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Multiple Sclerosis is a chronic disease that causes the body to attack its own nerve cells through the immune system. Worldwide, it affects about 2.5 million people, and while thus far there has been no definitive cure, several medications have been able to modify symptoms and help prohibit lesions from continuing to spread in the brain.
The rush for improvement
However, medications available have been through subcutaneous injections and are not obtainable as a typical, oral-pill treatment. Leading remedies include Teva Pharmaceutical's (Nasdaq: TEVA ) Copaxone and Biogen's (Nasdaq: BIIB ) Tysabri, both effective drugs, but they include many common side effects.
MS medications have the potential for blockbuster commercial success; for instance, Copaxone helped generate more than $1.3 billion in U.S. sales (2008) for Teva and is marketed in more than 50 countries worldwide. Inevitably, a handful of companies have been trying to find an oral medication to help the thousands of patients who are unable to handle the difficulties of utilizing injection-based medications.
Both Novartis (NYSE: NVS) and Merck KGaA have been among the leaders, hoping that a new all-star drug for MS could help boost revenues and make the pain of patent-loss much easier. In July of this year, as I searched for Swiss stocks trading on U.S. exchanges, I highlighted the potential for Novartis if the FDA actually approved its new MS medication, Gilenia.
Finally, some great news
In May of this year, Novartis came out with the unfortunate news that the FDA asked for additional analysis of its drug before considering approval. Thus the final decision was delayed by three months. Now, the day has finally arrived: The FDA has officially approved the drug, now named Gilenya. Three different studies this year have illustrated that Gilenya reduces the risk of relapses and worsening of the disease.
It's estimated that sales of the drug could quite easily reach $1 billion annually, which, as of last year's numbers, would be about 2.2% of Novartis' total revenues. It's not a ground-breaking number, but it's certainly a great start.
More important than just the sales number are the repercussions for the MS community. The National MS Society has stated on its website that, "In June 2010, the National MS Society was among individuals and patient advocacy groups that provided public testimony at an FDA advisory committee meeting about the unmet need for more therapies for people with MS."
As an investor in Novartis and, more importantly, as a son whose mother suffers from MS, I couldn't be more ecstatic about this news.