Biogen Idec

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

Biogen works to stave off proxy fights

Tracy Staton — Mon, 20 Oct 2008 10:09:28 -0400

Biogen Idec is building up its defenses against the sort of proxy battle it was forced to wage with activist investor Carl Icahn earlier this year. The company has revised its corporate bylaws to include obstacles for activist shareholders who want to nominate new directors or propose resolutions for a vote at annual meetings.

For instance, the company gave authority to its chairman to adjourn a shareholder meeting even if a majority isn't in favor. Shareholders who want to get resolutions or directors onto a ballot have to disclose their holdings in any financial instruments with values that depend on Biogen shares. And they'll have to fess up to any prior agreements with business partners or with its nominees about Biogen's future operations.

You'll recall that Icahn pushed Biogen to sell itself to the highest bidder earlier this year, arguing that the company was undervalued. But when Biogen solicited offers, no firm bids surfaced, and Icahn accused the company of just going through the motions. Then, he nominated his own slate of directors, but failed to get them on board.

- read the story in the Wall Street Journal

FDA lets dying lawyer have Tysabri

Tracy Staton — Fri, 17 Oct 2008 10:50:51 -0400

Biogen Idec said no, but the FDA said yes. We told you yesterday about the case of Fred Baron, a generous Democratic donor who's dying of multiple myeloma. The Clintons, Ted Kennedy and several other prominent politicians, as well as Lance Armstrong, were lobbying Biogen for Tysabri. Well, now Baron will get the drug, even though it's not yet approved for multiple myeloma treatment.

Biogen didn't cave, however; Baron's doctors at the Mayor Clinic worked with the FDA to find a "legal basis" for Tysabri use, the Associated Press reports. You'll recall that Tysabri is sold under a restrictive risk management program because of its links to a potentially fatal brain infection, PML. That program usually prohibits off-label use, and as you know, Tysabri is only approved to treat multiple sclerosis and Crohn's disease in the U.S. Clinical trials for multiple myeloma began in September.

You can be sure that the media will be following Baron's case, so we'll find out how he fares on Tysabri. One of the reasons his illness has attracted so much attention: Baron was the donor who acknowledged sending money to former presidential candidate John Edwards' ex-mistress. That adultery-and-payoff scandal hit the tabloids, of course. So it's no wonder that the money man is now making headlines.

- read the Washington Post story

Celebs plea for off-label Tysabri

Tracy Staton — Thu, 16 Oct 2008 10:54:08 -0400

No one can accuse Biogen Idec of playing favorites. The company has been under assault by luminaries from Bill and Hillary Clinton to Lance Armstrong, who are trying to get Biogen's Tysabri drug for Fred Baron, a legal bigwig who's dying of multiple myeloma. Tysabri is in Phase I testing in multiple myeloma patients. But Baron doesn't meet the trial criteria. And Biogen has an ironclad policy of refusing the med for so-called "compassionate use."

Biogen's reasoning is rooted in Tysabri's complex biography. As you all know, the drug was hailed as a major breakthrough for multiple sclerosis patients after its first launch, but then was pulled off the market in February 2005 because of links to a potentially fatal brain infection, PML. The drug was reintroduced in 2006 under a restrictive access program. Since then, Tysabri has won a broader market, with an approval to treat Crohn's disease. It's also seen a couple of new cases of PML in Europe; those cases were added to Tysabri's labeling.

Biogen CEO Jim Mullen (photo) has held up under the assault of publicity ginned up on Baron's behalf. Calls from the likes of Armstrong, Ted Kennedy, the Clintons, John Kerry and Henry Waxman haven't swayed him. The company doesn't want to set a precedent by allowing Baron to use Tysabri, given the PML risks--and the risk to Tysabri's future should Baron experience an adverse reaction. "We want to protect access for patients who are on the drug now and rely on it," a Biogen spokeswoman told Pharmalot. "[W]e feel like we can't make an exception in this case."

- read the story at Pharmalot

Rituxan holds off leukemia progress

Tracy Staton — Tue, 07 Oct 2008 10:41:37 -0400

Genentech and Biogen Idec are crowing today about Rituxan's performance in a leukemia trial. The late-stage research found that Rituxan in combo with two chemo drugs "significantly" boosted progression-free survival for patients who had relapsed with chronic lymphocytic leukemia. The trial data is now under independent review, the companies said, "for U.S. regulatory purposes."

In other words, expect an application for broader Rituxan use. "We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future," Genentech's SVP Dr. Hal Barron said in a statement.

