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Tuesday, May 12, 2015

Biogen recently announced that its next-generation multiple sclerosis drug Zinbryta has been submitted for FDA approval


The submission clears the way for an FDA decision early next year, and potentially sets the stage for Biogen to strengthen its dominance as a leader in multiple sclerosis treatment.

Targeting a big marketBiogen is the planet's biggest manufacturer of therapies used to treat multiple sclerosis, a disease that affects 2.5 million people globally, including 400,000 people in the United States. In multiple sclerosis patients, the immune system incorrectly attacks myelin, a fatty substance that protects nerves, as well as nerve fibers. Those attacks cause scar tissue that can interfere with messages being sent to or from the central nervous system, resulting in painful and debilitating symptoms.
There is no cure for multiple sclerosis, and because the disease can significantly impact a patient's day-to-day living, patients are typically prescribed medication that is taken chronically during their lifetime. Often, the complexity of those medications means that they carry higher price tags than drugs used for other diseases. As a result, the multiple sclerosis market is worth $17 billion annually.
According to a leading pharmacy benefit manager, multiple sclerosis is the second most costly specialty drug indication, and spending on MS therapies climbed 12.9% in 2014.

Protecting its moatSince its approval in 1996, Biogen's Avonex has been one of the most widely prescribed therapies used to help reduce the number of remissions an MS patient suffers each year. However, new medications taken orally, rather than injected, have recently begun to eat away at Avonex's market share.

In order to outmaneuver competitors, Biogen has responded by launching Tecfidera, its own oral multiple sclerosis therapy, and Plegridy, a longer-lasting formulation of Avonex. And now, Biogen is co-developing Zinbryta.

Improving treatmentZinbryta, which was formerly known as daclizumab, is a monoclonal antibody that is injected every four weeks. The drug works by binding to the interleukin-2 receptor subunit CD25, which is over-expressed on immune systems' T-cells in MS patients.
In clinical trials, Zinbryta significantly outperformed Avonex in both patient relapse rates and disease progression. Specifically, Zinbryta reduced relapses versus Avonex by 45%, and 73% of Zinbryta patients were relapse free at week 96, compared to 59% of Avonex patients.

Looking forwardThere's no guarantee that the FDA will approve Zinbryta, and there's no certainty that, if approved, it would become a top seller. There have been concerns regarding a higher rate of serious infection in patients taking Zinbryta than in Avonex patients, so that could weigh on script volume -- at least at first. However, because all multiple sclerosis drugs carry risks that require constant monitoring, doctors could eventually warm up to Zinbryta. An estimated 23% of MS patients are non-adherent to their existing therapy, and Zinbryta's monthly dosing potentially marks a substantial improvement in patient dosing burden as compared with the weekly Avonex.
If Zinbryta gains FDA approval and its improved efficacy and dosing wins over doctors, then the drug could become a blockbuster.

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