Wellbutrin XL

GSK accused of monopolizing Wellbutrin

Thu, 08 May 2008 06:59:57 -0400

Did GlaxoSmithKline try to monopolize the Wellbutrin market? A lawsuit now certified as class-action says so. The plaintiffs accuse GSK of artificially boosting Wellbutrin prices by fibbing to the U.S. Patent Office and engaging in "sham" patent litigation against generics makers. The patent lawsuits delayed copycat versions of the drug, the class action alleges, forcing purchasers to pay unnecessarily high prices. GSK didn't comment on the allegations, and so far its court defense has focused on class certification, rather than the lawsuit's specific claims.

Meanwhile, Glaxo is working to downgrade competitors to its Alli weight-loss med. The drugmaker filed a citizen's petition with the FDA, attempting to persuade the agency to change the rules on dietary supplements that claim to aid weight loss. Being overweight is a risk factor for disease, GSK reasons, so supplement makers should be required to get the FDA to sign off on their effectiveness claims before their products can be sold. That would be quite a change: FDA has long held that weight-loss claims don't imply disease treatment or prevention. If the FDA considers changing that, the fur will fly in the weight-loss market.

- see the story at Legal Intelligencer
- check out the Pharmalot item
- read GSK's petition
- get Pharmalot's take

ALSO: Yesterday we reported on GlaxoSmithKline's protest letter to Massachusetts officials. Today, some legislators say that letter may backfire, inspiring state lawmakers to "dig in their heels" on banning gifts to doctors, rather than leading them to reconsider the move. Report

New CEO expected to'strip' Biovail

Tue, 22 Apr 2008 06:59:56 -0400

To listen to news reports about incoming Biovail CEO Bill Wells, you'd think he was one of the horsemen of the Apocalypse. A director for three years, Wells is set to take over the helm May 1, and analysts say they're expecting him to come in swinging his sword. "I think he'll strip the company down to its bare bones and act very much like a private-equity firm," one analyst told the National Post.

Wells himself hasn't done much to quash such talk. He said Biovail needs to shrink costs to bring them into line with falling revenue. Options? The usual in pharma these days: cutting staff and closing some manufacturing facilities, he said: "Everything is on the table."

Biovail is certainly in need of help. The company has been shelling out cash on legal fees, dealing with accounting probes by both the U.S. Securities and Exchange Commission and Canadian securities watchdogs. Current and former execs have been accused of conspiring to brighten up financial results. Analysts say Biovail's pipeline looks sparse; worrisome, because generic competition is looming for Wellbutrin XL. Can Wells, a former McDonald's exec, deliver? We'll find out.

- here's the release on Wells
- read the story in the National Post
- check out the article in The Star
- get the news from the Ottawa Citizen

FDA probe clears generic Wellbutrin

Thu, 17 Apr 2008 06:59:54 -0400

Listen to all those generics makers heaving sighs of relief. The FDA has given the thumbs-up to Teva's generic Wellbutrin XL, which has been under investigation since early last year. Patients who'd switched from GlaxoSmithKline's branded form of 300 mg pill to Teva's Budeprion XL 300 mg complained that the drug simply didn't work. They also cited new side effects such as headaches and anxiety. ConsumerLab.com tested the copycat drug, finding that it released 34 percent of its active ingredient within two hours, compared with 8 percent for the branded form.

The FDA, however, concluded that the generic is "bioequivalent and therapeutically equivalent." The agency cited some "small differences" in the two different formulations, but said they're not outside the boundaries for equivalence. Depression does tend to recur, the agency said, so patients may simply have begun a new episode at the same time they switched meds.

But ConsumerLab.com said the FDA cites bioequivalency data not for the 300 mg pill in question but for the 150 mg form. "On top of that, the data they have clearly shows the drug is releasing much faster than the original," said lab chief Tod Cooperman, calling the agency's conclusion "a huge leap of faith."

Teva, on the other hand, says it's pleased with the outcome. And so are other generics makers, no doubt. If the agency had found Teva's version wanting, who knows what new regulations and trials new generics might have had to withstand?

- read the story in the LA Times
- check out the Pharmalot item

Related Articles:
Biovail loses effort to stop generic Wellbutrin. Report
Teva plans aggressive move into biogenerics. Report