Rituxan is now approved to combat rheumatoid arthritis and non-Hodgkins' lymphoma. Earlier this year, another late-stage study found that a similar Rituxan combo improved progression-free survival in leukemia patients who hadn't been previously treated. So the companies have promising data in both untreated patients and relapsed patients. We'll keep our eyes open for FDA action.

- read the joint release
- see the Associated Press article

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

Icahn snaps up more of Biogen

Tracy Staton — Tue, 12 Aug 2008 10:17:49 -0400

The Biogen Idec faithful have been preaching "buying opportunity" ever since the company announced two new cases of the brain infection that can afflict patients taking its vaunted multiple sclerosis drug Tysabri. After all, CEO James Mullen had warned that the potentially fatal malady, PML, could and would crop up again, and the MS sufferers taking the drug have been made fully aware of the risk.

We can now count Carl Icahn among those faithful. The activist investor has taken this opportunity to boost his stake in Biogen to 6 percent from about 4.3 percent. That's a $259 million investment.

What's next, given that Icahn rarely puts his money where his mouth won't go? According to SEC documents, he may talk to the company about "concerns relating to shareholder value." Hmm. You'll recall that Icahn recently pressured Biogen into putting itself up for sale, and then accused management sandbagging the bidding process. Perhaps another round of bids is in Biogen's future.

- read the post at the Wall Street Journal Health Blog
- see the item at StreetInsider

Analysts: Tysabri scrips will suffer

Tracy Staton — Thu, 07 Aug 2008 10:46:02 -0400

When Biogen Idec announced last week that a potentially fatal brain infection had cropped up again in Tysabri patients, markets reacted swiftly--and negatively. But investors were only guessing at how that new information might affect new scrips for the drug, which has been hailed as a miracle treatment by many multiple sclerosis patients. Now, financial analysts have done some number-crunching to quantify those long-term effects. And the news isn't good.

Deutsche Bank analyst Mark Schoenbaum told investors that his best-case scenario pegged Tysabri at 75,000 users by 2013--not nearly the 100,000 patients Biogen had been shooting for by 2010. Under more conservative estimates, Schoenbaum predicted 56,000 Tysabri patients, again by 2013. And worst case? If more safety problems emerge, the drug could get pulled from the market--again. (For what it's worth, though, other analysts have said they don't expect Tysabri to be withdrawn.)

Meanwhile, a JP Morgan analyst estimated that the number of Tysabri patients by 2010 would be only 50,000--even before the two cases of progressive multifocal leukoencephalopathy (PML) were reported. The analyst said he doesn't expect that estimate to drop much further.

- read the story in the Boston Globe

Biogen: Tysabri patients have PML

Tracy Staton — Fri, 01 Aug 2008 10:26:41 -0400

Biogen Idec CEO James Mullen predicted it, and now it's happened: Two Tysabri patients have come down with the potentially fatal brain infection, progressive multifocal leukoencephalopathy, or PML, that caused Biogen to withdraw the multiple-sclerosis treatment back in 2005. This time around, though, the company doesn't plan to pull the med or further restrict it.

As you know, Tysabri was allowed back onto the market in July 2006 under a strict risk-management program. Since then, 31,600 patients have started on the drug, and Biogen (and its partner Elan) won an additional indication for Crohn's disease. Mullen had been predicting that 100,000 patients would be using Tysabri by 2010, with quarterly sales of $250 million or better by the end of this year.

It's unclear whether this news will decimate those sales. Investors seem to think so; both Biogen and Elan have seen their shares drop precipitously this morning. And the fact that the sickest PML patient--who's now hospitalized--was only taking Tysabri for 14 months, because the duration of treatment seems to be a factor in the disease. (Previous PML patients had used Tysabri for some two years before discovering they had it.) This patient had used other MS drugs before taking Tysabri, which also appears to be a risk factor. The other patient, who's at home and ambulatory, had been on Tysabri for 18 months, and hadn't used any other MS treatments before.

But patients know about the PML risks before they go on Tysabri; the risk-management program makes sure of that. And so far, the number of PML cases appears to be in line with the statistical risk listed on the drug's label. So we'll have to watch the scrip numbers to see whether verification of that risk deters patients.

