Arthritis

FDA stresses dangers of transplant meds

Tracy Staton — Mon, 19 May 2008 11:25:52 -0400

The FDA is warning doctors again that organ-transplant drugs CellCept (from Roche) and Myfortic (Novartis) have been linked to miscarriages and birth defects when taken by pregnant women. Last October, the agency announced that it had received reports of these side effects, and at the time added warnings to the two drugs' labels. The new round of FDA alerts doesn't stem from additional reports of safety problems, but from the agency's fear that physicians didn't get the initial heads-up. Before prescribing the drugs, the agency says, doctors should confirm that their transplant patients are not pregnant, and should make sure that the patients are using effective contraception.

Patient who'd experienced miscarriages and birth defects were mostly mothers who took CellCept before their pregnancies were detected. Some were taking the med not because they'd received organ transplants, but to treat rheumatoid arthritis and lupus--both off-label uses for the drug.

The new warning comes just a month after another CellCept alert: FDA announced in April that it was investigating 16 patients who'd developed a rare neurological disease while taking it.

- check out the FDA alert
- see the Associated Press story

Enbrel gets black-box infection warning

Fri, 02 May 2008 06:59:56 -0400

Enbrel's new black box is now official. Wyeth and Amgen have put the final touches on a boxed warning about tuberculosis and other life-threatening illness; the label states that patients using the drug have contracted infections that led to hospitalization and death. The drug is primarily used to treat psoriasis, but also is used for rheumatoid arthritis and other autoimmune disorders.

Amgen and Wyeth co-market Enbrel in the U.S. and Canada. The drug posted $3.2 billion in sales in 2007.

- see the CNN Money coverage

ALSO: According to the latest CEO ranking by Forbes magazine, which measured performance against pay for 175 company chiefs, Amgen's Kevin Sharer came in near the bottom of the barrel, at 169th. Report

SPOTLIGHT: Rituxan falls short in lupus trial

Wed, 30 Apr 2008 06:59:52 -0400

In a big disappointment for Genentech and Biogen Idec, Rituxan failed its late-stage test against lupus. Already approved for non-Hodgkins lymphoma and rheumatoid arthritis treatment, Rituxan might have added $1 billion to its $2.3 billion in 2007 sales with a lupus indication. Report

SPOTLIGHT: Wyeth sales boosted by Enbrel

Tue, 22 Apr 2008 06:59:52 -0400

Despite major erosion in sales of its heartburn blockbuster Protonix, Wyeth managed to beat Wall Street's expectations for first-quarter earnings, posting a $1.2 billion profit on a 6 percent increase in revenues to $5.71 billion. Protonix sales fell 66 percent, but revenues from the arthritis treatment Enbrel skyrocketed by 36 percent. Report

SPOTLIGHT: Insurers hike co-pays for expensive meds

Mon, 14 Apr 2008 06:59:52 -0400

Health insurers are passing on the high cost of some meds to patients, asking them to pay up to one-third the price of expensive drugs; the policies affect drugs for such serious illnesses as cancer, multiple sclerosis, and rheumatoid arthritis, and they apply even to meds without cheaper equivalents. Report

SPOTLIGHT: Enbrel gets 'black box' infection warning

Mon, 17 Mar 2008 07:59:52 -0400

Amgen and Wyeth added a "black box" warning to their Enbrel arthritis drug to caution doctors and patients about the risk of infection, including tuberculosis. Release

Earnings from Schering, Sanofi, Teva

Tue, 12 Feb 2008 06:59:56 -0500

It's an earnings kind of day today, with two of the brand-name biggies reporting, plus the leading generics maker. Here are the results:

Schering-Plough reported a $3.4 billion loss for the fourth quarter, on charges related to its buyout of Organon BioSciences. Those accounting charges masked a 40 percent year-over-year increase in revenues to $3.72 billion. Products driving the increase include the arthritis med Remicade--which saw sales rise by 35 percent to $455 million--and the nose spray Nasonex.
Despite generic competition that ate into sales of its sleeping pill Ambien, Sanofi-Aventis reported a 31 percent increase in profits to $1.09 billion for the fourth quarter. However, prior year results included an accounting charge of $311.8 million. Strong Plavix sales, which grew by 14 percent year-over-year, helped feed revenues. But sales of the company's top 15 drugs declined 0.3 percent.
Generics maker Teva saw its fourth-quarter earnings jump by 20 percent, beating analyst expectations. Sales of the company's own treatment for multiple sclerosis, Copaxone, grew by 15 percent to become the no. 1 seller in the U.S. among MS meds.

