As drugmakers seek ways to elude IL-2 flaws, Clinigen secures the full rights to original troubled IL-2 drug Proleukin
Proleukin, the troubled IL-2 cancer drug sold by Novartis, has found a new home at Clinigen, while others in the field of immuno-oncology seek ways to create an improved version of the class of drugs sans the toxicity that has stymied the use of the original IL-2.
Last year, London-listed Clinigen $CLIN acquired the rights to sell the drug outside the United States from Novartis $NVS, in a deal where financial details were not disclosed. The drug, which is used to treat metastatic renal cell carcinoma and metastatic melanoma, has generated roughly $80 million in annual sales in the last few years, according to Evaluate Pharma. In the year leading up to June 30, 2018, Proleukin generated US sales of $60 million, according to Clinigen, citing IQVIA estimates.
Clinigen, which says it aims to revitalize medicines of importance that have been sidelined due to challenges, on Wednesday said it is acquiring the remaining US rights from Novartis in a deal up to $210 million in cash, including $120 million upfront. The rest will come in deferred and milestone payments. The deal is expected to be consummated by April.
Proleukin is currently being investigated in some 80 active trials for use in a plethora of diseases, and Clinigen is “exploring options with companies who are looking to create either new dosage versions of (the) Il-2 or combination regimens,” a spokesperson told Endpoints News, declining to elaborate further on its revitalization strategy.
The Proleukin acquisition will augment Clinigen’s earnings, adding at least 25% to its EPS in the first full financial year after the product transitions to the company, and is also expected to cut its debt burden.
The initial IL-2 approach showed the promise of the target, but safety issues including a dose-limiting tox profile and immunosuppression thwarted its potential. Now companies such as Nektar Therapeutics $NKTR are working on a next-gen IL-2 therapy, an effort that combined with Bristol-Myers’ $BMY Opdivo has recently hit a snag.
Clinigen already owns three products in the US: Foscavir, Ethyol and Totect, although Pfizer has won the commercial license to Foscavir and Cumberland Pharmaceuticals to Ethyol and Totect.