Biogen Shares Drop as Tysabri PML Cases Climb to 23, Europe May Seek Drug ‘Holiday’

Xconomy Boston — 

[Update: 10/23/09, 1:10 pm Eastern] Shares of Biogen Idec and its Irish partner Elan dropped this morning after European regulators said they are taking a new look at the risk and benefit of natalizumab (Tysabri) for multiple sclerosis, now that 23 patients on the drug have been diagnosed with a rare, potentially fatal brain infection called PML.

Cambridge, MA-based Biogen (NASDAQ: BIIB) fell 5.5 percent to $44.61 at 11 am Eastern time today, while Elan (NYSE: ELN) dropped 21 percent to $5.11. The European Medicines Agency said it has initiated the review to discuss any additional measures necessary to ensure the safety of natalizumab, according to a Reuters report.

The new report was bound to alarm some investors, because 23 cases of progressive multifocal encephalopathy, or PML, is significantly more than the tally of 13 cases the FDA counted last month. Cases of PML been adding up since the drug was re-introduced to the U.S. market in July 2006 after it was previously withdrawn because of the risk. Despite the chance of the infection, which the FDA pegged at about 1 in 1,000, patients have continued to seek out the treatment, which physicians say is the most effective therapy on the market for multiple sclerosis. (Natalizumab is also approved as a treatment for Crohn’s disease.) More than 46,200 people worldwide were taking the drug at the end of September, Biogen said earlier this week.

Biogen finance chief Paul Clancy told Dow Jones earlier this week that the company will discuss how to communicate the link between long-term use of the drug and increasing incidence of the dangerous side effect.

Regulators might choose to recommend that patients who take the drug for long periods of time take breaks, or “drug holidays,” said analyst Christopher Raymond of Robert W. Baird & Co., in a note to clients this morning. Since so many patients depend on the product to control their symptoms, it’s unlikely that regulators would force it off the market, he said.

“We deem it highly unlikely that either FDA or EMEA would pull Tysabri from the market,” Raymond said. “With PML risk well known, we think the most likely scenario would be additional labeling restrictions suggesting perhaps a drug holiday after an extended treatment period.”

[Updated comment from Biogen Idec.] There isn’t any data that suggests imposing a drug holiday would reduce the risk of patients getting PML, but there is data that shows symptoms of multiple sclerosis return quickly once patients quit taking natalizumab, says Biogen Idec spokeswoman Naomi Aoki. The company is talking with regulators about the best way to update the drug’s prescribing information to reflect the increased risk with extended usage, but even so, the incidence of PML still appears within the stated range of 1 in 1,000 patients, she says.

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10 responses to “Biogen Shares Drop as Tysabri PML Cases Climb to 23, Europe May Seek Drug ‘Holiday’”

  1. Maggie says:

    I have MS and could not tolerate other therapies. I was offered Tysabri and declined because I feel PML will continue to increase the longer a person is on it. Shame on Biogen for caring more about their profits than the lives of others.

  2. Lori says:

    Someone I love has PPMS and every MRI before he started Tysabri showed new damage. Now since being on Tysabri MRI’s are showing no new damage. To us the benefits greatly outway the risks. Thats the decision people have to make.

  3. Maggie says:

    I also know loved ones who are benefiting from Tysabri… This is a horrible disease.

  4. stephie says:

    All I can say to those using Tysabri is if you see even the slightest decline consider stopping the treatments or better yet don’t take more than 12 treatments. My sister is one of the unlucky ones. She had 25 treatments. She is now confined to bed and cannot talk at age 41. She cannot do anything for herself and is not expected to recover. Tysabri seemed to help her at first too.


  5. Maggie says:

    Stephanie, I’m so sorry to hear of your sister. I always knew a person’s chances of developing PML increased with the amount of Tysabri treatments. (And that’s before the “Experts” published that fact!)

    (Study) Now they have identified a virus (JC Virus) and if a person has this virus identified in their blood work they have a 1:1000 chance of developing PML, compared to 1:20,000. (Yeah my number may be off a little.) So, I have that virus and will not take a 1:1000 chance.

    My thoughts go to you, your sister and family. :(

    AND, I still think Biogen cares more about profits. They’re a business! People go into business to earn money.


  6. Patricia says:

    I have been on Tysabri for almost 4 years. I have no side effects from the Tysabri and just tested positive for JV virus. I have had no new lesions. I know all the chances of developing PML, but I feel since I was diagnosed late in life at the age of 61 that taking this chance will give me more life. This disease will not beat me I will beat the disease.

  7. Maggie Cosgrove says:

    Hi Patricia, Tysabri is a gamble…some will win and some will lose…I’m glad to hear of your success!!! I wish you many, many years of no new lesions! That’s wonderful! At least now they carefully monitor patients on Tysabri, unlike when it was first released. I say all you need to beat MS (or anything) is a great attitude, doctor and support. xxxooo be well!

  8. gerri blomquist says:

    You are saying that 1 in 1,000 get PML. Does that mean that they die? Does that mean that if they don’t die, are their brains seriously and permanently damaged? By getting the bloodwork done regularly, if I develop the virus, will I have time to stop my treatment before I die? How do we pick up this virus. How do we know if others have it? Do they show symptoms? If I get it , what are my first symptoms and if I show symptoms do I have time to stop the treatments before they harm me???
    I am happy to be on the drug, but I am scared. I need more education.

  9. Pat Jones says:

    I have been taking Tysabri for 57 treatments now and I have no side effects from them. Mr MRI shows no new lesions, they have remained the same since I have been on Tysabri. My blood shows I have the JV VIRUS, but I watch very carefully any new changes. This disease will never beat me I will beat yet.

  10. Maggie says:

    Hi, I’m sure the #s have changed over the years…and no it does not mean a person will die…they may not even become severely disabled. When Tysabri first came out a person on it wasn’t tracked as closely as they are now.

    If you’re on FB there’s are a couple of groups for ppl on Tysabri, who have PML or know someone who is/has…It’s Tysabri & PML (Progressive Multifocal Leukoencephalopathy) – Deferno Trust & the other group is Tysabri & PML (Progressive Multifocal Leukoencephalopathy). The person who developed the site unfortunately has a wife who is seriously ill due to Tysabri related PML. You can learn a wealth of information from this group…