- see Schering-Plough's release
- check out the news from the Associated Press
- find a link to Sanofi's press release
- read the Sanofi story in the Wall Street Journal
- see the Teva article

Roche sales surpass Novartis'

Wed, 30 Jan 2008 06:59:56 -0500

Eat dust, Novartis. Roche just posted sales of $42.2 billion, $2.4 billion more than its Swiss rival's $39.8 billion. Strong sales of its cancer drugs helped boost profits by 25 percent to $10.48 billion. The rheumatoid arthritis and lymphoma treatment Rituxan alone delivered revenues of $5 billion, becoming the company's best-selling drug ahead of cancer meds Herceptin and Avastin.

The outlook for 2008 isn't all rosy, however. Tamiflu sales, which dropped 19 percent to $1.9 billion in 2007, will continue to fall off, and Herceptin growth is expected to slow, too. Overall, sales growth will drop to the single digits--and this after seven consecutive years of double-digit increases.

It's flush with cash, though, which it plans to use to accelerate R&D spending and to acquire small to medium-sized companies; it's looking primarily in the diagnostics area, but also would consider small pharma deals. Mega-mergers, however, aren't in the cards, CEO Franz Humer said. Of course, Roche has its Ventana deal to wrap up by the second half of 2008.

- see the release from Roche
- read the article in the Financial Times
- check out CNBC's report
- read the news on cash spending at CNN Money

Related Articles:
Roche invests $387M in biotech. Report
Roche to boost R&D spend, reorganize research. Report
Roche shakes up R&D, eyes new buyouts. Report
Big Ventana owners could nix deal. Report

SPOTLIGHT: MabThera aims for new indications

Fri, 25 Jan 2008 06:59:52 -0500

Roche's antibody med MabThera (Rituxan) just aced two trials aimed at expanding uses for the drug: one that pitted MabThera against rheumatoid arthritis and another that used it against adult leukemia. One analyst called the drug "a pipeline in a molecule." Report

Alzheimer's: A new indication for Enbrel?

Thu, 10 Jan 2008 06:59:56 -0500

For yet another example of the trend toward teaching old drugs new tricks, check out Exhibit E for Enbrel. According to research released today, the anti-rheumatoid arthritis med has shown an amazing ability to rehabilitate Alzheimer's patients.

Made by Amgen, Enbrel is a TNF-alpha inhibitor, and excess TNF-alpha has been found in the cerebrospinal fluid of Alzheimer's patients. Previous research has shown that Enbrel injected into the spine of patients can cause marked improvement in symptoms that lasts up to six months. The new data , published in the Journal of Neuroinflammation, focuses on one man whose relief began within 10 minutes of the injection. Suddenly, he could remember things he'd been unable to recall before treatment, and his score on a common symptom assessment more than doubled.

Much larger studies are needed before any talk of getting a new indication for Enbrel--or its TNF-inhibitor counterparts Humira, made by Abbott Laboratories, and Remicade, made by Johnson & Johnson subsidiary Centocor. But don't expect this sort of research to stop with Alzheimer's. Considering the role inflammation plays in many diseases, we may see researchers throwing TNF-alpha inhibitors at all sorts of conditions, just to see what might stick.

- get the scientific details
- read the report from the BBC
- get more from the Journal of Neuroinflammation

Related Articles:
Amgen reps allege marketing abuse. Report
MAbs are hottest segment of biotech industry. Report
New vaccine may stop, slow Alzheimer's. Report