7. Opdivo

opdivo
Bristol Myers Squibb's Opdivo is slated to lose U.S. exclusivity in 2028. (BMS)

Opdivo
Company: Bristol Myers Squibb
2020 sales: $6.99 billion
Key patent expiration: 2028

Bristol Myers Squibb’s Opdivo doesn’t come close to its rival Merck & Co.’s immunotherapy Keytruda in terms of sales, but its $7 billion haul in 2020 is nothing to scoff at.

The $7 billion marked a 3% year-over-year decline. Company execs attributed the drop to the pandemic and have repeatedly said that the drug will return to growth this year.

Growth could be driven by some new indications. The drug—the first PD-1 inhibitor approved anywhere—only broke into the lucrative market for newly diagnosed metastatic non-small lung cancer last year. With two back-to-back FDA nods, Opdivo is now allowed to be used alongside BMS’ other immunotherapy, CTLA-4 inhibitor Yervoy, in those who have the PD-L1 biomarker and with Yervoy plus chemo for first-line patients regardless of their tumors’ PD-L1 status.

RELATED: How can the $23B market for PD-1 blockers grow? 'Pan-adjuvant' use is key: report

Opdivo is also ahead of Keytruda in stomach cancer. It snagged a first-in-class FDA go-ahead in April for previously untreated gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. In May, it became the first cancer immunotherapy to be approved as a postsurgery adjuvant treatment for esophageal or gastroesophageal junction cancer.

Uses before and after surgery are considered a big growth opportunity for PD-1/L1 blockers. For BMS, Bernstein analysts recently pegged Opdivo’s pan-adjuvant sales at $4.8 billion by 2028.

BMS is also looking to buoy Opdivo’s position with new drug combinations. These include a new checkpoint inhibitor, the LAG-3 antibody relatlimab. The Opdivo-relatlimab cocktail outperformed solo Opdivo at staving off cancer progression in front-line metastatic melanoma, according to phase 3 data unveiled at the recent ASCO annual meeting. And the company is also progressing the regimen into late-stage testing in the adjuvant setting.

RELATED: ASCO: Bristol Myers, leading the LAG-3 pack, posts phase 3 melanoma data for Opdivo-boosting relatlimab

By 2026, Opdivo’s global sales could reach $11.75 billion, Evaluate Pharma predicted in a report last April. It will lose U.S. market exclusivity in 2028, according to BMS’ recent securities filing. Drugmakers developing Opdivo biosimilars include Sydney company NeuClone Pharmaceuticals, Swedish firm Xbrane Biopharma and China’s Luye Pharma.

The problem for the New York pharma is that its two larger assets—newly acquired blood cancer med Revlimid and Pfizer-partnered blood thinner Eliquis—are also expected to face copycat assaults around the 2026-to-2028 timeframe.

To fill the revenue gap, the company has said that six new drugs could together contribute over $15 billion in peak sales. Five of them are from the $74 billion Celgene buyout, and the sixth comes from BMS’ own pipeline.

The five legacy Celgene drugs have all reached the market. They are CAR-T therapies Abecma and Breyanzi, which are difficult-to-make blood cancer drugs; JAK inhibitor Inrebic, which has been approved for myelofibrosis; blood disorder therapy Reblozyl; and S1P receptor modulator Zeposia, an anti-inflammation treatment greenlighted for multiple sclerosis and ulcerative colitis.

The asset from BMS' original pipeline, oral TYK2 inhibitor deucravacitinib, recently topped blockbuster Otezla in plaque psoriasis; Celgene had to sell Otezla to Amgen to win antitrust clearance for the BMS merger.

RELATED: Despite FTC's harsh words for biopharma M&A, Bristol Myers CEO Caforio still enthusiastic about deal-making

BMS has kept the M&A talks going in the wake of the Celgene deal, as it scouts for more heavyweight drugs to fuel its long-term growth. In a $13.1 billion deal last year, BMS bought MyoKardia and obtained late-stage heart drug mavacamten, which Evaluate Pharma previously predicted could reach $2 billion in 2026 sales.

BMS CEO Giovanni Caforio wasn’t shy about his intention for making more deals. He recently touted the company’s “significant financial flexibility” for M&A and put the focus on midsize bolt-on deals that could pull their weight in the second half of the decade.

The priority for the company’s business development activities is across solid tumors, hematology, immunology and cardiovascular disease, Caforio said during a conference call in April. Its existing presence provides an opportunity for it to acquire more assets in those areas and maximize their value, he said.

7. Opdivo