- read the Wall Street Journal article
- see the story in the Boston Herald

Earnings up, earnings down for drugmakers

Tracy Staton — Tue, 22 Jul 2008 10:30:14 -0400

A plethora of drug-and-device results today, from falling profits at Boston Scientific and Schering-Plough to higher earnings and flat sales at Merck. Here's the roundup:

Merck posted net income of $1.77 billion, up from $1.68 billion year-over-year; per-share results were 82 cents compared with 77 cents a year ago. Discounting foreign-currency gains, sales were relatively flat, slipping by just 1 percent to 6.05 billion. The company suffered a 48 percent drop in Fosamax revenues because of generic competition, while Vytorin and Zetia sales fell 9 percent. Singulair revenues--expected to rise--stayed flat. But blood-pressure meds Hyzaar and Cozaar saw sales grow by 11 percent to $941 million.
Schering-Plough's earnings suffered on Organon acquisition costs, ending up at $398 million, or 24 cents a share, compared with $517 million, or 34 cents, last year. Excluding those items, EPS would have come to 45 cents, the company says. Sales jumped by 55 percent to $4.92 billion--with $1.4 billion of that increase coming from Organon, which it bought last November. A standout drug was Remicade, which saw sales leap by 41 percent to $557 million.
Boston Scientific's earnings fell 15 percent to $98 million on restructuring charges and declining stent sales. Drug-coated stent revenues plummeted by 30 percent in the U.S. as Medtronic launched its new drug-coated product; worldwide, they fell 13 percent to $382 milion. Total sales came to $2.02 billion.
Biogen Idec boosted its earnings to 70 cents per share for the quarter, compared with 54 cents a year ago, on revenues of $993 million. That's a 28 percent increase over last year's second-quarter sales. On an adjusted basis, EPS came to 91 cents, beating analysts' estimates of 84 cents.
Forest Laboratories posted EPS of 79 cents per share, down from 83 cents a year ago; the numbers suffered from a charge related to Forest's parting ways with Daiichi Sankyo on Azor marketing. Revenues grew by 4.2 percent to $967 million. Sales of its antidepressant, Lexapro, grew by 6.1 percent to $894 million, while Alzheimer's drug Namenda pulled in $219 million, up 14 percent.

- see Merck's earnings at MarketWatch
- get Boston Scientific's news from the Wall Street Journal
- check out Biogen's numbers at MarketWatch
- read Schering's results, also at MarketWatch
- find Forest's earnings release

Biogen CEO: Tysabri to reach $1B in 2008

Tracy Staton — Mon, 21 Jul 2008 11:10:50 -0400

Two years ago this week, Biogen Idec relaunched Tysabri, the multiple sclerosis and Crohn's disease treatment, after a safety scare. Now, the drug is shaping up to be a blockbuster, the Wall Street Journal reports.

Tysabri was recalled in 2005 after three patients developed a rare brain infection and two died. FDA let the drug back on the market the next year under a monitoring program. Just two years later, Tysabri is expected to surpass $1 billion in annual sales, according to Biogen CEO James Mullen. First-quarter sales were $160 million, and second-quarter numbers will be announced tomorrow.

- read the WSJ article

Biogen, Icahn trade insults via the SEC

Tracy Staton — Thu, 05 Jun 2008 19:59:32 -0400

Remember when shareholder Carl Icahn bullied Biogen Idec into putting itself on the block last year? The company entertained offers but ended up saying, "No deal." Now, Icahn and Biogen are trading jabs in front of investors. In letters to shareholders in advance of the annual meeting--where Icahn is backing three directors for election to the board--Icahn called Biogen execs liars. "[A] number of the statements made by Biogen during this proxy contest are untrue," he wrote, under an all-caps headline that screamed "BIOGEN'S SALES PROCESS: WHEN WILL WE KNOW THE TRUTH?"

Not to be outdone, Biogen wrote its own letter to shareholders, lobbying them to vote for the company's candidates for the board instead of Icahn's. "Carl Icahn is promoting a self-serving agenda," the filing states. "Mr. Icahn and his nominees have put forth no ideas to improve stockholder value."

One issue, as Icahn sees it, is whether a potential buyer walked because it couldn't talk to the Irish drugmaker Elan, which partners with Biogen on the multiple sclerosis drug Tysabri. According to Icahn's SEC filing, the news of this bidder only emerged because he sued Biogen over the sale-that-wasn't. But a Biogen spokeswoman said the board was kept apprised throughout the bidding process.

Who'll win the war of words--and proxies? We'll have to wait till June 19, the day of Biogen's annual meeting, to find out for sure.

