When Amgen bought marketing rights to psoriasis pill Otezla for $13.4 billion two years ago, the company was likely counting on not having to compete against early generics. And now, thanks to a win in court, Amgen appears poised to enjoy several more years of exclusivity in the key U.S. market.
After facing legal challenges from generics makers Sandoz and Zydus Pharmaceuticals, Amgen's patent portfolio on the blockbuster medicine has held up in court. With the win and pending potential appeals, Amgen's drug should be free from having to face those competitors until early 2028.
Before the trial, Novartis' Sandoz unit admitted that its Otezla generic infringed a range of patents that expire between 2023 and 2034. For its part, Zydus admitted that its copycat infringes some of the same patents but not a key one that expires in 2023.
With that, the trial was centered on the issue of whether Zydus’s generic infringes a 2023 patent, Amgen said Tuesday. After reviewing the arguments, the U.S. District Court for the District of New Jersey upheld four patents but ruled against Amgen on some claims in a 2034 patent.
That’s a big win for the branded drugmaker, which picked up Otezla from Celgene before that company sold to Bristol Myers Squibb in 2019’s largest biopharma M&A deal.
Still, a Novartis spokesperson said Sandoz is "pleased" with the ruling as it "held as invalid a key 2034-expiring Amgen patent covering specific dosage regimens for treating psoriasis" with the drug. The ruling "enables Sandoz to launch our generic apremilast product in the US in 2028, 6 years prior to the expiry date of the latest-expiring Amgen patent asserted in litigation," Novartis' spokesperson said.
Since taking over Otezla marketing, Amgen has generated some hefty sales with its new med. Thanks to the drug’s oral mode of delivery, it has succeeded against injectable rivals during the pandemic. During a conference call last summer, Amgen’s executive vice president of global commercial operations Murdo Gordon said that more patients started on the medicine during the first few months of the pandemic than those who started on Otezla’s psoriasis rivals. That came despite the fact that COVID-19 caused a decline in new patient starts across the treatment class.
Overall for 2020, the drug generated $2.2 billion. In the first half of the 2021, sales declined 5% in part thanks to lower prices, but the drug “continued to maintain first-line share leadership in psoriasis,” the company said.
While it appears Amgen won't have to worry about generics right away, the company's key med could face forthcoming competition from Bristol Myers Squibb's TYK2 inhibitor deucravacitinib, an oral med that has outperformed Otezla in head-to-head trials. Even amid that potential competition, Amgen and analysts believe the company can still succeed in mild to moderate patients.
Editor's note: This story was updated with a statement from Novartis.