DoJ bark may be bigger than bite in Gilead probe

Doomsday predictions appear to be subsiding for HIV and AIDS drug maker Gilead Sciences, which announced late Friday it had been subpoenaed for documents concerning its manufacturing, quality and distribution practices.

The request, from the U.S. Attorney for the Northern District of California, applies to a host of the company's products, including AIDS drugs Atripla, Emtriva, Truvada and Viread, hepatitis drug Hepsera, pulmonary hypertension drug Leitairis and an experimental fixed-dose combination of Truvada and Edurant.

The two tight-lipped parties said little else. But ISI Group analyst Mark Schoenebaum notes Gilead has been subpoenaed before, though the 2006 incident was "not criminal in nature or related to manufacturing," according to Pharmalot.

The scarcity of information, which led some pundits on Monday to anticipate the worst in the way of production shutdowns and penalties, had the opposite effect on Schoenebaum. He concludes that such speculation "may be largely overblown." Yet he somehow anticipates that if Gilead is fined, the total might be "somewhere between $200 million and $750 million."

Oppenheimer analyst Bret Holley expects little damage from the investigation, too. "For one thing, the DOJ seems to conduct a lot of investigations lately that go nowhere, and has probed Gilead before without incident," he says in Barron's.

- see the Pharmalot story
- here's the Gilead statement
- see the Barron's story