Bloomberg ran an article here Tysabri May Have Limited Benefit in Crohn's, FDA Says (Update5) that says Tysabri might not be as effective for Crohn's disease as previously thought.

Although Tysabri has been shown to be approximately twice as effective in the treatment of multiple sclerosis as other drugs, it seems that Tysabri hasn't clearly distinguished itself as being any better than existing Crohn's drugs.

I'm sure that this is sad news for sufferers of Crohn's disease as I know that they were hoping for much better results from Tysabri. Apparently, investors felt disappointed also, since Biogen's shares fell approximately 2 percent on the NASDAQ, down $1.18 to $57.01. By contrast, the stock has risen a total of 16 percent this year.

• Vince

Merck Serono Completes Patient Enrollment in CLARITY Phase III Pivotal Clinical Trial of Oral Cladribine

GENEVA, Switzerland, January 16 /PRNewswire-FirstCall/ — Merck Serono (virt-x: SEO and NYSE: SRA) announced today that patient enrollment has been completed in the CLARITY (CLAdRIbine Tablets Treating MS OrallY) study, a Phase III pivotal clinical trial evaluating the efficacy and safety of Merck Serono’s proprietary oral formulation of cladribine for the treatment of relapsing forms of multiple sclerosis (MS).

“The completion of patient enrollment into the CLARITY pivotal trial is a major milestone in the development program of oral cladribine,” said Franck Latrille, Merck Serono’s Head of Product Development. “It brings us one step closer to our objective of offering patients the first oral therapy for first line treatment of multiple sclerosis, with the convenience of short courses of therapy given intermittently.”

The CLARITY study is a two-year (96 weeks), randomized, double-blind, placebo-controlled, international trial. It enrolled more than 1,300 patients and will provide data on key endpoints including clinical relapses, disability progression and magnetic resonance imaging (MRI). Study participants have been enrolled in one of the three arms of the study to receive one of two different dose regimens of oral cladribine or matching placebo tablets. In the study, oral cladribine is given in two or four treatment cycles in the first year, with each cycle consisting of daily administration for five consecutive days, which means study patients take oral cladribine therapy for only 10 or 20 days during the year. In the second year, two treatment cycles are administered.

The increased convenience resulting from the oral intermittent administration of oral cladribine has the potential to address an important unmet medical need in patients with MS.

Oral cladribine was designated a Fast Track product by the US Food and Drug Administration (FDA) in September 2006. Under Fast Track designation, oral cladribine is eligible for Priority Review and the FDA may consider portions of the marketing application for review before the New Drug Application (NDA) is completed.

About Oral Cladribine

Merck Serono’s proprietary oral formulation of cladribine is currently being evaluated in Phase III as a treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of MS. Through its differentiated mechanism of action, oral cladribine may offer a safe and effective new option to patients with MS.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif(R) (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif(R), the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone(R) (mitoxantrone for injection concentrate) for worsening forms of MS. Full prescribing information for these products can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development including: osteopontin, an MMP-12 inhibitor, a JNK inhibitor and interferon beta:Fc. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS, with a whole genome scan currently underway.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

What do you think about Biogen and Elan applying to sell Tysabri as a drug for Crohn’s Disease? According to this article at RebOrbit, that’s exactly what they plan to do.

I don’t know about some of you but I am not comfortable with the idea of using Tysabri for MS yet. I think the approval was pushed through and as we know, there have been some complications from the drug. However, I believe that all those cases involved using Tysabri in conjunction with Avonex. Still, I think I’ll just stick with my Copaxone and B-12 for now!

For those who suffer from Crohn’s Disease, I hope that this works out well for you. I have a cousin who suffers from it and I know it’s not pleasant to have to deal with.

You guys go on over and read that article at the link that I gave you. I think you’ll find it to be good information. An excerpt of the article is shown below:

By Jeffrey Krasner, The Boston Globe

Dec. 16–[tag-self]Biogen Idec Inc[/tag-self]. and [tag-self]Elan Corp[/tag-self]. said yesterday that they have applied to the Food and Drug Administration for approval to sell Tysabri, a multiple sclerosis drug, to treat patients with Crohn’s disease.

The drug is already being evaluated as a treatment for Crohn’s by the European Medicines Agency, and both companies had long predicted they would file a Crohn’s application with the FDA by the end of the year. But in November, Biogen Idec chief executive James C. Mullen told the Globe he didn’t expect European regulators to approve the Tysabri request, and might ask the Cambridge company to conduct additional clinical trials.