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BIOGEN FILES NEW DRUG APPLICATION FOR ADUCANUMAB IN JAPAN

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease
Aducanumab is now under regulatory review in Japan, Europe and the United States

CAMBRIDGE, Mass. and TOKYO, [December 10, 2020] (GLOBE NEWSWIRE)?– Today, Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Aducanumab, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia.

“Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” said Michel Vounatsos, Chief Executive Officer at Biogen. “Japan has met the challenges of a rapidly-aging population by demonstrating global leadership in setting policies that aim to increase support for Alzheimer’s disease patients and caregivers. We look forward to the regulatory review of aducanumab with the hope that, if approved, it could help further manage the impact of this devastating disease.”

“As Japan has the oldest population in the world, it is anticipated that the social burden of Alzheimer’s disease will continue to grow,” said Dr. Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “For more than 30 years, Eisai has been dedicated to dementia research and development, and working with people living with Alzheimer’s and their caregivers to fight this disease. The filing of the application is an important step in serving patients and their families as aducanumab may help reduce clinical decline and potentially maintain the ability to live an independent life for as long as possible. Aducanumab also has the potential to help address the public health challenges our aging population faces in Japan.”

The Japanese regulatory authority will review the application through the standard review process. In addition to the filing in Japan, aducanumab is under Priority Review with the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021 and is also under review with the European Medicines Agency.

About Aducanumab

Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients’ ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., Ltd. have collaborated on the development and commercialization of aducanumab globally.

EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).

About Alzheimer’s Disease

Alzheimer’s disease is a progressive neurological condition that impairs thinking, memory and independence, leading to premature death. The disease currently cannot be stopped, delayed or prevented and is a growing global health crisis, affecting those living with the disease and their families. According to the World Health Organization (WHO), tens of millions of people worldwide live with Alzheimer’s disease, and the number will grow in the years ahead, outpacing the healthcare resources needed to manage it and costing billions of dollars.

According to the Health, Labor and Welfare Ministry, it is estimated approximately 4.6 million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012). Alzheimer’s disease is suspected to represent around 60-70% of dementia cases.

Alzheimer’s disease is characterized by changes in the brain, including the abnormal accumulation of toxic amyloid beta plaque, which begins approximately 20 years before patients exhibit symptoms of the disease. MCI due to Alzheimer’s disease is one of the earliest stages of the disease when symptoms start to be more visible and can be detected and diagnosed. Current research efforts are focused on catching and treating patients as early as possible for the best chance of slowing or stopping the progression of Alzheimer’s disease.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

We routinely post information that may be important to investors on our website at?www.biogen.com. Follow us on social media –?Twitter,?LinkedIn,?Facebook,?YouTube.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai’s corporate philosophy is based on the?human health care?(hhc)?concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our?hhc?philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing of a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform.” Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a “Dementia Ecosystem,” by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit?https://www.eisai.com.

Biogen Safe Harbor?

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about potential regulatory discussions, submissions and approvals and the timing thereof; the potential clinical effects of aducanumab; the potential benefits, safety and efficacy of aducanumab; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including aducanumab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including aducanumab; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; uncertainty of success in the development and potential commercialization of aducanumab; risks relating to the potential launch of aducanumab, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for aducanumab and other unexpected difficulties or hurdles; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

EISAI TO PRESENT LATEST DATA ON PERAMPANEL AT THE 74TH AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will present the latest data on its in-house discovered and developed anti-epileptic agent (AED) perampanel (product name: Fycompa^?), at the 74th American Epilepsy Society Annual Meeting (AES2020), to be held virtually from December 4 to 8, 2020.

A total of 43 poster presentations regarding perampanel are planned, including analysis results from the phase III clinical trial (FREEDOM/Study 342), which evaluated the effectiveness and safety of the perampanel monotherapy in the open-label extension (52 weeks) for epilepsy patients with partial onset ?seizures (POS) from 12 to 74 years of age without prior treatment history. Additionally, results from the phase III clinical trial Study 311 evaluating safety and tolerability of perampanel as an adjunctive therapy in pediatric epilepsy patients with POS or primary generalized tonic clonic (PGTC) seizures from 4 to less than 12 years of age will be presented.

Perampanel is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. In Japan and the United States, perampanel is currently approved for monotherapy and adjunctive use in the treatment of POS (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older, as well as adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

Eisai considers neurology, including epilepsy, a therapeutic area of focus. As we provide perampanel globally, Eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. Eisai seeks to address the diverse needs of, as well as increase the benefits provided to, patients with epilepsy and their families.

