FDAnews
www.fdanews.com/articles/90426-pharma-blog-watch

Pharma Blog Watch

February 9, 2007

Alli — an Interim Acomplia? (Pharma's Market)
In his blog, Mike Huckman discusses the FDA's approval of GlaxoSmithKline's Alli as the first OTC treatment for obesity. Alli (orlistat) is equivalent to the prescription drug Xenical marketed by Roche, which "sold $555 million worth of Xenical last year — far from tipping the scale of billion-dollar blockbuster status."

"The reason [Xenical] didn't grow that large is because the drug, frankly, has some nasty side effects," he writes. "As far as Alli is concerned, obesity experts and analysts say if the side effects are a turn-off, patients should sit tight until the FDA makes a decision on sanofi-aventis' Acomplia. That prescription drug could become the next diet-pill craze, and it doesn't cause the same problems. Analysts believe Acomplia could be approved within the next few months."

New GI Data on Arcoxia (Pharmalot)
Ed Silverman discusses Merck's recently published study that "finds the incidence of upper gastrointestinal events in patients on Arcoxia was less than in those folks taking diclofenac."

"That's good news for Merck, which sells Arcoxia in 62 countries, but must still convince the FDA that it's worth sticking out its regulatory neck to approve its newest Cox-2 painkiller. Despite being tarred-and-feathered for its handling of Vioxx, the agency hasn't ruled out such a move. Merck is working furiously to ensure that it happens," he writes.

"Ah, but not so fast. An accompanying Lancet editorial points out that, although Arcoxia reduced upper [gastrointestinal (GI)] events, the upside was actually tiny — to prevent one uncomplicated GI problem, you had to treat 259 patients."