Amgen AMGN announced that the U.S. Court of Appeals for the Federal Circuit has affirmed a district court’s decision in a patent litigation case related to blockbuster psoriasis therapy Otezla (apremilast) against generic drug-makers Sandoz [Novartis’ NVS generic arm] and India-based Zydus Pharmaceuticals.
Following the above decision, generic drug-makers are barred from marketing Otezla generics till February 2028.
The appeal disputed the validity of three Amgen’s patents issued in the country — patent no. 7,427,638 (for pharmaceutical compositions of apremilast), patent No. 7,893,101 (for a crystalline form of apremilast) and patent No. 10,092,541 (for methods of treating psoriasis with apremilast according to a specific dosing schedule). While the Federal Circuit upheld the validity of the first two patents, it ruled against the last patent. Had the last patent been validated by the appeals court, the patent protection would have been extended till 2034.
Novartis’ Sandoz and Zydus had acknowledged that their generic Otezla formulations infringed the above patents prior to court proceedings.
The appellate court affirmed the permanent injunction entered by a New Jersey district court in 2021 — also upholding the ‘638 and ‘101 patents but ruling against the ‘541 patent — barring generic drug-makers from marketing Otezla generics until February 2028. However, the Novartis generic arm and Zydus contested this decision and filed an appeal against the district court’s decision.
In the year so far, Amgen has lost 6.3% compared with the industry’s 4.3% fall.
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Per a Reuters article, a spokesperson for Novartis’ Sandoz was pleased with the decision since the company could now market its Otezla generic in 2028, which is still six years early when compared with 2034.
Currently, Otezla is approved in the United States for treating three indications in adults – plaque psoriasis, active psoriatic arthritis and oral ulcers associated with Behçet’s disease.
Amgen acquired Otezla in 2019 from Celgene Corporation, prior to its merger with Bristol Myers BMY. Per the terms of the acquisition, Amgen paid $13.4 billion to the Bristol Myers company.
Otezla faces competition from the Bristol Myers’ oral pill Sotyktu, which was approved by the FDA last September for treating moderate-to-severe plaque psoriasis in adults. Last month, Bristol Myers announced that the drug was approved for a similar indication in the European Union. These approvals are based on late-stage clinical studies wherein treatment with once-daily Sotyktu has demonstrated superior efficacy over twice-daily Otezla in patients with moderate-to-severe plaque psoriasis.
Amgen Inc. Price
Zacks Rank & Stock to Consider
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Lisata Therapeutics LSTA, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Lisata Therapeutics’ 2023 loss per share have improved from $3.81 to $3.58. During the same period, the loss estimates per share for 2024 have narrowed from $4.01 to $3.12. The company’s shares have gained 32.4% in the year-to-date period.
Earnings of LSTA beat estimates in two of the last four quarters while missing the mark on the other two occasions. On average, the company’s earnings witnessed a negative surprise of 5.63%. In the last reported quarter, Lisata Therapeutics’ earnings beat estimates by 20.83%.
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