The 2017-2018 Annual Awards Ceremony for Advanced Collectives and Outstanding Individuals of Undergraduates in China Medical University, held on Nov. 27, 2018, marks the kickoff of the “Eisai China Scholarships” and “Eisai China Grants” that Eisai China Inc. (ECI) provides to seven famous Chinese universities in 2018. Ms. Jun Zheng, ECI’s Senior Regional Manager of NTA Business Unit, Wenge He, Secretary of the Party Committee of the School of Pharmacy of China Medical University, and Xiaoyue Ji, Deputy Director of the Training Center of Rural Doctor of China, presented the awards to the representatives of the students.

The 2017-2018 Academic Year China Medical University-Eisai China Scholarships and Grants are awarded as follows:

Awarding objects: 25 undergraduates formally registered in clinical medicine and pharmacy related majors.

1. The Eisai China Scholarships are awarded to 3 students in the long schooling clinical medicine major, 4 ones in the 5-year clinical medicine major, and 3 ones in the pharmacy-related majors, 10 winners in total with RMB 4,000 yuan per person.
   2. The Eisai China Grants are awarded to 5 students in the long schooling clinical medicine major, 5 ones in the 5-year clinical medicine major, and 5 ones in the pharmacy-related majors, 15 winners in total with 4,000 yuan per person.

(Photo of the representatives of the winners)

ECI started the Eisai China Scholarships and Grants Program in China Medical University in 2014, and donates over RMB100, 000 yuan every year to reward the hardworking undergraduate students with excellent academic performance and financial difficulties. As of 2018, a total of 50 outstanding students have received scholarships in the five consecutive years, and 75 students with good performance and financial difficulties have received grants.

Eisai China launched the Scholarships and Grants Program in 2000. By the end of 2018, the firm has donated more than RMB 8 million yuan to Chinese institutions, which benefited more than 1,800 outstanding students and students with financial difficulties. Congratulations to all those who have harvested both excellent results and rewards through hard work in 2018. We hope that you will work even harder and complete your studies with persistent diligence and excellent performance. In the following days let’s look forward to more news from the winners of the Eisai China Scholarships and Grants in Sun Yat-Sen University, China Pharmaceutical University, School of Basic Medical Sciences of Fudan University , Peking University Health Science Center, West China Medical Center of Sichuan University, and School of Pharmacy of Shenyang Pharmaceutical University .

In recent years, Eisai China Scholarships and Grants Program has been highly valued and strongly supported by Ms. Yanhui Feng, President of China region of Eisai, as well as the Eisai top management team. Relevant leaders have participated in the Scholarships and Grants awarding activities for times, and adjusted and improved the awards settings. The original purpose of the Eisai China Scholarships and Grants Program is to promote the development of China’s higher medical education, to reward the outstanding students and help students with financial difficulties successfully complete their studies, to train more medical professionals for the society, and practice the firm’s human health care?(hhc) corporate philosophy.

Corporate Mission: We give first thought to patients and their families, and to increasing the benefits health care provides.
Corporate Vision:? We, in compliance with all relevant laws and ethical standards under any healthcare system and in any business activities, strive to become a?human health care?company with existence value.
Corporate Values: Innovation, Inspire High, Integrity, Ownership, Team Work

Eisai has been smoothly developing its business in China since the early 1990s, starting with the establishment of Shenyang Eisai Pharmaceutical Co., Ltd. in 1991, followed by the establishment of Eisai Suzhou Pharmaceutical Co., Ltd. in Suzhou Industrial Park, a pharmaceutical manufacturing facility which was officially renamed Eisai China Inc. in 2002. With the development of its business in China, Eisai (Suzhou) Trading Co., Ltd. was established in Suzhou Industrial Park in 2010 and Eisai China Holdings Ltd. was set up in 2014. In 2015, Eisai (Liaoning) Pharmaceutical Co., Ltd. was officially established through the full takeover of a local generic drug manufacturer. So far, a development mode has been formed, consisting of Eisai China Holdings Ltd. for capital control and management, while Eisai China Inc., Eisai (Liaoning) Pharmaceutical Co., Ltd. and Eisai (Suzhou) Trading Co., Ltd. for business support.

