Elan

Another Tysabri patient contracts PML

Tracy Staton — Thu, 30 Oct 2008 11:08:47 -0400

Another Tysabri patient has taken ill with the deadly brain infection progressive multifocal leukoencephalopathy, or PML. It's the sixth such case overall, and the third since the multiple sclerosis drug was reintroduced to the market in 2006 under a strict risk management program. This sixth patient, a woman, is alive, as are three of the five previous PML cases linked to Tysabri. About 35,500 patients were taking the drug at the end of last month, according to Biogen Idec.

The Wall Street Journal said the new case would "[darken] the commercial prospects for the medicine." There's no doubt that growth in Tysabri usage already has slowed since the two previous post-reintroduction cases were announced in July. And the latest news sent shares of Biogen, listed on the Nasdaq Stock Market, down 11 percent to $37.40 in after-market trading yesterday. Depository receipts of Biogen's marketing partner, Ireland's Elan, fell 23 percent after the announcement.

The new case also calls into question the theory that strictly governing Tysabri's usage would prevent PML from arising. But even so, the number of cases remains small, compared with the number of patients using the drug.

- read the WSJ story

Tysabri to get new Euro label

Tracy Staton — Fri, 26 Sep 2008 10:55:19 -0400

The European Medicines Agency called for an update to product information for Biogen Idec and Elan's multiple sclerosis drug Tysabri, highlighting the risk of a potentially deadly brain infection. But the EMEA also confirmed that it still believes the drug's benefits outweigh its risks. EMEA release

Tysabri may deliver 'sustained improvement'

Tracy Staton — Mon, 22 Sep 2008 11:18:35 -0400

Tysabri may have scored a big plus for drugmakers Biogen Idec and Elan. A trial of the multiple sclerosis treatment showed that it might actually improve the physical disability patients suffer, rather than simply slowing down or staving off decline. "Tysabri-treated patients are significantly more likely to experience a sustained improvement in disability compared to placebo patients," said Frederick Munschauer a neurologist from the State University of New York, adding that, "This [post hoc] analysis represents the first evidence supporting a sustained improvement in function" from an approved MS drug.

That's good news for Biogen and Elan, offering even greater benefit to outweight the risk of a very rare but potentially deadly brain infection that, when it first appeared in Tysabri patients, forced the medication off the U.S. market. Tysabri has since been reintroduced under a risk-management program and continues its comeback story, despite the recent announcement that the infection, primary multifocal leucoencephalopathy, had cropped up again in two patients in Europe.

- see the Biogen release
- read the story in the Irish Times
- get analyst reaction at FinFacts

FDA, Biogen mull Tysabri label changes

Tracy Staton — Tue, 26 Aug 2008 11:15:54 -0400

The FDA is huddling with Biogen Idec and Elan on amendments to Tysabri's label. The reason, of course, is the news of two cases of the brain disorder progressive multifocal leukoencephalopathy, or PML, that emerged in late July.

In a notice on the agency's website, the FDA reiterated its belief that Tysabri taken on its own may generate a smaller risk of PML than when it's taken in combo with other meds that alter the immune system.

Compared with the response the last time PML emerged in Tysabri patients, it's mild. As you know, Tysabri was pulled from the market when PML first cropped up, but was allowed back on the market on a strict risk-management program, under which patients using the drug are monitored for infection. Investors showed their relief by pushing Biogen shares up by about 2 percent to $53.48, and Elan shares by 5 percent, to $14.25.

- check out the release
- read the Wall Street Journal story
- see the item in the Wall Street Journal Health Blog

Elan scouts Dublin-area sites for plant

Tracy Staton — Mon, 30 Jun 2008 10:04:23 -0400

Elan, Ireland's biggest drugmaker, is hunting the Dublin area for sites for a new $300 million manufacturing plant, with a location near its partner Wyeth in Grangegorman seen as the front runner. The company is also considering sites along Ireland's east coast. Report

AZ, Amgen earnings flat; Shire sales leap

Fri, 25 Apr 2008 06:59:54 -0400

It's a mixed bag of drugmaker earnings reports today, with two biggies posting flat results and two smaller firms chalking up respectable gains.

