Bristol-Myers confident of approvals linked to higher Celgene investor payout: Bristol executive

NEW YORK (Reuters) - Bristol-Myers Squibb Co is confident it will receive U.S. approvals for all three experimental drugs tied to a potentially higher payout for Celgene shareholders under terms of its acquisition of the U.S. biotech company, Bristol’s chief medical officer said.

FILE PHOTO: Logo of global biopharmaceutical company Bristol-Myers Squibb is pictured on the blouse of an employee in Le Passage, near Agen, France March 29, 2018. REUTERS/Regis Duvignau/File Photo

New York-based Bristol-Myers bought Celgene for more than $74 billion in a deal announced last January. As part of that agreement, Celgene shareholders received a so-called CVR, or contingent value right, worth $9 per share if three high-profile drugs in Celgene’s pipeline receive U.S. approvals by March 2021.

“We don’t see why we would not be on track for that,” Bristol-Myers CMO Samit Hirawat said in an interview when asked the prospects for achieving that goal.

The CVR BMY_r.N closed on Wednesday at $3.41 per unit, implying that investors currently give the company a roughly 40% chance of succeeding. That will depend on the U.S. Food and Drug Administration, which must still review and approve all three drugs.

The first of the three medicines included in the CVR - Celgene’s multiple sclerosis drug ozanimod - is already being considered for approval by the FDA. A decision is expected by the end of this March.

Bristol-Myers said in December that the lymphoma treatment liso-cel had produced positive results in a clinical trial. It recently submitted an application seeking FDA approval and is awaiting feedback from the agency.

The final asset included in the CVR is a CAR-T therapy for multiple myeloma known as bb2121, or ide-cel, that has produced promising results in trials.

“We continue to remain on track for filing of ide-cel and are looking forward to that approval based on the data, some of which has been shared,” said Hirawat, who joined Bristol-Myers in June.


Hirawat came to Bristol-Myers from Novartis, where he had run oncology development for the Swiss drugmaker. As chief medical officer, he oversees Bristol’s drug development programs.

Having such a large portfolio of established and experimental assets “opens up the door for opportunities of a proprietary combination” he said of multi-drug therapies that would be fully owned by the company.

“One that easily comes to mind, for example, would be cell therapies along with a PD-1 inhibitor,” such as Bristol’s blockbuster cancer immunotherapy Opdivo, Hirawat said. That type of combination could be helpful for some patients whose lymphoma has stopped responding to other treatments, he suggested.

Hirawat said Bristol-Myers is currently developing its strategy for selecting which Celgene drugs it will test in new combination therapies, and could begin announcing those plans by the end of the year.

Once viewed as the company’s most important growth driver, Opdivo sales have flattened, hovering at around $1.8 billion a quarter for the past four quarters. The sales have faltered due to the dominance of Merck & Co’s rival immunotherapy Keytruda in newly-diagnosed advanced lung cancer, the most lucrative oncology market.

Opdivo sales are projected to dip in 2020, according to Refinitiv data. But the deal also brought in Celgene’s still growing cash cow Revlimid, which had sales of $2.77 billion in the third quarter.

In addition to Opdivo’s 19 current approvals, there are 20 more opportunities that the company is exploring, Hirawat said. That includes a combination with relatlimab, a new class of immunotherapy called a lag-3 inhibitor.

“That has the potential of bringing a new IO (immuno-oncology) therapy in the armamentarium of treatment of melanoma which currently doesn’t exist,” he said.

Bristol-Myers shares were up nearly 3% on Thursday at $65.69. They are up around 33% over the last year.

Reporting by Michael Erman and Carl O’Donnell; Editing by Bill Berkrot