FIrst PCSK9 Inhibitor in Japan,

Providing A new TREATMENT option for certain patients who have high risk in cardiovascular events and do not adequately respond to statins

TOKYO (April 21, 2016) – Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; General Manager and Representative Director: Eiichi Takahashi, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Yoshihiko Hatanaka, “Astellas”)  announced that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha® SC Injection (generic name: Evolocumab (Genetically Recombination) Injection) 140 mg Syringe has become available in the Japanese market today.

Repatha® is indicated for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).

Repatha® is a human monoclonal antibody that inhibits PCSK9.1 Repatha® binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha® increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.2

Yukiya Suzuki, the Head of Sales and Marketing of Amgen Astellas said, “Amgen Astellas is a Tokyo-based joint venture between Amgen, a biotechnology company with a history of more than 35 years of providing innovative medicines worldwide, and Astellas Pharma Inc., a company with a deep understanding and expertise in serving the medical needs of Japanese patients and physicians. Amgen Astellas began operations in 2013, and today we are pleased to begin providing Repatha®, the first product of Amgen Astellas and Japan’s first PCSK9 inhibitor. We are committed to serving the medical needs of the country and are excited about the potential of Repatha® to help improve the treatment of patients with high cholesterol who have high risk in cardiovascular events and do not adequately respond to statins.”

Yukihiko Sato, Senior Vice President, Sales & Marketing Japan of Astellas said, ”We expect Repatha® as a new therapeutic option will contribute further to the patients with cardiovascular disease.”

Amgen Astellas and Astellas will co-promote Repatha®.

Product outline of “Repatha® SC Injection 140mg Syringe” is as follows.

Brand name:

Repatha® SC Injection 140mg Syringe

Generic name:

Evolocumab (Genetically Recombination)

Indication:

Familial Hypercholesterolemia, Hypercholesterolemia

Only when patients who have high risk in cardiovascular events and do not adequately respond to HMG-CoA Reductase Inhibitors

Precautions Related to Indications:

  1. Prior to evolocumab therapy, patients should have a confirmed diagnosis of familial hypercholesterolemia or hypercholesterolemia by going through assessment.
  2. When applying evolocumab to patients with non-familial hypercholesterolemia, it should be carefully considered for patients who have high risk of cardiovascular events based on risk factors e.g. comorbid conditions including coronary artery disease, non-cardiogenic stroke, peripheral arterial disease, diabetes and chronic renal disease or medical history.

Dosage regimen:

Heterozygous Familial Hypercholesterolemia and Hypercholesterolemia:In general, for adults, evolocumab (genetically recombination) of 140mg is administrated every 2 weeks or evolocumab of 420mg is administrated every 4 weeks subcutaneously

Homozygous Familial Hypercholesterolemia:In general, for adults, evolocumab (genetically recombination) of 420mg is administrated every 4 weeks subcutaneously. Evolocumab of 420mg every 2 weeks can be administered when the efficacy is not adequate. If evolocumab is administered as adjunctive therapy for patients with LDL apheresis, as starting dose, evolocumab of 420mg every 2 weeks can be administered subcutaneously

Precautions Related to Dosage and Administration:

Evolocumab should be administered as an adjunct to HMG-CoA reductase inhibitor therapy [Efficacy and safety of evolocumab monotherapy in Japanese patients not confirmed.]

Price

Repatha® SC Injection 140mg Syringe: 22,948yen

Drug Price Listing Date

April 20, 2016

Launch Date

April 21, 2016

* For more information, please see the latest Japan Prescribing Information.

* The official guidance of point to consideration regarding Repatha® under the coverage of National Health Insurance is issued by Medical Affairs Division of Ministry of Health, Labour and Welfare.

References

1 Amgen Data on File, Investigator Brochure.

2 Data on File: Study 20120122 Phase III in Japanese study report.