Abbott Confirms Long-Term Commitment to HIV Care with the Planned Development of New Formulations

ABBOTT PARK, Illinois, July 15, 2011 -

Abbott (NYSE: ABT) announced today that
it plans to develop two new formulations of its HIV medicines,
Kaletra (lopinavir/ritonavir) and Norvir (ritonavir), to offer new
formulation options for people living with HIV-1. The company is
currently investigating a new powder formulation of Norvir as well
as a co-formulation of three HIV medicines - lopinavir, ritonavir
and 3TC (lamivudine).

The Norvir powder formulation is planned to make it easier to
store the medicine. The investigational fixed-dose combination of
lopinavir, ritonavir and 3TC combines three established HIV
medicines and could reduce the daily number of tablets a patient
takes. Additionally, this tablet may offer a more cost-effective
treatment option for patients. The fixed-dose combination, if
developed and approved, would be designed to be taken in
combination with one additional anti-HIV medicine.

Abbott is developing the new formulations with the ambition to
make a contribution to the World Health Organization’s Treatment
2.0 strategy. This strategy includes providing treatment options to
make the most of the resources available in those developing
countries that carry the heaviest HIV burden.

“Abbott’s HIV research program confirms our continued commitment
to develop and provide effective, quality HIV medicines for
patients around the world,” said Scott C. Brun, M.D., divisional
vice president, infectious disease development, Global
Pharmaceutical Research and Development, Abbott. “Advances in HIV
treatment formulations are critical as doctors and patients shift
their goals from surviving HIV to living with HIV.”

Please see below for Use and Important Safety Information about
Kaletra and Norvir.

Norvir Powder Formulation

Norvir is most often used in combination with other protease
inhibitors as a pharmacokinetic enhancer to increase the blood
levels of antiviral medicines that belong to the same group as
Norvir (protease inhibitors).The investigational formulation of
Norvir is planned to be a heat-stable powder that could be
sprinkled over food or added to liquid. This planned formulation
could be particularly important for delivering this HIV medicine to
developing countries where refrigeration may not be an option.
Norvir and another protease inhibitor are given with two additional
medications as a daily combination regimen.

“When Abbott originally developed the liquid form of Norvir, we
were limited to the technology that was available at the time,”
said Brun. “We have developed improved formulation approaches that
now allow us to explore a new formulation of Norvir that we hope
will be better suited to the needs of HIV-infected children.”

New
fixed-dosecombination

The investigational fixed-dose combination of Kaletra and 3TC,
given with an additional anti-HIV drug, has the potential to offer
doctors and patients a simplified medicine that could reduce the
number of prescriptions a patient receives and tablets a patient
takes.

“Kaletra and 3TC have a long history of use in both the
developed and developing worlds,” said Brun. “We are working to
ensure that this co-formulation will be heat-stable, which would
make it suitable to conditions in areas where storage options are
limited.”

Abbott‘s Commitment to
HIV

Abbott has been a leader in HIV/AIDS research since the early
years of the epidemic.

The company developed the first HIV diagnostic test more than 25
years ago. Norvir, one of the first protease inhibitors, was
launched in 1995 as both a capsule and an oral solution, and
remains an essential component of most protease inhibitor-based
treatment regimens. And 10 years after its introduction,
lopinavir/ritonavir remains a part of the most commonly used
second-line treatment regimens in resource limited settings,
according to the World Health Organization Price Reporting
Mechanism.

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 and
a number of nutritionals, devices and diagnostics to help people
living with HIV.

Expanding on its scientific contributions, Abbott and the Abbott
Fund have invested more than $200 million in developing countries
to improve the lives of people affected by HIV/AIDS through
programs targeting critical areas of need, including strengthening
healthcare systems, supporting children affected by HIV/AIDS and
advancing HIV testing and treatment.

Globally, prescribing information varies. Refer to the
individual country full prescribing information for complete
information. For U.S. full Prescribing Information about Kaletra
and Norvir, visit Kaletra.com and Norvir.com.

Information about KALETRA

Use

Kaletra is an antiretroviral medicine called a protease
inhibitor used to help control human immunodeficiency virus (HIV).
 Kaletra is used by children 2 years of age or older and
adults.  Kaletra is used in combination with other
antiretroviral medicines.  

Kaletra does not cure HIV infection or
AIDS and does not stop the risk of passing HIV to others. People
taking Kaletra may still develop infections or other illnesses
associated with HIV disease and AIDS.

Important Safety Information

Kaletra should not be taken by people who are allergic
(hypersensitive) to lopinavir, ritonavir or any of the other
ingredients of Kaletra or people who have severe liver
problems.

Kaletra should not taken with any of the following medicines:
astemizole, terfenadine, oral midazolam, triazolam, pimozide,
cisapride, ergotamine, dihydroergotamine, ergonovine, and
methylergonovine, amiodarone, lovastatin, simvastatin, vardenafil,
sildenafil used to treat pulmonary arterial hypertension and
products containing St. John’s Wort (Hypericum perforatum).
 