Some say that youth is poetry, and future is a dream. We sincerely wish that all the students majored in medical science and pharmacy work hard, scale new heights, be fearless of challenges and stay true to the mission; we hope that every award-winning student stay true to the mission in considering the problems and decisions in their study and future work, and act to achieve the goal of “human health care” to salute the youth!

COMMENCES PROVIDING THE FIRST NEW THERAPY FOR UNRESECTABLE HEPATOCELLULAR CARCINOMA IN CHINA IN ALMOST A DECADE

 

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that its Chinese subsidiary Eisai China Inc. (ECI) has launched the kinase inhibitor LENVIMA^?(product name in China:?樂衛(wèi)瑪^?, generic name: lenvatinib mesylate) in China.

In China, LENVIMA was approved first as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy in September 2018. Through this launch, LENVIMA is the first new systemic therapy in approximately ten years available for the first-line treatment of unresectable HCC in China,¹?where the incidence of HCC is the highest in the world.¹

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, and collaboration between the companies is progressing around the world. Going forward, ECI and Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s Chinese subsidiary MSD China will work to jointly provide information on LENVIMA in China as well.

Liver cancer is the second leading cause of cancer-related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions. Specifically, in China, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide.¹?HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.

Today, LENVIMA is approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan and Europe, and in combination with everolimus as a second-line treatment for renal cell carcinoma in over 45 countries, including in the United States and Europe. In addition to China, LENVIMA is approved for use in the treatment of HCC in Japan, the United States, Europe, and other countries in Asia and around the world.

The Chinese pharmaceutical market is the second largest market in the world after the United States, and in 2017 was worth US$122.2 billion and growing at a rate of 4% on a local currency basis, maintaining growth.²?Eisai considers China as a key region for driving its global business following after Japan and the United States, and with the launch of LENVIMA in China, seeks to contribute further to increasing the benefits provided to cancer patients and their families.

 

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

 

[Notes to editors]
1. About LENVIMA^??(lenvatinib mesylate)
Discovered and developed in-house by Eisai, LENVIMA is an orally administered kinase inhibitor with a novel binding mode that selectively inhibits the multi activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.

Currently, Eisai has obtained approval for LENVIMA as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a second-line treatment for renal cell carcinoma in over 45 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx^??for renal cell carcinoma.

In addition, LENVIMA has been approved as a treatment for hepatocellular carcinoma in Japan, the United States, Europe, China and other countries. Furthermore, Eisai has submitted applications for an indication covering hepatocellular carcinoma in Chinese Taiwan (December 2017), Brazil (March 2018), Russia (August 2018) and as well as in other countries. In Japan, over 5,000 patients have been treated with LENVIMA since approval of the HCC indication.

It is important to note that the dose for LENVIMA for patients with unresectable HCC is based on the patient’s weight (12 mg for patients weighing 60 kilograms or more, 8 mg for patients weighing less than 60 kilograms); the recommended dosage and dose adjustments are described in the full prescribing information.

 

2. About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. 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^??(lenvatinib). Under the agreement, the companies will jointly develop and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA^??(pembrolizumab). In addition to ongoing clinical studies of the combination, the companies will jointly initiate new clinical studies evaluating the LENVIMA and KEYTRUDA combination to support 11 potential indications in six types of cancer (bladder cancer, endometrial cancer, head and neck cancer, hepatocellular carcinoma, melanoma and non-small cell lung cancer), as well as a basket trial targeting six additional cancer types. The LENVIMA and KEYTRUDA combination is not approved in any cancer types today.

 

3. About Unresectable HCC
Liver cancer is the second leading cause of cancer-related deaths and is estimated to be responsible for 750,000 deaths per year globally. Additionally, 780,000 cases are newly diagnosed each year. There is a large regional difference, with about 80% of new cases occurring in Asian regions, including China and Japan.¹?HCC accounts for 85% to 90% of primary liver cancer cases. HCC is associated with chronic liver disease, in particular cirrhosis. Major causes of cirrhosis include hepatitis B virus and hepatitis C virus. However, according to a recent investigation, non-B/non-C HCC is on the rise. Surgery is the first option for treatment, but for patients with unresectable HCC who are not amenable for potentially curative therapeutic interventions, which include liver transplant, surgical resection, and tumor ablation (typically radiofrequency ablation or cryotherapy), or who are not suitable for transarterial chemoembolization (TACE), treatment options are limited and the prognosis is very poor.

