Gilead's Candidate under EMA Review - Analyst Blog

Gilead Sciences Inc. ( GILD ) announced recently that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application ( MAA ) filed by the company for its HIV combination pill, Quad. The application, seeking marketing approval for Quad in the EU, was filed by Gilead on November 24, 2011.

Quad refers to a single tablet regimen ( STR ) of Gilead's elvitegravir, cobicistat, a boosting agent to facilitate the once-daily dosing of elvitegravir and Truvada. The European application was filed by Gilead on the basis of encouraging data from two late-stage studies (102 and 103).

We remind investors that the company filed a new drug application (NDA) for the candidate with the US Food and Drug Administration (FDA) in October 2011. The application was also based on studies 102 and 103. The approval of Quad by the regulatory authorities will boost the already formidable antiviral franchise at Gilead. The combination pill, which has significant commercial potential, will enhance patient convenience.

Gilead seeks to Expand Truvada Label

With the objective of further strengthening its antiviral franchise, Gilead recently filed a supplemental new drug application (sNDA) seeking to expand the label of one of its leading HIV therapies, Truvada, a fixed-dose combination of the company's Viread and Emtriva.

The company filed the application with the FDA, seeking to market Truvada, for pre-exposure prophylaxis to reduce the risk of uninfected adults getting infected by HIV. The successful label expansion of the drug would make it the first FDA approved therapy to bring down the risk of adults being infected by HIV.

Our Recommendation

We currently have a Neutral recommendation on Gilead. The stock carries a Zacks #3 Rank (short-term Hold rating).

We are optimistic about the growth potential of Gilead's HIV franchise led by Truvada and Atripla. Atripla is a combination of Truvada and Bristol-Myers ' ( BMY ) Sustiva. Moreover, the company's attempts to expand its HIV portfolio also please us. However, the threat of genericization looms over many of its key drugs. Gilead is looking to combat the generic threat through acquisitions.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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