At least one top executive is out the door at Bristol Myers Squibb after several regulatory missteps in the company's cell therapy department.
Longtime Celgene exec and current Bristol Myers' head of hematology, Nadim Ahmed, is leaving the company as of Friday. Ahmed, who steered the business through three virtual drug launches in 2020—Rebloyzl, Onureg and Inrebic—left BMS to pursue other opportunities, a company spokesperson said.
The news came after the company failed to get CD19-targeted CAR-T candidate liso-cel across the FDA finish line by the end of 2020, dashing investors' hope of realizing a $9-apiece payment tied to the Celgene buyout—the latest in a series of setbacks in the cell therapy division.
Chief commercial officer Chris Boerner will take over Ahmed’s hematology duties, which will be rolled into his larger commercial responsibilities.
“Throughout 2020, we have established a strong foundation for Bristol Myers Squibb as a new company, a biopharma leader with a bright future ahead," the company said in an emailed statement. "Bringing the commercial teams together under Chris Boerner’s leadership will build on the strong foundation established since the creation of our new company, and enable accelerated development and deployment of important capabilities.”
However, at least one analyst wondered about the timing of Ahmed's departure. Mizuho analyst Salim Syed said a tweet last week leaked the departure news and sparked questions over Ahmed’s status with BMS. The analyst, in an interview with Fierce Pharma, said he’s “pretty sure” Ahmed doesn’t have a new job lined up.
The timing is “very interesting,” he said, noting that it’s just two weeks after Bristol’s contingent value rights deadline. When the calendar turned to 2021, the company hadn’t met requirements to pay its $6.4 billion CVR Bristol Myers issued with the Celgene merger.
Ahmed’s departure will raise questions over whether he was a “fall guy” or potentially even a whistleblower for potential litigation, Syed said. Investors are wondering why the established drug maker struggled with regulatory procedures for key drug applications, and whether it was negligent.
Some investors wonder whether the company “in any way” tried not to pay the CVR, Syed said.
“I suspect we’ll learn more over time if litigation is pursued and folks are deposed,” Syed said.
On Friday, Syed shared a communication from BMS stating that the departure was "unrelated" the CVR.
"We’re very grateful to Nadim, he’s done a great job at BMS since the time the deal closed," the company said in a statement. "The company decided to consolidate commercial under one leader, as a result Nadim has decided to leave. The company remains very confident in the potential approval of liso-cel, and the decision to change our commercial leadership structure is unrelated to liso-cel and the CVR."
RELATED: Bristol Myers CVR down the drain as CAR-T drug's FDA manufacturing inspection spots problem
Manufacturing problems noted during an FDA pre-approval inspection in mid-December were at least partly to blame for Bristol Myers' failure to meet the year-end approval deadline on liso-cel. But the manufacturing woe at the viral vector facility, operated by Bristol Myers' contractor Lonza, actually came on top of a Form 483 the FDA slapped on the New York pharma's own cell therapy facility in Bothell, Washington, in October.
Before these manufacturing problems, the FDA had delayed a liso-cel decision previously scheduled for November. That was COVID-19's fault—the agency has been limiting its inspection activities during the pandemic.
But the November PDUFA data itself came as a result of a three-month postponement the FDA delivered on liso-cel's application. At that time, the FDA had requested additional information from BMS and needed more time to review it.
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Then there's bluebird bio-partnered ide-cel, whose timely approval was also a condition required to trigger the $9-per-share contigent value rights payment. The FDA had originally refused to review the BCMA-targeted CAR-T therapy's application in multiple myeloma, again due to the manufacturing portion of the documents. The two companies refiled in July and the application has been put under priority review with a decision set for late March.
Liso-cel and ide-cel are important pipeline assets featured in Bristol Myers' $74 billion acquisition of Celgene. Together, the cell therapy franchise was among a short list of drugs that could deliver at least $4 billion in peak sales, Bristol Myers CEO Giovanni Caforio said at the annual J.P. Morgan Healthcare Conference.
But the meds have to make it through the FDA first, and in the meantime, CVR investors are unhappy.
Ahmed joined Celgene in 2010 and rose to president of hematology and oncology in 2017 before joining Bristol Myers in late 2019 at his current position. He was responsible for all commercial strategy and execution activities, and he's directly responsible for the company’s cell therapy business, according to Bristol Myers.
Boerner became executive VP and chief commercial officer in 2018 after running BMS' international marketing, replacing Murdo Gordon who is now chief commercial officer at Amgen.
Editor's note: This story was updated Friday with a BMS statement shared by Syed.