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28 February 2020AmericasSarah Morgan

Biogen blocking bid rejected; signs $2.4bn deal

The US Court of Appeals for the Federal Circuit has rejected Biogen’s bid to block a bioequivalent version of its multiple sclerosis drug, pending an appeal against a lower court’s ruling.

Yesterday, February 27, the Federal Circuit denied Biogen’s request for an injunction against Banner Life Sciences, finding that Biogen had failed to establish that an injunction pending appeal was warranted.

Banner had created a bioequivalent version of Biogen’s Tecfidera (dimethyl fumarate), which treats patients with relapsing forms of multiple sclerosis.

A district court ruling had cleared the way for the US Food and Drug Administration (FDA)  to approve Banner’s drug product, Bafiertam (monomethyl fumarate).

“Unless this court issues an injunction while it considers the merits of Biogen’s expedited appeal, Banner will be permitted—once the FDA grants final approval, and the district court’s temporary restraining order expires—to immediately launch its drug product, which relies on data from Biogen’s Tecfidera drug product,” said Biogen in its request for an injunction.

However, Biogen’s argument was rejected, and the appeal was placed on the May 2020 oral argument calendar.

Biogen and Sangamo unite

On the same day, Biogen announced a global licensing collaboration with biotech Sangamo Therapeutics to develop gene regulation therapies.

Biogen will pay Sangamo $350 million upfront and Sangamo is eligible to receive up to $2.37 billion in potential milestones, as well as royalties.

The companies will leverage Sangamo’s proprietary zinc finger protein (ZFP) technology to “modulate the expression of key genes involved in neurological diseases”. In June 2018, LSIPR interviewed Sandy Macrae, CEO of Sangamo Therapeutics, about its technology which he believes rivals CRISPR in its potential.

Biogen and Sangamo will develop and commercialise ST-501 for tauopathies including Alzheimer’s disease, ST-502 for synucleinopathies including Parkinson’s disease, a third undisclosed neuromuscular disease target, and up to nine additional undisclosed neurological disease targets.

Alfred Sandrock, executive vice president, research and development at Biogen, said: “As a pioneer in neuroscience, Biogen will collaborate with Sangamo on a new gene regulation therapy approach, working at the DNA level, with the potential to treat challenging neurological diseases of global significance.

“We aim to develop and advance these programmes forward to investigational new drug applications.”

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23 June 2020   Mylan has succeeded in having a key Biogen patent covering multiple sclerosis drug Tecfidera invalidated by a US federal court.
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18 March 2021   A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity, according to a lawsuit filed by Biogen and Alkermes.
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More on this story

Americas
23 June 2020   Mylan has succeeded in having a key Biogen patent covering multiple sclerosis drug Tecfidera invalidated by a US federal court.
Americas
18 March 2021   A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity, according to a lawsuit filed by Biogen and Alkermes.
Big Pharma
23 June 2021   Taiwanese pharmaceutical company PharmaEssentia Corporation has failed to convince a district court judge to throw out a €140 million award to AOP Orphan Pharmaceuticals.

More on this story

Americas
23 June 2020   Mylan has succeeded in having a key Biogen patent covering multiple sclerosis drug Tecfidera invalidated by a US federal court.
Americas
18 March 2021   A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity, according to a lawsuit filed by Biogen and Alkermes.
Big Pharma
23 June 2021   Taiwanese pharmaceutical company PharmaEssentia Corporation has failed to convince a district court judge to throw out a €140 million award to AOP Orphan Pharmaceuticals.