Abbott Submits Application To EMEA For A New, More Convenient Kaletra® Formulation

(2005-07-31)

Abbott announced today that it submitted a line extension Marketing Authorization Application to the European Medicines Agency (EMEA) for the approval of a new, more convenient tablet formulation of its protease inhibitor (PI) Kaletra ® (lopinavir/ritonavir).

The tablet was developed using a proprietary melt-extrusion technology intended to allow patients to take fewer tablets per dose as part of their treatment regimen. In addition, the tablet will not require refrigeration, as the current soft capsule formulation does. Kaletra is the market share leader among protease inhibitors for the treatment of HIV in the European Community.

"Kaletra has been an important treatment option in HIV therapy and this next-generation formulation could enhance dosing convenience for patients, while maintaining treatment effectiveness," said Scott Brun, M.D., divisional vice president of Infectious Disease Development, Abbott. "Abbott remains committed to the fight against HIV through the enhancement of our existing treatments and the development of next-generation therapies."

If approved, the new tablet will provide patients with a tablet composed of 200 mg lopinavir and 50 mg ritonavir, as compared to the current soft capsule, which contains 133.3 mg lopinavir and 33.3 mg ritonavir. While the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, the number of Kaletra pills patients need to take per day is reduced from six soft capsules to four tablets as part of their HIV treatment regimen.

The submission package included data from bioequivalence studies. The company is conducting clinical trials with the tablet formulation in patients living with HIV.

Abbott announced on May 3, 2005, that it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for the approval of the new tablet formulation.

Kaletra Safety Information

Kaletra (lopinavir/ritonavir) is always used in combination with other anti-HIV medicines to treat people with HIV infection. Kaletra should not be taken by patients who have had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir.

Taking certain medications with Kaletra could create the potential for serious side effects that could be life threatening. Kaletra should not be taken with astemizole, cisapride, dihydroergotamine, ergonovine, ergotamine, methylergonovine, midazolam, pimozide, terfenadine or triazolam.

In addition, Kaletra 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 Kaletra 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 Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.

In Kaletra 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 Kaletra may sometimes get a skin rash. This is not a complete list of reported side effects. Kaletra oral solution contains alcohol.

Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. For more information, including full prescribing information, please visit www.kaletra.com.

About Abbott

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 is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, device and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries.

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