Ahead of US Biosimilar Etanercept Competition, Amgen Acquires Apremilast

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis (PsA) and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Celgene’s sale of the drug, for which Amgen is to pay $13.4 billion in cash, or approximately $11.2 billion net of the present value of $2.2 billion in anticipated future cash tax benefits, is in connection with Celgene’s merger with Bristol-Myers Squibb.

In 2018, apremilast was responsible for $1.6 billion in sales for Celgene, and Amgen has indicated that it believes it has an opportunity to deliver double-digit sales growth over the coming 5 years through new indications and through global expansion. Additionally, the drug will retain its exclusivity through 2028.

Robert Bradway, chairman and chief executive officer of Amgen, said in a statement that the acquisition of an oral therapy for psoriasis and PsA “fits squarely within our portfolio” of brands, including brand-name etanercept (Enbrel) and biosimilar adalimumab (Amgevita), which has already launched in the European Union and will launch in the United States as Amjevita in 2023.

“We will take advantage of our 20 years of experience in inflammatory disease to realize the full global potential of Otezla as an affordable option for patients with these serious, chronic inflammatory conditions,” added Bradway.

The acquisition of the drug, which will be contingent on Bristol-Myers Squibb entering into a consent decree with the Federal Trade Commission in connection with its proposed merger with Celgene, is expected to close by the end of the year.

Bringing apremilast onboard could help Amgen to mitigate the effects of eventual biosimilar competition for etanercept, which also treats psoriasis and PsA, in the United States. To date, 2 biosimilars referencing Enbrel are approved in the United States: Sandoz’s Erelzi and Samsung Bioepis’ Eticovo. Neither of the drugs has launched, however, although etanercept biosimilars are available in other highly regulated territories.

Recently, a US court sided with Amgen in a long-running patent dispute with Sandoz over etanercept, potentially keeping biosimilar competition at bay until 2029. However, Sandoz plans to appeal the decision, and if the court sides with Sandoz, biosimilar competition for the blockbuster Enbrel could begin in the United States much sooner.