Aggressive Gilead considers head-to-head PAH showdown with Actelion

Gilead COO John Milligan

Gilead ($GILD) is burnishing its reputation as one of the most aggressive drug developers in the business. In an interview with Bloomberg, COO John Milligan says the big biotech outfit--which is expected to generate megablockbuster revenue from the newly approved Sovaldi for hep C--is pondering a head-to-head study to determine whether Letairis is better or worse than Actelion's ($ATLN) recently approved lung drug Opsumit.

Head-to-head studies "can be very valuable, if you win," Milligan told the business news service. "We have been willing to do head-to-head studies historically. If you don't have the courage of your convictions that your drug is better than the other company's drugs, then really, why are you developing it?"

Opsumit is Actelion's successor to Tracleer, the Swiss biotech's franchise lung drug for pulmonary arterial hypertension. New PAH drugs have been crowding into the disease space recently, setting up some confrontations in the marketplace. Bayer won an approval for Adempas last fall and United Therapeutics ($UTHR) landed a surprise OK of its own soon after. Gilead, always looking to command as much market share as possible, clearly seems to believe that it can come out on top with its drug, which was originally OK'd in 2007.

As drugmakers around the world find themselves competing more and more frequently, head-to-head studies have become more important for the biotech world, particularly in late-stage diabetes drug work, for example. Actelion, a careful organization with a tremendous dependence on PAH drug revenue, has already ruled out doing a head-to-head study, saying that it would take 5,000 patients to undertake a head-to-head, reports Bloomberg. Their late-stage work required only 742 patients with the rare condition.

Actelion is given high marks in the industry for the close relationships it built up with physician specialists in PAH. A head-to-head study could give Gilead a leg up in a tough market--or cede the lead to Actelion.

- here's the report from Bloomberg