Apremilast is a Small Molecule owned by Amgen, and is involved in 103 clinical trials, of which 85 were completed, 16 are ongoing, and 2 are planned.

Apremilast (CC-10004) is a PDE4 inhibitor. PDE4 inhibits the expression of anti-inflammatory cytokines such as interleukin (IL)-10 in a protein kinase A-dependent manner. The drug candidate also blocks the synthesis of other pro-inflammatory cytokines and chemokines such as tumor necrosis factor alpha, IL 23, CXCL9, and CXCL10 in multiple cell types. Inhibition of PDE 4 regulates IL-8 and IP-10 expression and TNF-a production by keratinocytes. Cellular immune system triggered keratinocyte response is implicated in the pathogenesis of psoriasis. A cytokine produced by immune cells and synovial fibroblasts in the inflamed synovium enhances the inflammatory response in arthritis. Autoimmune disorders are also highlighted by the heightened immune response and inflammatory responses. The drug candidate binds to the catalytic site of the PDE4 enzyme thereby blocking cAMP degradation. This results in inhibition of TNF-a gene expression and subsequent immune responses.

The revenue for Apremilast is expected to reach a total of $29.3bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Apremilast NPV Report.

Apremilast was originated by Celgene and is currently owned by Amgen.

Apremilast Overview

Apremilast (Otezla) is a musculoskeletal system agent. It is formulated as a film-coated tablets, tablets for oral route of administration. Otezla is indicated for the treatment of adult patients with active psoriatic arthritis. It is also indicated in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla used alone or in combination with disease-modifying antirheumatic drugs for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or were an intolerant to previous DMARD therapy and in pediatric patients, indicated for the treatment of chronic plaque psoriasis moderate to severe in adult patients who have not responded, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet type A PUVA), and for the treatment of adult and pediatric patients with oral ulcers associated with Behçet’s Disease.

It is under development for the treatment of atopic dermatitis (atopic eczema),prurigo, hidradenitis suppurativa, vitiligo, bullous pemphigoid, acne vulgaris, plaque psoriasis (psoriasis vulgaris), psoriasis, psoriatic arthritis, behcet disease.

It was also under development for gouty arthritis, discoid lupus erythematosus (DLE), sarcoidosis, genito urinary system and sex hormones, rosacea, osteoarthritis, crohn's disease, rheumatoid arthritis, asthma, pruritus, ankylosing spondylitis, ulcerative colitis, canker sores, covid-19 and erosive oral lichen planus.

Amgen Overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

The company reported revenues of (US Dollars) US$25,979 million for the fiscal year ended December 2021 (FY2021), an increase of 2.2% over FY2020. In FY2021, the company’s operating margin was 29.4%, compared to an operating margin of 35.9% in FY2020. In FY2021, the company recorded a net margin of 22.7%, compared to a net margin of 28.6% in FY2020. The company reported revenues of US$6,652 million for the third quarter ended September 2022, an increase of 0.9% over the previous quarter.

Quick View – Apremilast

Report Segments
  • Innovator (NME)
Drug Name
  • Apremilast
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Infectious Disease
  • Mouth and Dental Disorders
  • Musculoskeletal Disorders
  • Ophthalmology
  • Respiratory
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.