Main poster presentations^*

Poster Number	Abstract title/Planned Date and Time (Eastern Standard Time)
299 Poster session 2	Perampanel for the Treatment of Focal and Generalized Seizures in Patients with Epilepsy with Tumor Etiology: Evidence from Clinical Practice Live poster discussion: December 6 (Sun.) 12:00 – 13:30
347 Poster session 2	Long-Term (52 weeks) Effects of Adjunctive Perampanel on Cognition, Growth, and Development in Japanese Pediatric Patients (Aged 4 to <12 Years) with Partial-Onset Seizures in Study 311 Live poster discussion: December 6 (Sun.) 12:00 – 13:30
358 Poster session 2	Exploring the Evidence for Broad-Spectrum Effectiveness of Perampanel: Rationale and Methods of a Systematic Review of Clinical Data in Generalized Seizures Live poster discussion: December 6 (Sun.) 12:00 – 13:30
555 Poster session 3	Clinical Factors Associated with Seizure Freedom in Patients with Partial-Onset Seizures (POS) Receiving Perampanel 4 mg/day in FREEDOM Study 342 Live poster discussion: December 6 (Sun.) 17:15 – 18:45
556 Poster session 3	Sustained Seizure Freedom with Perampanel 4 mg/day Monotherapy in Patients with Newly Diagnosed/Currently Untreated Recurrent Partial-Onset Seizures: Post Hoc Analysis of?Study 342 (FREEDOM) Live poster discussion: December 6 (Sun.) 17:15 – 18:45
567 Poster session 3	Open-label Phase 2 Study to Evaluate the Interchangeability of the Novel Intravenous Formulation of Perampanel from Oral Tablet in Japanese Patients with Epilepsy Live poster discussion: December 6 (Sun.) 17:15 – 18:45
762 Poster session 4	Long-term Evaluation of Adjunctive Perampanel on Mental Health in Pediatric Patients with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) in Study 311 Live poster discussion: December 7 (Mon.) 9:00 – 10:30
979 Poster session 4	Perampanel Plasma Concentrations and Clinical Effects Following 4 mg/day Monotherapy in Patients with Partial-Onset Seizures (POS): Post Hoc Analysis of Study 342 (FREEDOM) Live poster discussion: December 7 (Mon.) 9:00 – 10:30

^*Note: Posters will be available from December 4 on the conference website and remain available for 90 days.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to editors]

1. About perampanel (product name: Fycompa)Perampanel is a first-in-class anti-epileptic agent (AED) discovered and developed by Eisai. With epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Perampanel is available in drug form to be taken once daily orally at bedtime. A tablet and fine granule formulation have been approved in Japan. An oral suspension formulation and tablet have been approved in the United States and Europe.

Perampanel is currently approved in more than 70 countries and territories, including Japan, the United States, China, and other countries in Europe and in Asia as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. In Europe the approved age range has been expanded to 4 years and above. In addition, perampanel has been approved in more than 65 countries, including the United States, Japan, in Europe and in Asia for treatment as an adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In Europe the approved age range has been expanded to 7 years and above. In Japan and the United States, perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older.

To date, perampanel has been used to treat more than 300,000 patients worldwide across all indications.

Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with seizures associated with Lennox-Gastaut syndrome. In addition, Eisai is conducting development of an injection formulation.

2. About EpilepsyEpilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%. In a partial-onset seizure, an abnormal electrical disturbance occurs in a limited area of the brain, and may subsequently spread throughout the brain, becoming a generalized seizure (known as a secondarily generalized seizure). In a generalized seizure, abnormal electrical disturbances occur throughout the brain, and can be followed by a loss of consciousness or physical symptoms manifested throughout the whole body.

Epilepsy affects approximately 1 million people in Japan, 3.4 million people in the United States, 6 million people in Europe, 9 million people in China, and approximately 60 million people worldwide. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs,^*?this is a disease with significant unmet medical needs. Although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. As causes and clinical symptoms of pediatric epilepsy are not uniform, and prognoses can range from very positive cases to obstinate cases, special consideration for each patient is required of treatments.

^*“The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?” National Institute of Neurological Disorders and Stroke, accessed May 24, 2016,

http://www.ninds.nih.gov/disorders/epilepsy/detail_epilepsy.htm#230253109

EISAI AND WREN THERAPEUTICS ENTER INTO RESEARCH COLLABORATION AGREEMENT FOR DRUG DISCOVERY FOR SYNUCLEINOPATHIES

This collaboration aims to develop a disease modifying treatment for synucleinopathies based on network kinetics of α-synuclein misfolding and aggregation

TOKYO, Japan and CAMBRIDGE, United Kingdom, November 30 2020?– Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Wren Therapeutics Ltd. (Headquarters: Cambridge, UK, “Wren”) today announced that the companies have entered into an exclusive research collaboration agreement aiming to advance the discovery of novel small molecules that target α-synuclein for the potential treatment of synucleinopathies including Parkinson’s disease and dementia with Lewy bodies.

Wren possesses a novel network kinetics drug discovery platform that precisely quantifies the effects of small molecules on the protein misfolding and aggregation pathway that causes neurodegenerative diseases. Wren’s approach to synucleinopathies is focused on identifying novel small molecules that selectively control the aggregation process of α-synuclein, which is associated with the onset and progression of these diseases. The collaboration will use Wren’s network kinetics drug discovery platform, alongside Eisai’s extensive experience in drug discovery for neurodegenerative disorders, to accelerate the development of clinical candidates.

Dr. Samuel Cohen, Chief Executive Officer of Wren, commented: “We are delighted to have formed this collaboration with Eisai, a company with a distinguished track record and company-wide commitment to providing innovative treatments for patients suffering from neurodegenerative diseases. We believe that by combining our unique, predictive and quantitatively driven platform with Eisai’s deep expertise in neurology, we can together advance highly differentiated small molecules targeting α-synuclein for the treatment of debilitating protein misfolding disorders such as Parkinson’s disease.”

