The recent ruling in favor of upholding Amgen’s patents for its phosphodiesterase inhibitor Otezla (apremilast) until its patent expiry in 2028 is an important safeguard for Amgen, according to GlobalData, and will allow the company to protect the last seven years of Otezla’s sales. The leading data and analytics company notes that, despite Otezla’s assured legal protection from generic competition, the drug will continue to face strong commercial pressure in the remaining years of its life cycle as new oral agents for moderate PsO patients begin to enter the market.

Tiffany Chan, Immunology Analyst at GlobalData comments: “Amgen has an incredibly strong incentive to protect Otezla, as it only recently acquired the asset from BMS’ Celgene in 2019, handing over $13.4bn. Amgen reported $2.2bn in 2020 sales, and expected to recoup the cost of the acquisition in roughly 5-6 years.

“Otezla is currently approved for use in plaque psoriasis (PsO), psoriatic arthritis (PsA) and oral ulcers associated with Behcet’s disease. In PsO specifically, Otezla is the only branded small molecule currently available, and this indication is responsible for the majority of its sales.”

For many years, Otezla was the main branded therapy available for the treatment of mild and moderate PsO and PsA patients. However, the drug’s monopoly on this share of the patient population is becoming less and less certain.

Chan adds: “Although PsO and PsA therapies have historically focused on moderate and severe patients, over the last several years, there has been increasing research focused on drugs targeting mild patients. Notably, BMS utilized Otezla as an active comparator in its Phase III development program of novel TYK-2 inhibitor deucravacitinib – also an oral agent that will likely be targeting mild to moderate PsO patients.”

“Deucravacitinib’s pivotal study results are highly anticipated at the European Academy of Dermatology and Venereology Congress 2021 later this month. If approved, key opinion leaders (KOLs) interviewed by GlobalData anticipate that deucravacitinib will pose a significant threat to Otezla’s remaining sales.”