AstraZeneca's profits suffered under restructuring costs and falling Nexium sales, reporting a $2.1 billion gain, 5 percent less than the same quarter last year. Sales were 10 percent higher at $7.7 billion, but much of that increase came from the weak dollar. Analysts and shareholders were unimpressed; UBS wrote that the "ramifications of [the first quarter results] could be far reaching."
Amgen's earnings were mostly flat: Net income of $1.14 billion compared with $1.11 billion a year ago, with accounting charges eating into earnings. Revenues, however, slid by 2 percent, to $3.61 billion. No big surprise, considering that sales of its biggest drug, Aranesp, free-fell by 25 percent; it and its sister med Epogen have been hamstrung by safety concerns for months now.
U.K. specialty pharma Shire posted a 33 percent hike in sales to $702 million, slightly ahead of analyst expectations. EPS was up to 22.7 cents from 21.3 cents during last year's first quarter. One sour note: The company estimated that its Vyvanse ADHD drug--which the company hopes will replace its soon-to-go-off-patent Adderall--would generate sales on the "lower end" of its predicted range of $350 million to $400 million.
Ireland's Elan also posted a big increase in sales--22 percent, to $214.7 million--but still reported a loss of $85.5 million. At least the loss is smaller than last year's $93 million. The revenue increase came from surging sales of its lead drug, the MS treatment Tysabri it co-markets with U.S.-based Biogen Idec.

- see the AstraZeneca piece in the Financial Times
- check out MarketWatch's story on Amgen
- read the Shire article at Orange
- find Elan's numbers in Forbes

'Cloud of risk' swells around Tysabri

Thu, 28 Feb 2008 06:59:56 -0500

The multiple sclerosis drug Tysabri has hit an obstacle on its comeback trail. Drug makers Biogen Idec and Elan warned doctors yesterday that serious liver injury could arise in patients using the med. In some patients, signs of liver problems showed up just six days after their first dose.

The new warning was included in prescribing information for Tysabri use in patients with Crohn's disease, a new indication approved by the FDA last month. Now it's being added to inserts for patients using the product for MS. The rate of liver injuries is less than one in 1,000 patients.

You'll recall that Tysabri was taken off the market in 2005 after a few patients developed a rare neurological disorder. In 2006, the FDA allowed it to be sold under a restricted distribution program. Since then it's been slowly gaining market share; it brought in $343 million for Biogen last year.

After nabbing the new indication last month, Biogen said it hoped to attract 100,000 new patients to the drug by 2010. We'll see whether the new warnings have any effect on those numbers. Some analysts are wary; one called Tysabri "a drug with a cloud of risk hanging over it."

- read the story in the Wall Street Journal
- see the item at Pharmalot
- check out the coverage at CNBC

Related Articles:
Docs raise new Tysabri fears in NEJM. Report
After reintroduction, Tysabri builds patient base. Report
FDA allows Tysabri back on market. Report

Biogen CEO: Pharma too wimpy to deal

Fri, 11 Jan 2008 06:59:58 -0500

Biogen Idec CEO to Big Pharma: You just didn't have the guts to make a deal. In an interview with the Boston Globe this week, Biogen honcho Jim Mullen said major drug makers are more conservative than smaller biotechs like Biogen and its crosstown neighbor Genzyme. "They never would have pursued some of the drugs we pursued," Mullen said.

In other words, biotech is daring, pharma is timid; biotech is Mighty Mouse, pharma is the huge, whimpering lion with a thorn in its paw.

Mullen went on to detail specific problems with the deal: Tysabri, Biogen's MS drug that has faced safety problems in the past but could deliver blockbuster sales if they can be avoided in future. And then there are Biogen's major partnerships with Elan and Genentech, which could have complicated dealmaking.

Or could it have been that, at $25 billion to $30 billion, Biogen was just overpriced, as some industry observers and analysts have suggested? Nah.

- read the article from the Boston Globe

Related Articles:
Biogen shares deflate as it gives up on sale. Report
Is Big Pharma souring on Biogen deal? Report
Sources: Biogen gets bidders, with Pfizer in lead. Report
What's Biogen Idec really worth to Big Pharma? Report

FDA reviews safety of Bristol antibiotic

Thu, 15 Nov 2007 06:59:54 -0500

Call it a distant possible death warning. Prompted by a study suggesting the drug may increase the risk of death, FDA has embarked on a safety review of Maxipime, a Bristol-Myers Squibb antibiotic. For now, the agency isn't recommending any prescribing changes. The review will take about four months. In the meantime, FDA wants healthcare providers to enter any Maxipime side effects into the MedWatch adverse event reporting system.

Marketed in the U.S. by Elan, Maxipime is an injectable used to treat serious infections such as pneumonia. The possible risks were first made public in May, when The Lancet Infectious Diseases medical journal published an article suggesting Maxipime patients were more likely to die than patients treated with other drugs in the same class. The company's own review of the data "concluded that the safety profile has not changed," a spokesman said.

- see the FDA's early communication about the safety review
- read the CNN Money report for more

Related Articles:
Dry antibiotic pipeline concerns infectious disease experts. Report
WHO: Infectious disease a growing threat. Report
The challenges of infectious disease. Report
Study finds alarming spread of MRSA. Report
Targets found for antibiotic development. Report

Is Big Pharma souring on Biogen deal?

