Amgen as well as Regeneron Pharmaceuticals and Sanofi are looking to offer their own drugs for lowering cholesterol, both of which are due to receive a final decision from the U.S. Food and Drug Administration (FDA) by Aug. 27 and July 24, respectively.
Assuming the FDA will be approving its cholesterol drug; Amgen is planning on offering Repatha in biweekly doses of 140 milligram injections or monthly doses of 420 milligrams.
Regeneron and Sanofi, on the other hand, are set on making Praluent available in biweekly injections in 75 or 150 milligram doses. Both drugs are part of a new class of antibodies that function to target PCSK9, a protein responsible for maintaining levels of bad cholesterol in the body.
Given the two drugs are designed to target the same protein to lower cholesterol levels, being available in different doses may be what decides which of the two will be more successful in the market. This is because the difference in dosage will likely lead to different sales strategies for Repatha and Praluent.
A monthly injection with a higher dose may be ideal because it is convenient and more potent, but a low-dose option will enjoy a pricing advantage, which can be significant since there are millions part of the market Repatha and Praluent are tapping into.
The pharmaceutical companies have not said anything about price points for their new offerings but industry experts say that Praluent will be priced much lower than Repatha, making the low-dose drug more appealing to health insurers concerned about keeping medication costs down.
Geoffrey Porges, an analyst with Sanford Bernstein, predicts that Repatha will be priced at $10,000 for both its weekly and monthly doses, while Praulent will start at $5,000 for its lower dose and jump to $10,000 for the higher dose.
Based on Wall Street estimates, the PCSK9 drugs from Amgen and Regeneron/Sanofi are looking to generate around $2.5 million in yearly sales by 2020. By 2026, that number can rise to $20 billion for the drug class, claim other predictions.
More than the price, Dr. Steven Nissen, cardiovascular medicine department chairman for the Cleveland Clinic, is more concerned about how effective the drugs will be.
"What counts is how much you can lower LDL cholesterol," he explained. However, he doesn't deny that a lower price, as offered by a lower-dose option, will be more attractive to some people.
There remain concerns about the drugs, including how exactly the FDA will allow Repatha and Praluent to be used and if drastic differences will develop between the two. Results from larger trials should be available by 2017.
Photo: Eric Molina | Flickr
