Bristol Myers Squibb Hematology Chief Departs Following CAR-T Therapy Setback

Compiled by Keke

Nadim Ahmed, Longtime Celgene Executive and Current BMS Hematology Head, to DepartAccording to recent reports from foreign media, Nadim Ahmed, a long-serving executive at Celgene and the current head of hematology at Bristol-Myers Squibb (BMS), is set to leave the company. A company spokesperson stated that Ahmed had driven business growth in 2020 through the launches of three drugs—Reblozyl, Onureg, and Inrebic—but is now departing BMS to pursue other opportunities.

Previously, BMS failed to secure U.S. Food and Drug Administration (FDA) approval for its CD19-targeted CAR-T candidate cell therapy drug, liso-cel, by the end of 2020, dashing investors’ hopes of realizing the $9-per-share payment associated with the Celgene acquisition. This marks the latest in a series of setbacks for the company’s cell therapy division.

It is reported that Chief Commercial Officer Chris Boerner will take over Ahmed’s responsibilities as Head of Hematology, thereby assuming greater commercial accountability.

“Throughout 2020, we have built a solid foundation for BMS to emerge as a new company and a promising leader in the biopharmaceutical industry,” BMS stated in an email. Under the leadership of Chris Boerner, the company will unify its commercial teams, build upon the strong foundation established since the formation of the new company, and accelerate the development and deployment of critical capabilities.

Mizuho analyst Salim Syed believes that a tweet last week leaked the news of Ahmed’s departure and sparked external questions about Ahmed’s position at BMS. In an interview with Fierce Pharma, the analyst said he was “very confident” that Ahmed currently does not have a new job.

Syed pointed out that the timing of this departure is “very interesting,” as there are only two weeks left until the deadline for the payout of Bristol-Myers Squibb’s (BMS) contingent value rights (CVR) shares. By 2021, the company had not yet met the requirements to trigger the $6.4 billion CVR payment issued in connection with its merger with Celgene.

Syed stated that Ahmed’s departure would raise questions about whether he was a “scapegoat” or a whistleblower in potential litigation. Investors want to know why the established pharmaceutical company, Bristol-Myers Squibb (BMS), has struggled with regulatory procedures for key drug applications and whether there was any negligence. Some investors even suspect that the company may have attempted, “in any way,” to avoid paying the CVR.

Syed said, “I suspect that as time goes on, if lawsuits are filed and BMS executives are removed from their positions, we will learn more.”

In mid-December last year, the U.S. FDA identified manufacturing issues during a pre-approval inspection, which could be interpreted, at least in part, as Bristol-Myers Squibb (BMS) failing to meet the year-end approval deadline for liso-cel. However, difficulties in manufacturing operations at the viral vector plant operated by BMS’s contractor, Lonza, had already become apparent earlier. In October last year, the U.S. FDA issued a Form 483 to Lonza’s cell therapy facility in Bothell, Washington. This form is a list of observations cited by the regulatory agency as evidence of non-compliance, issued to food or medical product manufacturers found to be in violation during inspections.

Even before these manufacturing issues arose, the U.S. FDA had already postponed its original November decision on the approval of liso-cel. This was an adverse consequence of the COVID-19 pandemic, during which the regulatory agency restricted its inspection activities. At that time, the U.S. FDA requested additional information from BMS and required more time for review. However, one of the conditions for the CVR—originally scheduled to be approved by December 31—has now been missed. Troubled investors are wondering why there is still no news regarding the fate of liso-cel, especially given that it has been designated as a breakthrough therapy, a status that should warrant every assistance in expediting regulatory decisions.

ide-cel, co-developed with Bluebird Bio, also triggered the $9 per share CVR payment upon its timely marketing approval. The U.S. FDA initially refused to review the application for this BCMA-targeted CAR-T therapy for multiple myeloma, also due to issues in the manufacturing section of the submission. BMS and Bluebird Bio resubmitted the application in July; it was granted priority review, with a decision expected in late March of this year.

Liso-cel and Ide-cel are key pipeline assets acquired by BMS through its $74 billion acquisition of Celgene. At the J.P. Morgan Annual Healthcare Conference, BMS CEO Giovanni Caforio stated that the cell therapy franchise is one of a portfolio of products expected to generate peak sales of at least $4 billion.

But these drugs must first be approved by the U.S. FDA, and meanwhile, CVR’s investors are dissatisfied with this.

Ahmed joined Celgene in 2010 and was promoted to Head of Hematology and Oncology in 2017, before joining Bristol-Myers Squibb (BMS) at the end of 2019 to assume his current role. According to BMS, he oversees all commercial strategy and execution activities and is directly responsible for the company’s cell therapy business. Boerner succeeded Murdo Gordon as Executive Vice President and Chief Commercial Officer in 2018, after managing BMS’s international marketing operations; Gordon is currently the Chief Commercial Officer at Amgen.

Reference Source:

1.Bristol Myers hematology chief Ahmed's out the door amid CAR-T missteps

2.Bristol Myers' top hematology exec is on his way out — right on the heels of a $6B CVR implosion