On September 21, Amgen (NASDAQ: AMGN) announced that a court had ruled in its favour regarding upholding several patents for the company’s phosphodiesterase inhibitor, Otezla (apremilast). Amgen had filed a copyright infringement suit against competitors Novartis’ Sandoz and Zydus Cadila. The recent ruling prevents these and other manufacturers from distributing generic versions of apremilast, protecting Otezla until its patent expiry in 2028. Amgen has an incredibly strong incentive to protect this particular asset, as it only recently acquired Otezla in 2019 from BMS’ Celgene for $13.4bn. 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 a majority of its sales. This patent ruling is an important safeguard for Amgen to be able to protect the last seven years of Otezla’s sales and its multi-billion-dollar investment before the launch of generics.
Despite Otezla’s assured legal protection from generic competition, GlobalData expects the drug will continue to face strong commercial pressure in the remaining years of its life cycle. 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. 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 interviewed by GlobalData anticipate that deucravacitinib will pose a significant threat to Otezla’s remaining sales.