Gilenya - Novartis

Gilenya (fingolimod)
Launch Date: September 2010
First Full-Year Sales (2011): $494 million
First-Half 2013 Sales: $889 million
Analyst Estimate for 2018: $2.48 billion

What set Gilenya apart when it was approved in 2010 was that it was the first oral drug for multiple sclerosis found to actually modify the course of the disease. It was effective, and for patients afraid of the needle, it made compliance less daunting.

Sales-wise, it has been in the fast lane from the beginning. Approved in September of that year, it produced only about $15 million in 2010 but jumped to nearly half a billion dollars in sales in its first full year. It easily surpassed the blockbuster milestone last year with $1.195 billion in revenues and has racked up $889 million in the first 6 months of this year. Analysts are predicting about $2.1 billion in sales by 2016, although that was revised downward after safety concerns surfaced in 2011 when a patient died within 24 hours of starting the drug.  

Gilenya does come with some serious potential side effects, including a slowed heart rate after the initial dose. It works as a powerful immunosuppressant, and that can trigger problems as well. After 11 deaths among Gilenya patients, and a series of other serious side-effect reports, the Institute for Safe Medication Practices suggested in 2012 that Novartis ($NVS) and the FDA consider limiting its use. In August 2013, the FDA sent out an alert that a Gilenya patient developed a rare but often fatal brain infection, progressive multifocal leukoencephalopathy, or PML. Novartis said it is unlikely the infection was related to Gilenya, but it and the FDA are investigating.

The newest alert may lead some doctors to be more cautious about prescribing Gilenya. Still, given how debilitating multiple sclerosis can be, patients are willing to take risks if they think a drug will improve their lives. Perhaps the biggest threat to Gilenya is another drug--Biogen Idec's ($BIIB) Tecfidera, approved in April 2013. A much-anticipated oral treatment, it took off immediately, and analysts believe it will be a major contender for market share.

Novartis has been accumulating follow-up data on Gilenya since its approval. One new analysis showed a benefit for patients switching to Gilenya from interferon, while other studies suggested that Gilenya helped hold off brain lesions, brain-volume loss, and other markers of disease progression.

For more:
Novartis' MS drug Gilenya tied to rare brain infection
EMA approves Novartis' Gilenya
Novartis persuades NICE to endorse Gilenya
Gilenya market share drops after FDA review
Biogen prices Tecfidera below oral MS rival Gilenya

-- Eric Palmer (email | Twitter)

Gilenya - Novartis