Good News/Bad News For Gilead

It’s a complicated turn of events for Gilead, the maker of HIV drug Viread. The 9th Circuit Court has reinstated a securities class action suit against the drug maker which claims that Gilead had misled investors about the demand for Viread.

The suit charges that Gilead fostered demand for Viread by using improper marketing such as “aggressively promoting off-label uses.” Among the off-label uses were “marketing to patients co-infected with Hepatitis B.” The suit (PDF) claims that 75% – 95% of Viread sales came from such off-label sales.

Little Viread is sold as a stand-alone drug today as it is most commonly prescribed as part of the combination pills Atripla and Truvada. However, the drug has been studied in recent years as a possible daily HIV preventive, with one AIDS activist even calling for it to be “coformulated with Viagra.”

However, on the same day that the above lawsuit was green-lighted, comes word that the FDA actually HAS just approved Viread as a treatment for chronic Hepatitis B in the United States. The drug is already approved for such use in Europe. So Gilead wins by having one of the few drugs approved to treat Hep B, but loses for how they got to that approval. I think. Insiders?