Amid flat sales, Amgen places faith in new drugs
- Amgen has focused a substantial amount of resources on its PCSK9 inhibitor Repatha (evolocumab). Third quarter results posted Thursday afternoon showed sales of the cholesterol-lowering drug totaled $40 million, a modest increase over the previous quarter but still slower growth than some expectations.
- The biotech is banking on imaging and outcomes data for the drug to help build a foothold in the market. Still, much had been expected for the drug, which is competing with Sanofi and Regeneron's also slow-starting Praluent (alirocumab).
- Although the company upped the lower end of its guidance range by $100 million, flat overall product sales did little to encourage investors. Shares of Amgen fell by nearly 10% in morning trading Friday.
Amgen is still hoping Repatha will get a boost in the atherosclerosis market, based on a recent imaging study which showed that the molecule had an positive impact on atherosclerotic plaque in patients treated with maximum doses of statins. New outcomes data could also help convince reluctant payers to cover the comparatively pricey drug.
"Cardiovascular outcomes data, which are expected in the first quarter next year, will obviously be important for Repatha and should definitively establish the importance of this therapy for those at risk of cardiovascular disease," said Amgen CEO Bob Bradway, speaking on an investor call Thursday.
In recent quarters, Amgen's revenue has been driven by sales of Enbrel (etanercept) and Neulasta (pegfilgrastim). But lower demand and the threat of biosimilar competition have dampened volume growth. Novartis' Erlezi, a biosimilar of Enbrel, was recently approved by the FDA, but is not yet on the market.
Biosimilar competition from Novartis Zarxio has already hurt the once high-selling Neupogen (filgrastim). Sales plunged by 36% year over year.
Bradway also noted a launch of Amgen's own recently approved biosimilar of AbbVie's Humira (adalimumab) in 2017 would be unlikely, given ongoing patent litigation.
With flat or slipping revenues from its blockbusters, Amgen is looking for stronger pick up from both Repatha and its multiple myeloma drug Kyprolis (carfilzomib).
While Kyprolis failed to meet its primary endpoints in a recent combination study with melphalan and prednisone in first line treatment of multiple myeloma, Amgen is still upbeat about the drug's potential as a combination drug in this indication.
"I would stress that we are committed to advancing Kyprolis into first-line therapy and we are close to finalizing a study design focused on the combination of Kyprolis, Revlimid and dexamethasone in transplant-eligible newly diagnosed multiple myeloma patients, where we have seen very encouraging data from large investigator sponsored studies," said Sean Harper, Amgen's head of R&D.
Sales of Kyprolis totaled $183 million in Q3, up 34% from the same period a year prior.
- Amgen Statement
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