Immunomedics’ turbulent period continues with the exit of CEO Michael Pehl a few weeks after the biotech’s lead breast cancer drug was rejected by the FDA.
Pehl’s resignation on Feb. 23—just over a year after taking the job—is for “personal reasons,” according to Immunomedics and, according to analysts at Jefferies, stems from his desire to return to Europe with his family.
Jefferies also said that on the strength of Immunomedics’ quarterly update, they still believe that Immunomedics’ antibody-drug conjugate IMMU-132 (sacituzumab govitecan) is “approvable” as a third-line treatment for late-stage, metastatic triple-negative breast cancer (TNBC). However, they are now delaying the predicted U.S. launch date by a year to 2021.
The FDA issued a complete response letter (CRL) for IMMU-132 last month, which the company said stemmed from manufacturing issues, with no need for new clinical or preclinical data. There’s still no word on a meeting with the regulator to discuss the deficiencies in detail and Jefferies now thinks the timeline to resolve them looks likely to be extended.
“The unexpected departure of CEO adds to the conjecture that the CRL may demand longer/tougher solution than initially expected,” the analysts wrote in a research note, which suggests as its best case scenario that IMMU-132 should be approvable for TNBC in the U.S. based on current phase 2 data.
The worst case scenario would be delayed approval to 2022 if the FDA insists on waiting for phase 3 results that will also form the basis of filings in Europe, they added, but they are still predicting U.S. sales of around $3 billion at peak in 2033 and another $435 million in royalties from EU sales that year.
There are also unanswered questions about an FDA inspection of Immunomedics’ manufacturing facility for IMMU-132 in Morris Plains, New Jersey, which found chemistry, manufacturing and control deficiencies—specifically related to data integrity and process control for sterility—and resulted in a Form 483.
The biotech got an enforcement report from the FDA earlier this month but will need a re-inspection as part of the process for refiling IMMU-132, according to an SEC filing.
As soon as Pehl tendered his resignation Immunomedics appointed venBio’s Behzad Aghazadeh as executive chairman to steady the ship and made a series of other appointments, which included making Usama Mali’s role of interim CFO permanent.
Immunomedics also appointed Magis Consulting’s Scott Canute—previously a Genzyme manufacturing executive—as an executive director and added Mirati Therapeutics’ CEO Charles Baum, M.D., Ph.D., to the board.