R&D, Setbacks

In the wake of deep R&D cuts, Bayer flags safety concerns for a top PhIII drug

Less than a week after Bayer announced plans to carve down its internal R&D group, laying off 900 R&D staffers, the German company has tipped the market that one of its crucial late-stage development efforts has run into serious trouble.

Joerg Moeller

R&D chief Joerg Moeller, who gathered the reins in research after the departure of Andreas Busch in late 2017, told an investment group in London Monday that the company was halting its development work on vilaprisan, a uterine fibroid drug that has been billed as a top blockbuster prospect at the company.

“For vilaprisan we have just some days ago put clinical development of our ongoing trials on hold,” he noted, according to a report in Reuters. “That is due to very recent safety findings in long-term toxicology studies … We have therefore decided as a precautionary measure to stop enrollment into our ongoing program and evaluate the data.”

I queried Bayer about the issue, and got this back mid-morning:

We recently observed safety signals in pre-clinical toxicological studies in rodents investigating long term safety of vilaprisan – a drug candidate we develop for the treatment of uterine fibroids and endometriosis.

Although these are preliminary pre-clinical findings that have not been observed in other vilaprisan studies we decided as a precautionary measure to pause recruitment in the ongoing clinical studies with vilaprisan until a thorough analysis of the findings has been achieved.

No new patients will be enrolled in the program. Patients currently on treatment will continue their ongoing treatment course according to study protocol until further notice from Bayer.

Bayer went on to note that they had alerted the proper authorities and will monitor patients for safety issues.

This isn’t the first uterine fibroid effort to raise alarms.

The setback occurs as Allergan is still dealing with the FDA’s rejection of its uterine fibroid drug Esmya after European regulators cited it for triggering a rare liver disease. The EMA earlier this year put restrictions on the use of the drug to protect women on the therapy.

AbbVie, meanwhile, has been rolling out Orilissa after that drug was first approved for endometriosis last July. The therapy has passed muster for uterine fibroids in Phase III as well, raising hopes that AbbVie can gain significant revenue from this drug as they expand the market.

Bayer, meanwhile, is transitioning its R&D operations as it works out a global restructuring, with plans to cut back on what it spends on internal research in favor of more alliances with outside biopharma companies. A couple of years ago, though, they included vilaprisan among a group of drugs they touted as likely blockbusters able to earn more than $6 billion in peak sales.

What happened with the rest?

Their PI3k cancer drug Aliqopa was first approved a year ago, going into a third-line setting against heavy competition. They have a high-risk heart drug called vericiguat, anetumab ravtansine failed a mid-stage study for mesothelioma and no longer features on the late-stage end of the pipeline report and finerenone is in Phase III for kidney disease, alongside darolutamide for cancer. Darolutamide hit its goal in Phase III for non-metastatic castration-resistant prostate cancer a couple of months ago, though they held back all the data for a later conference.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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