PhIII failure dashes Novartis' hopes of Gilenya label expansion

Novartis ($NVS) is looking to expand sales of oral multiple sclerosis therapy Gilenya, which currently trails Biogen Idec ($BIIB) pill Tecfidera in the MS arena despite its first-to-market advantage. But it looks like it won't be doing that with a primary progressive MS (PPMS) indication anytime soon.

Novartis Pharmaceuticals Global Development Head Vasant Narasimhan

Monday, the Swiss pharma announced the drug had missed its main goal in its Phase III INFORMS trial, failing to significantly outperform placebo on a combination of disability measures in a study of 970 PPMS patients. With the company's hopes for a PPMS label expansion will go the chance for a wide-open shot at an untreated population that represents 10% of the 2.3 million MS patients worldwide.

As Novartis Pharmaceuticals' global head of development, Vasant Narasimhan, said in a statement, "relatively little" is known about PPMS, making finding effective treatments a tough prospect. "We will actively work with the MS community to review and analyze the INFORMS results to help increase the understanding of this devastating disease," he said.

But in the meantime, Gilenya is still looking up at high-flying Tecfidera, which didn't take long to snap up enough market share to pass the combined sales of Novartis' drug and Sanofi's ($SNY) fellow oral rival Aubagio. While Gilenya enjoyed a robust rollout of its own, racking up half a billion dollars in sales in its first full year on the market and easily cracking the blockbuster barrier the year after that, safety scares and some serious potential side effects--including a slowed heart rate after the initial dose--put a bit of a damper on things.

That's not to say the drug isn't still churning out serious sales: Last year, it generated $1.93 billion for the Basel-based drugmaker, trumping the $876 million Tecfidera brought in after hitting the scene in April. But this year, things are a little different: Biogen's pill nearly matched last year's sales haul with its $787 million third-quarter bounty alone, topping Gilenya's $653 million Q3 tally in the process.

Novartis hasn't stopped touting results that might help it reclaim the edge, recently highlighting Gilenya's ability to stem brain-volume loss and protect the organ from atrophy. And it hasn't given up hope for a label expansion, either: The company is testing the drug in Phase III trials as a treatment for pediatric MS and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), according to Reuters.

- read Novartis' release
- get more from Reuters

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