Could a patent dispute over Celgene MS hopeful ozanimod tank the BMS deal?

celgene
Bristol-Myers Squibb has said that merging with Celgene will make it a leading player in immunology, but much of that success will rely on the FDA approval of MS candidate ozanimod. (Celgene)

As if Bristol-Myers Squibb didn’t have enough to worry about, what with major investors trying to scuttle its $74 billion acquisition of Celgene, now a new concern has emerged—and it involves one of the six drug candidates that BMS executives have cited as justification for the massive merger.

That drug is ozanimod, Celgene’s multiple sclerosis treatment, which analysts had pegged as a potential blockbuster until the FDA handed the company a crushing refuse-to-file notice early last year. The FDA asked for more data on preclinical and clinical pharmacology, forcing Celgene to delay its application for approval until this year.

But now Credit Suisse analysts have spotted another potential hurdle to the commercialization of ozanimod: intellectual property. BMS, which has been scrambling over the last few weeks to quell investors’ concerns about the deal, is downplaying the risk, but that’s of no comfort to the analysts.

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Credit Suisse learned that Novartis holds a key patent on the class of medicines to which ozanimod belongs, S1P modulators. The patent covers dose titration, “a critical component of ozanimod’s product profile as all three proposed indications currently require dose titration,” Credit Suisse said in a note sent to investors earlier this week. Celgene is also developing the drug to treat ulcerative colitis and Crohn’s disease.

RELATED: Activist Starboard steps up revolt on Bristol-Celgene merger—and BMS strikes back

The analysts initially sent out a note saying BMS was aware that the patent could be a roadblock, but after the company’s investor-relations folks stepped in, Credit Suisse tweaked its warning. While Credit Suisse fears the patent could present a problem, the revised note said, BMS executives “believe they will be able to manage through this hurdle and are not overly concerned about it.”

Perhaps, but the last thing BMS needs right now is an influential Wall Street firm raising yet another question mark about the Celgene acquisition, which comes up for an investor vote on April 12. Activist investor Starboard Value scooped up BMS shares after the deal was announced and promptly spoke out against it. Wellington Management, a major BMS shareholder, is also trying to sway investors against it.

“A key concern surrounding the Bristol/Celgene deal has been around the ability for Bristol to execute on Celgene’s pipeline,” Credit Suisse said in its note.

Indeed, Starboard sent a letter to BMS shareholders in late February listing five reasons the merger would not be in the best interests of investors, one of which was that “the Celgene pipeline is extremely risky and will continue to require significant research & development (R&D) funding.”

Starboard asserted that BMS will be facing a massive patent cliff from Celgene’s multiple myeloma blockbuster Revlimid, which will require replacing more than 60% of the company’s total revenues in the next seven years. BMS has said it can rebuild Celgene’s revenue base off the pipeline of the combined companies, which includes ozanimod and several cancer treatments. But “we believe this is an aggressive assumption and may not be realistic based on historical precedents,” Starboard said.

RELATED: Does Bristol-Myers have a plan B if activists scuttle its Celgene buy?

Most analysts are still betting the deal will happen, largely because the dissenters may not have enough voting power to prevent it. And BMS is so confident that it won't discuss a backup plan—and it's unclear if it has one, Wolfe Research analyst Tim Anderson said in a recent note to investors.

Anderson is one of several analysts who have long been suggesting that BMS itself might be acquired, and it’s a scenario that Starboard has presented as potentially more valuable for shareholders than the Celgene merger would be. But when Anderson asked BMS about that, management “stopped short of saying whether there has been any informal indication of interest in BMS by another party,” he wrote.

After Starboard’s most recent public denouncement of the deal, BMS responded by filing a 46-page presentation to the SEC, which it also posted online. It laid out five reasons shareholders should give the deal a thumbs-up, one of which was that the combined company would be a leading player in the cardiovascular, immuno-oncology and immunology markets.

That last one, of course, would require that ozanimod doesn’t hit any more roadblocks on its path to market.

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