Amgen has started shipping its Corlaner heart failure therapy to wholesalers in the US just a few days after getting FDA approval for the drug.
Corlaner (ivabradine) – the first new medicine for chronic heart failure in the US in almost a decade – will be available in pharmacies before the end of the week, according to Amgen‘s head of global commercial operations.
The company notes there are in the region of six million people in the US with CHF – with around one million eligible for treatment with Corlaner – and the disease costs a massive $30bn a year, mainly relating to hospitalisations.
Clinical data suggest Corlaner can reduce hospitalisations for worsening heart failure, said Amgen’s R&D chief Sean Harper, who said the new drug “is an excellent way to introduce ourselves to the company to the US cardiology community” as the company prepares for the possible launch of its cholesterol-lowering PCSK9 inhibitor Repatha (evolocumab) later this year.
Repatha and other PCSK9 inhibitors such as Sanofi/Regeneron’s alirocumab and Pfizer’s bococizumab are considered future blockbusters thanks to their ability to help more patients meet cholesterol targets. Amgen recently filed for approval of is drug in Japan with the help or partner Astellas.
Rounding out a trio of new cardiology products at the biopharma company is omecamtiv mecarbil or AMG 423 for acute heart failure, for which phase II data on an oral formulation is due later this year.
Amgen has priced Corlaner at around $4,500 per year which would make it a lucrative product if it sees significant take up, although analysts are divided on its potential, with some predicting blockbuster sales at peak and others under $200m in 2018.
The drug has been marketed for years in Europe by privately-held Servier under the Procoralan brand name.
Revenues top $5bn in Q1
The comments came as Amgen reported first quarter revenues that rose 11% to breach the $5bn barrier, while operating profit was up by nearly a third to $2.45bn.
The rise in sales came on the back of a 13% increase in sales of Enbrel (etanercept) to $1.12bn – thanks to price increases and despite a reduction in market share in some of its approved indications, particularly psoriasis.
Top seller Neulasta (pegfilgrastim) climbed 4% to $1.13bn, with the greatest growth coming from Prolia (denosumab) for osteoporosis – up 39% to $272m – and recently-introduced multiple myeloma therapy Kyprolis (carfilzomib) which added $108m, up 59%.
Launches this year already include Blincyto for acute lymphoblastic leukemia, which added $15m in its first quarter on the market, as well as a new on-body injector device for Neulasta that does away with a follow-up hospital visit for cancer chemotherapy patients.
Meanwhile, Amgen is looking ahead to new launches in the coming quarters after late-stage clinical successes for kidney disease therapy AMG 416, a biosimilar version of AbbVie’s blockbuster immunotherapy Humira (adalimumab) and Kyprolis in the new indication of second-line multiple myeloma.