rheumatoid arthritis

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

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

ALSO NOTED: Forest takes charge on Azor split; GSK launches Tykerb-Herceptin trials;

Tue, 13 May 2008 06:59:50 -0400

> Forest Laboratories will take a $44.1 million charge on termination of its deal to co-promote the hypertension drug Azor with Daiichi Sankyo. Report

> GlaxoSmithKline launched its large-scale trials pitting Tykerb against Genentech's Herceptin in early-stage breast cancer. Tykerb report

> Worried that antipsychotics are prescribed when they're not needed, Washington State is working on a plan to ensure that the meds are used appropriately in children on Medicaid. Report

> Schering-Plough is getting the country's largest rooftop solar-energy system, according to PPL Renewable Energy, which is installing the panels at Schering's Summit, NJ, campus. Report

> Already a problem in Southeast Asia, counterfeit malaria drugs are flooding African areas already hard hit by the disease, according to a new study. Report

> Daiichi Sankyo posted a 24.3 percent increase in fiscal-year profits to $941.5 million, but revenues fell by 5.3 percent, and it expects smaller profits in the year to come. Report

> Solvay reported a slight rise in first-quarter rise sales and profits. Report

> Following Wal-Mart, Kroger expanded its popular $4 generic drug program. Report

> India's Ranbaxy has flexed its research muscles once again, this time signing a five-year pact with Merck to develop new anti-infectives. Ranbaxy report

> Faced with a patent fight that has frustrated efforts to find a buyer, Trimeris has begun to hand back out $80 million in cash as it winds down its operations. Trimeris report

> Elixir Pharmaceuticals has dropped its bid for an $86 million IPO, saying that market conditions aren't right. At the same time, Aldagen, a small biotech company with 18 employees, is making a bid to raise $80 million in an IPO. IPO report

> Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Report

Emerging Drug Developer: Resolvyx Pharmaceuticals. Profile

And Finally... The Republic Party's new slogan sounds a little familiar to the folks marketing Effexor XR. Report

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

As former exec indicted, BMS posts growth

Thu, 24 Apr 2008 06:59:56 -0400

A triad of Bristol-Myers Squibb news today, some good, some not-so-good. First, let's get the earnings out of the way: The company reported a decline in earnings on restructuring charges, but adjusted results beat Wall Street forecasts; Bristol-Myers also managed to boost sales by 20 percent--yes, 20 percent--to $5.18 billion. Whither those restructuring charges? You'll recall that BMS announced 4,300 job cuts and a plethora of plant closures, measures designed to save $1.5 billion annually by 2010.

Meanwhile, a former Bristol-Myers senior VP has been indicted for misleading the government about a deal to keep generic Plavix off the market. According to the indictment, Andrew Bodnar told regulators that Bristol hadn't cut a deal with Apotex when he himself had negotiated it. Bodnar's indictment is just the latest bit of fallout from the 2006 deal; BMS already kicked out its CEO and pleaded guilty to federal charges, paying a $1 million fine.

And in the U.K., Bristol-Myers got the thumbs-down from the National Institute for Clinical Excellence on its rheumatoid arthritis treatment Orencia. NICE says it's not cost-effective and so it shouldn't be paid for by the National Health Service.

- get the earnings news in the Houston Chronicle
- see the indictment story at the WSJ Health Blog
- find out more on the indictment from Pharmalot
- check out the NICE brief at CNN Money

ALSO NOTED: GSK to invest $47M in Irish plant; AstraZeneca, GSK get downgraded;

Fri, 18 Apr 2008 06:59:50 -0400

> GlaxoSmithKline is set to create 50 new jobs in Dungarvan, Ireland, over the next three years with a $47 million expansion of its over-the-counter manufacturing facility there. Report

> AstraZeneca and GlaxoSmithKline saw their stock ratings cut at J.P. Morgan yesterday, to "underweight" from "neutral"; the Wall Street firm judged the drug makers' long-term earnings predictions to lack credibility. Report

> Meanwhile, Morgan Stanley double-upgraded Novartis' stock to "overweight" from "underweight," citing positive news from the Swiss drug maker's vaccines division. Report

> Fund manager Capital Group recently cut its stake in AstraZeneca to the extent that it's no longer the drug maker's largest shareholder for the first time since AZ's creation via merger in 1999. Report

> Ahmedabad, India-based Lincoln Pharma is setting up a joint venture with an unidentified U.S. company to make tablets, capsules, and ointments at a new manufacturing plant. Report

