Japan – Biogen Japan and Eisai Provide Update on Co-Promotion Of Multiple Sclerosis Treatments In Japan

Mar 3, 2023 | Business

Biogen Japan Ltd. and Eisai Co., Ltd. announced today the termination of the co-promotion agreement that has been in place since January 2018 for Biogen Japan’s multiple sclerosis (MS) treatments TECFIDERA (dimethyl fumarate), TYSABRI (natalizumab, genetic recombinant) and AVONEX (interferon beta 1a, genetic recombinant) in Japan as of March 31, 2023.

The two companies have been jointly engaged in promotional activities for MS treatments in Japan. However, since a certain objective has been achieved regarding penetration of the products into the Japanese market, the two companies decided to terminate this co-promotion agreement. As a result, Biogen Japan will have full responsibility for all operations related to the products after a transition period between the two companies. Upon termination of this agreement, Biogen will pay Eisai 31 million USD.

The termination of this co-promotion agreement does not impact any of the other agreements between Biogen and Eisai.

For more information, visit www.eisai.com/news/2023/news202315.html.

Contacts:

Biogen Japan Ltd.

Japan – Biogen and Eisai Amend Collaboration Agreements on Alzheimer’s Disease Treatments

Mar 15, 2022 | Business

Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM (aducanumab-avwa). Effective as of January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM rather than sharing global profits and losses. The royalty rate starts at 2% and reaches 8% when annual sales exceed $1 billion. Effective immediately Biogen’s existing final decision-making rights on ADUHELM have converted to sole decision making and commercialization rights worldwide. Overall, economic arrangements for both companies in 2022 are expected to remain materially unchanged with Eisai’s share of expenses capped at an agreed amount for the costs related to development, commercialization and manufacturing of ADUHELM for the period from January 1, 2022, to December 31, 2022. Once the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM’s economics beyond these royalties.

The companies will continue to jointly develop and commercialize the investigational therapy lecanemab. Eisai continues to serve as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. Both companies share economics equally with Eisai booking all sales for lecanemab and Biogen reflecting its 50% share of profits and losses. The supply agreement related to lecanemab has been extended from five to 10 years. Biogen will manufacture the lecanemab drug substance in its Solothurn, Switzerland facility with the goal of providing reliable commercial supply worldwide.

“This amended collaboration agreement will increase operational efficiency and agility in addressing market developments, including the final determination of CMS on coverage of ADUHELM,” said Michel Vounatsos, Chief Executive Officer at Biogen. “In addition we are pleased to be expanding our agreement with Eisai through a new long-term manufacturing contract.”

“The collaboration between both companies has resulted in the approval of ADUHELM in the U.S. as the first treatment to address a defining pathology of Alzheimer’s disease, which is a significant step into a new chapter of Alzheimer’s therapy,” said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “We believe this new arrangement will be more effective and enable more focused execution with the goal of maximizing the value of both ADUHELM and lecanemab. Eisai will increase its focus on lecanemab and remains committed to bringing a new treatment option expeditiously to patients in need worldwide.”

About Biogen

As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological 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, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.

The company routinely posts information that may be important to investors on its website at www.biogen.com.

About Eisai

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 the potential clinical effects of ADUHELM and lecanemab; the potential benefits, safety and efficacy of ADUHELM and lecanemab; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; clinical development programs, the anticipated benefits and potential of Biogen’s manufacturing of lecanemab, clinical trials and data readouts and presentations; 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 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; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks associated with current and potential future healthcare reforms; 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.

MEDIA CONTACTS:

Biogen Inc.
Ashleigh Koss
+1-908-205-2572
public.affairs@biogen.com

Eisai Inc. (U.S. Media)
Public Relatio

Biogen Announces Reduced Price for Aduhelm to Improve Access For Patients With Early Alzheimer’s Disease In The United States

Dec 21, 2021 | Business

Eisai Co., Ltd. announced today that, effective January 1, 2022, Biogen will reduce the wholesale acquisition cost (WAC) of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in the United States by approximately 50%. For a patient of average weight (74 kg), the yearly cost at the maintenance dose (10 mg/kg) will be $28,200.

Over the past several months, Biogen has listened to the feedback of our stakeholders. Too many patients are not being offered the choice of ADUHELM due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer?s disease. Biogen recognizes that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system and Biogen is now taking important actions to improve patient access to ADUHELM.

Biogen is taking this action with the goal of lowering out-of-pocket expenses for patients and reducing the potential financial implications for the U.S. healthcare system. ADUHELM’s reduced price takes into consideration the questions raised about this first in class of therapies, the potential eligible population and revised pharmaco-economic assumptions. Biogen believes with insurance coverage, and access to diagnostics and specialized centers, approximately 50,000 patients may initiate treatment with ADUHELM in 2022.

