Novartis has won the blockbuster competition to be first on the U.S. market with an oral MS drug that can slow down the disease and reduce the risk of relapses. The FDA has approved Gilenya, and Novartis plans to have supplies ready for marketing in a matter of weeks.
The agency's approval was all but certain, given a unanimous vote in its favor by an expert panel. Now the pharma giant can step out ahead of Merck KGaA, which is looking for its own approval of an oral MS therapy. And some analysts say Novartis' candidate, as a new first-line therapy to replace the injectables currently garnering $11 billion a year--therapies marketed by Biogen Idec, Merck KGaA and Teva--could generate up to $3.5 billion in annual sales.
"As a result of the broad label granted to Gilenya, we forecast it will generate peak sales of around $3.5 billion, significantly ahead of current consensus expectations which remain below $2 billion," Jefferies analysts speculate. Gilenya is a novel immunomodulator. Earlier this year the FDA approved Acorda's oral therapy Ampyra to help improve patients' ability to walk.
For Novartis, the approval marks a major strategic accomplishment, creating a new franchise in a lucrative market in which a high concentration of patients and physicians are likely to be eagerly aware of a more convenient alternative to the biologics now available.
Adam Feuerstein at the TheStreet acknowledges the high expectations, but also sounds a warning note: "Counteracting the excitement for the new MS pill, however, is a side effect profile that may make doctors hesitant to use Gilenya ahead of older, more established MS drugs." Merck KGaA, which stumbled in the final leg of the race with Novartis when the agency refused to accept its initial application for cladribine, is now up for a priority review with a decision due in the fourth quarter.
Biogen Idec, meanwhile, adopted an aggressive defensive position once word spread of the approval. After acknowledging patients' desire to see an oral MS treatment, the big biotech touted its own late-stage candidate and cautioned against any quick adoption of Gilenya over the current standards. Warned Biogen: "The long-term safety profile of Gilenya has yet to be established and there is limited data for it in patients with certain common comorbidities."