And this also doesn't take into consideration Kyprolis failing, romo lack of vert data, delayed and lackluster Parsabiv data, the competitive migraine CGRP market where Amgen has no Neuroscience experience
https://seekingalpha.com/article/4063148-time-buy-amgen
Repatha's 15% risk reduction on the primary endpoint—a composite that included cardiac death, hospitalization and revascularization procedures—means that preventing a CV "event" will be costly, Bernstein analyst Ronny Gal said in a Friday note.
At a cost of $7K/year, this translates to $958K per event saved," Gal wrote. "Thus, in our view, payers will continue to restrict access to the drug.
Barclays analysts weren't impressed, either. "We view this news as negative, with the results unlikely to drive significant expansion of the PCSK9 class following heavy restrictions among payers who believed the increased cost relative to current care standards (i.e. statins) not [commensurate] with the benefit," the analysts wrote in a Friday note.
https://seekingalpha.com/article/4063148-time-buy-amgen
- About Repatha, I don’t think the clinical data from the outcome trial (FOURIER) will be sufficient to drive a meaningful improvement of formulary coverage for this drug. It’s true that the drug has achieved its primary and secondary endpoint and in particular it has demonstrated a 20% benefit on true MACE (cardiovascular death, myocardial infarction or stroke), but I don’t think these results will be sufficient to change the PBMs restrictions to the drug. As reported on Fierce Pharma, streets analysts weren’t impressed by the results, and I agree with this view:
Repatha's 15% risk reduction on the primary endpoint—a composite that included cardiac death, hospitalization and revascularization procedures—means that preventing a CV "event" will be costly, Bernstein analyst Ronny Gal said in a Friday note.
At a cost of $7K/year, this translates to $958K per event saved," Gal wrote. "Thus, in our view, payers will continue to restrict access to the drug.
Barclays analysts weren't impressed, either. "We view this news as negative, with the results unlikely to drive significant expansion of the PCSK9 class following heavy restrictions among payers who believed the increased cost relative to current care standards (i.e. statins) not [commensurate] with the benefit," the analysts wrote in a Friday note.
- About Neulasta, Amgen has been able to preserve this drug from biosimilar competition in Europe and the US. Two potential competitors, Apotex and Sandoz, have received CRLs (Complete Response Letters) from the FDA, while in Europe, the patent will expire in August 2017 for the big 5 European Countries. Despite that, a lot of players are still working on potential biosimilars for Neulasta, including Sandoz, Apotex, Pfizer, and Richter. So I think it’s reasonable to model conservatively that the company could face biosimilars competition for Neulasta in 2018 or 2019. Thus, I model 15% erosion annually for Neulasta since 2018, accounting for a mix of market share and pricing erosion. A good overview of the clinical development for this drug could be found here.
- Lastly, I’m skeptical about the ability of Amgen to preserve its market share for Enbrel. This drug will face huge competition over the coming years, with potential biosimilars for its two key competitors, Remicade and Humira, which will be approved over the next 3-4 years. In addition to that, despite the drug is still not facing biosimilar competition, Amgen announced few quarter ago that they will not be able to retain any pricing power for Enbrel in 2017, given increasing restrictions by the PBMs. I think the worst is coming for Amgen related to its Enbrel franchise, thus I model 20% erosion annually for Enbrel since 2019, accounting for a mix of market share and pricing erosion