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Biogen’s R&D chief Ehlers heads for the exit

Follows multiple late-stage Alzheimer's study failures

Michael Ehlers

Michael Ehlers

Biogen’s head of R&D Michael Ehlers (pictured above) is leaving the company after three years, and some high-profile failures in its late-stage pipeline.

Ehlers is moving on to take the chief executive position at a new gene therapy start-up called Limelight Bio on 11 October, while Biogen’s chief medical officer Alfred Sandrock is taking overall responsibility for R&D at the company.

Along with his CEO role at Limelight, Ehlers is also taking on a CSO position at venture capital firm Apple Tree.

The departure comes after a difficult few months in which Biogen has pulled the plug on two of its amyloid-targeting Alzheimer’s disease programmes – aducanumab and elenbecestat – after disappointing efficacy results in phase 3 trials, as well as a lung disease therapy due to toxicity.

Ehlers joined Biogen in 2016 with the express aim of taking the lead on its emerging neuroscience pipeline, having been chief scientific officer at Pfizer’s neuroscience R&D unit in his previous role.

The Alzheimer’s programmes were the centrepiece of Biogen’s pipeline, and while one Eisai-partnered anti-amyloid candidate (BAN2401) remains in late-stage development with data due in 2022 there is little optimism of a positive outcome given the ever-lengthening list of failed amyloid programmes across the industry.

There are more immediate problems at Biogen however. Multiple sclerosis blockbuster Tecfidera (dimethyl glutamate) is coming under increasing competitive pressure, and analysts aren’t confident that a follow-up with an improved tolerability profile – Vumerity (diroximel fumarate) – is differentiated enough to compensate as Tecfidera sales stall.

Biogen is heavily reliant on its wider MS portfolio, and a slew of newly launched or anticipated rival therapies like Novartis’ Mayzent (ozanimod) and Roche’s Ocrevus (ocelizumab) are already threatening to take market share from its products.

One bright spot for Biogen has been its fast-growing Spinraza (nusinersen) for rare disease spinal muscular atrophy (SMA), which was launched on Ehlers’ watch and quickly achieved blockbuster sales levels.

Second-quarter revenues for the drug didn’t quite meet analysts’ expectations however, and with competition now in the market from Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) – and potentially also Roche’s small-molecule drug risdiplam which is due to be filed before year end – the jury is out on future growth rates.

Biogen recently presented compelling results for Spinraza in an early, pre-symptomatic setting, which could help it fight Zolgensma in this cohort of high-need patients.

Biogen CEO Michel Vounatsos thanked Ehlers for the “substantial progress made in our pipeline during his three years at Biogen” adding that he has “transformed the R&D organisation and I believe he has built the best neuroscience team in the industry”.

Biogen has been directing its attention to other areas such as immunology and ophthalmology, recently acquiring Nightstar Therapeutics to add a pipeline of gene therapies for inherited retinal diseases for example, which has reduced its exposure to high-risk neurology projects.

There’s still plenty in the neuroscience pipeline however, including tofersen for amyotrophic lateral sclerosis (ALS) which stems from an alliance with antisense specialist Ionis and is due for a phase 3 readout in 2021.

Biogen is still viewed as having a risky pipeline overall, and Ehlers’ departure won’t do anything to improve investor confidence. Shares in the company fell a little over 2% after the news came out.

Article by
Phil Taylor

2nd October 2019

From: Marketing



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