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Pharmacokinetic data presented at ICAAC on investigational HIV protease inhibitor 433908 (908)

Chicago, Sept. 16, 2003 Pharmacokinetic (PK) data from two clinical studies of the investigational HIV protease inhibitor (PI) 433908 (908) were presented here today at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The studies were conducted to evaluate the interactions of 908 with medications commonly used for heartburn and lipid disorders. Results from the first study indicate that 908 can be co-administered with the antacids Maalox TC or Zantac (ranitidine HCL). In a second study, results demonstrate that co-administration of 908 with the cholesterol-lowering drug Lipitor (ATO), did not significantly affect the PK of 908, but ATO exposure was considerably increased as expected.

908 is currently under review by the Food and Drug Administration following submission of data by GlaxoSmithKline from three pivotal Phase III clinical trials studying the safety and efficacy of the drug. The compound was co-discovered by GSK and Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX).

"These data provide further information about the use of 908, which is currently under review by the FDA as an HIV protease inhibitor dosed once daily (when boosted with ritonavir) or twice daily (boosted or unboosted). 908 is designed to be dosed in four tablets per day, with no food or water restrictions," said Doug Manion, M.D., vice president of clinical development and medical affairs for GSK.

908 Co-administered with Maalox TC or Zantac

"It is common for HIV patients to take antacids or other medications to alleviate heartburn or other gastrointestinal problems: therefore, it is important to assess whether a new drug interacts with these commonly administered therapies," said Susan Ford, clinical pharmacokineticist for GSK and lead author of poster A-1606 presented at ICAAC. "These pharmacokinetic data suggest that 908 can be co-administered with Maalox TC or Zantac without dose adjustments or separation of
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
16-Sep-2003


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