Decision Looms on New Multiple Sclerosis Drug

Will good news from Europe echo on this side of the Atlantic within the next few days? Biogen Idec (NASDAQ: BIIB  ) is certainly hoping so. The biotech's multiple sclerosis drug Tecfidera received a positive recommendation for market authorization approval from the European Union's Committee for Medicinal Products for Human Use, or CHMP, last Friday. Next up for Tecfidera is a decision by the U.S. Food and Drug Administration due this week. A final decision in Europe will come in the next two months.

Many in the MS community are anxiously awaiting availability of Tecfidera. What's behind the buzz -- and how likely is it that the MS drug will gain approval? 

Disrupting the market?
While there is no cure, several treatments are currently available for slowing the progression of multiple sclerosis.  Beta interferon drugs help prevent damage to myelin, a sheath that shields nerve fibers. Leading beta interferon drugs are Biogen's Avonex, Betaseron from Bayer, and Rebif, which is co-marketed by EMD Serona and Pfizer (NYSE: PFE  ) . All three drugs are administered through injection. Common side effects include inflammation at the injection site and flu-like symptoms.

Teva Pharmaceuticals' (NYSE: TEVA  ) Copaxone also works by protecting myelin. Like the beta interferon drugs, Copaxone is taken via injection with one of the most common side effects relating to inflammation at the site of injection.  

Another treatment that has demonstrated success with slowing progression of MS is Tysabri. Biogen and Elan Pharmaceuticals (UNKNOWN: ELN.DL2  ) co-market the drug for now, but the two companies recently announced a deal where Biogen would buy full rights for Tysabri for $3.25 billion. Similar to the other drugs already mentioned, Tysabri is administered through injection. It has some of the same kinds of side effects as the others, but also can increase the possibility of patients getting a rare brain infection that can lead to death or severe disability.

The inconvenience and possibility of reactions associated with these injections opened the door for commercial success of drugs that can be taken orally. Novartis' (NYSE: NVS  ) Gilenya was the first MS pill to gain FDA approval in 2010. Gilenya racked up 2012 sales of $1.2 billion. However, sales were dampened somewhat in early 2012 after the FDA and the European Medicines Agency announced investigations of several deaths related to heart problems in patients taking Gilenya.  

Last September, the FDA approved another oral treatment for MS -- Sanofi's Aubagio. Sanofi received good news from Europe at the same time as Biogen, getting a positive recommendation from CHMP for Aubagio last week.

However, many expect Tecfidera to become the biggest seller in the MS market with annual sales topping $3.25 billion within the next four years. With all of the treatments already available, why is there such eagerness for Biogen's new drug? Three reasons stand out.

First, like Gilenya and Aubagio, Tecfidera is a pill and therefore won't have the inconvenience and injection site reactions associated with most of the other available drugs. Second, the drug has demonstrated solid efficacy  -- reducing patients' annual relapse rate by nearly half. Third, Tecfidera's safety profile looks to be better than the others, with the most common side effects including flushing and gastrointestinal effects such as nausea and diarrhea. Biogen hopes that the drug's convenience, efficacy, and safety will score big with patients and prescribers.

Cart before the horse?
Is all this talk getting the cart before the horse, though? Tecfidera still hasn't been approved either in the U.S. or Europe. The FDA delayed its decision on the drug by three months back in October to "allow additional time for review of the application." Murphy's Law has raised its ugly head before with promising drugs. 

Like most observers, I don't expect there will be any roadblocks with approval for Tecfidera either in the U.S. or in Europe. CHMP's positive recommendation last week was definitely a good sign. The FDA delay was a standard extension and not particularly unusual. The agency didn't ask for any additional information from Biogen, so no new concerns were raised about Tecfidera's chances of approval.

Anything can happen with regulatory approval processes, but I look for more good news for Biogen this week. I also expect that Tecfidera will live up to the high expectations held by many. The drug should be a great addition to Biogen's already-strong MS portfolio. The cart might still be in front of the horse for now, but I suspect that we'll see plenty of horsepower from Biogen and Tecfidera over the years to come.

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