Biogen gears up for Alzheimer's drug launch

There are serious doubts about whether the FDA will approve Biogen’s Alzheimer’s candidate aducanumab – but is gearing up to file it with the regulator and is already looking ahead to a potential launch.

Chief executive officer Michel Vounatsos said that the company plan to file its dossier of clinical evidence for aducanumab with the FDA “as soon as possible” in a conference call with analysts as the troubled pharma announced its full year results.

The dry figures on display belie the drama that unfolded in 2019. In March, Biogen axed phase 3 development of aducanumab after deciding that it wasn’t working, only to stun markets in October by announcing plans for a filing after seeing what looks like a beneficial effect in certain patients at a high dose.

Earlier this week, the FDA even approved a re-dosing study for Alzheimer's patients formerly enrolled on the abandoned trials, and could start receiving the drug again as early as March.

Meanwhile, Biogen is remaining coy about exactly when it plans to file its dossier with the FDA, although the company is already gearing up in case the regulator gives a positive decision.

Biogen CEO Michel Vounatsos

Cited by Reuters, Vounatsos said: “We are actively preparing for the potential launch of aducanumab with an initial focus on the United States.”

Alfred Sandrock, executive vice president of research and development said the company has had a “high level of constructive engagement” with the FDA, adding that “it’s basically a matter of putting together documentation”.

The company is already factoring in launch costs in its guidance for 2020, saying it expects to spend up to 20.5% of total revenue as it ramps up its sales force to market the drug.

After a filing, the medical community and investors will get a strong indication about whether aducanumab is approvable if the FDA convenes a meeting of its expert advisors, which is highly likely in the case of a novel drug.

Any new drug for Alzheimer's would be a major achievement as there has been nothing new to hit the market since 2003, and available treatments only help manage symptoms instead of slowing or halting progression.

If aducanumab is approved, it will be in the nick of time for Biogen, which could see its blockbuster multiple sclerosis pill Tecfidera face generic competition for the first time this year.

A key decision in a patent dispute is expected this week but in the meantime sales grew in Q4, and were up 5% to $1.2 billion.

Biogen has just launched a follow-up drug to Tecfidera called Vumerity, which is less likely to produce the gastrointestinal side-effects that cause some patients to quit.

After a launch in October it’s too early to say whether Vumerity has been a success with sales of just $5 million – but Vounatsos said it has had positive reception from health insurers.

Competition is tough though with Novartis’ Mayzent and Merck KGaA’s Mavenclad among recent MS launches.

Biogen said Q4 sales were up 4% compared with the same period last year, and total revenues grew 17% to $14.4 billion.