Dr. Teiji Kimura, Vice President, Chief Discovery Officer of the Eisai Neurology Business Group, commented: “Synucleinopathies such as dementia with Lewy bodies and Parkinson’s disease represent a significant unmet medical need due to the lack of any effective disease-modifying treatments. The accumulation of α-synuclein oligomers with protein misfolding is an important hallmark of these diseases. The Wren team, with its world-renowned founding scientists, is pioneering a new and fundamentally different approach to addressing protein misfolding diseases. By integrating capabilities across both companies we expect this exciting collaboration to be uniquely successful in identifying novel disease-modifying therapeutics for patients suffering from dementia with Lewy bodies, Parkinson’s disease and related disorders.”

Media Inquiries
Eisai Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120

Wren Therapeutics Ltd.
Emer Reynolds
Email: [email protected]

<Notes to editors>

About Wren’s novel network kinetics drug discovery platform

Wren’s proprietary network kinetics drug discovery platform enables an entirely new approach to drug discovery, designed specifically to address the unique challenges associated with protein misfolding diseases. The kinetics-based approach solves for the distinct molecular reaction network that underlies each misfolding disease and produces a fully predictive, quantitative map of the network and its dynamics. The platform identifies the optimum intervention points in the network to reduce the populations of toxic misfolded and aggregated species, and subsequently makes it possible to identify and optimise molecules with the desired kinetics inhibitory activity.

About Synucleinopathies

Synucleinopathies are neurodegenerative diseases characterised by the aberrant misfolding and aggregation of α-synuclein in neurons and glial cells. Synucleinopathies include Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA).

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.

For further information on Eisai Co., Ltd., please visit https://www.eisai.com.

About Wren Therapeutics Ltd.

Wren is a spin-off company from the University of Cambridge (UK) and Lund University (Sweden), focused on drug discovery and development for protein misfolding diseases. Wren is advancing an entirely novel approach to address this class of diseases, based on more than a decade of research from its scientific founders focused on the chemical kinetics of the protein misfolding process. Wren’s predictive, quantitative platform is built on concepts from the physical sciences and is a fundamental shift from the descriptive, qualitative methods of traditional biology, which have failed to successfully address these complex systems. Wren is using its unique approach to develop a broad pipeline of therapeutics for protein misfolding diseases.

For further information on Wren, please visit www.wrentherapeutics.com

AbbVie and Eisai Announce an approval for additional indication of HUMIRA?, a fully Human Anti-TNFα Monoclonal Antibody, for the treatment of pyoderma gangrenosum for the first time in the world

AbbVie GK (Headquarters: Minato-ku, Tokyo; President: James Feliciano, hereafter “AbbVie”) and Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito, hereafter “Eisai”) today announced an approval of additional indication of HUMIRA^??(generic name: adalimumab [recombinant], hereafter “HUMIRA”), a fully human anti-TNFα monoclonal antibody, for the treatment of pyoderma gangrenosum (hereafter “PG”). HUMIRA was granted orphan drug designation for the treatment of PG in 2019. This indication counts for HUMIRA’s 12th indication in Japan and makes HUMIRA the world’s first drug indicated for the treatment of PG.

This approval of the additional indication is based on the data from the Japanese phase III clinical trial^1?conducted in Japanese patients. This study was conducted to evaluate the efficacy and safety of HUMIRA targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment. The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target pyoderma gangrenosum ulcer area reduction (PG Area Reduction: PGAR) at Week 26 of administration, which is the primary endpoint of this trial, was 54.5% (12 of 22 patients)¹. The most common adverse drug reactions in patients receiving HUMIRA were skin bacterial infection¹.

PG is an inflammatory skin disease that rapidly progresses after its onset and is classified into the following 5 types: ulcerative type, bullous type, pustular type, vegetative type, and a type that develops around a stoma².^?In ulcerative PG, the most common type, appears as painful, pustules, papules and nodules in the lower extremities, especially in the lower legs, and efferently expands to form raised ulcer lesions with infiltration on the margins³. The ulceration accompanied by intense pain and is known to cause serious effects on patients’ quality of life (QOL)⁴.^?Although the pathogenic mechanism of PG is not fully understood, it is reported that approximately 20-30% of PG cases are caused by a slight injury or an external stimulus⁵.^?PG mostly affects people in their 50s to 70s, and its incidence is reported to be 3.0? per million/year in Japan⁶.

AbbVie and Eisai are committed to further contribute to the improvement of QOL of many more patients by making efforts to promote the appropriate use of HUMIRA, including its use for this indication, and to provide information on HUMIRA.

About HUMIRA

HUMIRA? is a fully human anti-TNF-α monoclonal antibody. In Japan, it is approved for “the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage); hidradenitis suppurativa, the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis*, intestinal Beh?et’s disease, and non-infectious intermediate, posterior and panuveitis that are refractory to the conventional therapies, induction and maintenance therapy for moderate to severely active Crohn’s disease (limited to patients who have had an inadequate response to conventional therapy), and treatment of moderate to severe ulcerative colitis (limited to patients who have had an inadequate response to conventional therapy ).”

* HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is approved. HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved.

