Sanofi's new cholesterol-lowering drug Praluent was banned from the market for 12 years.

Sanofi's bombshell

Both Repatha and Praluent are monoclonal antibody drugs that target a protein called proprotein convertase subtilisin 9(PCSK9), which reduces the liver's ability to clear low-density lipoprotein cholesterol (LDL-C) from the blood, and LDL-C is recognized as a major risk factor for cardiovascular disease (CVD). PCSK9 inhibitors offer an entirely new treatment modality to combat LDL-C and are seen as the biggest advancements in lipid-lowering since statins such as Lipitor and Zocor.

Present was Sanofi's star drug of high hopes. Analysts say the drug is a potential blockbuster that will generate $2 billion for Sanofi and Renewable Dollar by 2020. At a time when the number of blockbusters is dwindling, the drug is an extremely important asset for both companies. At a time when the performance of insulin drug Lantus continues to decline, Sanofi hopes that Praluent and several other new drugs can help its sales pick up again.

The cost of treatment is £ 4000 a year in Praluent, nearly ten times the cost of previous statins, according to the UK's medical cost control department. At present, Praluent has been approved for listing in the United States, the European Union, Canada, Mexico and Japan.

Review race, patent bite

Long before the Praluent went on the market, Amjin clung to it, accusing it of infringing three patents on its own drug Repatha. At that time, Amjin's review process was ahead of Sanofi.

Amgen's sense of crisis proved to be correct. Sanofi bought an accelerated review voucher for US $67.5 million, which greatly shortened the Praluent review cycle and surpassed Amgen. In July 2015, Amgen and Sanofi were approved their new generation of PCSK9 inhibitors in the European Union and the United States with only three days to go. Then Amgen's Repatha was also listed in the United States, and the battle for lipid reduction officially began.

In March 2016, a U.S. court ruled that Sanofi/Regenera's Praluent infringed two of Amjin's Repatha patents. Before the verdict, Sanofi and Regenera admitted that they had infringed the patent and turned to whether the patent itself should be recognized: "The patent goes beyond Amjin's discovery and makes it improperly cover a new class of therapies". On January 4, 2017, the judge denied Sanofi's request to overturn the sentence.

On January 6, Delaware District Judge Sue Robinson ruled that Sanofi and Regenera would stop selling for Praluent12 years because the drug infringed Amgen's patent for a similar drug Repatha, which expired in 2029. Shares of Amgen rose 4.3 percent to $159.51 in after-hours trading that night. Regeneration shares fell 1.1 per cent to $376.61 before being suspended.

The sales ban takes effect 30 days after the verdict, during which the company can appeal. Sanofi and Regenera are determined to appeal, saying that "the suspension of Praluent will greatly endanger the interests of patients."

Analysts said that this unexpected judgment may push Repatha sales to a peak, of course, the possibility of a successful appeal is still not ruled out. And if Sanofi and Regeneration do reverse, Amjin will face the loss of a large number of insurance payers and markets, as well as its reputation.

If the appeal is unsuccessful, Sanofi will have to withdraw the Praluent from the U.S. market. However, some analysts believe that the more likely outcome is that Sanofi will pay Amgen 15% to 20% of Praluent sales as royalties. Such an outcome would put Amgen in a proactive position.

Source:http://www.y-lp.com/pages/Article.aspx?id=5640859089507734977