Amgen Wins PCSK9 Patent Battle in Japan; Sanofi to Withdraw Praluent from Market

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The Japanese pharmaceutical website Nikkan Yakugyo (jiho.jp) recently reported that Sanofi’s PCSK9 inhibitor cholesterol-lowering drug, Praluent (alirocumab), is set to withdraw from the Japanese market due to the company’s loss in a patent lawsuit against Amgen regarding PCSK9 inhibitors this April.

In Japan, Amgen launched Repatha (evolocumab) in April 2016, marking the first PCSK9 inhibitor to be marketed in the country. In June of the same year, Sanofi also introduced its competing product in the same class, Praluent, to the Japanese market.

In the lawsuit against Sanofi, Amgen claimed that Sanofi infringed on its patents related to PCSK9 antigen-binding proteins and sought to block the sale of Praluent. Last October, the Japan Intellectual Property High Court ruled in favor of Amgen, but Sanofi challenged this decision and appealed to the Supreme Court. On April 24 this year, the Supreme Court rejected Sanofi’s appeal, upholding the lower court’s ruling.

Sanofi:In Compliance with the Ruling, Praluent to Withdraw from the Japanese Market

In a document distributed to healthcare institutions, Sanofi stated that, in accordance with the latest decision, it can no longer sell Praluent in Japan.

Notably, less than a month before the verdict, Praluent secured a price increase of up to 3.1% in April 2020 through a rare post-launch premium, driven by data demonstrating reduced cardiovascular (CV) risk. In November 2018, Praluent expanded its drug label to allow use not only in patients with an inadequate response to statins but also in those who do not meet the criteria for statin therapy.

Sanofi did not specifically mention alternative products to healthcare institutions in its documents, but some previous prescriptions for Praluent may shift to Repatha.

On May 7, a representative of Sanofi Japan told Jiho, “We will comply with the judicial ruling, but this means that there is now only one PCSK9 inhibitor monoclonal antibody medication available in Japan for the treatment of hypercholesterolemia. This will lead to limitations in treatment options.”

Currently, Amgen and Sanofi are also engaged in similar patent litigation in the United States and Europe. However, a representative of Sanofi Japan stated that the ruling in Japan “will not affect cases overseas.”

Amgen:Strengthening the Supply System to Prepare for Patient Transition

Amgen is clearly confident of victory in the Japanese lawsuit, as it has been strengthening its supply chain in Japan for the past six months to prepare for the transition of Japanese patients from Praluent to Repatha. The company has established a supply mechanism with its partner Astellas to ensure that all patients wishing to continue PCSK9 inhibitor therapy can seamlessly switch to Repatha.

Hajime Seki, Head of Legal at Amgen Japan, stated in an interview with Jiho on May 8: “Amgen is confident that it had already won this battle before the High Court’s judgment, and proceeded to strengthen the supply system for Repatha, while engaging in discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding revisions to its post-marketing surveillance (PMS) agreement.”

Data show that Repatha’s sales in Japan amounted to approximately JPY 3 billion in 2019. In terms of value, Repatha held a 70% market share in the PCSK9 inhibitor segment in Japan, with the remaining 30% accounted for by Praluent. According to the latest ruling, many patients who have been using Praluent will now switch to Repatha.

On May 1 this year, the PMDA revised Amgen’s PMS protocol, enabling the company to more proactively collect data on patients switching from Praluent to Repatha. The company’s sales representatives are currently informing healthcare providers of these changes via phone and email.

Hajime Seki stated, “At present, there are no specific safety or efficacy concerns associated with medication switching; however, we will make every effort to more actively register and follow up on cases of medication switching.”

Similar litigation is ongoing outside Japan. In Germany, a regional court ruled in favor of Amgen and issued a sales injunction prohibiting Sanofi and Regeneron from manufacturing, selling, and marketing Praluent in Germany. However, the dispute has not yet concluded, as Sanofi has filed different claims.

According to Amgen’s earnings report released on April 30, Repatha’s global sales in the first quarter of this year amounted to $229 million, representing a 62% increase from the same period last year, primarily driven by a 98% growth in volume. Of this total, sales in the U.S. market reached $124 million, while sales outside the U.S. totaled $105 million.

Regarding Sanofi, Praluent’s global sales in the first quarter amounted to €73 million, representing a 28.6% year-on-year increase. Sales in the U.S. market rose by 55.0% to €32 million, while sales in other markets (excluding Europe) grew by 83.3% to €11 million. In Europe, first-quarter sales remained stable at $30 million, flat compared to the previous year, as Praluent has been suspended from sale in Germany since August 2019 following a patent litigation ruling by the Düsseldorf Regional Court.

In early April, Sanofi completed its restructuring plan with Regeneron regarding Praluent. Under the agreement, Sanofi will be solely responsible for sales of Praluent in markets outside the United States, while Regeneron will handle the U.S. market. Effective April 1, Sanofi no longer records sales of Praluent in the U.S. market.

Reference Source:

1、Praluent Barred in Japan after Top Court Nixes Sanofi’s Patent Claim

2、Amgen Boosting Repatha Supply System to Gear Up for Praluent Switches