Nonproprietary name:	Adalimumab <recombinant>
Brand name:	Fully Human Anti- TNF- α Monoclonal Antibody “HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL; HUMIRA for Subcutaneous Injection 40 mg Syringe 0.4 mL; HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL; HUMIRA for Subcutaneous Injection 40 mg Pen 0.4 mL; and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL”

EISAI COMMENCES “PaDiCo” SMARTPHONE APPLICATION SERVICE IN JAPAN TO SUPPORT THE DAILY LIVES OF PATIENTS WITH PARKINSON’S DISEASE

WITH SIMPLE OPERATION, APP RECORDS AND VISUALIZES SYMPTOMS TO SUPPORT COMMUNICATION BETWEEN PATIENTS AND DOCTORS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has commenced the “PaDiCo” smartphone application service in Japan to support the lives of patients with Parkinson’s disease. The app is available for free download via the App Store (iPhone) or Google Play (Android).

It is estimated that the number of patients with Parkinson’s disease in Japan is approximately 200,000,¹?and the number of patients tends to increase year by year with the aging of the population.^{1, 2}?The basic treatment for Parkinson’s disease is drug therapy.²?However, as the disease progresses, the medication is no longer working effectively, and wearing-off phenomenon in Parkinson’s disease may occur, such as total or partial immobility.

The wearing-off phenomenon are diverse, including the motor symptoms such as tremor and muscular rigidity (stiffness), and the non-motor symptoms such as constipation, pollakiuria and sweating. Thus, it is considered to be difficult to understand wearing-off phenomenon. Understanding these symptoms at an early stage and providing patients with appropriate treatments may help control the progression of the disease.

The PaDiCo is equipped with a function that allows, with a simple operation, patients with Parkinson’s disease to record the time when wearing-off phenomenon appeared and visualize it on a weekly basis. In addition, the PaDiCo enables patients, in prior to visiting a medical institution, to score the fluctuations in their physical conditions and symptoms at that time and record it on the app. Recording the patient’s daily conditions is useful to patients for accurately relaying symptoms to their attending physicians. Furthermore, patients can send alerts or messages to pre-registered family members and close friends via SMS (Short Message Service) function of the PaDiCo by simply pressing the access button of the application displayed on the smartphone screen, for times such as their symptoms are severe. Besides, this app features an SOS display function, drug management, and useful information for patients in daily life such as a comprehensive exercise program recommendable for patients with Parkinson’s disease.

Eisai focuses on continuously creating new drugs in the field of Parkinson’s disease whilst delivering Parkinson’s disease treatment Equfina^??with a novel mechanism of action in Japan. We will, beyond providing drugs, further contribute to improving the QOL (quality of life) of patients with Parkinson’s disease and assisting their families to liven up a daily life by disseminating information through the PaDiCo and the PD Net, the Parkinson’s disease information site operated by Eisai.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to editors]

About key features of the PaDiCo App *This app is not a medical device.

The name PaDiCo comes from a combination of the underlined letters of?Parkinson,?Digital, and?Communication. The app is equipped with various functions for patients with Parkinson’s disease; such as recording and visualizing off” time, recording their conditions and symptoms, an auxiliary function for sending messages, an SOS display function, and enabling users to receive useful information for a daily life such as a comprehensive exercise program recommendable for the patients with Parkinson’s disease.

1) A function that allows users with a simple operation to record “off” time and visualize it on a weekly basis, and a function to record the physical conditions and symptoms of patients with Parkinson’s disease

For the treatment of Parkinson’s disease, it is important to understand the patient’s symptoms at an early stage, and offer an appropriate treatment. With the PaDiCo app, users can record “off” time and visualize it on a weekly basis with a simple operation. Also, the app enables users to check the average data by month / year. In addition, the PaDiCo can be used to score the physical conditions and symptoms of patients daily and to record the fluctuations. These records will help patients for accurately relaying symptoms to and proceeding communication with the attending physicians.

2. An auxiliary function for sending messages, an SOS display function, and a function to provide useful information for daily life of the patients with Parkinson’s disease such as recommended exercise training programs

The app enables users to send a pre-created message to registered family members and close friends via SMS function by simply pressing the access button on the smartphone screen, even when the symptoms of Parkinson’s disease are severe to patients. In addition, this app is equipped with a function that allows users to request an assistance in an emergency as needed by pressing the SOS button on the smartphone screen and presenting a screen with support methods to the surroundings. Also, the app enables users to record and manage their administration of registered medicines by simply scanning the two-dimensional code for the electronic version of a medication notebook into this application. Additionally, the app provides various useful information to patients with Parkinson’s disease for their daily lives, such as exercise training programs recommendable for patients.

PaDiCo Information Desk:?[email protected]?(available in Japanese only).

Information on how to use the app is available through the Parkinson’s disease information website “PD Net”.

https://patients.eisai.jp/pdnet/?(available in Japanese only)

PD Net is a website for an accurate understanding of symptoms and progression of Parkinson’s disease. Also, PD Net provides useful information to patients with Parkinson’s disease and their families to have better understanding of the disease and the consultation at hospital.

¹?Japanese Society of Neurology “Parkinson’s disease clinical practice guideline 2018”
²?Japan Intractable Diseases Information Center – Parkinson’s disease (designated intractable disease 6):

https://www.nanbyou.or.jp/entry/169?(available in Japanese only)

JYSELECA? (FILGOTINIB) FOR RHEUMATOID ARTHRITIS LAUNCHES IN JAPAN

A once-daily, oral, JAK inhibitor for the treatment of rheumatoid arthritis in patients who have had an inadequate response to conventional therapies

Gilead Sciences K.K. (Head office: Chiyoda-ku, Tokyo; President and Representative Director: Luc Hermans; “Gilead”) and Eisai Co., Ltd. (Head office: Bunkyo-ku, Tokyo, CEO: Haruo Naito; “Eisai”) today announced that Jyseleca^??(filgotinib maleate 200 mg and 100 mg tablets), a new once-daily, oral, JAK (Janus kinase) inhibitor that preferentially inhibits JAK1, will be launched in Japan on November 18 for the treatment of rheumatoid arthritis (RA), with prior regulatory approval by the Japanese Ministry of Health, Labour and Welfare.