 

4. History of Eisai’s Business in China
Eisai has been conducting business in China for over 25 years. Eisai expanded into the market in 1991 through a joint venture company, and in 1996, established Eisai China Inc. (Suzhou, Jiangsu Province), a 100% subsidiary with manufacturing / marketing capabilities. In 2010, Eisai (Suzhou) Trading Co., Ltd. was established for directly importing products and in December 2015, Eisai entered the generic pharmaceutical business in China by buying out Eisai (Liaoning) Pharmaceutical Co., Ltd. for the purpose of providing a stable supply of high-quality generic medicine to fulfil the medical needs of Chinese patients. These three companies were consolidated under Eisai China Holdings Ltd., which was established in December 2014.

In January 2018, construction of a new oral solid dose production facility and administration building was completed at the new Suzhou Plant within the Suzhou Industrial Park, and Eisai is working to establish the new Suzhou plant as the plant with the largest production capacity under the Eisai Group.

The core products of Eisai’s Chinese business include peripheral neuropathy treatment Methycobal^?, liver disease/allergic disease agents Stronger Neo-Minophagen^??C / Glycyron^??tablets, anti-Alzheimer’s agent Aricept^?, proton pump inhibitor Pariet^?, gastritis/gastric ulcer treatment Selbex^?, and Parkinson’s disease treatments Comtan^?, Stalevo^??and Eldepryl^??as well as the pipeline product branched-chain amino acid formula Livact^??Granules.

 

¹?GLOBOCAN2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.?http://globocan.iarc.fr/
²??Copyright??2018 IQVIA., IQVIA World Review 2018?, reproduction prohibited

KEYTRUDA^??is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

On October 27, 2018, the “2018 ADS” (ADS: Advance Dementia Science) was held by Eisai China Inc. in Beijing, China. The 2018 ADS is a communication platform that Eisai China established for doctors; the forum covers multi-aspects such as basic researches in the cognitive fields, new methods of diagnosis, clinical hotspots, research and development for new drugs, social and government policies, and etc., with well-known professors from China, Japan and South Korea discussing and interacting with over 300 participants on-site and over 400 participators online.

At the beginning of the summit, Mr. Benzhi Zhao, Deputy Secretary General of China Population Welfare Foundation, and Ms. Yanhui Feng, President of Eisai China, delivered their speeches. Mr. Zhao introduced China Population Welfare Fund Federation and the progresses of public welfare activities such as Yellow Bracelets Project and etc., and indicated that Alzheimer’s disease (AD) is one of the most commonly seen diseases leading to cognitive dysfunction in middle-aged and elderly people, and that through the “Yellow Bracelets” activity aiming to “bring equal love to both ends of life”, he looked forward to working together with Eisai to contribute more to Chinese patients in the future. Ms. Feng showed her warm welcome to all experts and guests in the “2018 ADS” and her sincere appreciation for their supports. She said that Eisai is committed to building AD-themed academic communication platforms and will continue to increase R&D for new drugs in this field. Meanwhile, with its?human health care (hhc)?corporate philosophy, Eisai, together with all sectors of the society, will make more contributions in disease cognition, prevention and control, patient care and other aspects.

From left: Benzhi Zhao, Yanhui Feng, Jianping Jia, Xin Yu

?

Professor Jianping Jia and Professor Xin Yu were invited to serve as the chairman of the summit. They both expressed their gratitudes to Eisai China for building such an academic communication platform, which provides experts from China, Japan and Korea and the participants with an opportunity to share their frontier academic progresses and clinical practices, and wished the summit a complete success.

