Novartis Sees Red Over Regeneron Eye Disease, Cancer Drugs

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Dana A. Elfin Washington Editor Randy Kubetin Washington Managing Editor

By Dana A. Elfin

Novartis is setting its sights on the market for age-related macular degeneration eye drugs, a debilitating vision condition affecting more than 2 million U.S. patients.

The company is wielding patents as part of its strategy to gain a firm foothold in the highly lucrative AMD drug market, a market worth approximately $5 billion. It has high hopes for its drug candidate RTH258 (brolucizumab), which it plans to launch in 2019 once it obtains regulatory approval from the Food and Drug Administration.

The Switzerland-based drug giant sued Regeneron Pharmaceuticals Inc. in the U.S. District Court for the Southern District of New York March 19, claiming Regeneron’s process for making an active ingredient in its AMD drug Eylea (aflibercept) and its colorectal cancer drug Zaltrap (ziv-aflibercept), infringes Novartis’ patented technology.

Regeneron’s manufacturing of the drugs’ active ingredient--aflibercept--uses a Novartis technology covered under Novartis’s U.S. Patent No. 5,688,688 (the ‘688 patent), Novartis claimed. The patent covers gene expression vectors for the expression of certain molecules in mammalian cells—in this case, Chinese hamster ovary cells. An expression vector is used to introduce a specific gene into a target cell.

Aflibercept is an inhibitor of a growth factor that when overexpressed can contribute to diseases such as AMD and cancer.

Novartis is seeking compensatory damages and potentially triple damages for the alleged infringement.

Novartis Plans Market Shake-up

Currently, the AMD market is ruled by two drugs: Lucentis, which Roche’s Genentech sells in the U.S. and which Novartis sells outside the U.S., and Tarrytown, N.Y.-based Regeneron’s Eylea, on which Regeneron partners with Bayer AG. Regeneron sells Eylea in the U.S. and Germany-based Bayer sells the drug outside the U.S.

Lucentis (ranibizumab) was approved in 2006 and Eylea in 2011. Those two drugs have combined annual sales of approximately $4.7 billion.

Novartis’s brolucizamab would compete with Lucentis and Eylea. The company says brolucizamab has clinical advantages over the other two AMD drugs because it requires less frequent injections into the eye and brolucizumab performed better in decreasing retinal thickness and fluid.

Novartis plans to file for regulatory approval of the drug in the fourth quarter of this year, Eric Althoff of Novartis’s global media relations team told Bloomberg Law in a March 20 telephone call.

But Eylea’s makers say they’re not worried. In January, Rafiq Hasan, Bayer AG’s global head of ophthalmology, said he was optimistic about the drug’s future financial prospects.

Rakoczy Molino Mazzochi Siwik LLP and Mauriel Kapouytian Woods LLP represent Novartis.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bloomberglaw.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bloomberglaw.com

For More Information

The complaint is at http://src.bna.com/xcg.

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