The price for Otezla is higher than many analysts expected.
Amgen said Monday it would purchase apremilast (Otezla), an oral drug approved for moderate-to-severe plaque psoriasis, adult patients with active psoriatic arthritis (PsA), and adult patients with oral ulcers associated with Behçet disease, from Celgene for $13.4 billion.
The Federal Trade Commission is requiring the sale as a condition of Celgene’s $74 billion merger with Bristol-Meyers Squibb, which is developing its own oral drug for psoriasis and psoriatic arthritis. BMS-986165, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is in phase 3 clinical trials.
Amgen said the purchase offers several benefits: It fits well with its existing stable of anti-inflammation drugs, including etanercept (Enbrel); it has existing intellectual property rights through at least 2028 in the United States; and it has at least low double-digit sales growth, on average, over the next 5 years. In 2018, apremilast sales were $1.6 billion.
Enbrel, which is also approved to treat psoriasis, had sales last year of more than $5 billion.
Psoriasis is one of the most prevalent immune-mediated diseases in the United States, affecting as many as 8 million people. Up to 40% of patients with psoriasis develop PsA, which leads to permanent joint deformities, particularly when left untreated. Compared with patients with psoriasis who do not have PsA, patients with psoriasis and PsA have greater disease burdens and different treatment patterns.
Treatment includes topicals and phototherapy; older systemic drugs such as methotrexate and cyclosporine; the Janus kinase inhibitor tofacitinib (Xeljanz); drugs that block tumor necrosis factor-alpha, such as Amgen’s Enbrel; and biologics that block interleukin (IL) 17, IL-12, and IL-23.
The price for Otezla is higher than many analysts expected; last month, FiercePharma reported a possible range of $5 billion to $10 billion. While Amgen said Monday patents last “at least” through 2028, the report said other patents on the drug end as early as 2023, while one other patent expires in 2034. The 2028 patent has been challenged by about 20 generic drug makers, according to FiercePharma.
However, Amgen has history on its side when defending patents, particularly in the case of Enbrel. Earlier this month, a judge for the United States District Court for the District of New Jersey ruled in favor of Amgen in a long-running patent lawsuit concerning Sandoz’s biosimilar etanercept, Erelzi, referencing Enbrel. The FDA approved Erelzi in 2016, but the biosimilar has not launched in the US market due to the patent suit brought by Amgen, Immunex, and Roche. The judge in the case ruled that Sandoz failed to show by clear and convincing evidence that the 2 patents at issue in the case are invalid.