In the main session of the frontier progresses of the Alzheimer’s disease, experts delivered speeches on topics inclusive of the introduction of the product lines for Alzheimer’s disease, the current status and outlook for dementia in China, biomarker diagnosis of Alzheimer’s disease, treatment and care for mental behavior symptoms in patients with cognitive impairment, and clinical diagnosis and treatment strategies for cognitive impairment, and etc., discussed the development direction of Alzheimer’s disease, shared policies concerning the cognitive disorder management system in China, Japan and Korea, and talked about continuous drug therapy and appropriate care for dementia patients and more topics. With wide interactions and communications on-site and through online live broadcast, the participants said that they benefited a lot from the summit. In the practice parallel session, presentations and discussions were held on issues in China, Japan and South Korea, such as the consultation methods of cognitive disorders, new R&D strategies for drugs of Alzheimer’s disease, community management for patients with cognitive disorders, and etc. In the clinical hotspots parallel session, academic presentations on the neuropsychological assessment and treatment of aphasia, the whole course management model and practice in Alzheimer’s disease patients in China and etc. were conducted, and experts discussions concerning the recommendations and applications of the cognitive assessment system for cerebral small vessel diseases, national stroke registration and baseline data reports of cognitive and sleep subgroups, memory clinic optimization management, select of memory clinic evaluation scales, and the application of memory clinic patient follow-up system etc. were carried out. In the idea exchanges and opinion collisions, the participators harvested the latest academic advances and clinical practices.

2018 ADS · Beijing Summit

In 1906, Dr. Alzheimer found plaques and fiber tangles in the brain of a patient named Auguste D. Today, 112 years later; dementia has become a worldwide problem for human beings. The latest data released by World Alzheimer Report 2015 showed that 1 patient with dementia was diagnosed every 3 seconds in the world. About 50 million people worldwide are suffering from dementia in 2018, and the number is believed to be tripled to 152 million in 2050. Alzheimer’s disease is becoming a global crisis as the population ages. Raising awareness of the society to Alzheimer’s disease and regulating AD diagnosis and treatment process are keys to treat the disease, which requires joint efforts of clinicians, patients, caregivers, and social organizations.

Alzheimer’s disease is a field that Eisai China has focused for long. It introduces Aricept? to China and pushed its entry into China’s National Reimbursement Drug List while keeping long-term investment in new drugs R&D in this field. Adhering to the corporate philosophy of?hhc, Eisai brings to China its rich experiences that it accumulated in other markets, and endeavors to cooperate with all sectors of the society to increase the social concern and appropriate understanding on Alzheimer’s disease in China through carrying out “Remember I Love You”, a public welfare activity for re-recognizing Alzheimer’s disease, the Yellow Bracelet Activity, and etc.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced that Eisai presented the latest data from the Phase II clinical study (Study 201) of BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease, at a symposium session titled “Clinical and Biomarker Updates from BAN2401 Study 201 in Early Alzheimer’s Disease” held on October 25 at the 11^th?Clinical Trials on Alzheimers Disease (CTAD) conference in Barcelona, Spain.

Study 201 is a placebo-controlled, double-blind, parallel-group, randomized study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild Alzheimer’s dementia (collectively known as early Alzheimer’s disease) with confirmed amyloid pathology in the brain. Patients were randomized to five dose regimens, 2.5 mg/kg bi-weekly, 5 mg/kg monthly, 5 mg/kg bi-weekly, 10 mg/kg monthly and 10 mg/kg bi-weekly, or placebo. This study used a Bayesian Adaptive Randomization Design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses. The 10 mg/kg monthly and 10 mg/kg bi-weekly doses were determined to have greater efficacy, and as a result, the proportion of patients allocated to those treatment arms was greater.

Conventional statistical methods on predefined clinical outcomes at the 18 month final efficacy time point ?included Alzheimer’s Disease Composite Score (ADCOMS), Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog), and Clinical Dementia Rating Sum of Boxes (CDR-SB).

The most current data presented at CTAD 2018 highlight topline results, originally presented by Eisai in July at the Alzheimer’s Association International Conference (AAIC) 2018, as well as new data from pre-specified subgroup analyses and cerebrospinal fluid (CSF) biomarkers. The full CTAD presentation is available on the Investor Relations section of the Eisai website.

From conventional statistical analysis of the topline results, the highest treatment dose demonstrated a statistically significant reduction in brain amyloid measured by positron emission tomography (PET) ?at 18 months (p<0.0001). This dose also showed a statistically significant slowing of clinical decline on ADCOMS of 30 percent compared to placebo at 18 months (p=0.034). A group-level correlation between clearance of brain amyloid and slowing of clinical decline on ADCOMS was confirmed (Pearson’s correlation coefficient of 0.838). A linear regression model testing the slope of change from baseline on the rate of disease progression using ADCOMS showed a significant difference over 18 months (p<0.001) for the highest treatment dose versus placebo, suggesting a potential disease-modifying effect.

