GlobeNewswire

Data to be Presented From Biogen's Alzheimer's Disease Clinical Development Portfolio at the 2018 Alzheimer's Association International Conference (AAIC)

Del
  • Ongoing Alzheimer's disease research programs target possible causes of the disease through multiple modalities
  • Data to be presented from Alzheimer's disease clinical development portfolio including aducanumab, elenbecestat, and BAN2401  
  • Data underscore Biogen's long-term commitment to furthering Alzheimer's disease research and treatment, with a focus on patients with early stage disease

CAMBRIDGE, Mass., July 18, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq:BIIB) announced it will present data from its Alzheimer's disease clinical development portfolio at the upcoming Alzheimer's Association International Conference (AAIC) in Chicago (July 22-26). Data being presented are part of Biogen's research programs targeting several of the identified causes of Alzheimer's disease, focusing on early-stage disease.

"The data to be presented at AAIC exemplify our belief that treatments are needed at the earliest stages of Alzheimer's disease to impact the underlying pathophysiology and delay disease progression," said Samantha Budd Haeberlein, vice president, clinical development at Biogen. "We are pleased to present new findings at this year's meeting and continue to demonstrate our commitment to the millions of people living with Alzheimer's disease."

Biogen presentations will include a new analysis from the Phase 1b (PRIME) study of aducanumab, an investigational anti-amyloid beta antibody therapy for mild cognitive impairment (MCI) due to Alzheimer's disease and mild dementia due to Alzheimer's disease. Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive and functional impairment in people with MCI due to Alzheimer's disease and mild Alzheimer's disease dementia, and is being co-developed with Eisai as of October 2017.

In addition, Biogen's collaborator Eisai will present topline Phase 2 clinical study results of BAN2401, an anti-amyloid beta protofibril antibody, and data on elenbecestat, a BACE (beta amyloid cleaving enzyme) inhibitor. Elenbecestat is currently being evaluated in two global Phase 3 clinical studies (MISSION AD 1/2) in early Alzheimer's disease.

These presentations will highlight: 

Alzheimer's disease investigational therapies:

  • 24-Month Analysis of APOE Epsilon4 Carriers in PRIME, a Randomized Phase 1B Study of the Anti-Amyloid Beta Monoclonal Antibody Aducanumab - Poster #22959 - Sunday, July 22, 9:30 a.m.-4:15 p.m. CT
  • Elenbecestat, a Novel BACE Inhibitor, Demonstrates Similar Pharmacokinetics and Safety in Japanese Subjects During Multiple Dosings as in Other Studies - Poster #P1-01 - Sunday, July 22, 9:30 a.m.-4:15 p.m. CT
  • 24-Month Analysis of Change From Baseline in Clinical Dementia Rating Scale Cognitive and Functional Domains in PRIME, a Randomized Phase 1B Study of the Anti-Amyloid Beta Monoclonal Antibody Aducanumab - Oral #22962 - Sunday, July 22, 3:15-3:30 p.m. CT
  • Treatment of Early AD subjects with BAN2401, an Anti-ABeta Protofibril Monoclonal Antibody, Significantly Clears Amyloid Plaque and Reduces Clinical Decline - Presentation # DT-01-07 - Wednesday, July 25, 3:30 p.m.-4:00 p.m. CT
  • Elenbecestat, E2609, a BACE Inhibitor: Results from a Phase-2 Study in Subjects with Mild Cognitive Impairment and Mild-to-Moderate Dementia Due to Alzheimer's Disease - Poster # P4-389 - Wednesday, July 25, 9:30 a.m.-4:15 p.m. CT
  • Lumipulse® G Total Tau to Beta-Amyloid 1-42 Ratio Cut-Point Determination for Amyloid Eligibility Screening - Poster #P4-075 - Wednesday, July 25, 9:30 a.m.-4:15 p.m. CT
  • Anti-Tau Antibody BIIB092 Binds Secreted Tau in Preclinical Models and Alzheimer's Disease Cerebrospinal Fluid - Poster #P4-021 - Wednesday, July 25, 9:30 a.m.-4:15 p.m. CT

General Alzheimer's disease research:

  • Cognitive and Other Neuropsychological Assessments Documented in Electronic Health Records Prior to or at Alzheimer's Disease Diagnosis - Poster #22897 - Sunday, July 22, 9:30 a.m.-4:15 p.m. CT
  • Supporting Disease Modification via Analyses of the Link between Clinical Endpoints and Biomarkers in Alzheimer's Disease Clinical Trials - Poster #24795 - Sunday, July 22, 9:30 a.m.-4:15 p.m. CT
  • Translational Research - the View from Pharma - Platform #S2-02-02 - Monday, July 23, 8:20-8:40 a.m. CT
  • Cognitive Reserve Modulates the Association of Cerebral Amyloid Pathology with Cognitive Performance in Persons with Alzheimer's Disease Dementia - Poster #22491 - Tuesday, July 24, 9:30 a.m.-4:15 p.m. CT
  • AD PACE: Alzheimer's Disease Patient And Caregiver Engagement Initiative-- Determining What Matters Most to Alzheimer's Patients and Care Partners to Inform the Design and Development of New Therapies, Determinations of Payment and Coverage, and the Delivery of Care and Services - Poster #P4-164 - Wednesday, July 25, 9:30 a.m-4:15 p.m. CT

Biogen's platform presentation on the 24-month Clinical Dementia Rating Scale analysis of PRIME and the APOE Epsilon4 analysis of PRIME poster will be available concurrently with the applicable sessions on the Investors section of the Biogen company website, www.biogen.com.  

Eisai's BAN2401 slide presentation will be available concurrently with the AAIC presentation on the Investor section of the Eisai company website at www.eisai.com.

About Aducanumab
Aducanumab (BIIB037) is an investigational compound being studied for the treatment of early 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. As of October 22, 2017, Biogen and Eisai Co. Ltd. are collaborating on the development and commercialization of aducanumab globally. In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of aducanumab, a process allowing priority reviews by the FDA for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.

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 ABeta 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.

About Elenbecestat
Elenbecestat is an oral BACE (beta amyloid cleaving enzyme) inhibitor currently being investigated in Phase 3 clinical studies for Alzheimer's disease discovered by Eisai and in collaboration with Biogen. By inhibiting BACE, a key enzyme in the production of ABeta peptides, elenbecestat reduces ABeta 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 3 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.

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 - TwitterLinkedInFacebookYouTube.

Biogen Safe Harbor 
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 the Phase 1b study of aducanumab and results of certain subgroup analyses in the Phase 1b study, about Eisai's presentation on the results from the Phase 2 study of BAN2401, the potential clinical effects of aducanumab, BAN2401 and elenbecestat the potential benefits, safety and efficacy of aducanumab, BAN2401 and elenbecestat, the identification and treatment of Alzheimer's disease, the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai and the potential of Biogen's commercial business and pipeline programs, aducanumab, BAN2401 and elenbecestat. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "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 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 the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including aducanumab, BAN2401 and/or elenbecestat; the occurrence of adverse safety events; risks of unexpected costs or delays; we may encounter other unexpected hurdles; uncertainty of success in the development and potential commercialization of aducanumab, BAN2401 and/or elenbecestat, 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; failure to protect intellectual property and other proprietary rights; 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 our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports Biogen has filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

MEDIA CONTACT: 

David Caouette  
+1 617 679 4945
public.affairs@biogen.com
INVESTOR CONTACT: 

Matt Calistri
+1 781 464 2442 
IR@biogen.com 




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biogen Inc. via Globenewswire

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Tenaris Convenes General Meeting of Shareholders27.6.2019 00:04:00 CESTPressemelding

LUXEMBOURG, June 26, 2019 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE, Buenos Aires and Mexico: TS and MTA Italy: TEN) announces that it has published the convening notice to the General Meeting of Shareholders that will be held on July 29, 2019, at 11:00 a.m. (Central European Time) at Tenaris’s registered office, located at 29, avenue de la Porte-Neuve, 3rd Floor, L-2227 Luxembourg, to consider, and if thought fit, approve the delisting of Tenaris’s shares from the Buenos Aires stock exchange, Bolsas y Mercados Argentinos S.A., through a voluntary withdrawal from listing. The convening notice (which includes the agenda for the meeting and the procedures for attending and/or voting at the meeting) can be downloaded from the Luxembourg Stock Exchange’s website at www.bourse.lu/regulated-information-oam. In addition, the convening notice, together with the total number of shares and voting rights as of the date of the convening notice, and the proxy materials for the meeting (which include t

Acreage Obtains Final Order for Plan of Arrangement with Canopy Growth and Confirms Record Date for Acreage Shareholders Entitled to Receive the Option Premium26.6.2019 23:20:00 CESTPressemelding

