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 and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.