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Gilead's Stribild Approved in the EU

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Good news flowed in at Gilead Sciences, Inc. (GILD) from Europe when the European Commission (EC) approved the company’s Gilead’s HIV combination pill Stribild. Approval was granted for treating HIV infected adults.

The patients are either antiretroviral treatment-naïve or are infected with the dreaded virus without known mutations associated with resistance to any of the three antiretroviral agents present in Stribild (elvitegravir, cobicistat and Truvada). We note that Truvada itself is a combination of Viread and Emtriva.

Approval was based on encouraging data from two late-stage studies -- 102, which compared Stribild to Atripla and 103, which compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. While Norvir is marketed by AbbVie Inc. (ABBV), Reyataz is marketed by Bristol-Myers Squibb Company (BMY).

Stribild was approved for the indication in the US in Aug 2012. The drug is also approved in other countries such as Canada, Australia, South Korea, Japan and Turkey. EU approval of the drug has boosted the drug’s sales potential. We note that Stribild is Gilead’s third single tablet HIV regimen to be approved in the EU after Atripla and Eviplera.

Apart from the strong product portfolio, Gilead possesses an impressive pipeline. The most promising pipeline candidate is sofosbuvir (formerly GS-7977), which is being developed to treat patients infected with hepatitis C virus (:HCV). Earlier in the month, Gilead announced that its Marketing Authorisation Application (MAA) for sofosbuvir submitted to the European Medicines Agency (:EMA) on Apr 17, 2013, has been validated and is under review.

The EMA granted Gilead’s request for accelerated assessment of the company’s MAA for sofosbuvir. The acceptance of the request is expected to bring down EMA’s review time of the application by two months.

Gilead also intends to seek sofosbuvir approval in other countries. Gilead expects sofosbuvir to be available in the EU by the first half of 2014, assuming approval. Gilead is also seeking US approval for sofosbuvir. Approval of sofosbuvir would not only boost Gilead’s top line but would also strengthen its position in the lucrative HCV market.

Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Celgene Corporation (CELG) appears to be more attractive in the biopharma space with a Zacks Rank #2 (Buy).

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