Wed, 14 Nov 2007 06:59:57 -0500

Remember last week's rumors that Big Pharma was poised to jump at the chance to bid for Biogen Idec? This week, analysts aren't so sure. Investors are suddenly shying away from the Cambridge, MA-based biotech because word on the street is that a deal may be too rich even for a major drug maker to swallow.

Yesterday, Biogen stock dropped to just over $69 during the day, its lowest point since the company put itself on the block a month ago. Compare that to $84.75 on October 15. What's the problem? Some market observers say potential bidders sell drugs that compete with Biogen's. Others point to Biogen's partnerships with Genentech (for Rituxan) and Elan (for Tysabri) as complicating factors. And news on the Street says some potential bidders--namely Roche and Sanofi-Aventis--have dropped out.

One analyst told the Boston Globe that it all hinges on Tysabri, Biogen's MS drug. If the buyer thinks Tysabri will go platinum, then the company doesn't look overpriced. If not, well, then Biogen's the goose that might not lay a golden egg.

- check out this Boston Globe report

Related Articles:
Tysabri: The comeback kid. Report
Sources: Biogen gets bidders, with Pfizer in lead. Report
What's Biogen Idec really worth to Big Pharma? Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec in play after Icahn makes his move. Report

Pfizer among Biogen front-runners

Thu, 08 Nov 2007 06:59:58 -0500

Merger-watch fans, listen up. The Financial Times is reporting some tantalizing details about the bidding for Biogen Idec, the biotech based in Cambridge, MA, that sent stock analysts into an uproar when it put itself up for sale a few weeks ago. Unnamed sources told the London newspaper that the sequence of events leading to that surprise announcement actually began with Pfizer offering $80 per share for the company. Investor Carl Icahn (photo) then made a counter-offer, and the company retained financial advisors to conduct an orderly sale. Even now, Pfizer remains one of the front-runners for Biogen, the sources said, along with Merck and Johnson & Johnson.

Some other buyers have already dropped out of the race, spooked by the "nosebleed prices" expected. Icahn offered $23 billion, so the winning bid is likely to be higher. Are Biogen's assets worth that much? They include the multiple sclerosis drug Tysabri, in partnership with Elan; the lymphoma and arthritis remedy Rituxan, in collaboration with Genentech; and the MS drug Avonex, which is wholly owns. It also has a pipeline of drugs in development, including two promising MS products.

Meanwhile, headhunters are getting calls from Biogen types expecting a sale to lead to the layoff ax. The non-executive staff is anxious, recruiters said, even though the company continues to hire new workers.

- check out the buyout report from the Financial Times
- read about Biogen staff seeking shelter at Inside Recruiting

Related Articles:
Biotech stocks surge as investors anticipate buyouts. Report
Speculation soars over Pfizer's interest in biotech. Report
What's Biogen Idec really worth to Big Pharma? Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec in play after Icahn makes his move. Report
Who should Pfizer buy? Report

No new PML cases linked to Tysabri

Tue, 28 Aug 2007 06:59:56 -0400

Hear that sigh of relief? Biogen Idec announced Tuesday that, as of mid-July, there had been no new reported cases of the rare brain disease linked with its multiple sclerosis drug Tysabri. That means no new cases since the drug was reintroduced last July under a U.S. program that monitors patients for any signs or symptoms of the disease, progressive multifocal leukoencephalopathy, or PML. This comes on the heels of Tysabri's re-instatement on the National Health Service formulary in the U.K last week. And more good news may be in the offing: An FDA committee backed Biogen's bid to make Tysabri an approved treatment for Crohn's disease in early August. No word yet on whether the agency will give it the final nod.

- read this AP article

Related Articles:
Tysabri: The comeback kid. Report
After reintroduction, Tysabri builds patient base. Report
FDA allows Tysabri back on market. Report

Tysabri: The comeback kid

Thu, 23 Aug 2007 06:59:54 -0400

Call Tysabri the comeback kid. The multiple sclerosis drug, made by Elan and Biogen Idec, was pulled from the U.S. market in 2005 after reports of its links to a rare but potentially fatal brain disease. Sales resumed last year when regulators decided its efficacy outweighed the risks for some patients; tough guidelines were drawn up to help ensure safety.

Now, the UK's National Institute for Health and Clinical Excellence has reinstated Tysabri on the National Health Services' formulary. The action isn't unexpected, but it's significant because the NHS must begin paying for the drug within three months of a NICE approval. Also, continental drug regulators often follow the UK's lead. Analysts predict sales of the drug could now reach $800 million.

- see this report on the NHS' endorsement
- read the AFX report on Tysabri's comeback

Related Articles:
FDA committee backs Tysabri for Crohn's. Report
After reintroduction, Tysabri builds patient base. Report
FDA allows Tysabri back on market. Report