to severe.
Changes in body fat have been seen in some patients
receiving antiretroviral therapy. Some patients receiving
ritonavir have had large increases in triglycerides and
cholesterol.

    The most commonly reported side effects of moderate
severity are: feeling weak or tired, nausea, vomiting,
diarrhea, loss of appetite, abdominal pain, changes in
taste, tingling, feeling or numbness in hands or feet or
around the lips, headache, and dizziness.

    Ritonavir does not cure HIV infection or AIDS and dose
not reduce the risk of passing HIV to others.

    About Abbott

    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 60,000 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:

    Media Outside the U.S.  
     Tracy Sorrentino, 
     Abbott Laboratories
     Tel: [phone], 

    U.S. Media 
     Melissa Brotz, 
     Abbott Laboratories
     Tel: [phone] 

SOURCE  Abbott Laboratories