Jyseleca is indicated for RA (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. The therapy has received approval in Japan and Europe.

Based on a co-promotion agreement entered into by Gilead and Eisai in December 2019, Gilead will hold the marketing authorization of Jyseleca, while Eisai will be responsible for product distribution of Jyseleca in Japan. The companies will collaborate in product information provision activities in Japan.

“It is estimated that approximately 600,000 to 1 million people¹?are living with RA across Japan,” said Luc Hermans, MD, President and Representative Director, Gilead Sciences, K.K. “While RA treatment is advancing, many patients still do not experience sufficient disease remission, and many unmet medical needs remain. Gilead and Eisai are committed to delivering the new treatment option Jyseleca and supporting RA patients in Japan.”

“Eisai has extensive clinical development and commercialization experience in RA and has established a solid RA franchise in Japan,” said Hidenori Yabune, President of Eisai Japan, Senior Vice President, Eisai. “With the launch of Jyseleca, we will make further contributions to meet the diverse needs of RA patients and improve their QOL (quality of life).”

Multiple clinical trials are being conducted to investigate the potential role of filgotinib in a variety of diseases, including the Phase 3 SELECTION program in ulcerative colitis and the Phase 3 DIVERSITY program in Crohn’s disease. The safety and efficacy of filgotinib has not been demonstrated for these uses.

1) Committee on Rheumatology and Other Diseases, Committee on Disease Control, Health Science Council, “Current status of rheumatology from the perspective of internal medicine”, March 26, 2018.
Overview of Jyseleca^?

Brand name	Jyseleca^?
Generic name	filgotinib maleate
Indications	Rheumatoid arthritis (including prevention of structural joint damage) in patients who have had inadequate response to conventional therapies
Composition	Light brown film-coated tablet
Dosage and Administration	The recommended dosage for adults is filgotinib 200 mg once-daily, which can be adjusted to filgotinib 100 mg once-daily, depending on the condition of the patient
Date of regulatory approval	September 25, 2020
Date of listing on drug price list (Japanese National Health Insurance)	November 18, 2020
Date of launch	November 18, 2020
Manufacturer	Gilead Sciences K.K.
Drug price (Japan)	Jyseleca^??100 mg tablet: 2,550.90 yen Jyseleca^??200 mg tablet: 4,972.80 yen

Jyseleca^??is a registered trademark of Gilead Sciences, Inc. and its associated companies.

?About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more information on Gilead Sciences, please visit the company’s website at?www.gilead.com.

For more information on Gilead Sciences K.K., please visit the company’s website at?https://www.gilead.co.jp/.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our?human health care?(hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our?hhc?philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit?https://www.eisai.com.

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. There is also the possibility of unfavorable results from ongoing and additional clinical trials involving Jyseleca and the risk that other regulatory authorities may not approve Jyseleca for the treatment of rheumatoid arthritis and other indications, and any marketing approvals, if granted, may have significant limitations on its use. Further, it is possible that Gilead may make a strategic decision to discontinue development and commercialization of Jyseleca, and as a result, Jyseleca may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

CONTACTS:
Gilead Sciences
Ken Takashima, Media, Japan
+81-3-6745-0850

Eisai
Public Relations Dept
+81-3-3817-5120

EISAI SELECTED FOR MEMBERSHIP IN DOW JONES SUSTAINABILITY ASIA PACIFIC INDEX 2020 FOR SEVENTH TIME

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been selected for a membership in the Dow Jones Sustainability Asia Pacific Index (DJSI Asia Pacific), the Asia Pacific version of the Dow Jones Sustainability Indices (DJSI), which are a family of premier global indices for socially responsible investment (SRI). This marks Eisai’s seventh selection.

The DJSI family was jointly established between RobecoSAM AG (Switzerland) and S&P Dow Jones Indices LLC (United States) in 1999 and assesses the corporate sustainability performance of eligible member companies based on economic, environmental and social criteria. The DJSI is one of the important investment criteria for the investors around the world who emphasize on corporate initiatives for improving non-financial value focused on environmental, social, and governance (ESG).This year, the DJSI Asia Pacific has selected top 158 companies (82 of which are from Japan) from among the approximate major 600 companies in the region. Eisai received high scores in categories such as Innovation Management, ?Climate Strategy, Environmental Reporting as well as Human Rights.

In addition to the DJSI Asia Pacific, Eisai has been selected for the FTSE4Good Index Series, which is another global benchmark SRI index as well as for the MSCI Japan Empowering Women Index (WIN), the FTSE Blossom Japan Index, the MSCI Japan ESG Select Leaders Index and S&P/JPX Carbon Efficient Index, which are the four ESG investment indices for Japanese stocks adopted by the Government Pension Investment Fund (GPIF).

