Amgen Comments On the Supreme Court of Japan Ruling On PCSK9 Patent Infringement Litigation

Amgen believes that patent protection is essential not only for Amgen but also for the entire biotechnology and pharmaceutical industry to make the significant investments required to discover and develop new innovative therapeutics that serve unmet patient needs. We, therefore, will protect our innovations and take consistent action against patent infringers. This in turn benefits patients as it enables investment and development of future innovative medicines.

On April 24, 2020, the Supreme Court of Japan ruled in favor of Amgen, rejecting all appeals from Sanofi K.K. and upholding the IP High Court’s decision that Sanofi’s Praluent® (alirocumab) infringes Amgen’s valid patents covering a narrow class of antibodies that inhibit a human protein called PCSK9. The Court ruling means that Sanofi K.K. is prohibited from manufacturing, distributing, importing, or offering to distribute Praluent® in Japan.

Amgen K.K., the marketing authorization holder of the PCSK9 inhibitor Repatha® (evolocumab) in Japan, will implement the injunction taking particular care to minimize disruption in the clinical practice. Our priority is to ensure continuous care for patients in need of a PCSK9 inhibitor. Amgen K.K., together with our co-promotion partner Astellas, will work with healthcare professionals and all relevant partners to prioritize patients’ interests and facilitate a seamless transition for patients who wish to continue taking a PCSK9 inhibitor.

Repatha is the first PCSK9 inhibitor approved worldwide to significantly lower patients’ low-density lipoprotein (LDL) cholesterol levels and the risk of major cardiovascular events such as heart attack and stroke. Amgen scientists were instrumental in deciphering the role of PCSK9 and its inhibition in the body and were the first in the world to invent this class of therapeutic antibodies. Repatha is approved in Japan for the same indications for which Praluent is approved.

 

IMPORTANT JAPAN PRODUCT INFORMATION

INDICATIONS

Familial hypercholesterolemia, Hypercholesterolemia

Only when

  • patients have high risk for cardiovascular events, and
  • and do not adequately respond to HMG-CoA reductase inhibitors or are not suitable for HMG-CoA reductase inhibitor therapy.
PRECAUTIONS RELATED TO INDICATIONS

(1) Prior to Repatha therapy, patients should undergo adequate medical examinations and tests to confirm a diagnosis of familial hypercholesterolemia or hypercholesterolemia.

(2) In patients with non-familial hypercholesterolemia, the use of Repatha should be considered for patients with high risk of cardiovascular events based on confirmed risk factors e.g. comorbid conditions including coronary artery disease, non-cardiogenic cerebral infarction, peripheral arterial disease, diabetes mellitus and chronic renal disease or medical history.

For patients who are not suitable for HMG-CoA reductase inhibitor therapy:

Repatha should be used for the following.

  • Patients for whom the use of HMG-CoA reductase inhibitors is difficult due to a history of adverse reaction, etc.
  • Patients for whom the use of HMG-CoA reductase inhibitors is contraindicated.
DOSAGE AND ADMINISTRATION

Heterozygous familial hypercholesterolemia and Hypercholesterolemia:

In general, for adults, 420mg of evolocumab (genetical recombination) is administrated subcutaneously every 4 weeks

Homozygous familial hypercholesterolemia:

In general, for adults, 420mg of evolocumab (genetical recombination) is administrated subcutaneously every 4 weeks. In case of insufficient response, 420mg of evolocumab can be administered subcutaneously every 2 weeks. If evolocumab is administered as adjunctive therapy for patients with LDL apheresis, as starting dose, 420mg of evolocumab can be administered subcutaneously every 2 weeks.

PRECAUTIONS RELATED TO DOSAGE AND ADMINISTRATION

Unless a patient is not suitable for HMG-CoA reductase inhabitor therapy, Repatha should be administered in combination with a HMG-CoA reductase inhibitor.

Please see full Japan Prescribing Information for additional information.

Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha® availability or find more information, including full Prescribing Information, at www.amgen.com and www.Repatha.com.

Important U.S. Product Information

Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).
  • as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old or in pediatric patients with primary hyperlipidemia or HeFH.

Important U.S. Safety Information

Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.

Allergic reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse reactions: The most common adverse reactions (>5% of patients treated with Repatha and occurring more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. 

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising.

Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

The most common adverse reactions in the Cardiovascular Outcomes Trial (>5% of patients treated with Repatha and occurring more frequently than placebo) were: diabetes mellitus (8.8% Repatha, 8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha, 4.8% placebo).    

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha compared with 7.7% in those assigned to placebo.  

Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis.

Immunogenicity: Repatha is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha. 

Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha® availability or find more information, including full Prescribing Information, at www.amgen.com and www.Repatha.com.

About Amgen K.K.

Amgen K.K. is a wholly owned Japanese affiliate of Amgen Inc., one of the largest independent biotechnology companies in the world. Amgen K.K., formerly Amgen Astellas Biopharma K.K., was established in October 2013 as joint venture between Amgen and Astellas, and changed its corporate name when it became a wholly owned subsidiary of Amgen. Under the mission, “To serve patients,” Amgen K.K. focuses on the development of innovative medicines, and addressing severe unmet medical needs of patients in Japan by bringing Amgen’s global pipelines, ranging from cardiovascular diseases, cancer, bone diseases through neurological diseases.