It is a critical time for the Alzheimer’s disease community as the Centers for Medicare and Medicaid Services (CMS) is considering the possibility of coverage of not only ADUHELM, but also this entire new class of Alzheimer’s disease therapies that mainly have Abeta removing effects. We hope the actions today will facilitate patient access to these innovative Alzheimer’s treatments.

The reduced price is part of the Company’s ongoing commitment to further inform treatment choice. Biogen recently presented new p-tau181 biomarker data at the Clinical Trials on Alzheimer’s Disease conference (CTAD) and announced its plan to complete the Phase 4 confirmatory post marketing study of ADUHELM in an accelerated timeline of four years. ADUHELM’s accelerated approval by the U.S. Food and Drug Administration has served as a catalyst for significant investment and additional research and innovation for Alzheimer’s disease.

In addition, the reduced price will have a minor impact on the consolidated result forecasts for the period ended March 31, 2022. There are no changes to the consolidated financial forecast announced on November 1, 2021.

About ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Aducanumab-avwa is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.

ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.

Cost, Coverage and Co-Pay Assistance

The WAC of ADUHELM, which is an infusion once every four weeks, will be $2,171.40 per infusion for a patient of 74 kg?the average weight of a U.S. patient with mild cognitive impairment (MCI) or mild dementia. A 170 mg vial will be $479.40 and a 300 mg vial will be $846.00. The yearly cost at the maintenance dose (10 mg/kg) would be $28,200. The cost during the first year of treatment will be $20,500 due to the titration period. WAC is a list price and not the net price or the price paid by patients with insurance. The out-of-pocket cost for patients with insurance will vary depending on their coverage.

For patients facing difficulty affording ADUHELM, financial assistance programs are available. For more information, please contact Biogen Support Services at +1-833-425-9360.

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






Topic: Press release summary

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab (BAN2401)

Jul 30, 2021 | Business

Eisai Co., Ltd. and Biogen Inc. today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) — granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 — following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects with early Alzheimer’s disease (AD) (Mild Cognitive Impairment [MCI] due to AD and mild AD) at the Alzheimer’s Association International Conference (AAIC) held in Denver, Colo., United States and virtually from July 26 to 30, 2021 (Presentation No.: 57780).

Lecanemab Study 201 and OLE
Lecanemab is an investigational humanized monoclonal antibody that preferentially binds to soluble amyloid- beta (Aβ) aggregates (protofibrils). Lecanemab reduced brain Aβ and slowed clinical decline in an 18-month Phase 2b proof of concept study (Study 201, n=856) in early AD (Alz Res Therapy 13; 2021). After analysis of the core study, there was an off-treatment gap period of 9-59 months (period of time between the last dose of lecanemab in the core and the OLE baseline; average of 24 months). After this off-treatment gap, the OLE evaluating the 10 mg/kg IV biweekly lecanemab dosing was implemented (n=180 from core study enrolled). The clinical effect of treatment with lecanemab was assessed via the adjusted mean change of the AD Composite Score (ADCOMS), the primary clinical endpoint of the core study. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment. Additional clinical endpoints included Clinical Dementia Rating-Sum of Boxes (CDR-SB) and AD Assessment Scale – Cognitive Subscale (ADAS- Cog).

May suggest a potential disease-modifying effect
For subjects with early AD at Study 201 OLE baseline, the dose-dependent clinical treatment effect of lecanemab administration relative to placebo during the core phase was maintained. While off-treatment during the gap period, people who received 10 mg/kg IV in the core continued to perform better than those who received placebo on ADCOMS. While off-treatment during the gap period, subjects declined at the same rate on key clinical measures in all core treatment groups. The increase in adjusted mean change between the three month follow up after the core 18-month and OLE baseline for lecanemab bi-weekly, lecanemab monthly and placebo dosing respectively were 0.11 (0.07 to 0.18 ), 0.10 (0.12 to 0.22) and 0.09 (0.19 to 0.28) for ADCOMS. Similar results were observed for CDR-SB and ADAS-Cog. This may suggest a potential disease-modifying effect of lecanemab.

Potential relationship between the plasma Aβ42/40 ratio, brain amyloid by PET and treatment
Low values of plasma Aβ42/40 ratio is recognized as an indicator of elevated amyloid in the brain, and was assessed in a subset of participants in Study 201.1 The plasma Aβ42/40 ratio increased during the core phase and OLE in those treated with lecanemab and decreased during the gap period, potentially demonstrating the relationship between the plasma Aβ42/40 ratio and treatment with lecanemab. The lecanemab treatment related increases in plasma Aβ42/40 ratio were inversely correlated with treatment related reduction of brain amyloid in the core and OLE (Poster No. 57760).

