12. Amgen

amgen
Perhaps no other biopharma company is more deeply and broadly entangled in patent fights and copycat competition than Amgen. (Amgen)

Amgen
2017 revenue: $22.85 billion
2016 revenue: $22.99 billion
Headquarters: Thousand Oaks, California

It was a transitional year for Amgen: Demand for newer products such as Kyprolis, Prolia and Repatha just wasn’t high enough to offset declines in mature brands, including Enbrel, Neulasta and Epogen. And as threats from copycat products loom, that's not likely to change in 2018. On the horizon, though? A first-in-class migraine drug, Aimovig, that could win approval May 17.

Perhaps no other biopharma company is more deeply and broadly entangled in patent fights and copycat competition than Amgen is. For some drugs, the would-be copies have been tripped up. For others, patent litigation is holding off biosimilar rivals.

Consider Enbrel. In 2017, sales of the rheumatoid arthritis blockbuster were down 9% to $5.43 billion. Samsung Bioepis’ biosimilar version Benepali was approved in Europe in 2016, and it's taking a toll on sales, but that’s Pfizer’s problem. Amgen’s concern is Novartis’ Sandoz, which has had its own FDA-approved biosimilar lurking since August 2016, but hasn’t been able to launch because of a patent fight with Amgen. A delayed trial is now set to start on June 20.

Or Neulasta, which returned $4.53 billion (about 87% from the U.S.) in 2017. The platelet-booster lost U.S. patent protection in 2015. But biosimilar hopefuls have stalled. Coherus and a partnership between Biocon and Mylan both tried and failed to win FDA approval for their candidates last year. But both groups have since said they expect to launch their biosims in the U.S. by the end of 2018.

Or the anemia drug Epogen, sales of which declined 15% to $1.10 billion in 2017. Last year, the FDA served a complete response letter to Pfizer's biosim, citing manufacturing shortfalls. But the pharma refiled in November. That spells trouble for 2018; Johnson & Johnson, which sells the same drug under the name Procrit, calculated its 2018 guidance assuming biosimilar assault this year.

Other copycats loom, too. Sensipar enjoyed an 11% U.S. sales jump to $1.37 billion last year, but 2017 could be the final year it sees that sort of growth. Generics, including two recently approved products from Cipla and Aurobindo, could hit at some point in 2018.

With all these competitors in sight, Amgen has looked to newer drugs for growth. But not all of them have delivered as expected.

PCSK9 inhibitor Repatha, for example, hasn’t lived up to expectations, and even after Amgen padded its case with cardiovascular outcomes benefits from its closely watched Fourier trial, sales didn't make much of a leap. The fact that Repatha didn't prove to cut the risk of death was a disappointment. Launched in 2015 with a retail price of $14,000 per year before rebates and discounts, the drug only generated $225 million in U.S. sales last year and $94 million from other parts of the world.

Amgen continues to work with payers to cut prices in return for better coverage, but Bernstein's Ronny Gal said his team of analysts “still do not expect much commercial impact.” He could be wrong, though, as Repatha brought in sales of $123 million for Q1 2018, which represents a 151% year-over-year growth.

Meanwhile, Amgen was in yet another patent fight with Repatha rival Praluent from Sanofi and Regeneron. The California drugmaker took the unusual step of asking a court for an injunction that would pull Praluent off the market, but the duo persuaded the patent appeals court in Washington, D.C., to nix that idea and send the cast back to district court. The pair also reported their own CV benefits for Praluent in March, and, determined to knock Amgen off the leading position in the market, they've cut prices and inked an exclusive deal with pharmacy benefits manager Express Scripts.

Kyprolis, the multiple myeloma treatment, and the bone med Prolia could chip in some growth. Kyprolis’ U.S. sales grew only 1% last year, but Amgen hopes to up that with two sets of overall survival data in combo regimens that showed a 21% reduction in the risk of death versus standard of care.  But it's the Novartis-partnered migraine drug Aimovig, which has a PDUFA date of May 17, that's Amgen's biggest long-term hope. Of course, Aimovig will have to contend with other CGRP meds nearing the market, and that competition could give payers leverage. A recent notice from Express Scripts already raised the specter of pricing pressure.

Meanwhile, on the offensive side of the biosimilar contest, Amgen reached a settlement with AbbVie to push back the launch of its Humira biosim till Jan. 31, 2023. Its Allergan-partnered Avastin biosimilar, Mvasi, has FDA approval, and the agency is nearing a final decision on the pair's Herceptin copycat.

12. Amgen

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