Deutsche Bank Comments on Gilead (GILD) Harvoni EMA Marketing Authorization

Deutsche Bank maintained a Buy rating on Gilead Sciences (NASDAQ: GILD) with a price target of $142. Earlier its Harvoni marketing authorization was approved in the EU. Analyst Robyn Karnauskas noted its label was slightly broader than expectations.

"We note that prevalence of GT3 and 4 is higher in the EU vs. US (GT3- US 6% vs. EU on avg. 23%; GT4/5/6- US 3% vs. EU on avg. 7%), and believe that this broader indication is appropriate for the EU. We do not know if the co is planning on expanding the US label at some point based on these particular differences in the EU label. We highlight the key differences below," said Karnauskas.

• "GT1 Naïve w/o cirrhosis: Harvoni can be considered for 8 wks of treatment in both regions. However the US label specifies that pts must have HCV RNA at > 6M IU/mL; the EU indication does not specify. Our guess would be that doctors’ judgment will be key. We do note at the Liver Meeting that docs were more focused on maximizing cure rates over shortening duration. We don’t know if that trend will hold in EU."
• "GT1 Naïve w/ or w/o cirrhosis: US label specifies 12 wks of treatment; the press release w/ the EU indication is not specific as it only indicates that it ranges between 12 or 24 wks depending on prior treatment history and cirrhosis status. Perhaps treatment will be same since data would support that fact, but we will have to see how EU docs use this drug in the pop."
• "GT1 experience w/o cirrhosis: US label specifies 12 wks of treatment; EU PR is not specific, but we assume treatment duration is the same," she added.

For an analyst ratings summary and ratings history on Gilead Sciences click here. For more ratings news on Gilead Sciences click here.

Shares of Gilead Sciences closed at $100.44 yesterday.

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