The Forest Whispers My Name III » biogen

Biogen halts enrollment In Tysabri trial, citing “slow pace” a.k.a “their test subjects are dropping like flies”.

pmb — Sat, 19 Mar 2011 08:10:05 +0000

7 more PML cases, 1 more corpse, and they cite “slow pace”? And people say I’M morbid.

Biogen Idec Inc. has halted enrollment in a large, long-term clinical trial aimed at testing the earlier use of multiple sclerosis drug Tysabri, citing a slower-than-expected pace of finding participants.

The Surpass study aims to test the effectiveness of Tysabri, sold with Elan Corp, when patients switched from more widely used drugs. Tysabri has proved to be highly effective; however, because of a link to a rare brain infection, the patients taking the drug tend to be those who have stopped responding to other drugs or have aggressive cases of MS.

The study started a year ago and had aimed to enroll 1,800 patients to be followed for about two years, yielding data in 2013 or 2014. Enrollment was stopped last month, but participating patients will continue in the trial.

Biogen spokeswoman Kate Weiss declined to comment on the number of patients enrolled, citing policy. The company has decided to devote its resources toward “risk stratification” efforts for the drug and remains dedicated to studying its effectiveness, she said.

Tysabri has been linked in a small number of patients to a serious brain infection called progressive multifocal leukoencephalopathy, or PML. Global sales rose 16% to $1.2 billion last year, although growth has been lower than originally expected in recent years because of the risks of the infection.

Biogen is developing a blood test that may better determine the chances of patients contracting PML. The test recently received CE Mark approval in Europe and the companies are conducting large studies of its effectiveness.

The Surpass trial was designed to measure Tysabri’s effectiveness in patients with active MS that have switched from either Teva Pharmaceutical Industries Ltd.’s Copaxone or Rebif, sold by Pfizer Inc. and Germany’s Merck KGaA.

The goal of the Surpass trial is to get physicians to use Tysabri when patients aren’t responding to their current therapy, rather than switching them to more mainstream therapies and using Tysabri as a last resort.

But the design of the trial meant that patients weren’t assured that they would switch treatments at all, something that proved to be a hurdle, Weiss said.

The difficulty comes as many new MS treatments are in development, and Novartis AG (NVS) recently launched Gilenya, the first oral treatment for the condition.

“The MS environment is changing and we need to adapt to that change,” Weiss said. “This made it challenging to enroll in light of the current clinical trial landscape and the trial itself.”

Go (1) , Tysabri, go. (1) Go die in a fire.

pmb — Thu, 18 Mar 2010 23:34:53 +0000

NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) disclosed four more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 35.

Tysabri is considered a highly effective therapy for MS, (so, just imagine if it wasn’t.. duh) and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped amid concerns about the risk of PML that led to its 18- month market withdrawal beginning in 2005.

“The overall rate is about the same,” said Biogen spokeswoman Naomi Aoki. “It remains consistent with what is outlined in our label.” – this is the label that says “can cause death”, right? I see.

The last update came from the FDA, which cited 31 cases as of Jan. 21, in a recent safety update noting that MS patients using the drug had increased risk of getting PML as the number of infusions of the medicine increase.

Despite the risk, the agency said the benefits of the medicine continue to outweigh the risks. Which is absolutely true, If the patients are suicidal.

The most recent update translates to about 1.56 cases per 1,000 patients on the drug for between two and three years.

By contrast, the incidence is about 0.54 case per 1,000 patients in those using it for one to two years, and it is almost non-existent in patients using it for less than a year.

The number of cases is important because if the infection rate climbs too high, sales of the drug may drop.

Tysabri’s withdrawal from the market occurred after three patients developed PML. The infection re-emerged in mid-2008, and Biogen provided regular updates about the cases until mid-2009. The company is now providing monthly updates.

But i now know how Tysabri “helps” MS – people DON’T die from the MS, they die from the “cure”.

Eat your heart out, Darwin. Evolution? HAH.

Current Mood: Annoyed

Drug Manufacturer Receives Fast Track Designation From FDA

pmb — Sat, 11 Jul 2009 22:14:15 +0000

Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017).

The company is currently enrolling patients in a global Phase III study evaluating the effectiveness and safety of either bi-weekly or once-monthly injections of the therapy in people with relapsing remitting MS.

If the trial reports promising results it means that people could inject their medication less often without sacrificing effectiveness.

The FDA’s Fast Track program is designed to speed up the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

Biogen Idec plans to enrol more than 1,200 patients with relapsing remitting MS in the Phase III, randomized, double-blind, placebo-controlled trial called ADVANCE designed to evaluate the effectiveness and safety of PEGylated interferon beta-1a.

Current Mood: bouncy

Biogen shares drop on 10th Tysabri PML case

pmb — Wed, 01 Jul 2009 19:02:14 +0000

Shares of Biogen Idec sank after the biotechnology giant confirmed that another patient taking the multiple sclerosis drug Tysabri has been diagnosed with a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML.

The patient, who lives overseas and had been taking Tysabri for more than 30 months, is the 10th person to come down with PML since the multiple sclerosis drug was allowed back onto pharmacy shelves in 2006. Three of those cases have been diagnosed this month.

The news prompted Deutsche Bank to lower its rating on Biogen Idec’s stock to “hold” from “buy.” Investors responded with a sell-off that pushed shares of Biogen (Nasdaq: BIIB) down 5.5 percent, to $47.32, at the close of trading Monday.

Tysabri, which Biogen Idec produces at its manufacturing facility in Research Triangle Park, is seen as a critically important product for the company and its partner on the drug, Irish pharma Elan (NYSE: ELN).

Tysabri was intended to be an improved treatment for MS that could take the place of blockbuster MS treatment Avonex, Biogen’s top-selling drug and one also made in RTP.

But Tysabri has had trouble with PML since first coming on the market in 2004. The drug was shelved by the Food and Drug Administration in 2005 because three patients who had taken Tysabri in clinical trials developed PML, with two of the cases fatal.

The FDA allowed Tysabri back on the market a year later under a special risk monitoring program.

Tysabri has worked well to combat multiple sclerosis symptoms in patients but it has not generated the revenue the Biogen and Elan had projected – due in most part to PML worries. The three PML cases reported this month have come in patients who had taken Tysabri for 30 months or longer, and fears are growing that prolonged exposure to Tysabri increases the risk of PML. Biogen Idec disputes that conclusion.

Still, some doctors have started giving patients a holiday from Tysabri in an effort to avoid PML. In such scenarios, a patient takes Tysabri for two years before taking a break from the drug and turning to other therapies for treatment. That trend is putting further downward pressure on the drug’s sales.