Week's news analysis

Mylan bets on MS therapies

By The Editor - 02 september 2020

What does Biogen's future look like? Murky, choppy or not? For the past months, news from the biotech has been rather mixed. Do analysts need to fret about? On the one hand, its treatment against Alzheimer, aducanumab is under FDA review with a decision expected next March. But on the other hand, the company is facing generic competition on one of its main blockbusters Tecfidera, a multiple sclerosis (MS) therapy, more than seven years before the end of the patent protection in the US.

Mid-August, Mylan announced it would launch its generic version of Tecfidera on the US market after having obtained final FDA approval. It would be the first generic of any MS treatment in an oral solid dosage form available to patients in the US.

The launch came two months after a US district court ruled that Mylan had demonstrated "clear and convincing evidence" that asserted claims in Biogen's patent '514, due to expire in 2028, were "invalid for lack of written description." The patent was set to expire in 2028, so the decision will erode years of potential exclusivity if it's upheld.

The US District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera patent but the biotech is appealing the decision. But as it could take 12 to18 months for a resolution, it would give Mylan plenty of time to ramp up sales of its new generic.

According to Evaluate Pharma, "over 20 other challenges could follow if Biogen loses a separate challenge in the Delaware courts", where companies have asked if the decision in the West Virginia court could be applied to them. In 2019, Tecfidera sales reached $3.9 billion and made up 39 % of yhe biotech's total revenues.

Outside of multiple sclerosis Biogen has to face others challenges: firstly with its Alzheimer's drug candidate aducanumab future, and secondly with its spinal muscular atrophy drug Spinraza .The SMA treatment is the company's second-best selling medicine behind Tecfidera. It faces competition from Roche's Evrysdi, the category's first entrant that can be administered at home rather than at a clinic.

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