A request from a health authority in July 2014 required an amendment to be implemented restricting enrollment of APOE4 carriers in the highest treatment dose arm (10 mg/kg bi-weekly), resulting in an imbalance of APOE4 carriers in that arm versus placebo. To assess the influence of APOE4 status on the observed effect in the highest treatment dose, the rates of clinical decline for APOE4 carriers and non-carriers in the placebo group were analyzed and shown not to be statistically significantly different from each other on ADCOMS, ADAS-Cog and CDR-SB. Analysis on clinical outcome measures was also conducted in pre-specified subgroups of APOE4 status. At the highest treatment dose, APOE4 carriers treated with BAN2401 saw 63% less decline in disease progression, while non-carriers saw 7% less decline, as measured by ADCOMS versus placebo at 18 months. These results suggest that the treatment effect for the 10 mg/kg bi-weekly dose is related to treatment with BAN2401 and not due to an imbalance in subject allocation by APOE4 status. In addition, the pooled 10 mg/kg bi-weekly and 10 mg/kg monthly doses result in less decline on ADCOMS versus placebo at 18 months (overall; 21%, APOE4 carriers; 25%, APOE4 non-carriers; 6%). More detailed results were presented at CTAD.

Analyses of clinical outcome measures on pre-specified subgroups, by clinical stage and by use of concomitant Alzheimer’s disease medications, were also conducted. Treatment with the highest treatment dose also resulted in less decline in disease progression on ADCOMS at 18 months versus placebo across subgroups of clinical stage (MCI due to AD subgroup; 33% and mild AD subgroup; 35%) and use of concomitant Alzheimer’s disease medications (with concomitant AD meds; 23% and without concomitant AD meds; 41%). The study was not powered to show statistical significance in subgroups.

Exploratory data on CSF biomarkers of neurodegeneration that are elevated in AD were also presented by Eisai. To increase the sample size of the CSF subgroup, analyses were conducted on samples from the combined 10 mg/kg bi-weekly and 10 mg/kg monthly cohorts. From the results, markers of synaptic damage (neurogranin), tau pathology (phosphorylated-tau, p-Tau), and axonal degeneration (neurofilament light chain, NFL) showed trends that are suggestive of impact on underlying disease pathophysiology.

BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration. The most common treatment emergent adverse events were infusion-related reactions and amyloid-related imaging abnormalities (ARIA), both of which were dose-dependent. Incidence of ARIA-E (edema) was greater in APOE4 carriers. Ten percent of ARIA-E cases (5 of 48 patients) were symptomatic and included headache, visual disturbances, and confusion. Sixty percent of ARIA-E occurred within the first three months of treatment and approximately 89 percent of cases were mild to moderate in severity.

Eisai and Biogen are currently discussing the next steps for BAN2401 with regulatory authorities. An open-label extension for patients previously enrolled in Study 201 is being planned, with enrollment expected to begin this year.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

Biogen Safe Harbor Statement?
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 about results from the Phase 2 study of BAN2401; the potential clinical effects of BAN2401; risks and uncertainties associated with drug development and commercialization; the potential benefits, safety and efficacy of BAN2401 and therapies for other neurological diseases; the timing and status of current and future regulatory filings; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; and the potential of Biogen’s commercial business and pipeline programs, including BAN2401, elenbecestat and aducanumab. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” 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 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, unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; 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 BAN2401, elenbecestat, and/or aducanumab; the occurrence of adverse safety events; risks of unexpected costs or delays; the risks of other unexpected hurdles; uncertainty of success in the development and potential commercialization of BAN2401, elenbecestat, and/or aducanumab, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights, and uncertainties relating to intellectual property claims and challenges; uncertainty as to whether the anticipated benefits and potential of Biogen’s collaboration arrangement with Eisai can be achieved; product liability claims; and third party collaboration risks. 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 Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press 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.

