Biogen took a major hit last week when a federal court tossed out its patent protections for multiple sclerosis drug Tecfidera. That loss could be Mylan's gain—but it would require the Pennsylvania generics maker to chance an "at-risk" launch, one analyst says.
While Biogen appeals the West Virginia federal court ruling, Mylan could have a shot at a limited market for its Tecfidera generic—roughly equivalent to around $550 million in annual sales, according to SVB Leerink analyst Ami Fadia.
Mylan would benefit from one of two potential results from Biogen's patent appeal, which could take as long as 13 months: Either Mylan chooses to launch at risk immediately after an FDA approval, or it chooses to settle with Biogen contingent on a positive appeal, Fadia said in a note to investors Monday.
Choosing to work with Biogen would put Mylan in a "unique position to negotiate" on an expedited generics launch sometime in the late 2021 timeframe, Fadia noted. However, both decisions are complicated by Biogen's chances at an appeal—which Fadia called "unlikely"—and Mylan could determine that waiting around for a positive ruling would put it in a worse position, with more generics primed for launch.
"We still think that Mylan could potentially settle with Biogen for a favorable exclusivity window if it is able to reach terms that exclude the other generic companies involved in the other Delaware District Court case," Fadia wrote. "However, this depends on whether the West Virginia decision can get vacated and Biogen would be willing to deal in such terms."
As Mylan plots its next move, it's also taking the final, arduous steps of its generics mega-merger with Pfizer's Upjohn unit—a process that has faced delays thanks to COVID-19.
In April, EU regulators said they had approved the transaction after the pair of drugmakers agreed to sell some Mylan generic drugs across 20 countries in the European Economic Area and the U.K. In a statement, Mylan said the required divestitures are “substantially in line with” the company’s previously stated expectations.
Biogen, meanwhile, is looking at an uncertain future for its $4 billion-per-year blockbuster at a pivotal moment for the drugmaker. Even with patent protection for Tecfidera, Biogen is facing an increasingly competitive MS market with a suite of serious rivals.
In its first year on the market, Roche's Ocrevus hit blockbuster sales, making it one of the most successful drug launches of the last two years. Novartis is also proving to be a tough competitor with Mayzent, and now it’s gunning for even more of the MS market with ofatumumab, its once-monthly at-home injection.
Biogen's own Tecfidera follow-up, Vumerity, notched an FDA approval in late 2019, but it's only snared around 1.3% market share, Piper Sandler analysts said in a Friday note to clients.
Tecfidera's loss also puts extreme pressure on the success of Alzheimer's candidate aducanumab, which has had its own rough road in recent years
In May, Biogen said it had wrapped construction on a "state-of-the-art" facility in Solothurn, Switzerland, that will be ready to manufacture aducanumab at scale beginning in mid-2021. However, the drug will need an approval first, and market watchers have been skeptical of its chances.
On an earnings call in April, CEO Michael Vounatsos said Biogen's aducanumab filing with the FDA had been pushed back to the third quarter from an initial first-quarter forecast. Analysts repeatedly asked about the delay on that call, and Vounatsos said the company is “prioritizing quality of submission versus the timing.” Plus, some members of the company's executive team came down with COVID-19, also contributing to the delay, R&D chief Al Sandrock said.
Analysts, who had previously anticipated a potential 2020 approval, pushed their expectations out as far as 2022. And they have reason for skepticism: Last March, the candidate flunked a futility analysis before Biogen decided to bring it back six months later for a try at approval.