With promising trial results and an FDA approval seemingly near, Amgen Inc.'s osteoporosis drug Evenity was expected to contribute at least something to the company's top line this year.
But Amgen on Sunday evening reported the drug raised unexpected heart-safety concerns. Now the best hope is that its FDA approval will only be pushed to next year and that its commercial opportunity will merely be limited, not eliminated. Otherwise, it may not be worth the effort to keep seeking approval.
This isn't great news for Amgen, whose shares fell more than 2 percent on Monday. But it doesn't fundamentally alter that company's trajectory. The same can't be said for its partner UCB SA or its competitor Radius Health Inc..
It's true Amgen could very much use a new approval. It is trying to rely more on newer medicines and less on best-selling legacy products such as Enbrel, Neulasta, and Neupogen, all of which are set to decline.
But delaying or losing about $500 million in projected Evenity sales in 2021 won't doom Amgen's transition. Its migraine drug candidate erenumab and cholesterol medicine Repatha are far more important for its future. And with $38 billion in cash and equivalents on its books and a reputation for cost management, Amgen should be OK even if this is the end of the line for Evenity.
This is far more consequential for UCB, Amgen's Belgian partner in the drug's development, which has less than a fifth of Amgen's revenue. This is the only Phase 3 drug in the company's research pipeline; its other R&D efforts are in Phase 2 trials or earlier and likely won't hit the market for years. Its leading drugs currently on the market are expected to start declining in the early 2020s, just as it hoped Evenity would ramp up sales.
An equally disproportionate beneficiary is Radius, an until-now revenue-free biotech that got an FDA approval for its own osteoporosis drug Tymlos less than a month ago. That drug has a far easier path to success, now that it may not face Amgen's medicine this year, or possibly ever.
Radius still must show Tymlos can compete with Eli Lilly & Co.'s older Forteo and other medicines, particularly when cheaper generic versions of these drugs arrive in the next few years. But Amgen's slip-up means Radius will have an easier time getting insurers to cover its drug and more attention from doctors. Analysts will need to raise their somewhat anemic estimates for Tymlos sales.
And the combination of increased clarity and an easier path to sales growth may make Radius a more-appealing acquisition target.
Evenity's fate will likely make a difference of a few ticks for Amgen's stock price and earnings estimates. But UCB and Radius still have a major stake in the future of this medicine.
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