People must tell their doctor or pharmacist if they are taking
or have recently taken any other medicines, including medicines
obtained without prescription.

Kaletra must not be taken once daily in combination with
efavirenz, nevirapine, nelfinavir, amprenavir, carbamazepine,
phenobarbital, or phenytoin.

People must tell their doctor if they
have/had:

• Haemophilia type A and B as Kaletra might increase the
  risk of bleeding.
• Diabetes as increased blood sugars has been reported in
  people receiving Kaletra.
• A history of liver problems as people with a history of
  liver disease, including chronic hepatitis B or C are at increased
  risk of severe and potentially fatal liver side effects.

People must tell their doctor if they
experience:

• Nausea, vomiting, abdominal pain, difficulty breathing and
  severe weakness of the muscles in the legs and arms as these
  symptoms may indicate raised lactic acid levels.
• Thirst, frequent urination, blurred vision or weight loss as
  this may indicate raised sugar levels in the blood.
• Nausea, vomiting, abdominal pain as large increases in the
  amount of triglycerides (fats in the blood) have been considered a
  risk factor for pancreatitis (inflammation of the pancreas) and
  these symptoms may suggest this condition.
• Changes in body shape due to changes in fat
  distribution. These may include loss of fat from legs, arms and
  face, increased fat in the abdomen (belly) and other internal
  organs, breast enlargement and fatty lumps on the back of the neck
  (’buffalo hump’). The cause and long-term health effects of these
  conditions are not known at this time.
• In some people 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. It is believed that these symptoms are due to an
  improvement in the body’s immune response, enabling the body to
  fight infections that may have been present with no obvious
  symptoms. If people notice any symptoms of infection, their doctor
  should be informed immediately to seek necessary treatment.
• Joint stiffness, aches and pains (especially of the hip,
  knee and shoulder) and difficulty in movement as some people taking
  these medicines may develop a bone disease called osteonecrosis
  (death of bone tissue caused by loss of blood supply to the bone).
  The length of combination antiretroviral therapy, corticosteroid
  use, alcohol consumption, severe immunosuppression (reduction in
  the activity of the immune system), higher body mass index, among
  others, may be some of the many risk factors for developing this
  disease.
• Muscle pain, tenderness or weakness, particularly in
  combination with these medicines. On rare occasions these muscle
  disorders have been serious.
• Symptoms of dizziness, lightheadedness, fainting or sensation
  of abnormal heartbeats. Kaletra may cause changes in heart rhythm
  and electrical activity of the heart. These changes may be seen on
  an ECG (electrocardiogram).

People taking sildenafil or tadalafil and Kaletra together may
be at risk of side effects such as low blood pressure, passing out,
visual changes and penile erection lasting more than 4 hours. If an
erection lasts longer than 4 hours, they should get medical help
immediately to avoid permanent damage to their penis. Their
doctor can explain these symptoms.

Women taking oral contraceptive or using a patch to prevent
pregnancy should use an additional or different type of
contraception since Kaletra may reduce the effectiveness of oral
and patch contraceptives.

Pregnant or nursing mothers should not take Kaletra unless
specifically directed by their doctor.

Kaletra should not be given to children younger than 2 years of
age unless specifically directed by their doctor. Kaletra once
daily has not been evaluated in pediatrics.

Very common (meaning affects more than 1 user in 10) side
effects of Kaletra include diarrhoea, nausea and upper respiratory
tract infection.  This is not a complete list of reported side
effects.

For more information about Kaletra, the local Summary of Product
Characteristics should be consulted.

Information about Norvir

Use

Norvir is a protease inhibitor used to control HIV infection.
Norvir is used in combination with other anti-HIV medicines
(antiretrovirals) to control HIV infection in adults and children
of 2 years of age and older.

Norvir can be used at full dose on its own, or at lower doses
(called booster doses) with other medicines.

Norvir is not a cure for HIV infection or AIDS and does not
lower the risk of passing HIV to others. People taking
Norvir may still develop infections or other illnesses associated
with HIV infection or AIDS.

Important Safety Information

Norvir should not be taken by people who are allergic
(hypersensitive) to ritonavir or any of the other ingredients of
Norvir or people who have severe liver disesase.

Norvir should not be taken with the following medicines:
astemizole, terfenadine, amiodarone, bepridil, encainide,
flecainide, propafenone, quinidine, dihydroergotamine, ergotamine,
ergonovine, methylergonovine, clorazepate, diazepam, estazolam,
flurazepam, triazolam or oral (taken by mouth) midazolam,
clozapine, pimozide, pethidine, piroxicam, propoxyphene, cisapride
rifabutin, voriconazole, simvastatin, lovastatin, alfuzosin,
fusidic acid, sildenafil used to treat a lung disease called
pulmonary arterial hypertension, and products containing St John’s
wort (Hypericum perforatum).

