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Gilead's Combination of Antiretrovirals Truvada, Sustiva Not Bioequivalent to Two Drugs Alone, Study Says

August 10, 2005

Gilead on Tuesday announced that its reformulation of a fixed-dose combination antiretroviral drug combining the company's Truvada with Bristol-Myers Squibb's drug Sustiva is not bioequivalent to the two drugs when used separately, AFX International Focus reports. In order to receive FDA approval for a new co-formulated drug, a drug company must demonstrate that the new formulation results in the same levels of medication in the blood as when the combined drugs are taken separately, according to Gilead (AFX International Focus, 8/9). An earlier formulation of the fixed-dose combination in April also failed to demonstrate bioequivalence (Chang, TheStreet.com, 8/9). The company said it now plans to test as many as three additional formulations of the combination antiretroviral over the next several months. Previously, Gilead -- which together with BMS had hoped to create a fixed-dose combination antiretroviral to eliminate the need for HIV-positive patients to take multiple pills each day -- had said it hoped to submit an application for the new treatment to FDA by the end of 2005. However, the company said it now will make such a submission in the first half of 2006 at the earliest (AP/MSN Money, 8/9). Following the announcement, shares of Gilead fell 5% in after-hours trading (TheStreet.com, 8/9).

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