> Belgian healthcare group Omega Pharma reported lower-than-expected first quarter sales of $308 million because of a decline of domestic revenues in Spain. Report

> Further solidifying RNA's "next big thing" status, GlaxoSmithKline and Regulus Therapeutics today announced a $600 million alliance to discover, develop and market microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Report

> Dynavax's shares took a beating this morning after the FDA placed a clinical hold on the company's trial of Heplisav, a hepatitis B therapy. Report

> India-based drugs have made a name for themselves as makers of copycat drugs. But some of these companies are shifting gears and developing their own drugs from scratch. Report

> After observing serious safety problems in a Phase II trial, Wyeth and ViroPharma are dropping development of HCV-796. Report

> Want to get a good forecast of the influenza strains Americans, Europeans and other people around the globe need to guard against? Then look to Asia. Report

> Researchers are hot on the trail of a cheaper, easier HPV vaccine. Report

And Finally... An FDA-approved drug used to treat Lou Gehrig's disease, Rilutek (riluzole), may slow the growth of melanoma. Release

ALSO NOTED: J&J reports big revenue growth; Drugmakers fight U.K.'s Aricept ruling;

Tue, 15 Apr 2008 06:59:50 -0400

> Johnson & Johnson reported a 7.7 percent increase in first-quarter sales, to a record-setting $16.2 billion; EPS grew by 8.6 percent to $1.26 excluding special charges. Report

> Eisai, Pfizer, and Shire are fighting a U.K. ruling that restricts access to Alzheimer's drugs such as Aricept to patients in later stages of the disease. Report

> Schering-Plough will report its first-quarter results tomorrow with a conference call; CEO Fred Hassan will offer an update on the company's business and its "major initiatives," most likely including Schering's new $1.5 billion cost-cutting plan. Report

> Abbott Laboratories is prepping for an antitrust trial over the AIDS drug Norvir, scheduled to start Friday. Report

> A combo of Lipitor and Celebrex--both made by Pfizer--inhibited the growth of prostate cancer cells in mice; human trials are being planned. Report | Report

> Genentech and its partner Biogen Idec said their blockbuster lymphoma and rheumatoid arthritis med Rituxan didn't show efficacy against multiple sclerosis in a 96-week trial. Report

> Forest Labs reported fourth-quarter earnings of $172.8 million on a 12 percent increase in revenues to $990.9 million. Release

> Laureate Pharma said it's made a deal with Alopexx Pharmaceuticals to manufacture the latter's product candidate mAb F598 antibody for use in clinical trials. Release

> Teva Pharmaceuticals got 180-day exclusivity for a generic version of the Ortho-McNeil antipsychotic med Risperdal. Report

> Roche said it would pay $160 million for the British pharma Piramed, which is developing meds for cancer and inflammatory diseases such as rheumatoid arthritis. Release

> The European commission gave Bristol-Myers Squibb and Otsuka permission to market their Abilify drug for treatment and prevention of mania in bipolar patients. Report

> Belgian healthcare group Omega Pharma will distribute Chrisal International's anti-dust mite spray in Europe, a Belgian newspaper reports. Report

> Hit by a clinical trial delay triggered by a surprise change-up at the FDA, Canada's Vasogen has hit the brakes on spending and announced plans to lay off 85 percent of its work force. Report

> Shares of AtheroGenics shot up this morning on the news that an interim analysis of late-stage data for AGI-1067 showed a statistically significant reduction in Hemoglobin A1c--a standard measure for blood sugar control. Report

And Finally... New York still feels the effects of a cholera epidemic almost 200 years ago. 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

BMS, Repligen settle Orencia fight

Tue, 08 Apr 2008 06:59:54 -0400

Four companies, two disputed patents, two multimillion-dollar settlements.

Repligen and Bristol-Myers Squibb buried the hatchet over Orencia, the rheumatoid arthritis treatment that's been subject to a patent dispute between the two companies. Bristol-Myers will pay $5 million plus royalties on U.S. net sales of Orencia to settle the disagreement. Repligen expects its first years' receipts from BMS to be around $30 million.

Meanwhile, Depomed will get about $10 million in payments and royalties in settlement of a patent infringement case against Ivax Corp. and its parent company, Teva Pharmaceuticals. The drug in question was the diabetes treatment Glucophage XR.

- check out the Orencia agreement
- see the Depomed news in the San Jose Business Journal

Related Articles:
NICE snubs Orencia, picks 3 rivals. Report
Regulatory panel gives BMS' Orencia unanimous approval. Report