AMAG CMO hits the exit just as biotech searches for new CEO to right a ship rocked by Makena controversy
Heading into 2020, AMAG Pharmaceuticals has sketched big plans to salvage its wobbly operations — battling a revenue squeeze and a critical FDA review of its preterm birth drug — under a new CEO. Today, it announced that the chief medical officer won’t be staying, either.
Julie Krop, who joined AMAG in 2015, will decamp by the end of the month, leaving a void in the biotech’s development group just as it pledges to persuade the FDA to keep Makena on the market and advance a “potentially exciting pipeline.”
The biotech has been under considerable scrutiny since an advisory committee convened by the FDA voted to yank its approval for Makena. First given an accelerated OK in 2011, the drug had failed to prove in a confirmatory trial that it prevents preterm birth any more than a placebo.
In response to the thumbs down, where votes were split, Krop said her team was working with regulators to generate additional efficacy data while keeping the drug available to patients.
The fate of Makena — a version of an old drug known as 17p — is the subject of a fierce debate among doctors and insurers. It’s currently the only option available for at-risk pregnant women, advocates say, and the FDA is mandated by law to pull generic options alongside the branded one should they decide to do so.
Makena sales took a hit in Q4 of 2019, registering at $122.1 million compared to $322.3 million during the same period in 2018.
In the wake of the FDA panel’s negative opinion, AMAG has also decided to divest a pair of women’s health therapies, namely Intrarosa for pain during sex and Vyleesi, the controversial second “female Viagra” following Addyi.
Adding up all of that triggered an impairment charge of $155 million. AMAG acquired Vyleesi and Intrarosa in early 2017 for a total upfront cost of $123.5 million.
A search for William Heiden’s successor as CEO is underway, with a transition expected in the next quarter. His departure followed that of 110 sales staffers who were cut during a sweeping reorganization last year.