Novartis eye drug franchise hit by failed Fovista studies

[December 12, 2016]  By John Miller

ZURICH (Reuters) - Novartis's bid to bolster its eye drug portfolio suffered a setback on Monday when it announced combining Lucentis with Fovista in patients with neovascular age-related macular degeneration (nAMD) did not produce better outcomes than treatment with Lucentis alone.

Two phase III studies that combined Ophthotech's Fovista with Lucentis "did not meet the primary endpoint of superiority", Novartis said in a statement.

Two years ago, the Swiss drugmaker signed a potential $1 billion licensing deal with Ophthotech to market Fovista outside the United States.

It had hoped a successful combination with Lucentis could help it counter waning sales of Lucentis, which has been hurt by competition from other drugs.

With the trials' failure, however, Novartis said it still hoped analysis of underlying data would provide further understanding and guidance on helping nAMD patients.

"The proven efficacy of Lucentis monotherapy was not improved by the addition of" Fovista, said Vasant Narasimhan, Novartis's chief drug development officer. "Together with Ophthotech we continue to analyze the data."

Novartis shares slipped 0.3 percent in early trading.

Age-related macular degeneration affects up to 25 million people worldwide and is the leading cause of early blindness in the industrial world.

In the first nine months of 2016, Lucentis's sales for Novartis outside the United States fell 11 percent, on top of a previous decline in 2015, due to competition from drugs including Regeneron's Eylea.

"A positive result of the study would have been welcome to add a little pep to waning Lucentis sales," wrote Michael Nawrath, a Zuercher Kantonal Bank analyst, in a note. "For the small company Ophthotech this will be much worse than for Novartis, but it's still a negative result."

The failure leaves Novartis hoping for more-favorable results from a separate phase III trial of its investigational medication RTH258 against nAMD, due to be published early next year.

The failure also impacts Roche, which has marketing rights for Lucentis in the United States and had a deal with Novartis for a share of revenue from Fovista outside the United States.

(Editing by Jason Neely and Mark Potter)

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