PSCK9 inhibitor Japan patent battle to end! Anjin wins Sanofi will withdraw from the market.

Japanese pharmaceutical website Jiho.jp recently reported that Sanofi's PCSK9 inhibitor cholesterol-lowering drug Prairocumn is pulling out of the Japanese market after it lost a patent lawsuit against Amgen for PCSK9 inhibitors in April.
in Japan, Amgen launched Repatha (evolocumab) in April 2016, the first PCSK9 inhibitor to be listed in Japan.
In June of the same year, Sanofi also launched the same type of competitive product, Praluent, in the Japanese market.
in its lawsuit against Sanofi, Amgen claims that Sanofi infringed its PCSK9 antigen binding protein-related patent and tried to block the sale of Praluent.
last October, Japan's High Court of Intellectual Property ruled in favour of Amin, but Sanofi challenged the decision and appealed to the Supreme Court.
On April 24 this year, the Supreme Court rejected Sanofi's appeal and upheld the lower court's decision.
Sanofi: Following the ruling, Praluent will withdraw from the Japanese market Sanofi said in a document distributed to medical institutions that, according to the latest decision, Sanofi can no longer sell Praluent in Japan.
note that less than a month before the verdict, Praluent received a price increase of up to 3.1 percent in April 2020 thanks to data that reduced cardiovascular risk.
in November 2018, Praluent expanded its drug label to allow use not only in patients who do not respond to statins, but also in patients who do not meet statin drug requirements.
Sanofi did not specifically mention alternatives to medical institutions in the document, but some previous Praluent prescriptions may have been switched to Repatha. "We will follow the judicial ruling, but this means that there is now only one PCSK9 inhibitor antibody drug available in Japan to treat hypercholesterolemia," a sane Japan representative told Jiho on May 7,
.
this will lead to treatment options.
" Amin and Sanofi are currently conducting similar patent litigation in the United States and Europe.
Representative of Sanofi Japan, japan," said japan's ruling "will not affect overseas cases."
Amin: Strengthening the supply system and preparing for the patient transition amforward is clearly confident that the Japanese litigation will succeed, as the company has been strengthening the Japanese supply system for six months in preparation for the transition of Japanese patients from Praluent to Repatha.
the company has established a supply mechanism with partner Astellas to enable repatha for all patients who wish to continue using PCSK9 inhibitors. Hajime Seki, legal director of
Amkin Japan, told Jiho in an interview on May 8: "Amkin is confident that it has won this battle before the High Court ruling and is working to strengthen the Repatha supply system, while discussing the revision of its post-market monitoring (PMS) agreement with the Japan Medicines and Medical Devices Administration (PMDA). according to
" data show that Repatha's sales in Japan in 2019 will be about 3 billion yen, with Repatha having a 70% market share in the Japanese PCSK9 inhibitor sector in terms of value, with the remaining 30% held by Praluent.
According to the latest ruling, many patients who have used Praluent will now switch to Repatha.
May 1 this year, PMDA revised Amgent's PMS protocol to enable the company to collect more proactively patient information from Praluent to Repatha.
the company's sales representatives are currently notifying healthcare providers of the changes by phone and email. "At this time, there are no specific safety or efficacy issues associated with drug conversion, but we will make every effort to register and follow up more actively on drug conversion cases," said Hajime Seki, a
.
" Similar lawsuits are still ongoing outside Japan.
in Germany, a district court has ruled in favor of Amin and issued a sales ban on Sanofi and Regeneron from producing, selling and marketing Praluent in Germany.
, however, the fight is not over, as Sanofi filed different lawsuits.
according to Amtobank's April 30 earnings report, Repatha's global sales for the first quarter were $229 million, up 62 percent from the first quarter of last year, driven by a 98 percent increase in capacity, including $124 million in the U.S. and $105 million outside the U.S. market.
Sanofi, Praluent's global sales for the first quarter were EUR 73 million, up 28.6 per cent from a year earlier, with the US market up 55.0 per cent to EUR 32 million and other markets (excluding Europe) up 83.3 per cent to EUR 11 million.
in Europe, Praluent was suspended from sales in Germany in August 2019 due to a ruling by the Dusseldorf District Court, which held sales across Europe steady at $30 million, the same as last year.
early April, Sanofi completed a restructuring plan related to The Regeneration Dollar on Praluent.
under the restructuring plan, Sanofi will be solely responsible for Praluent's sales outside the U.S., while Regeneron will be responsible for the U.S. market.
as of April 1, Sanofi will no longer record Praluent's sales in the U.S. market.
Source: 1, Praluent Barred in Japan Top Court Nixes Sanofi's Patent 2, Amgen Boosting Repatha Supply System to Gear for Praluent Switches.