- Itching to ditch its reliance on a single cancer medication for the bulk of revenues, Celgene plans to increase investment in R&D throughout 2017 to push a slew of pipeline candidates — and, most importantly, its highly anticipated immunology drug — to market.
- The company's blockbuster oncology med Revlimid (lenalidomide) yet again made up the lion's share of revenues, raking in $1.88 billion during the first quarter — nearly 64% of net product sales. While another cancer drug, Pomalyst (pomalidomide), also had a solid 33% sales growth year-over-year, a steep decline in Otezla (apremilast) revenues since last quarter and an average performance from Abraxane (paclitaxel) underscored the need for fresh blood in the portfolio.
- During a first quarter earnings call, Celgene estimated that 14 of its pipeline drugs could bring in at least $1 billion in revenue. But investors have been particularly dazzled by ozanimod, an immune system regulator under investigation as a treatment for multiple sclerosis (MS), as well as a few bowel diseases.
The Phase 3 SUNBEAM study of ozanimod tested two doses of the drug against Biogen's Avonex (interferon beta-1a) in patients with relapsing multiple sclerosis, the most common form of the disease.
Topline results released in February showed Celgene's treatment outperformed the competition in reducing annualized relapse rates, and the company plans to roll out data from another late-stage, confirmation trial during the second quarter.
Ozanimod is considered competitive, and its approval would not only give Celgene a place in the MS market, but fortify its immunology and inflammation business. The big biotech has signaled plans to file the drug for U.S. approval by the end of 2017.
Globally, the markets it would target, including relapsing MS, Crohn's disease and ulcerative colitis, are expected to reach $45 billion by 2020, according to data compiled by Celgene.
The psoriasis drug Otezla currently stands as the company's only immunology and inflammation therapy, and though its sales increased 24% year-over-year, they also declined 21% sequentially from the fourth quarter.
Celgene executives pointed to U.S. buying trends as the reason for Otezla's decline between the two quarters. A larger than expected contraction of the psoriasis and psoriatic arthritis market was exemplified by a 12.4% decline in weekly market volume, according to additional data compiled by the company.
Newly negotiated contracts with payers that work around the stepping requirements — a provision among some plans where patients have to fail responding to one drug or a set of drugs before taking a biologic — should help offset some of the market decline, and Celgene said it expects Otezla sales to grow as the year progresses.
But ozanimod, if approved, would help bolster the business. Company leadership touted the drug as differentiated from other assets, such as mongersen (GED-0301), which is in mid- and late-stage testing for Crohn's disease and ulcerative colitis, and rival therapies, such as Novartis' Gilenya (fingolimod), another sphingosine 1-phosphate receptor.
Celgene spent $995 million, or about 34% of net sales, on R&D expenses in the first quarter. Though a chunk of that spending was due to its recent acquisition of Delinia, executives said they anticipate R&D expenses as a percentage of revenue to increase for the remainder of 2017.