AMGEN AND KYOWA KIRIN TO JOINTLY DEVELOP AND COMMERCIALIZE KHK4083, A PHASE 3-READY, POTENTIAL FIRST-IN-CLASS TREATMENT FOR ATOPIC DERMATITIS Agreement Renews Successful Global Collaboration That led to Several Groundbreaking Therapies in Multiple Disease Areas
KHK4083 Depletes OX40-Expressing T cells Associated with Atopic Dermatitis and Several Other Inflammatory Diseases
Moderate-to-Severe Atopic Dermatitis Affects Nearly 30 Million People in Major Global Markets¹
Amgen to Host Investor Call at 8:00 a.m. EST

Amgen Webcast Investor Call

Amgen will host a webcast call for the investment community on June 1, 2021, at 8:00 a.m. EST. Peter H. Griffith, executive vice president and chief financial officer, David M. Reese, M.D., executive vice president of Research and Development, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will participate.
Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

About the KHK4083 Phase 2 Study

In February 2021, Kyowa Kirin reported that KHK4083 met the primary endpoint in a Phase 2 randomized, double-blind and placebo-controlled clinical study conducted in the U.S., Japan, Canada, and Germany. The study included 274 patients with moderate-to-severe atopic dermatitis, who were not adequately controlled with topical agents. All KHK4083 cohorts achieved superiority to the placebo cohort for the primary endpoint of percent change from baseline in Eczema Area and Severity Index (EASI) at 16 weeks with statistical significance. In addition, there was significant difference in the percentage of patients achieving an EASI-75 (EASI score of 75% or greater improvement from baseline) at 16 weeks and the percentage of patients achieving the Investigator's Global Assessment (IGA) of 0 or 1 with an improvement of 2 points or more at 16 weeks in all KHK4083 cohorts compared to the placebo cohort. Sustained efficacy of KHK4083 was observed beyond week 16.
Common treatment-emergent adverse events for KHK4083 cohorts were pyrexia, nasopharyngitis, worsening of atopic dermatitis and chills during the first 16 weeks. Pyrexia and chills events were mild to moderate in intensity, most of them were due to injection reaction and observed only after the first administration of the investigational product. There were no events of severe hypersensitivity reactions and no deaths observed in the study.

About Atopic Dermatitis

Atopic dermatitis is a chronic disease in which the immune system becomes disordered and overactive, triggering inflammation that damages the skin barrier. People with atopic dermatitis can get rashes anywhere on the body that can ooze, weep fluid and bleed when scratched, making skin vulnerable to infection. Skin can become dry and discolored, and repeated scratching can cause thickening and hardening of the skin. Atopic dermatitis typically begins in childhood, affecting 15% to 20% of children and 1% to 3% of adults worldwide. The incidence of the disease has increased two- to three-fold since the 1970s. People who have asthma and/or hay fever or who have family members who do, are more likely to develop atopic dermatitis.

About OX40

OX40 is a co-stimulatory molecule that is one of the tumor necrosis factor receptor (TNFR) family members. It plays an important role in maintaining T cell proliferation and survival and in the formation of memory T cells. OX40 is expressed on the surface of effector T cells (CD4 positive) activated by antigens. It has been reported that effector T cells expressing OX40 are present in the lesions of atopic dermatitis.

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the collaboration with Kyowa Kirin Co., Ltd. to jointly develop and commercialize KHK4083, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen’s business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.
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References

• 1.
  Decision Resources Group, Atopic Dermatitis/Atopic Eczema Disease Landscape & Forecast, April 2021. © [2021] DR/Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. Major global markets are the U.S., France, Germany, Italy, Spain, the U.K. and Japan.

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