Eisai’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. By strengthening its ESG initiatives and increasing non-financial value, Eisai is striving to sustainably enhance corporate value based on this corporate philosophy.

LENVIMA? Plus KEYTRUDA? Demonstrated Statistically Significant Improvement in Progression-Free Survival, Overall Survival and Objective Response Rate Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

LENVIMA? Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib
Results of Investigational Phase 3 CLEAR Trial (Study 307)/KEYNOTE-581 to be Presented at Upcoming Medical Meeting

TOKYO and KENILWORTH, N.J., Nov. 10, 2020 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 CLEAR trial (Study 307)/KEYNOTE-581 evaluating LENVIMA^?, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA^?, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., as well as LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

LENVIMA plus KEYTRUDA met the trial’s primary endpoint of Progression-Free Survival (PFS) and its key secondary endpoints of Overall Survival (OS) and Objective Response Rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. LENVIMA plus everolimus also met the trial’s primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor). The safety profiles of both LENVIMA plus KEYTRUDA and LENVIMA plus everolimus were consistent with previously reported studies. Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.

“The results for KEYTRUDA plus LENVIMA versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of KEYTRUDA-based combinations for the first-line treatment of advanced renal cell carcinoma,” said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. “Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.”

“The results from CLEAR (Study 307)/KEYNOTE-581 support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. “These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers.”

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. are continuing to study the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

About CLEAR (Study 307)/KEYNOTE-581

CLEAR (Study 307)/KEYNOTE-581 is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov,?NCT02811861) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib alone for the first-line treatment of patients with advanced RCC. The study enrolled approximately 1,050 patients who were randomized to one of three treatment arms to receive LENVIMA (18 mg orally once daily) in combination with everolimus (5 mg orally once daily) [arm A]; or LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (200 mg intravenously every three weeks) [arm B]; or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment) [arm C]. The primary endpoint is comparison of PFS between arm A versus arm C, and arm B versus arm C, by independent review per RECIST v1.1 criteria. Key secondary endpoints include OS, ORR and safety.

About Renal Cell Carcinoma (RCC)

Worldwide, it is estimated there were more than 403,000 new cases of kidney cancer diagnosed and more than 175,000 deaths from the disease in 2018.¹?In Japan, there were over 24,000 new cases and 8,000 deaths in 2018.¹?In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020.^?2?Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs.³Renal cell carcinoma is about twice as common in men as in women.⁴?Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC.^5,6?Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.⁷

About LENVIMA^??(lenvatinib) Capsules

LENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. The combination of LENVIMA and everolimus showed increased anti-angiogenic and anti-tumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signaling in vitro and tumor volume in mouse xenograft models of human renal cell cancer greater than each drug alone. Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 65 countries including Japan, the United States, in Europe and Asia, and for unresectable hepatocellular carcinoma in over 65 countries including Japan, the United States, in Europe, China and in Asia. Additionally, it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 55 countries, including the United States, in Europe and Asia. In Europe, the agent was launched under the brand name Kisplyx^??for renal cell carcinoma. In addition, it is approved in combination with KEYTRUDA as a treatment for advanced endometrial cancer that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in countries including the United States, Australia and Canada. Continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

About KEYTRUDA^??(pembrolizumab) Injection

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck & Co., Inc., Kenilworth, N.J., U.S.A. has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

About the Merck& Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer) across 19 clinical trials.

Eisai’s Focus on Cancer

Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these?Ricchi, with the aim of contributing to the cure of cancers.

About Eisai

Eisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our?human health care(hhc) philosophy. We strive to realize our?hhc?philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of?hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.

For more information about Eisai, please visit?www.eisai.com?(for global),?us.eisai.com(for U.S.) or?www.eisai.eu?(for Europe, Middle East, Africa), and connect with us on Twitter (U.S.?and?global) and?LinkedIn?(for U.S.).

Merck?& Co., Inc., Kenilworth, N.J., U.S.A.’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck & Co., Inc., Kenilworth, N.J., U.S.A., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck & Co., Inc., Kenilworth, N.J., U.S.A. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit?www.merck.com/clinicaltrials.

About Merck?& Co., Inc., Kenilworth, N.J., U.S.A.?　

For more than 125 years, Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck & Co., Inc., Kenilworth, N.J., U.S.A. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit?www.merck.comand?connect with us on?Twitter,?Facebook,?Instagram,?YouTube?and?LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

¹?GLOBOCAN2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 20122018.
https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdfhttp://globocan.iarc.fr/.

²?“Cancer Stat Facts: Kidney and Renal Pelvis Cancer.” Surveillance, Epidemiology, and End Results Program (SEER), National Cancer Institute,?https://seer.cancer.gov/statfacts/html/kidrp.html.
³?American Cancer Society. Key Statistics About Kidney Cancer,?https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html
⁴?“Key Statistics About Kidney Cancer.” American Cancer Society.?https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.
⁵?Thomas A. Z. et al. The Role Of Metastasectomy In Patients With Renal Cell Carcinoma With Sarcomatoid Dedifferentiation: A Matched Controlled Analysis.?The Journal of Urology. 2016 Sep; 196(3): 678–684,?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5014677/.
⁶?Shinder B et al. Surgical Management of Advanced and Metastatic Renal Cell Carcinoma: A Multidisciplinary Approach. Frontiers in Oncology. 2017; 7: 107.?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5449498/#__ffn_sectitle.
⁷?Padala, S. A., Barsouk, A., Thandra, K. C., Saginala, K., Mohammed, A., Vakiti, A., Rawla, P., & Barsouk, A. (2020). Epidemiology of Renal Cell Carcinoma. World journal of oncology, 11(3), 79–87.?https://doi.org/10.14740/wjon1279

European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer’s Disease

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease

Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. Clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease demonstrate that treatment with aducanumab resulted in the removal of amyloid beta and better clinical outcomes. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease.