- read the Boston Globe article
- see the item at the WSJ Health Blog

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

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

ALSO NOTED: Bayer sues Watson over Yasmin; Zimmer weeds out doc conflicts

Mon, 21 Apr 2008 06:59:50 -0400

> Open another chapter in the Bayer fight to protect Yasmin patents: Watson Pharmaceuticals filed for FDA approval for its copycat version of the birth control pill, and Bayer sued to keep the drug off the market. Release

> Device maker Zimmer is working to cut "potential or perceived conflicts of interest" in any consulting deals with docs, by banning all gifts to healthcare professionals, pulling back on sponsoring doctor presentations at conferences, and reviewing royalty deals for potential conflicts--and in some cases, suspending payments. Report

> Alabama's Supreme Court ruled that GlaxoSmithKline and Novartis will have to face claims that they inflated Medicaid drug prices--together. The drugmakers had argued for separate trials. Report

> Shire has seen its share price drop by 22 percent over the past six months as investors worry that patients aren't switching to the ADHD treatment Vyvanse, its lead drug. Report

> India's Dabur Pharma said longtime shareholders the Burman family would sell its entire 65 percent stake in the company to a unit of Germany's Fresenius. Report

> Amylin Pharmaceuticals posted a larger first-quarter loss on higher marketing costs for diabetes meds Byetta and Symlin; the company lost $68.8 million last quarter versus $49.4 million during the same period last year. Report

> QLT said that its Visudyne eye treatment marketed by Novartis posted first-quarter sales of $36.5 million, a decline of 40 percent from first quarter of last year, because of increased competition from new macular degeneration meds. Report

> BrainCells is moving its lead program into a Phase IIa trial after boosting its second venture round with a second tranche. Report

> The FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. Report

> The war between Biogen Idec and Wall Street raider Carl Icahn is heating up. Report

> Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Report

> The U.K.'s Renovo has seen shares bounce back on the news that two more mid-stage studies have produced positive results. Report

And Finally... With a new safety threat reported almost every day, is this becoming the United States of Anxiety? Report

ALSO NOTED: Senate panel offers more FDA funding; Japan OKs Roche's Actemra, Abbott's Humira

Wed, 16 Apr 2008 06:59:50 -0400

> A bipartisan Senate panel agreed that the FDA is "seriously underfunded" and asked Commissioner Andrew von Eschenbach for an estimate of how much more money the agency could use wisely in the coming fiscal year. Report

> Roche' Japanese partner, Chugai Pharmaceutical, got regulators' blessing to sell Actemra as a rheumatoid arthritis therapy in Japan; it's the first big approval for the potential blockbuster. Release

> Japan also cleared Abbott Laboratories' Humira to treat rheumatoid arthritis, the med's first approval in Japan. Release

> Abbott Laboratories reported a 34 percent increase in first-quarter earnings to $938 million on $6.77 billion in sales. Release

> U.K. pharma Shire plans to move its tax base to Ireland to take advantage of its 12.5 percent tax rate on global earnings, rather than Britain's 28 percent. Report

> The FDA gave the nod to GlaxoSmithKline's migraine pill Treximet, a modified version of the soon-to-go-off-patent Imitrex. Release

> Akorn won the FDA's blessing for its Ofoxacin Ophthalmic Solution, a generic anti-infective used to treat conjuncitivitis and other eye infections. Release

> About 26,000 patients are using Tysabri, the multiple sclerosis treatment sold by Elan and Biogen Idec, and the companies have received no reports of a brain infection that prompted the drug's temporary withdrawal in 2005. Report

> Roche snapped up the UK's Piramed today in a $175 million deal that includes a $15 million milestone payment--the latest in a series of new acquisitions. Report

> After a brief period as a high-flying stem cell company, CellCyte Genetics' share price has fallen back to earth, wiping out much of the $440 million market valuation achieved last fall and leaving it in "precarious" financial shape. Report

> NJ Biz examines Genta, which has gone into survival mode as it seeks a way to gain FDA approval of its lead cancer therapy, Genasense. Report

And Finally... A new advance in cloning could lead to designer babies. Report

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

Biogen CEO: Tysabri patients will get PML

Wed, 19 Mar 2008 07:59:54 -0400

Expect the unexpected. That's essentially what Biogen Idec CEO James Mullen (photo) told investors yesterday when he predicted that more cases of a rare, fatal brain disorder will arise in Tysabri patients. "[W]e anticipate there will be some additional cases of PML," Mullen said, adding that he doesn't believe they would cause regulatory problems for the drug.

You'll recall that Biogen pulled Tysabri in 2005 when two patients acquired PML, or progressive multifocal leukoencephalopathy. It since has returned to the market under a patient-monitoring program. Despite the risks, many MS patients use Tysabri because it works. So many, in fact, that Mullen has been predicting blockbuster status for Tysabri by 2010. The drug's recent FDA approval for Crohn's disease could only help.

Recently, though, Biogen and marketing partner Elan warned doctors of the potential for liver damage in Tysabri patients. Injury could happen within six days of starting treatment, the letter warned.

- see the Triangle Business Journal story

Related Articles:
No new PML cases linked to Tysabri. Report
Tysabri: The comeback kid. Report
After reintroduction, Tysabri builds patient base. Report
FDA allows Tysabri back on market. Report