ABBOTT STATEMENT REGARDING NEW INITIATIVES TO EXPAND ACCESS AND AFFORDABILITY TO LOPINAVIR/RITONAVIR IN THE DEVELOPING WORLD
- Low and low-middle -income countries to see significant price reductions -
ABBOTT PARK, Ill., Aug. 13, 2006 - Abbott today said that it is implementing new initiatives aimed at expanding access and affordability to its new lopinavir/ritonavir tablet in the developing world. Abbott's comprehensive program is designed to ensure long-term, sustainable access to high-quality HIV medicines and includes:
- A sustainable pricing structure that reduces the price of lopinavir/ritonavir tablets to $2,200 per patient per year in low-income and low-middle-income countries.
- Maintaining a price of $500 per patient per year in Africa and the least developed countries (LDCs).
- Registering Aluvia (lopinavir/ritonavir), Abbott's new, non-refrigerated tablet formulation of lopinavir/ritonavir with decreased pill burden, as broadly in the developing world as the current Kaletra (lopinavir/ritonavir) soft-gel capsules.
- Significant investment in additional manufacturing capacity, to meet anticipated increased demand for high-quality, second-line HIV treatments.
- Development of a new pediatric formulation of its lopinavir/ritonavir tablet to meet the treatment needs of HIV-positive children worldwide which is currently underway.
Abbott develops and produces high-quality medicines that enhance and extend patient lives. Achieving universal access to HIV treatment requires other investments on the parts of government and other groups in health infrastructure, skilled healthcare workers, enhanced regulatory systems and distribution chains.
"As a caregiver of HIV patients in the developing world, I am pleased with Abbott's continued effort to develop new and innovative programs related to medication costs," said Robert Redfield, M.D., director of Clinical Care and Research, Institute of Human Virology, Baltimore, Md. "These efforts will enable individual countries to maximize their ability to provide medicine for their citizens."
Abbott's pricing program for the developing world
Today's announcement results in price reductions in low-income and low-middle-income countries by reducing the price to $2,200 per patient, per year in
45 low-income and low-middle-income countries. This action broadens Abbott's preferential pricing to 114 countries from the 69 African countries and LDCs. Prices apply to all developing world public funders of HIV medicines, specifically governments and non-governmental organizations. The new pricing structure will apply to both tablet and soft-gel capsule formulations of lopinavir/ritonavir and will be effective immediately. As previously announced, Abbott will continue to sell lopinavir/ritonavir at $500 per patient per year in Africa and the LDCs.
Aluvia: lopinavir/ritonavir tablets in the developing world
Aluvia is the same high-quality, non-refrigerated product as Kaletra tablets. Lopinavir/ritonavir is a recommended second-line treatment for HIV infection in the developing world by the World Health Organization. Protease inhibitors, such as lopinavir/ritonavir, are important treatment options in the fight against HIV when first-line regimens fail.
The tablet will have broad availability, just like the lopinavir/ritonavir capsule, which is the among the most widely registered protease inhibitors in the world. The company is working to register lopinavir/ritonavir tablets in Africa, Asia and Latin America as rapidly as possible. Local registrations are the best way to provide rapid access to the greatest number of patients. Abbott has registered the current lopinavir/ritonavir capsules in more than 100 countries.
Abbott is developing a pediatric version of the lopinavir/ritonavir tablet to provide greater dosing flexibility for physicians to treat children living with HIV. Abbott already offers liquid formulations of its protease inhibitors for children.
Background on HIV/AIDS in the developing world
According to the 2006 UNAIDS report, it is estimated that more than
35.5 million people in the developing world have HIV, while only 1.3 million are being treated. In several countries, favorable trends in incidence are related to changes in behavior and prevention programs. Changes in incidence along with rising AIDS mortality have caused global HIV prevalence to level off. However, the number of people living with HIV has continued to rise, due to population growth and, more recently, the life-prolonging effects of antiretroviral therapy.
