Banner Life Sciences LLC says full approval of its drug Bafiertam for treating relapsing forms of multiple sclerosis is expected no later than June 20, 2020, following the expiration of a patent covering Biogen Inc.'s blockbuster drug Tecfidera.
Banner said Jan. 2 it received tentative approval for its new drug application in a letter in mid-November. Bafiertam is not a generic version of Tecfidera. Bafiertam is a novel fumarate bioequivalent alternative to Tecfidera (dimethyl fumarate).
Tecfidera has been a huge revenue-producer for Biogen, racking up U.S. sales of $1.55 billion in the first six months of 2018.
Banner’s drug will compete with Tecfidera. The High Point, N.C.-based specialty pharmaceutical company said final Food and Drug Administration approval for its product is expected after Biogen’s U.S. Patent No. 7,619,001 covering Tecfidera expires.
Bafiertam is positioned to enter the market before any generic versions of Tecfidera are eligible to do so. And full approval of Bafiertam could come even earlier depending on the outcome of pending litigation with Biogen over the ‘001 patent, the company said. That litigation is pending in federal district court in Delaware and Banner is hoping the court will rule on the patent some time this year, Franck Rousseau, Banner’s chief executive officer, told Bloomberg Law Jan. 2.
In 2018, Biogen agreed to drop patent infringement litigation it brought against Banner over two other Tecfidera patents—U.S. Patent Nos. 7,320,999 and 8,399,514—leaving Banner free to enter the market after the expiration of the ‘001 patent.
Banner is looking to partner with another company to commercialize Bafiertam, its sole product so far, Rousseau said. It’s likely the drug will have a more favorable profile than Tecfidera with fewer side effects than the Biogen drug. Currently, some patients stop taking Tecfidera because of side effects like bloating and flatulence, Rousseau said.
Meanwhile, almost 30 companies have filed abbreviated new drug applications seeking to bring generic versions of Tecfidera to market, Rousseau said, but the earliest any of them could enter the market would be September 2020.
Relapsing-remitting multiple sclerosis (RRMS) is the most common form of MS affecting an estimated 2 million people worldwide.
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