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Datamonitor Healthcare provides analysis on the latest events in the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor segment. Analyst Kevin Shannon shares his views on Praluent’s recent US sales block, a penalty for infringing on Amgen’s drug patent.

 

On 5 January, Amgen secured a court ruling blocking Praluent (alirocumab; Sanofi/Regeneron) from being sold in the US. This ruling clears the way for Amgen’s Repatha (evolocumab) to potentially become the sole proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in the US market. The imposition of the order will be delayed by 30 days, during which time Sanofi is expected to appeal the decision to the US Federal Circuit Court of Appeals, although the negotiation of a settlement is another potential option.

 

Amgen’s win over Sanofi and Regeneron came after a US district judge refused to overturn a verdict from March 2016, upholding Amgen’s patents related to the PCSK9 protein. However, the judge’s decision to ban Regeneron and Sanofi from selling Praluent in the US, as a penalty for infringing on Amgen’s patent, came as a surprise to many. Most experts anticipated that Regeneron and Sanofi would be asked to pay royalties to Amgen, but the judge determined that Regeneron and Sanofi had “demonstrated irreparable harm” to Amgen, and that monetary compensation would be inadequate.

 

This decision is a major victory for Amgen in a potentially lucrative market. Repatha and Praluent are currently forecast to each earn more than $2bn in annual revenue in the US by 2024 (see Datamonitor Healthcare’s Forecast: Dyslipidemia). Failure to reverse the ban on Praluent in the US would likely result in Repatha gaining the majority of Praluent’s expected revenue, potentially doubling Repatha’s value. However, it is important to keep in mind that PCSK9 inhibitor sales to date have been disappointing, primarily due to insurance companies’ refusal to provide reimbursement. These drugs reduce low-density lipoprotein cholesterol to previously unattainable levels, but lack data on their ability to reduce the rates of heart attacks, strokes, and death. Data from a cardiovascular outcomes trial for Repatha are expected in Q1 2017, and will provide more information on the clinical outcomes associated with PCSK9 inhibitors. A positive result will spur uptake of the PCSK9 class, and likely allow it to attain its forecasted revenue.

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