In sub-Saharan Africa, the region with the largest burden of the AIDS epidemic, data also indicate that the HIV incidence rate has peaked in most countries. Meanwhile, evidence continues to emerge of resurgent epidemics in the United States and in some countries in Europe, and of largely hidden epidemics among their counterparts in Latin America and Asia.
Lopinavir/ritonavir Important Safety Information
Lopinavir/ritonavir is indicated for the treatment of HIV-1-infected adults and children above the age of two years, in combination with other antiretroviral agents.
Most experience with lopinavir/ritonavir is derived from the use of the product in antiretroviral therapy-naive patients. Data in heavily pretreated protease inhibitor-experienced patients are limited. There are limited data on salvage therapy on patients who have failed therapy with lopinavir/ritonavir.
The choice of lopinavir/ritonavir to treat protease inhibitor-experienced
HIV-1-infected patients should be based on individual viral resistance testing and treatment history of patients. Lopinavir/ritonavir is not recommended for children less than two years of age.
Lopinavir/ritonavir should not be taken by patients who have had an allergic reaction to any of its ingredients, including lopinavir or ritonavir, or any of the excipients, or by patients with severe hepatic insufficiency.
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 amiodarone, astemizole, cisapride, midazolam, pimozide, terfenadine, triazolam and ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine and methylergonovine).
In addition, lopinavir/ritonavir should not be taken with lovastatin, simvastatin, rifampin, fluticasone propionate, other glucocorticoids or products containing St. John's wort (Hypericum perforatum). Particular caution should be used when taking lopinavir/ritonavir with sildenafil. Co-administration of efavirenz, nevirapine, nelfinavir or amprenavir with lopinavir/ritonavir tablets 400/100mg is not recommended. 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.
Particular caution must be used when prescribing Kaletra with medicinal products known to induce QT prolongation. Kaletra could increase concentration of these co-administered products and may increase their associated cardiac adverse events.
Levels of ethinyl estradiol may be decreased when estrogen-based oral contraceptives are co-administered. Alternative or additional contraceptive measures are to be used. Please consult your local prescribing information for country specific recommendations.
Cases of pancreatitis have been reported. Liver problems, which can be fatal, have also 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 combination antiretroviral therapy. The long-term consequences of these events are currently unknown. Some patients receiving combination antiretroviral therapy have had sometimes marked increases in total cholesterol and triglycerides. Immune reactivation syndrome has been seen in HIV-infected patients with severe immune deficiency at the time of starting combination antiretroviral therapy (CART). Typically, reactions were seen within the first few weeks or months after starting CART.
At this stage of development, little information is available on the cross-resistance of viruses selected during therapy with lopinavir/ritonavir.
In lopinavir/ritonavir adult clinical trials, the very common and commonly reported side effects of moderate to severe intensity were diarrhea, insomnia, headache, nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder, rash, lypodystrophy, asthenia and abnormal liver enzymes. This is not a complete list of reported side effects. In children two years of age and older, the safety profile is similar to that seen in adults.
Lopinavir/ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. For more information about lopinavir/ritonavir, please consult your local prescribing information.
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. With Kaletra, Abbott has developed two protease inhibitors, and offers nutritional products that meet the unique dietary needs of hundreds of thousands of people living with HIV.
Abbott and the Abbott Fund are working to expand capacity to deliver health services and are investing $100 million in developing countries to advance HIV testing, treatment and support services for people affected by HIV/AIDS. Abbott has helped improve the health and lives of millions of people affected by HIV/AIDS, through pioneering programs that help prevent mother-to-child transmission of HIV, expand access to testing and treatment, strengthen health systems, and provide support for children.
In addition, Abbott is among a handful of companies with a comprehensive AIDS-in-the-Workplace program in Africa, covering education and prevention, voluntary counseling and testing, and treatment for employees and their families.
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 65,000 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 www.abbott.com.
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