“Alzheimer’s disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency’s review of this application.”

“There are no treatments available that impact the progression of Alzheimer’s disease by addressing the underlying disease pathology. The potential that aducanumab may hold to effectively reduce the clinical decline brings new hope to people and families living with this devastating disease,” said Dr. Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “The acceptance of the Marketing Authorization Application in the European Union is an important milestone as we work towards making this potential treatment available around the world.”

Aducanumab is also under review with the U.S. Food and Drug Administration with Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021.

About Aducanumab

About Alzheimer’s Disease

The Alzheimer’s Disease International 2019 Alzheimer’s Yearbook estimates that approximately 10 million people in the EU suffer from dementia (excluding Mild Cognitive Impairment). AD is suspected to represent around 60-70% of dementia cases.

Alzheimer’s disease is characterized by changes in the brain, including the abnormal accumulation of toxic amyloid beta plaque, which begins approximately 20 years before patients exhibit symptoms of the disease. Mild Cognitive Impairment due to Alzheimer’s disease is one of the earliest stages of the disease when symptoms start to be more visible and can be detected and diagnosed. Current research efforts are focused on catching and treating patients as early as possible for the best chance of slowing or stopping the progression of Alzheimer’s disease.

About Biogen

We routinely post information that may be important to investors on our website at?www.biogen.com. Follow us on social media –?Twitter,?LinkedIn,?Facebook,?YouTube.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai’s corporate philosophy is based on the?human health care (hhc)?concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our?hhc?philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform.” Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a “Dementia Ecosystem,” by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit?https://www.eisai.com.

Biogen Safe Harbor?

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including aducanumab; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; uncertainty of success in the development and potential commercialization of aducanumab; risks relating to the potential launch of aducanumab, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for aducanumab and other unexpected difficulties or hurdles; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

EISAI TO PRESENT LATEST DATA ON PIPELINE ASSETS IN THE AREA OF ALZHEIMER’S DISEASE AND DEMENTIA AT THE 13TH CLINICAL TRIALS ON ALZHEIMER’S DISEASE CONFERENCE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will conduct a total of 7 presentations, including the latest data of the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (Development Code: BAN2401), at the 13^th?Clinical Trials on Alzheimer’s Disease (CTAD) conference to be held virtually from November 4 to 7, 2020.

Regarding lecanemab, Eisai will conduct four oral presentations. The first oral presentation will cover clinical study design and initial screening results of the newly initiated Phase III clinical study AHEAD 3-45 for preclinical Alzheimer’s disease (AD) patients. The second oral presentation will cover the latest analysis results on expression of amyloid-related imaging abnormalities-edema (ARIA-E) from the Phase II study (Study 201) conducted on early AD patients. The third oral presentation will cover changes in brain-Aβ amounts and preliminary analysis results on ARIA-E expression as observed in the first 12-month treatment period of the ongoing open-label extension (OLE) study of Study 201. The fourth oral presentation will cover baseline characteristics of currently enrolled subjects in the Phase III study Clarity AD being conducted on early AD patients.

Other presentation topics include the effectiveness of lemborexant on irregular-sleep-wake- rhythm-disorder (ISWRD) in AD as observed in mouse models in relation to clinical trials, as well results from a Phase I, First-In-Human (FIH), Single Ascending Dose (SAD) study of the novel anti-microtubule binding region (MTBR) tau antibody E2814.

Regarding aducanumab, Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States) will conduct an oral presentation on the design of its Phase IIIb redosing study EMBARK. A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for approval of aducanumab as an AD treatment, was accepted and received priority review designation in August 2020.

Lecanemab and aducanumab are being jointly developed by Eisai and Biogen Inc.

Regarding the joint research effort with Sysmex Corporation (Headquarters: Hyogo, “Sysmex”) for creation of simplified diagnosis of AD using blood, a poster will be presented on prediction of Amyloid Positivity Defined by Amyloid PET Centiloid through Plasma Aβ Ratio Measurement on a Fully Automated Immunoassay, HISCL^TM*.

Eisai aims to realize the prevention and cure of dementia through a multi-dimensional and holistic approach with a foundation of over 35 years of experience of drug discovery activities in the area of AD and dementia. Eisai strives to create innovative medicines as soon as possible to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, those living with the disease and their families.

^*HISCL^TM?is a trademark of Sysmex Corporation.