People must tell their doctor or pharmacist if they are taking
or have recently taken any other medicines, including medicines
obtained without a prescription.

People must tell their doctor if they
have/had:

• A history of liver disease.
• Hepatitis B or C and are being treated with a
  combination of antiretroviral agents, as they are at a greater risk
  of a severe and potentially life threatening reaction because of
  the effect on the liver. Regular blood tests may be required to
  check if the liver is working properly.
• Haemophilia, as there have been reports of increased
  bleeding in patients with haemophilia who are taking this type of
  medicine (protease inhibitors). The reason for this is not known.
  Additional medicine maybe needed to help blood clot (factor VIII),
  in order to control any bleeding.
• Erectile Dysfunction, as the medicines used to treat
  erectile dysfunction can cause hypotension and prolonged
  erection.
• Diabetes, as there have been reports of worsening of or
  the development of diabetes (diabetes mellitus) in some patients
  taking protease inhibitors.
• Kidney (renal) disease, since a doctor may need to check
  the dose of other medicines (such as protease inhibitors).

People must tell their doctor if they
experience:

• Changes in the distribution of the fat on their body, or
  a build up or loss of body fat
• Diarrhoea or vomiting that is not improving
  (persistent), as this may reduce how well the medicines are
  working.
• Feeling sick (nausea), vomiting or have
  stomach pain, because these may be signs of inflammation of
  the pancreas (pancreatitis). Some patients taking Norvir can
  develop serious problems with their pancreas.
• Symptoms of infection - Some patients with advanced HIV
  infection (AIDS) who then start anti-HIV treatment may develop the
  symptoms of infections they have had in the past even if they
  didn’t know they had them. It is believed that this happens because
  the body’s immune response improves and helps the body to fight
  these infections.
• Joint stiffness, aches and pains (especially of the hip,
  knee and shoulder) and difficulty moving, as this may be a sign of
  a problem that can destroy bone (osteonecrosis). Some patients
  taking a number of antiretroviral medicines may develop this
  disease.
• Muscle pain, tenderness or weakness, particularly in
  combination with antiretroviral therapy including protease
  inhibitors and nucleoside analogues. On rare occasions these muscle
  disorders have been serious.
• Dizziness, lightheadedness, fainting spells or abnormal
  heartbeat. Some patients taking Norvir may experiences changes
  in the electrocardiogram (ECG). People must tell their doctor if
  they have a heart defect or conduction defect.
• If people have any other health concerns, they should discuss
  these with their doctor as soon as they can.

People must tell their doctor if they
are taking any of the medicines listed below, as special care
should be taken.

• Sildenafil, tadalafil, vardenafil for impotence
  (erectile dysfunction). The dose and/or frequency of use of these
  medicines may need to be reduced to avoid hypotension and prolonged
  erection. People must not take Norvir with sildenafil if they
  suffer from pulmonary arterial hypertension.
• Digoxin (heart medicine). Their doctor may need to
  adjust the dose of digoxin and monitor them while they are taking
  digoxin and Norvir in order to avoid heart problems.
• Hormonal contraceptives containing ethinyl oestradiol as
  Norvir may reduce the effectiveness of these medicines. It is
  recommended that a condom or other non-hormonal method of
  contraception is used instead. Women may also notice irregular
  uterine bleeding if they are taking this type of hormonal
  contraceptive with Norvir.
• Atorvastatin or rosuvastatin (for high cholesterol) as
  Norvir may raise the blood levels of these medicines. People must
  talk to their doctor before taking any cholesterol-reducing
  medicines with Norvir.
• Steriods (eg dexamethasone, fluticasone propionate,
  prednisolone) as Norvir may raise the blood levels of these
  medicines which may lead to Cushing’s syndrome (development of a
  rounded face) and reduce production of the hormone cortisol. The
  doctor may wish to reduce the steroid dose or monitor side effects
  more closely.
• Trazodone (a medicine for depression) as, unwanted
  effects like nausea, dizziness, low blood pressure and fainting can
  occur when taken with Norvir.
• Rifampicin and saquinavir (used for tuberculosis and
  HIV, respectively) as serious liver damage can occur when taken
  with Norvir.

It is not known if Norvir passes into breast milk. To avoid
transmitting the infection, mothers with HIV should not breast feed
their babies.

Norvir is not recommended in children below 2 years of age.

Very common side effects of Norvir are stomach ache, vomiting,
diarrheoa, feeling sick (nausea), headache, a tingling sensation or
numbness in the hands, feet or around the lips or mouth, feeling
weak/tired, and a bad taste in the mouth.

For more information about Norvir, the local Summary of Product
Characteristics should be consulted.

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 nearly 90,000 people
and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on
the company’s website at href="www.abbott.com/">www.abbott.com.

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