Pharma

Here's some unhappy news for people with MS -- one of the few drugs being evaluated for helping with secondary progressive MS, dirucotide, has been pulled from further study following disappointing results from the phase III study MAESTRO-01. In this study, partners BioMS and Eli Lilly had hoped to show that the drug delayed how long it took subjects with MS to worsen. Unfortunately, this didn't happen, nor were the secondary goals of the study achieved. The companies also announced that the follow-on studies MAESTRO-02 and -03 will be discontinued. Participants in these trials are advised to contact their study investigators for more information on the discontinuation process.

In a small note of possible consolation, I have heard recently from different drug companies that they are interested in developing drugs for progressive MS. It will take time for these drugs to come to market, but the success of the first-line RRMS drugs has probably demonstrated that drugs for progressive stages of the disease would also find a receptive market. Hopefully some of these will meet with better luck than dirucotide.

The pharmaceutical company Merck KGaA has submitted an application to the European Medicines Agency (EMEA) (the European Union's FDA) asking them to approve oral cladribine as a therapy for patients with relapsing-remitting multiple sclerosis. Similar applications to the FDA and other countries' agencies will be following soon. The company hopes to be able to market this drug in 2010, which might make it the first oral drug officially authorized as a disease-modifying therapy in MS.

Cladribine is a chemotherapy drug that depletes white blood cells and is used to treat certain forms of leukemia. Recent results from the Phase III CLARITY trial showed that it reduced relapse rate and MRI disease activity in people with RRMS. The treatment schedule used in the trial involved taking the drug only 2 to 4 weeks per year. This drug would be easier to take than the current first-line therapies for MS, but would perhaps come with a greater risk of complications due to its strong effects on the immune system.

[Thanks for Stephanie S. for the pointer to this story!]

These market analysts are reporting that: The Multiple Sclerosis (MS) Market Has Total Global Revenues of Over $6bn in 2008. It Will Exceed $9bn During the Second Half of Next Decade.

I report this because the "good" side of this is that it means MS drugs can be very lucrative. Which means that pharma and biotech companies will consider MS as a target disease for their products. For the most part, more attention is better.

A cannabis-based medicine for MS from GW Pharmaceuticals has been filed for approval in Europe, paving the way for its potential approval at the end of 2009 or early in 2010.

Clinical trials have shown GW's drug Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies.

The subject basically says it all.

The FDA has granted priority review status to the experimental MS drug called Fampridine-SR.

Just received from Biogen Idec:

Please find below links to three Biogen Idec press releases that were distributed during AAN. The releases included data showing TYSABRI may have the potential to remyelinate brain lesions, patients reported a better quality of life after only three months of TYSABRI treatment, and AVONEX patients who started treatment shortly after their first attack fared better than those who delayed treatment.

• MRI DATA SHOWING TYSABRI® PROMOTED REMYELINATION PRESENTED AT THE 61ST ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY
• New Tysabri(R) Data Demonstrate Significant Effects On Health-Related Quality Of Life Measures In Multiple Sclerosis Patients
  
• First Ten-Year Follow-Up Shows That Treatment with AVONEX® Leads to Long-Term Benefits in Early Multiple Sclerosis Patients

Check out this article talking about two new oral drugs being tested for MS.

In the Phase III study of 1,200 patients with the RRMS, approximately 80 percent of MS patients who took the drug cladribine remained relapse-free for two years compared to only 61 percent of those participants given a placebo.

In another successful phase III study of over 1,200 patients with RRMS, 80 to 84 percent of MS patients who were given daily dosages of the drug fingolimod remained relapse-free after one year in comparison to only 67 percent of study participants who received Avonex, a typical injectable drug used to treat MS.

An independent safety drug board recommended BioMS continue trials of its multiple sclerosis treatment.

The U.S. Data Safety Monitoring Board completed a safety analysis of its phase 3 Maestro-03 trial of dirucotide, used for the treatment of secondary progressive MS, (SPMS) and ruled that the company should continue.

This is just a review done to make sure that any adverse events from the trial are warranted given the results - it is not saying anything about the effectiveness (at this point), just the safety. Good news for those with SPMS, though.

A sixth patient taking Biogen Idec Inc's multiple sclerosis drug Tysabri has developed a potentially deadly brain infection since the drug was reintroduced onto the market in July 2006.

The article, per usual current-day journalism standards, gives no details on the person, how they are doing, what will be done for them, etc. It also indicates that Biogen will only announce future cases by posting to their web site, but gives no indication of *where* on their web site.

I contacted Biogen Idec and got a prompt reply - the updates will be posted weekly at this location. I made a stink about this appearing in their "Investor Relations" section of their web site and not in the patient information section. It is my opinion that this sends a clear signal that Biogen Idec sees PML as a financial issue, and not as a patient safety issue.

Biogen - if you disagree, then put an easily findable link on tysabri.com so people who are putting this stuff in their veins can be as fully informed as your investors.

Turns out quite a few drugs are plaguing users with PML. Genentech just pulled its psoriasis drug, Raptiva from the market because it was causing PML.

At least four other drugs have been linked to PML risk. They include Roche’s Cellcept, used to prevent transplant rejections; Biogen Idec Inc. and Genentech’s cancer drug Rituxan; Biogen’s multiple sclerosis treatment Tysabri and Genzyme Corp .’s leukemia drug Campath.