Soliris is Alexion Pharmaceuticals’ (ALXN) anchor of success. The drug was approved for paroxysmal nocturnal hemoglobinuria, or PNH, as a first indication in 2007, followed by atypical haemolytic uremic syndrome, or aHUS, in 2011. (For more information on the drug, check out “Soliris: Alexion Pharmaceuticals’ Blockbuster Orphan Drug.”)
According to Wall Street analyst estimates, Soliris’ revenues in 2Q16 and 3Q16 should grow YoY (year-over-year) by 10% and 9% to reach $697.2 million and $728.9 million, respectively. As the population base for orphan drugs is smaller, extending the drug’s labels offers benefits in terms of potential volume gain. The same strategy is being adopted by Vertex Pharmaceuticals (VRTX) for its key drugs Orkambi and Kalydeco, by Regeneron (REGN) for its lead drug Eylea, and by Medivation (MDVN) for its flagship drug Xtandi.
How can Alexion stay ahead of the competition with Soliris?
The major threat to Soliris is competition from novel drugs or biosimilars near term. To stay ahead of the competition, Alexion is developing another innovative drug, ALXN1210.
Meanwhile, Alexion has announced in a press release for its REGAIN results that the study missed its primary endpoint. However, the total study data showed a favorable benefit-risk profile for eculizumab or Soliris. The company plans to discuss these results with US and European regulators.
Although the primary endpoint of the study wasn’t met, with an urgent need for a first-ever therapy, there’s still a possibility that Soliris will be approved for refractory generalized myasthenia gravis, or gMG. Along with these efforts, ALXN is focused on protecting Soliris’s innovation beyond the composition of matter expiry in 2020 and 2021.
To get exposure to Alexion Pharmaceuticals, you can opt to invest in ETFs like the First Trust NYSE Arca Biotechnology Index Fund (FBT), which has ~2.7% of its total holdings in Alexion Pharmaceuticals.