Abbott Study Shows Investigational Heat-Stable Norvir(R) Tablet Provides Similar Drug Levels to Current Norvir Capsule

Mexico City (ots/PRNewswire) -

- Pivotal Study of Norvir Tablet Bioavailability Will Form the
Basis of Request for Priority Regulatory Review

Abbott (NYSE: ABT) presented pivotal data at the XVII
International AIDS Conference (AIDS 2008) in Mexico City today
showing that its investigational Norvir(R) (ritonavir) tablet and the
current soft-gelatin capsule provide similar levels of drug in the
blood.

The heat-stable Norvir tablet will not require refrigeration,
making it more convenient for patients to use, particularly in
developing countries where the majority of people with HIV live.

"The heat-stable formulation of ritonavir may help to further
expand protease inhibitor-based HAART (highly active antiretroviral
therapy) in regions where the need for refrigeration of HIV medicines
is a major barrier to treatment and care," said Pedro Cahn, M.D.,
Ph.D., president, International AIDS Society.

The study compared the bioavailability of the 100mg ritonavir
tablet to that of a 100mg soft-gelatin capsule under non-fasting
conditions. The ritonavir tablet demonstrated similar bioavailability
to the current soft-gelatin capsule, and was generally well
tolerated. In this study performed in 93 healthy adult volunteers,
the safety profiles of the two formulations were similar, with no
serious adverse events reported.

Several formulations were evaluated, and the final formulation
evaluated in the bioavailability study is the product of significant
testing and formulation work. The data presented are the basis of
upcoming regulatory submissions.

Abbott has confirmed its intention to submit registration
applications for the tablet and request priority review by U.S. and
EU authorities before the end of the year.

Abbott intends to register the new Norvir tablet as broadly
worldwide as lopinavir/ritonavir, the most widely registered PI
worldwide, according to the World Health Organization. The
lopinavir/ritonavir tablet is approved for sale, available (in
countries where no regulatory approval is needed), or has been
submitted for registration in 157 countries around the world.

The Norvir tablet was developed using the Meltrex(R) technology,
which was also used in the development of Abbott's Kaletra(R)
tablets, which combine ritonavir and lopinavir. However, ritonavir on
its own required a different formulation to ensure that the tablets
remain stable over time and that the body can absorb the drug.

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 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 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 eight million rapid HIV tests to help prevent
mother-to-child HIV transmission.

Abbott and Abbott Fund 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.

For more information about Abbott's commitment to fighting
HIV/AIDS, please visit http://www.abbott.com/hiv.

About Norvir

Indication

NORVIR (ritonavir) is a class of medicines called HIV protease
(PRO-tee-ase) inhibitors. NORVIR is used in combination with other
anti-HIV medicines to treat people with human immunodeficiency virus
(HIV) infection. NORVIR is for adults and for children age one month
and older.

Important Safety Information

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

NORVIR must not be taken in patients who have had a serious
allergic reaction to NORVIR or any of its ingredients.

Taking NORVIR with certain medicines can cause serious or
life-threatening problems such as irregular heartbeat, breathing
difficulties or excessive sleepiness. Norvir must not be taken with
Cordarone(R) (amiodarone); ergotamine, ergonovine, methylergonovine,
and dihydroergotamines such as Cafergot(R); Migranal(R); D.H.E. 45(R)
and others; Halcion(R) (triazolam); Hismanal(R) (astemizole); Orap(R)
(pimozide); Propulsid(R) (cisapride); Quinidine(R), also known as
Quinaglute(R); Cardioquin(R); Quinidex(R); Rythmol(R) (propafenone);
Seldane(R) (terfenadine); Tambocor(R); (flecainide); Uroxatral(R)
(alfuzosin hydrochloride); Vascor(R) (bepridil); Versed(R)
(midazolam); and Vfend(R) (voriconazole).

NORVIR must not be taken with 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 NORVIR 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), rifampin, also known as Rimactane(R), Rifadin(R),
Rifater(R) or Rifamate(R); inhaled Flonase(R) (fluticasone),
metronidazole or disulfiram.

Rifampin and saquinavir should not be taken together with NORVIR.
Patients should tell their doctor if they are taking rifampin and
saquinavir.

The above lists of medicines are not complete. Patients should
discuss all medicines, including those without a prescription and
herbal preparations they are taking or plan to take, with their
doctor or pharmacist.

The most commonly reported side effects 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. This is not a complete list
of reported side effects.

Pancreatitis and liver problems, which can be fatal, have been
reported in patients receiving NORVIR. 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 NORVIR.

Some patients with hemophilia have increased bleeding with
protease inhibitors.

The effects of NORVIR on pregnant women or to their unborn babies
are not known. Mothers taking NORVIR should not breastfeed.

Refrigeration of NORVIR soft gelatin capsules by the patient is
recommended, but not required if used within 30 days and stored below
77 degrees F (25 degrees C). Avoid exposing NORVIR soft gelatin
capsules to excessive heat or cold. Store in the original container.

Store NORVIR oral solution at room temperature. Do not
refrigerate NORVIR oral solution. Avoid exposing NORVIR oral solution
to excessive heat or cold. Store in the original container.

About Kaletra

Indication

KALETRA (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 six 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 dihydroergotamine, 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,
Dilantin(R) (phenytoin) or Tegretol(R) (carbamazepine).

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 two 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 degrees F (25 degrees C), KALETRA oral solution should be
used within two months.

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 Fund

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.

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 more than 68,000 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/hiv
and http://www.abbottglobalcare.org.

Web site: http://www.abbott.com

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

Contact:
Jennifer Smoter, +1-847-935-8865, or Dirk van Eeden, +1-847-938-8848,
both of Abbott