Over the past five years, Celgene (NASDAQ: CELG) stock has soared 280%. That's better than any other biotech with a market cap of $50 billion or more.
Celgene's past success stemmed primarily from four drugs: Revlimid, Pomalyst, Otezla, and Abraxane. These drugs should continue to generate growth for the biotech in the future, with Revlimid on track to become the top-selling cancer drug in the world. However, the most important drugs in determining whether Celgene remains the best big biotech stock in the next decade are still in the pipeline. Here are the five drugs that will be most critical to Celgene's future success.
Celgene's head of hematology and oncology, Nadim Ahmed, referred to ozanimod as "one of the crown jewels of our portfolio" at the Cantor Fitzgerald Global Healthcare Conference this week. He wasn't exaggerating. Celgene thinks ozanimod could become a multibillion-dollar franchise.
The drug achieved primary and secondary endpoints in two late-stage clinical studies in treating relapsing multiple sclerosis (MS). Celgene expects to file for regulatory approval in the MS indication by the end of the year. Results from a late-stage study evaluating ozanimod in treating ulcerative colitis should be announced in 2018.
Ozanimod isn't the only pipeline candidate that could join Otezla in expanding Celgene's inflammation and immunology presence. GED-0301, also known as mongersen, also holds the potential to achieve peak sales of at least $2 billion. Otezla, ozanimod, and GED-0301 each use a different mechanism of action, which means that there should be room for all three drugs to compete in the inflammation and immunology space.
Celgene is evaluating GED-0301 in two clinical studies. Results from a late-stage trial of the drug as a treatment for Crohn's disease are expected next year. Data from Celgene's phase 2 study of GED-0301 in treating ulcerative colitis should be announced later this year.
Celgene's historical area of dominance has been in hematology. The biotech should continue that dominance if luspatercept lives up to its potential. Celgene expects the drug will be another megablockbuster following in the footsteps of Revlimid and Pomalyst.
Luspatercept is currently being evaluated in two late-stage studies, one targeting treatment of myelodysplastic syndromes and the other targeting treatment of beta-thalassemia. Nadim Ahmed said that enrollment in these studies was "way above our expectations" because of how investigators and patients are "voting with their feet" on their excitement about luspatercept by participating in the trials. Celgene anticipates potential regulatory approval of the drug in 2019.
Ahmed stated that Celgene's goal is to be a leader in solid tumors. Currently, Abraxane stands as the company's top drug in the arena. However, Celgene has high hopes for its next-generation proteasome inhibitor marizomib. The biotech thinks the experimental drug could generate peak annual sales topping $1.5 billion if approved.
The unique thing about marizomib is that it crosses the blood-brain barrier. That could be particularly beneficial for targeting glioblastoma, the most common type of brain cancer. Ahmed noted that phase 1/2 results for combination therapies featuring marizomib were encouraging. He said that Celgene is ready to get started with a pivotal clinical study of the drug.
Although Revlimid and Pomalyst will continue to be key treatments for multiple myeloma, Celgene's pipeline includes nine programs also targeting the indication. The candidate with the greatest potential is probably CC-220. Celgene thinks CC-220 could be yet another product to reach sales measured in billions of dollars.
It's still early, though. Enrollment is under way for a phase 1/2 study of CC-220 as a monotherapy and in combination with dexamethasone in treating multiple myeloma. The study isn't expected to wrap up until 2020. Celgene anticipates potential approval for CC-220 in 2022 at the earliest.
And there's more
These five aren't the only potential blockbusters in Celgene's pipeline. The company claims five other candidates that it thinks can achieve at least $1 billion annual sales.
Of course, what's in Celgene's pipeline two or three years from now could be quite different from what's in the pipeline now. One of the five drugs mentioned came from an acquisition: Celgene's buyout of Receptos in 2015 allowed it to pick up ozanimod. Two others stemmed from licensing deals -- luspatercept is being developed in collaboration with Acceleron Pharma (NASDAQ: XLRN), while marizomib was originally discovered by Triphase Accelerator.
Ozanimod, GED-0301, luspatercept, marizomib, and CC-220 should be key to Celgene's future success. But I wouldn't say Celgene's success totally depends on any one of these drugs. Even if the company experiences a setback with one candidate, Celgene has shown that it can find other strong contenders. That could be the best reason of all to think that Celgene will continue its winning ways into the next decade.
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