Otezla revenue performance
In the first nine months of 2018, Celgene’s (CELG) Otezla reported worldwide sales of $1.16 billion, which is a YoY rise of 27.75%. Out of these revenues, $915 million were earned from the US market, which is a YoY rise of 21.19%. International markets contributed $245 million worth of revenues, which is a YoY rise of 60.13%.
Lifecycle management activities
On October 8, Celgene issued a press release announcing favorable results from the phase 3 trial, STYLE, evaluating the efficacy of Otezla 30-mg twice-a-day dosage in the scalp psoriasis indication at the end of 16 weeks of therapy.
According to Celgene’s third-quarter earnings conference call, scalp psoriasis affects 60% to 80% of patients with moderate-to-severe psoriasis. Further, 60% of scalp psoriasis patients opt out of treatment, since usage of topicals in this indication is challenging. Celgene aims to penetrate this underserved market with Otezla, an oral therapy. Additionally, the company is also targeting the opportunity in the genital psoriasis indication with Otezla.
By expanding Otezla’s label in the scalp psoriasis indication, Celgene aims to further strengthen Otezla’s position in the pre-biologic immunology and inflammation segment. The company has submitted a supplemental new drug application seeking FDA approval for Otezla to treat ulcers associated with Behcet’s disease. The company also aims to file a regulatory application for Otezla in this indication in Japan in the fourth quarter.
According to Celgene’s third-quarter earnings conference call, the company aims to expand Otezla’s label in the early-stage psoriasis indication. The company has started the Phase 3 trial, ADVANCE, to evaluate the drug in the mild to moderate plaque psoriasis indication. The company has also started two trials in Japan and Europe to study Otezla in the moderate psoriasis indication. The company estimates that label expansion of Otezla could generate peak sales worth $500 million.
In the next article, we’ll discuss Celgene’s diversified inflammation and immunology pipeline in greater detail.