The hack is unlikely to affect Amgen’s financial reporting and other operations, nor does the pharma expect its ability to meet patient needs will be compromised.
A cybersecurity breach at Amgen has affected protected patient health information and other sensitive company data.
The pharma in an SEC filing on Friday revealed that “unauthorized activity” was detected in its cloud storage hosted by third-party service providers, flagging that “some of its data, including proprietary data, patient protected health information, and other information, has been exfiltrated” from these repositories. An investigation is ongoing.
Amgen deems the cybersecurity event to be “material,” according to the regulatory document, given the “volume of the files that appear to have been impacted” and the potentially sensitive nature of the information accessed.
Still, the hack has yet to have any discernible impact on Amgen’s ability to meet patient needs, the company said. The breach also doesn’t appear to have compromised the pharma’s financial reporting, manufacturing operations or products. Amgen doesn’t expect its financial condition to be affected.
Amgen “takes its obligation to safeguard privacy and security of its patients’ data very seriously,” the company said, adding that it will make the proper regulatory and legal notifications as needed. The pharma did not provide avenues of recourse to patients potentially affected by the breach.
Amgen is scheduled to report second quarter earnings on Tuesday.
The last few months have been tough for Amgen. In January, the FDA called for the voluntary withdrawal of its rare disease drug Tavneos, which was picked up in the $3.7 billion acquisition of ChemoCentryx in 2022. Amgen has refused. The standoff has only gotten more tense, with the FDA in April alleging that the pivotal data supporting Tavneos’ approval had been manipulated. Amgen has since requested a hearing with the regulator and last month submitted a data and analyses package to support its case—alongside patient testimonials.
Outside of the Tavneos troubles, Amgen in early July was forced to recall nearly a million bottles of its chronic heart failure drug Corlanor amid concerns of contamination.
Amgen isn’t the only Big Pharma company that has recently been targeted by hackers. In June, Novo Nordisk reported a similar data breach that affected “a limited amount of information related to patients participating in some of our clinical trials.” The Danish drugmaker at the time assured patients that only deidentified data had been accessed by the hackers but still urged trial participants to be vigilant and report any unusual events that could be linked to the breach.
