Amgen won the battle against Sanofi in sales of cholesterol-lowering PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors in the second quarter.
Although both Amgen’s Repatha (ingredient: evolocumab) and Sanofi’s Praluent (alirocumab) recorded an increase in revenue, Repatha sold over twice as much as Praluent globally in the second half.
Amgen said in a report that Repatha sold $152 million globally in the April-June period, up 3 percent from a year earlier.
Since Amgen released Repatha in the U.S. in 2015, the drug’s revenue has been sluggish. Despite its superior efficacy to that of conventional medications such as statin and ezetimibe, the high price of Repatha made it difficult for patients to use it.
|Amgen’s lipid-lowering drug Repatha (left) and rival drug Praluent by Sanofi.|
In October last year, Amgen slashed Repatha’s price by 60 percent and supplied it for $5,850 per year. Since then, the sales of the cholesterol-fighting medication have been on the rise to $830 million in the first quarter, and $910 million in the second quarter, in the U.S. market.
Sanofi’s Praluent, the sole rival of Repatha, has seen sales growth as well but its global sales failed to reach even half of those of Repatha.
According to Sanofi, Praluent’s global sales expanded 3.2 percent year-on-year to 660 million euros ($734.3 million), boosted by growth in Europe, in the second quarter.
Sanofi also decided to cut the price of Praluent by 60 percent in the U.S. in February. However, U.S. sales of the drug plunged 37.1 percent year-on-year to 240 million euros. During the same period, the medicine’s revenue surged 40.9 percent to 320 million euros.
However, Praluent is facing a crisis in the European market now. On July 11, Germany’s Düsseldorf Regional Court ruled that Praluent infringed on an Amgen patent of Repatha, ordering Sanofi to suspend the manufacturing, selling, and marketing of Praluent.
However, Sanofi immediately appealed the ruling at a higher court, and the court on July 23 had the lower court’s order on hold at the request of Sanofi. Germany accounts for about one-third of Praluent’s sales in Europe.
Aside from the lawsuit, Amgen and Sanofi are working hard to expand the use of Repatha and Praluent, respectively. The PCSK9 inhibitors’ low cost-effectiveness is an issue not only in the U.S. market but around the globe.
Rather than seeking expansive indications of PCSK0 inhibitors, the two companies are concentrating on classifying patients who are urgently required to have LDL-C reduction or who can maximize the effectiveness of PCSK9 inhibitors because of a relatively high cardiovascular risk, and prove the respective drug’s clinical benefits.
Through a sub-analysis of ODYSSEY outcomes, Sanofi confirmed that Praluent had the best preventive effect on patients with acute coronary syndrome (ACS) who had LDL-C levels at 100 mg/dL or higher. The company also said that the combination of Praluent and a maximum-dose statin was effective in reducing cardiovascular risk in high-risk diabetic patients with LDL-C levels higher than 70 mg/dL.
The company recently published a study on Lancet that Praluent therapy doubled the rate of reduction of cardiovascular events in diabetic patients with ACS, versus non-diabetic patients.
Amgen is also conducting EVOPACS trial to assess the early efficacy and safety of the combination therapy of Repatha and atorvastatin within three days maximum in patients with ACS. The company expects the outcome in September.