 

Media Inquiries

 

<Notes to editors>
1. About BAN2401?
BAN2401 is a humanized monoclonal antibody for Alzheimer’s disease that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. As such, BAN2401 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 BAN2401 for the treatment of Alzheimer’s disease pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401 and the parties amended that agreement in October 2017.

2. About Study 201
Study 201 is a placebo-controlled, double-blind, parallel-group, randomized Phase II clinical study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s dementia (collectively known as early Alzheimer’s disease) with confirmed amyloid pathology in the brain. This study used Bayesian Adaptive Randomization Design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses. The study design included five dose regimens and placebo, and considered the efficacy of BAN2401 as well as dose responsiveness through 16 interim analyses that assessed potential for early success, an analysis based on ADCOMS at 12 months (primary endpoint), and a comprehensive final analysis at 18 months (secondary endpoints). Patients who received treatment with BAN2401 were randomized to five dose regimens, 2.5 mg/kg biweekly (52 patients), 5 mg/kg monthly (51 patients), 5 mg/kg biweekly (92 patients), 10 mg/kg monthly (253 patients), or 10 mg/kg biweekly (161 patients). Biomarker endpoints included changes in Aβ accumulated in the brain as measured by amyloid PET (positron emission tomography) as well as in cerebrospinal fluid (CSF), while ADCOMS (Alzheimer’s Disease Composite Score), Clinical Dementia Rating Sum of Boxes (CDR-SB) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog) were measured as efficacy endpoints (clinical).

3. About ADCOMS
Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer’s Disease Assessment Scale-cognitive subscale), CDR-SB (Clinical Dementia Rating Sum of Boxes) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. This Study 201 utilizes ADCOMS as its key endpoint for assessing clinical symptoms.

4. About Amyloid PET Imaging
Amyloid PET (Positron Emission Tomography) imaging is a diagnostic method that enables the visualization of amyloid plaque present in the brain as well as the quantitative evaluation of amyloid plaque distribution and accumulation in the brain via administration of a minute amount of PET tracer, which specifically binds to amyloid plaque. Amyloid PET imaging enables the assessment of pathology change and assistance of diagnosis of patients with Alzheimer’s disease, including MCI due to AD, and could predict clinical response.

5. About Correlation Coefficient
The correlation coefficient indicates the strength of the relationship between two variables from two quantitative data distributions. The correlation coefficient ranges in value from -1 to 1, and as it approaches the absolute value of 1, it indicates a total positive linear correlation. In general, if a correlation coefficient is 0.6 or greater, it suggests there is a relationship between the variables.

6. About the Joint Development Agreement between Eisai and Biogen for Alzheimer’s Disease
Eisai and Biogen are widely collaborating on the joint development and commercialization of Alzheimer’s disease treatments. Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen’s investigational anti-amyloid beta (Aβ) antibody for patients with Alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three 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.

As to BAN2401 and elenbecestat, both companies will equally split overall costs, including research and development expenses. Eisai will book all sales for elenbecestat and BAN2401 following marketing approval and launch, and profits will be equally shared between the companies.

7. 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.

Leveraging the experience gained from the development and marketing of Aricept^?, a treatment for Alzheimer’s disease and dementia with Lewy bodies, Eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. As a pioneer in the field of dementia treatment, Eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.

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

8. 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. 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, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

We routinely post information that may be important to investors on our website at?www.biogen.com. To learn more, please visit?www.biogen.com?and follow us on social media –?Twitter,?LinkedIn,?Facebook,?YouTube.

9. About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. The company also develops a potential treatment for Complete Spinal Cord Injury. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with our strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential. BioArctic’s B-share is listed on Nasdaq Stockholm Mid Cap (STO:BIOA B).?www.bioarctic.com.

ADDITIONAL DATA FROM BAN2401 PHASE II RESULTS TO BE PRESENTED IN SYMPOSIUM SESSION

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that five oral presentations including a symposium, and two poster presentations, highlighting the latest data on its Alzheimer’s disease / dementia pipeline including anti-amyloid beta (Aβ) protofibril antibody BAN2401, oral beta secretase cleaving enzyme (BACE) inhibitor elenbecestat, anti-Aβ antibody aducanumab, and dual orexin receptor antagonist lemborexant, will be given at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place in Barcelona, Spain, from October 24 to 27. BAN2401, elenbecestat and aducanumab are being jointly developed by Eisai and Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States, “Biogen”).

