Press Release
Abbott Study Shows Investigational Heat-Stable Norvir® Tablet Provides Similar Drug Levels to Current Norvir Capsule
Pivotal Study of Norvir Tablet Bioavailability Will Form the Basis of
Request for Priority Regulatory Review
August 7, 2008
Mexico City — Abbott (NYSE: ABT)
presented pivotal data at the XVII International AIDS Conference (AIDS 2008) in
Mexico City today showing that its investigational Norvir® (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 US 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® technology, which was
also used in the development of Abbott’s Kaletra® 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
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® (amiodarone); ergotamine,
ergonovine, methylergonovine, and dihydroergotamines such as Cafergot®;
Migranal®; D.H.E. 45® and others; Halcion® (triazolam); Hismanal® (astemizole);
Orap® (pimozide); Propulsid® (cisapride); Quinidine®, also known as
Quinaglute®; Cardioquin®; Quinidex®; Rythmol® (propafenone); Seldane®
(terfenadine); Tambocor®; (flecainide); Uroxatral® (alfuzosin hydrochloride);
Vascor® (bepridil); Versed® (midazolam); and Vfend® (voriconazole).
NORVIR must not be taken with St. John’s Wort (hypericum perforatum),
Mevacor® (lovastatin) or Zocor® (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® (atorvastatin), Crestor®
(rosuvastatin), Viagra® (sildenafil), Cialis® (tadalafil), Levitra®
(vardenafil), oral contraceptives ("the pill") or the contraceptive
patch, Mycobutin® (rifabutin), rifampin, also known as Rimactane®, Rifadin®,
Rifater® or Rifamate®; inhaled Flonase® (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°F (25°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 dihydro ergotamine, ergonovine, ergotamine or
methylergonovines such as Cafergot® , Migranal® , D.H.E. 45® , ergotrate
maleate, and methergine, as well as Halcion® (triazolam), Orap® (pimozide),
Propulsid® (cisapride), or Versed® (midazolam).
KALETRA must not be taken with rifampin, also known as Rimactane® ,
Rifadin®, Rifater®, or Rifamate®; St. John’s Wort (Hypericum
perforatum); Mevacor® (lovastatin), or Zocor® (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® (atorvastatin), Crestor®
(rosuvastatin), Viagra® (sildenafil), Cialis® (tadalafil), Levitra®
(vardenafil), oral contraceptives ("the pill") or the contraceptive
patch, Mycobutin® (rifabutin), inhaled Flonase® (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®
(efavirenz), Viramune® (nevirapine), Agenerase® (amprenavir), fosamprenavir,
Viracept® (nelfinavir), phenobarbital, Dilantin® (phenytoin) or Tegretol®
(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°F (25°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 (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 more than
68,000 people and markets its products in more than 130 countries.
For more information on Abbott's HIV/AIDS programs, please visit
www.abbott.com/hiv and www.abbottglobalcare.org.
Media:
Jennifer Smoter
Dirk van Eeden |
(847) 935-8865
(847) 938-8848 |
