Gilead Sciences 8-K 2007
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Gilead Sciences, Inc.
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Item 8.01 Other Events.
In October 2006, Gilead Sciences, Inc., a Delaware corporation (the Company), along with its partners Bristol-Myers Squibb Company and Merck & Co., Inc. announced the submission of a marketing authorisation application (MAA) seeking approval of Atripla™ (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in the European Union to the European Medicines Agency (EMEA). On July 19, 2007, the Company provided an update on the status of the MAA during its conference call to discuss financial results for the second quarter of 2007. The Company announced that the main issue it is discussing with the EMEA relates to the method of administration of Atripla -- dosing with or without food. Unlike in the United States, the current European prescribing information states that Truvada® (emtricitabine and tenofovir disoproxil fumarate) should be administered with food, whereas efavirenz should be administered on an empty stomach. The Company has proposed to the EMEA that Atripla should be administered like efavirenz, on an empty stomach. The Company believes this is supported by data from two clinical studies and its post-marketing experience with Atripla in the United States. The Company has been working to resolve this issue with the EMEA to keep the approval of Atripla on track for the end of 2007. Requirements for additional data would delay the approval of Atripla in the European Union.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.