For BAN2401, a one-hour presentation will be given as a symposium to provide clinical and biomarker updates to the results initially presented in July 2018 from Study 201 in patients with early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia). The BAN2401 presentation will be webcast live. To access the live webcasts, please visit the Investors section of Eisai’s website on the day at?https://www.eisai.com/ir/index.html.

There will be an oral elenbecestat presentation which will include additional data on the Study 202 results that were initially presented in July 2018 in patients with mild cognitive impairment and mild to moderate Alzheimer’s disease. Elenbecestat is currently being investigated in two ongoing Phase III clinical studies (MISSION AD1/2) in patients with early Alzheimer’s disease.

Meanwhile, for aducanumab, there will be several presentations on late breaking abstracts ?including the results of analyses of cumulative safety data from the Phase Ib study PRIME long-term extension study of patients with early Alzheimer’s disease ?initially announced in August 2018. Currently, Eisai and Biogen are advancing two Phase III clinical studies (ENGAGE/EMERGE) on aducanumab.

In addition, there will be a presentation on data from a first-in-kind Phase II clinical study (Study 202) on the investigational sleep-wake regulation agent lemborexant in Alzheimer’s disease patients with irregular sleep-wake rhythm disorder (ISWRD). Discovered by Eisai, lemborexant has been jointly developed with Purdue Pharma L.P. (Headquarters: Connecticut, United States, “Purdue Pharma”) since August 2015.

Eisai is aiming to realize prevention and cure of dementia through a holistic approach to dementia drug discovery research based on a foundation of over 30 years of experience of drug discovery activities in the area of Alzheimer’s disease / dementia. Eisai is striving to create innovative medicines as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.

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

 

[Notes to editors]
1. About BAN2401
BAN2401 is a humanized monoclonal antibody for Alzheimer’s disease that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. As such, BAN2401 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 BAN2401 for the treatment of Alzheimer’s disease pursuant to an agreement concluded with BioArctic in December 2007.

2. About elenbecestat (generic name, development code: E2609)
Elenbecestat is an oral BACE (beta amyloid cleaving enzyme) inhibitor currently being investigated in Phase Ⅲ clinical studies for Alzheimer’s disease discovered by Eisai. By inhibiting BACE, a key enzyme in the production of Aβ peptides, elenbecestat reduces Aβ production, which is thought to lead to a reduction in amyloid plaque formations caused by the aggregation of toxic oligomers and protofibrils in the brain. Currently, two global Phase III clinical studies (MISSION AD1/2) of elenbecestat in early Alzheimer’s disease including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early stages of mild AD are underway. In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of elenbecestat, a process to facilitate development and expedite review by FDA for drugs deemed as having potential to treat serious conditions and addressing unmet medical needs.

3. About Aducanumab (BIIB037)
Aducanumab is an investigational compound being developed for the treatment of Alzheimer’s disease. Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of Alzheimer’s disease patients. Based on pre-clinical and Phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels.

In August 2016 aducanumab was accepted into the European Medicines Agency’s PRIME program. In September 2016 the U.S. Food and Drug Administration accepted aducanumab into its Fast Track program and in April 2017 aducanumab was accepted into the Japanese Ministry of Health, Labour and Welfare’s (MHLW) Sakigake Designation System.

4. About the Joint Development Agreement between Eisai and Biogen for Alzheimer’s Disease
Eisai and Biogen are widely collaborating on the joint development and commercialization of Alzheimer’s disease treatments. Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and 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 Alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three 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.

5. About Lemborexant (generic name, development code: E2006)
Lemborexant, a dual orexin receptor antagonist, is Eisai’s in-house discovered and developed small molecule compound that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). In individuals with sleep disorders, it is possible that the orexin system that regulates sleep and wakefulness is not functioning normally. During normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully counteract inappropriate wakefulness and facilitate the initiation and maintenance of sleep by interfering with orexin neurotransmission. Therefore, Eisai and Purdue have been developing lemborexant as a treatment for multiple sleep disorders.

In addition, a Phase II clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (ISWRD) and mild to moderate Alzheimer’s dementia is underway.