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Abbott Laboratories (ABT) Submits Application To U.S. FDA For A New, More Convenient Formulation Of Kaletra(R) (Lopinavir/Ritonavir)


10/19/2005 5:10:34 PM

ABBOTT PARK, Ill., May 3 /PRNewswire-FirstCall/ -- Abbott announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of a new, more convenient tablet formulation of its protease inhibitor (PI) Kaletra(R) (lopinavir/ritonavir). The tablet was developed using a proprietary novel melt-extrusion technology intended to allow patients to take fewer tablets per dose as part of their treatment regimen. In addition, the tablet would not require refrigeration, as the current soft-gel capsule formulation does.

Kaletra has been the leading protease inhibitor for the treatment of HIV in the United States since 2002 and is the only protease inhibitor listed as preferred for initial therapy in the "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," developed by a panel convened by the U.S. Department of Health and Human Services.

"Kaletra has been an important treatment option in HIV therapy over the past few years and this new formulation could enhance dosing convenience for patients without sacrificing 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-gel capsule, which contains 133.3 mg lopinavir and 33.3 mg ritonavir. It also reduces the number of Kaletra pills patients need to take per day from six to four as part of their HIV treatment regimen. The tablet formulation would also eliminate the need for refrigeration of the medication.

"As an HIV treatment educator and a patient, I know that patients continue to have many unmet needs related to their treatment regimens," said Octavio Vallejo, faculty, The UCLA Pacific AIDS Education and Training Center. "We are pleased that Abbott is striving to enhance Kaletra, which has been an important part of HIV treatment regimens for the past several years."

The submission package included data from bioequivalence studies. The company has plans to conduct clinical trials in patients living with HIV.

About Kaletra

Kaletra is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Kaletra should not be taken if a patient has had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir.

Taking Kaletra with certain drugs can cause serious problems or death. Kaletra should not be taken with dihydroergotamine, ergonovine, ergotamine and methylergonovine, such as Cafergot(R), Migranal(R), D.H.E. 45(R), Ergotrate Maleate and Methergine, as well as Halcion(R), Hismanal(R), Orap(R), Propulsid(R), Seldane(R) and Versed(R).

In addition, Kaletra should not be taken with rifampin, also known as Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R), Mevacor(R), Zocor(R) or products containing St. John's wort (Hypericum perforatum). Particular caution should be used when taking Viagra(R), Cialis(R) or Levitra(R) since the interaction with Kaletra may result in an increase in their related side effects. 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.

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 clinical trials, the most commonly reported side effects of moderate or severe intensity were: abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache and nausea. 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.

According to the updated guidelines released by a panel convened by the U.S. Department of Health and Human Services in April 2005, "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," Kaletra, in combination with zidovudine and lamivudine or emtricitabine, are recommended as the preferred PI-based regimens for the treatment of patients new to HIV therapy. Kaletra is the most prescribed protease inhibitor in the United States. For more information, including Kaletra (lopinavir/ritonavir) full prescribing information, please visit http://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. With Kaletra, Abbott has developed two protease inhibitors, and also offers nutritional products that meet the unique dietary needs of people living with HIV.

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 more than 60,000 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 http://www.abbott.com/ .

Abbott

CONTACT: Media, Nicole Wesley, +1-847-935-9877, or Laureen Cassidy,+1-847-938-7743, or Financial Community, Larry Peepo, +1-847-935-6722, all ofAbbott


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