■ Eisai oral presentation topics

Asset in Development, Session Number	Topic/Planned Date and Time (Eastern Standard Time)
BAN2401 OC 2	The AHEAD 3-45 Study of BAN2401 in Preclinical Alzheimer’s Disease: Study Design and Initial Screening Results Live oral presentation: November 4 (Wed.) 10:00 AM-10:15 AM Q&A Session: November 4 (Wed.) 11:25 AM-11:40 AM
BAN2401 OC 10	Baseline Characteristics for Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating BAN2401 in Early Alzheimer’s Disease Oral presentation available for on-demand viewing November 4 (Wed.) 1:00 AM
BAN2401 OC 14	BAN2401 and ARIA-E in Early Alzheimer’s Disease: Pharmacokinetic / Pharmacodynamic Time-to-Event Analysis From the Phase 2 Study in Early Alzheimer’s Disease Live oral presentation: November 5 (Thu.) 9:45 AM-10:00 AM Q&A Session: November 5 (Thu.) 11:15 AM-11:30 AM
BAN2401 LB 24	Preliminary Analysis of BAN2401 Effects On Brain Amyloid And ARIA-E Findings Over 12 Months Of Treatment In The Open-Label Extension Of The Phase2b Study BAN2401-G000-201 In Subjects With Early Alzheimer’s Disease Live oral presentation: November 7 (Sat.) 12:10 PM-12:25 PM Q&A Session: November 7 (Sat.) 12:25 PM-12:50 PM
Lemborexant LB 15	Irregular Sleep-Wake Rhythm Disorder in Alzheimer’s Disease: SAMP8 Mouse Strain as an Animal Model and Efficacy of the Dual Orexin (Hypocretin) Receptor Antagonist Lemborexant Oral presentation available for on-demand viewing November 6 (Fri.) 1:00 AM
E2814 LB 23	A Phase 1, First-In-Human (FIH), Single Ascending Dose (SAD) Study of the Novel Anti-Tau Therapeutic Antibody E2814?in Healthy Volunteers Live oral presentation: November 7 (Sat.) 11:55 AM-12:10 PM Q&A Session: November 7 (Sat.) 12:25 PM-12:50 PM

■ Eisai poster presentation topics

Asset in Development, Poster Number	Topic/Planned Date and Time (Eastern Standard Time)
General P 60	Congruence of Clinical Assessment Instruments with Online Narratives Over Social Media by Patients with Alzheimer’s Disease and Their Caregivers Available for on-demand viewing beginning November 4 (Wed.)

■ Biogen oral presentation topics

Asset in Development, Session Number?	Topic/Planned Date and Time (Eastern Standard Time)?
Aducanumab OC 3	EMBARK: A Phase 3b, Open-Label, Single-Arm, Safety Study to Evaluate the Long-Term Safety and Efficacy of Aducanumab in Eligible Participants with Alzheimer’s Disease Live oral presentation: November 4 (Wed.) 10:15 AM-10:30 AM Q&A Session: November 4 (Wed.) 11:25 AM-11:40 AM

■ Biogen poster presentation topics

Asset in Development, Poster Number?	Topic/Planned Date and Time (Eastern Standard Time)?
General P 70	Estimating progression rates across the spectrum of Alzheimer’s disease for amyloid positive individuals using National Alzheimer’s Coordinating Center data Available for on-demand viewing beginning November 4 (Wed.)

■ Sysmex-Eisai poster presentation topics

Asset in Development, Poster Number?	Topic/Planned Date and Time (Eastern Standard Time)?
General LP 10	Plasma Aβ Ratio Measured on a Fully Automated Immunoassay Predicts Amyloid Positivity Defined by Amyloid PET Centiloid Available for on-demand viewing beginning November 4 (Wed.)

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to editors]

1. About the Joint Development Agreement between Eisai and Biogen for AD

Eisai and Biogen are widely collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab (Development Code: BAN2401), an anti-Aβ protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen’s investigational anti-Aβ antibody for patients with AD, and the companies plan to pursue marketing authorizations for the two compounds worldwide. If approved, the companies will also co-promote the products in major markets, such as the United States, the European Union and Japan.

2. About the collaboration between Eisai and Sysmex

Eisai and Sysmex have entered into a comprehensive non-exclusive collaboration agreement aimed at the creation of new diagnostics in the field of dementia in February 2016. Leveraging each other’s technologies and knowledge, the two companies aim to discover next-generation diagnostics that will enable early diagnosis, selection of treatment options and the regular monitoring of the effects of treatment for dementia.

3. About lecanemab (Development Code: BAN2401)

Lecanemab is a humanized monoclonal antibody for AD that is the result of a strategic research alliance between Eisai and BioArctic AB (Headquarters: Sweden). Lecanemab selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Currently, a global clinical Phase III study (Clarity AD) of lecanemab in early AD is underway. Lecanemab is being jointly developed by Eisai and Biogen Inc. The National Institutes of Health, National Institute of Aging are providing funding for the A45 Study (grant number R01AG061848) and A3 Study (grant number R01AG054029).

4. About Lemborexant

Lemborexant, an orexin receptor antagonist, is Eisai’s in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-REM sleep, may influence lemborexant’s potential to facilitate improvements in sleep onset and maintenance. In June 2020, lemborexant was launched under the product name DAYVIGO^TM?in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in July 2020, it was launched under the product name DAYVIGO^? in Japan for the treatment of insomnia. Eisai has submitted new drug applications seeking approval of DAYVIGO in Canada, Australia and HKSA. In addition, a Phase II clinical study of lemborexant in patients with ISWRD associated with mild to moderate Alzheimer’s dementia is underway.

5. About Aducanumab (Development Code: BIIB037)

Aducanumab is an investigational human monoclonal antibody studied for the treatment of AD. Based on clinical data, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients’ ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).

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