Having spent over three decades without an approval, Immunomedics has a troubled past that culminated in a management shakeup at the behest of an activist shareholder campaign that was meant to rejuvenate the company’s fortunes. But that hope was shattered when the FDA rejected the company’s breast cancer drug in January, citing manufacturing issues.
To be sure, the company was not expecting the rejection. It hired a sales force back in November in anticipation of the January approval and told analysts in December that manufacturing issues the US health regulator had flagged in August had since been addressed.
It has now been revealed the FDA actually charged Immunomedics with a data integrity breach in its August 2018 inspection, citing manipulated samples and backdated batch records. In its heavily redacted report, the FDA said there was no assurance that samples, batch records and commercial batches manufactured before February 2018 were not impacted by the data manipulation.
The agency also underscored other shortcomings, including inadequate raw material sampling and testing as well as highlighting the insufficient cleaning of equipment and measures to prevent contamination.
Endpoints News has contacted Immunomedics $IMMU for comment.
“The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated,” Immunomedics chief Michael Pehl said in a statement last month, adding that the company intended to request a meeting with the FDA to better understand the agency’s requirements.
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