Cimzia

FDA orders tougher warnings on TNF drugs

Tracy Staton — Fri, 05 Sep 2008 11:06:40 -0400

Forty-five deaths have prompted the FDA to demand new warnings on TNF inhibitors. The agency received reports of 241 cases of the fungal infection histoplasmosis in patients taking the drugs, which are used to treat rheumatoid arthritis and other autoimmune disorders. Among them were 45 patients who died. In at least 21 cases, doctors didn't diagnose the problem and treatment was delayed; 12 of those cases were fatal.

The drugs--Remicade from Johnson & Johnson; Humira from Abbott Laboratories; Cimzia from UCB; and Enbrel, co-marketed by Amgen and Wyeth--already carry warnings of infection risk, including a specific warning about tuberculosis.

But the FDA wants specific language about histoplasmosis and other fungal infections, particularly because doctors appear to have overlooked them in those 21 patients. Twenty percent of the patients who developed the infections died, but more than half of those treated late didn't make it.

- check out Amgen and Wyeth's statement
- see the WSJ Health Blog post
- read the story in the New York Times

UCB revamps with 2,000 job cuts

Maureen Martino — Thu, 28 Aug 2008 08:40:52 -0400

Yet another pharma company is hopping on the layoff bandwagon. In an effort to become a focused central nervous system and immunology disease company--and prepare for patent expirations--Belgium's UCB Pharma is reallocating €300 million over the next three years and cutting 2,000 jobs. That's about 17 percent of the company's workforce.

The drug developer said about 2400 positions will become redundant, but that it will be creating around 400 new jobs. Three hundred other positions will be re-deployed to UCB's core sites. The company's top drug--the anti-epileptic treatment Keppra--will lose patent protection in January. The allergy drug Zyrtec also went off patent in the U.S. at the end of 2007. "Patent expires are challenging times," said Roch Doliveux, CEO of UCB.

The €300 million investment, part of the company's SHAPE project announced earlier this month, will boost UCB's CNS and immunology programs while improving the company's competitiveness.

"...[F]ollowing the recent approval of Cimzia for Crohn's disease in the U.S. and the positive opinions for Neupro for RLS and Vimpat for epilepsy in Europe, the time is now to take action to shape UCB for the future and become a specialist company focused on successfully delivering our new medicines to patients," explained Doliveux.

- check out UCB's release
- read this article for more

UCB's Cimzia app gets data boost

Tracy Staton — Thu, 12 Jun 2008 11:12:50 -0400

Will rheumatoid arthritis patients soon spell relief C-I-M-Z-I-A? The UCB drug, an anti-TNF biologic, got the FDA nod for Crohn's disease treatment in April, and an app for an arthritis indication is pending. At this week's rheumatology conference in Europe, researchers presented data showing that Cimzia added to methotrexate virtually stopped joint deterioration in its tracks--within 16 weeks of therapy, to be exact. Rheumatologists told Pharma Times that these were the quickest results of any RA drug regimen. Armed with this data, UCB will soon be pushing for an RA indication in Europe as well, company officials said.

This study closely follows news that UCB inked a deal with Otsuka Pharmaceuticals to commercialize and market Cimzia in Japan for Crohn's disease. The deal also covers UCB's epilepsy med Keppra.

- read the Pharma Times piece
- check out the Forbes story
- see the Otsuka coverage from Thomson Financial

Quick Cimzia launch overjoys UCB

Tue, 06 May 2008 06:59:54 -0400

UCB Pharma was delirious with glee when it managed to launch its new TNF inhibitor Cimzia for Crohn's disease just 48 hours after the FDA gave its blessing. As In Vivo notes, the joy is understandable: The agency's approval surprised skeptics and boosted shares by 20 percent immediately.

But the quick launch is significant for other reasons, too. Though they've become routine, it wasn't so long ago that the FDA was a mysterious, opaque agency, a sort of oracle from which approvals or denials might issue at any time. Then came user fees and deadlines, allowing drugmakers to prep their launches as the agency's action date approached, saving valuable patent-coverage time. Now, though, the understaffed agency has started missing more deadlines, and, infected with excess caution, second-guessing itself. So predictability is starting to suffer--and so might drugmakers' ability to plan ahead.

Not to mention new regulatory requirements, which dogged Cimzia through the approval process. But we'll let In Vivo tell the rest of that story.

- read the blog item