Assessing the long-term effect of continued treatment with lecanemab
Study participants with early AD at the OLE baseline who received placebo during the core phase and were treated for the first time with lecanemab during OLE, as well as those treated with lecanemab both during the core phase and during OLE, showed reduced clinical decline relative to natural disease progression (reference similar population from ADNI). The adjusted mean change from OLE baseline at the end of the 18-month OLE study period for core 10 mg/kg bi-weekly dosing, 10 mg/kg monthly dosing, and placebo groups respectively were 0.102, 0.165 and 0.07 for ADCOMS, all of which showed a slower rate of progression as compared to ADNI (0.214). Similar results were observed for CDR-SB and ADAS-Cog. The results support the concept of increased long-term benefit of continued treatment with lecanemab when initiated in the early AD stage.

These preliminary findings are based on limited data and are being further evaluated in the ongoing Phase 3 Clarity AD study for early AD.

“The findings from the lecanemab Phase 2b OLE study are encouraging as they supply further insights into outcomes with anti-amyloid therapies and we look forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway,” said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. “The unprecedented confluence of medical knowledge, data analytics, and technological advances make it an incredibly exciting time for Alzheimer’s research. This combined with Eisai’s precision research approach, which is a treatment paradigm based on a person’s pathophysiological biomarker profile along the Alzheimer’ disease continuum, makes our company uniquely positioned to research and develop new solutions for patients and their families.”

Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said, “The findings from the Open-Label Extension further strengthen our belief in the potential of addressing amyloid beta pathology in Alzheimer’s disease. We look forward to our ongoing collaboration with Eisai to study lecanemab and continuing to pioneer to address the high unmet need for Alzheimer’s disease patients.”

The enrollment of 1,795 patients with early AD in the Phase 3 Clarity AD clinical study was completed in March 2021. The study’s primary endpoint is expected to be completed by the end of September 2022. The Phase 3 clinical study, AHEAD 3-45, is currently evaluating lecanemab in individuals with preclinical AD.

For more information, visit https://www.eisai.com/news/2021/pdf/enews202165pdf.pdf.


Topic: Press release summary

Japan – Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021

Jul 30, 2021 | Business

Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer’s disease called ICARE AD-US, at the Alzheimer’s Association International Conference (AAIC), being held both virtually and in Denver, Colorado from July 26 – 30, 2021. ICARE AD-US, a prospective study of ADUHELMTM (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM. The virtual oral session (#57522) was titled, “ICARE AD-US: design of a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in United States.”

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

ICARE AD-US is a real-world study that will provide information on the long-term effectiveness and safety of ADUHELM as prescribed in routine clinical practice in the U.S. based on the label approved by the U.S. Food and Drug Administration (FDA). The primary objective of the study is to characterize and evaluate real-world, long-term changes in cognition, function and neuropsychiatric status in ADUHELM-treated patients. Secondary objectives are related to gaining a better understanding of ADUHELM safety in real-world clinical practice.

The study design includes an important goal to help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer’s disease studies, aiming to enroll at least 16 percent of the trial’s expected 6,000 participants from these communities. Alzheimer’s disease clinical trials commonly have one to two percent enrollment from these groups, even though Black/African Americans and Latinx people are respectively two and one-and-a-half times more likely than older White Americans to have Alzheimer’s disease.

The study intends to enroll patients with Alzheimer’s disease over four years from approximately 200 sites in the U.S. Patients will be monitored for a period of up to five years.

“Biogen is committed to both generating new data about ADUHELM and supporting steps to bring adequate representation to this trial and other clinical trials from traditionally underrepresented groups,” said Ivana Rubino, Ph.D., U.S. and Global Head of Medical, Alzheimer’s Disease at Biogen. “We believe this can help us better understand the safety and effectiveness of treatment in patients with Alzheimer’s disease across ethnicities, something that has challenged researchers in this field for decades. The ICARE AD-US study, designed in collaboration with Alzheimer’s disease experts, underscores both of these commitments.”

The ICARE AD-US study is one of three clinical programs designed to generate new data about ADUHELM. The others include EMBARK, the ongoing, Phase 3b re-dosing study for eligible patients previously enrolled in ADUHELM clinical trials, including the PRIME long-term extension, EMERGE and ENGAGE, and the confirmatory Phase 4 trial that is in the process of being designed and will be conducted to verify the clinical benefit of ADUHELM as part of the post-marketing requirements associated with the accelerated approval pathway of ADUHELM in the U.S.

“The ICARE AD-US study will provide important information on the safety, effectiveness and management of Alzheimer’s disease with ADUHELM, the first approved treatment for Alzheimer’s disease that targets the amyloid pathway, in the real-world setting across diverse populations,” said Harald Hampel, M.D., Ph.D., Vice President, Chief Medical Officer, Neurology Business Group, Eisai Inc. “It is important for Eisai and the larger scientific community to recruit patients of diverse ethnicities for clinical trials to help address health disparities.”

The presentation on the ICARE AD-US study will be available for 30 days on the AAIC conference website. Biogen will also post the presentation on the investors section of its website at investors.biogen.com.

For more information, visit https://www.eisai.com/news/2021/pdf/enews202164pdf.pdf.

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