What happened to Otezla, now owned by Amgen?
Otezla, originally developed by Celgene (now part of Bristol Myers Squibb), was acquired by Amgen in 2021 for $13.4 billion. As of my knowledge cutoff in 2023, Amgen owns the rights to Otezla, an oral medication for the treatment of psoriatic arthritis, psoriasis, and plaque psoriasis.
Why did Amgen buy Otezla?
Amgen acquired Otezla to expand its portfolio in the therapeutic area of inflammatory diseases and to diversify its revenue streams. Otezla generates significant revenue, approximately $1.5 billion in annual sales [1]. Amgen aims to leverage its resources to promote Otezla and continue research and development for similar treatments.
Is Otezla still a best-seller?
Yes, despite some competition from other treatments such as J&J's Tremfya, Otezla remains a top-selling drug, thanks in part to Amgen's significant sales and marketing efforts. Its market position is supported by strong clinical trial data demonstrating its efficacy in treating various types of psoriasis and psoriatic arthritis.
When does exclusivity expire?
Amgen has acquired a significant share of the Otezla patent portfolio, including exclusive marketing, sales, and distribution rights. The patent for Otezla's active ingredient, apremilast, was expected to expire in 2028 [2]. However, Amgen's purchase deal includes provisions to maintain patent protection until at least 2029 and possibly into the 2030s.
Can biosimilars enter the market before patent expiry?
Regulatory approvals and market accessibility may allow biosimilars to enter the market before the patent expiration date. Companies like Coherus and Sandoz have pursued biosimilar versions of apremilast. However, Amgen has the right to contest or dispute any biosimilar approvals, maintaining Otezla's market position during this period.
What side effects are patients asking about?
Common Otezla side effects include diarrhea, nausea, and headaches. More serious issues may include liver problems, depression, or suicidal thoughts. Amgen has a responsibility to provide adequate warnings and monitoring to patients and healthcare professionals to ensure the safe use of Otezla.
How does this impact patient access?
Otezla is a widely used treatment for psoriatic arthritis and psoriasis patients. Amgen's acquisition aims to ensure continued patient access to the treatment, which is crucial for those who have responded well to its efficacy. Amgen has made efforts to promote the drug and address regulatory pressures to ensure long-term availability.
Sources:
[1] Amgen's annual report 2022
[2] DrugPatentWatch.com – Apremilast Patent Expiration
[3] Amgen's press release announcing the Otezla acquisition