Biogen's last-ditch pitch for an injunction to protect Tecfidera is denied, paving way for Mylan generic
After a long and drawn-out court fight, it seems all but inevitable that a generic version of Biogen’s blockbuster Tecfidera will hit the market sometime later this year.
The Cambridge, MA-based company’s last-ditch efforts to stop a Mylan generic fell flat Thursday, as a federal appellate court denied Biogen an injunction in a ruling last month invalidating Biogen’s ‘514 patent for the multiple sclerosis drug. Had the patent not been wiped out, Biogen would have delayed generic competition until 2028.
Mylan would likely be launching its generic “at-risk” because the June court ruling is still under appeal, leaving the company open to considerable damages. But Mylan has already filed with the FDA to speed up its target action date, currently November 16, signifying its confidence in winning an appeal.
Biogen declined to comment, citing company policy on litigation matters, while Mylan pointed to their press release from the June ruling.
Given that Tecfidera accounted for $4.4 billion in 2019 sales — 39 percent of Biogen’s total revenue — a generic would have seismic consequences in the MS field.
News of the injunction didn’t faze Wall Street one way or the other, as Biogen remained mostly flat at around $276 per share. Robyn Karnauskas, an analyst at SunTrust Robinson Humphrey, reacted to Thursday’s news negatively, however, suggesting that if Mylan’s drug does reach the market in November, Biogen would see a “significant” erosion in 2021.
Karnauskas forecasted two scenarios for Biogen’s stock, contingent on the approval of aducanumab, one of the company’s other candidates being tested for the treatment of Alzheimer’s. Should aducanumab be approved — which is far from guaranteed, given the drug’s delayed filing process — and Mylan introduce its generic in November, Karnauskas could see the stock price fall to $260. If aducanumab is not approved, Biogen stock has the potential to shed almost half its value and drop to $160 per share.
Additionally, Karnauskas cited a key opinion leader who gave Biogen an 80 percent chance of losing its appeal in the June court ruling. The KOL also said it’s “safe enough” for Mylan to go the at-risk route because they’re a large enough company to withstand sanctions.
Both Biogen’s and Mylan’s drugs are dimethyl fumarate products, which help treat relapsing forms of MS in adults. Tecfidera is a twice-daily, delayed-release pill, and Mylan’s generic is likely to take a similar form. The Biogen patent was invalidated for “lack of written description,” wrote Stifel’s Paul Matteis last month.
There is some silver lining for Biogen, however, as its Tecfidera successor Vumerity won FDA approval last October. The drug, in-licensed from Alkermes, features an improved safety profile but some analysts expect it to only break $1 billion in a niche market with plenty of rivals. Further complicating matters is the Covid-19 pandemic leading to hugely disappointing sales numbers — since its launch Vumerity has only amassed $16 million in sales, compared to near or more than $1 billion for Biogen’s other MS drugs: Tecfidera, Avonex and Tysabri.
An already rough 2020 for Biogen could get rougher in a couple weeks. After one of the company’s meetings in early March functioned as a superspreader event for Covid-19, a Delaware District Court is expected to hear oral arguments in a separate Tecfidera patent case on August 11. But because the patent is already “dead,” according to the KOL, the judges on the Delaware court have impetus to rule against Biogen.