Press Release

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

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

Johannesburg, South Africa, April 4, 2006 — 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®, Cordaron®, D.H.E. 45®, Halcion®, Hismanal®, Mevacor®, Migranal®, Orap®, Propulsid®, Quinidine®, Rythmol®, Seldane®, Tambocor™, Vascor®, Versed®, Zocor® 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 does not reduce the risk of passing HIV to others.

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 60,000 people and markets its products in more than 130 countries.

 

 

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