NEW YORK, June 26, 2019 (GLOBE NEWSWIRE) -- On June 21, 2019, Acreage Holdings, Inc. (“Acreage”) (CSE:ACRG.U) (OTC: ACRGF) (FSE: 0ZV) obtained a final order from the Supreme Court of British Columbia approving the previously announced arrangement under section 288 of the Business Corporations Act (British Columbia) with Canopy Growth Corporation (“Canopy Growth”) (TSX:WEED) (NYSE:CGC) (together with Acreage, the “Companies”) (the “Arrangement”). On June 19, 2019, each of Acreage and Canopy Growth received all necessary shareholder approvals in connection with the Arrangement at their respective special shareholder meetings. Pursuant to the Arrangement, Canopy Growth will be provided with the option (the “Canopy Growth Call Option”) to acquire all of the issued and outstanding shares in the capital of Acreage (each, an “Acreage Share”), with a requirement to do so upon a change in federal laws in the United States to permit the general cultivation, distribution and possession of marijua

ERYTECH Announces Enrollment of First Patient in Phase 2 Clinical Trial Evaluating Eryaspase in TNBC26.6.2019 23:00:00 CESTPressemelding

LYON, France and CAMBRIDGE, Mass., June 26, 2019 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, today announced that the first patient has been enrolled in its Phase 2 clinical trial, named TRYbeCA2, evaluating its lead product candidate eryaspase for the treatment of first line triple negative breast cancer (TNBC). Following the positive Phase 2 results with eryaspase in second-line metastatic pancreatic cancer, ERYTECH selected triple-negative breast cancer as the next indication to expand the potential use of eryaspase in solid tumors. TNBC is an aggressive and metabolically active form of breast cancer with high rates of symptomatic metastases. A Phase 2/3 clinical trial in first-line metastatic TNBC, named TRYbeCA2, was designed and the Phase 2 part of the trial was launched in Spain, Belgium, Hungary and the United Kingdom. The t

EXIDE TECHNOLOGIES COMPLETES COMPREHENSIVE NEW FINANCING AND RECAPITALIZATION26.6.2019 19:37:00 CESTPressemelding

Milton, GA, June 26, 2019 (GLOBE NEWSWIRE) -- Exide Technologies (or the “Company”) (www.exide.com), a global leader in stored energy solutions for the automotive and industrial markets, today announced the completion of a comprehensive new financing and recapitalization transaction led by the Company’s institutional shareholders which has enhanced the Company’s liquidity, extended debt maturities and deleveraged its balance sheet. Issued $150 million new international notes, net proceeds of approximately $125 million Converted $175 million of existing second lien notes to equity Extended first lien note maturity to 2024 from 2022 in an exchange offer Extended second lien note maturity to 2027 from 2025 in an exchange offer Extended ABL credit facility maturity to July 2021 from January 2020 “We believe this transaction is a great outcome for Exide and is intended to significantly improve Exide’s financial position allowing for further growth and continued reinvestment in our business,

FIDO Alliance Announces New Identity Verification and IoT Initiatives to Expand the Reach and Impact of FIDO Authentication26.6.2019 16:30:00 CESTPressemelding

New working groups formed to secure adjacent technologies that are critical for end-to-end identity lifecycle management WASHINGTON, June 26, 2019 (GLOBE NEWSWIRE) -- IDENTIVERSE -- The FIDO Alliance today announced two new standards and certification initiatives in identity verification and the Internet of Things (IoT). These initiatives build upon the Alliance’s ongoing focus on driving the efficacy and market adoption of FIDO Authentication by addressing adjacent technology areas that leave security vulnerabilities on the web. Specifically, the Alliance aims to strengthen identity verification assurance to support better account recovery, and automate secure device onboarding to remove password use from IoT. The Alliance has formed two new working groups: the Identity Verification and Binding Working Group (IDWG) and the IoT Technical Working Group (IoT TWG) to establish guidelines and certification criteria in these areas. The FIDO Alliance will continue to focus on development and

Enablon’s Sustainable Performance Forum (SPF) Focuses on the Future of EHS, Risk and Sustainability26.6.2019 16:21:00 CESTPressemelding

New Risk, Safety and Sustainability innovations in mobility, IOT integrations, and artificial intelligence (AI) used live on stage with early-adopter customers CHICAGO and PARIS, June 26, 2019 (GLOBE NEWSWIRE) -- Wolters Kluwer’s Enablon, a global leader in EHS, Risk and Sustainability Management software, announced at SPF 2019 new innovations executing on its Industry 4.0 Connected Enterprise strategy. The global SPF conference series leads the industry with more than 1,000 attendees from over 35 countries, 20 industry user groups, 120 expert sessions and 80 customer and partner presentations. At SPF Americas and SPF EMEA, Enablon announced new solutions across its suite of applications in Health & Safety Management, Governance, Risk & Compliance, Environmental Management & Sustainability, Process Safety & Control of Work, and Product Stewardship & Quality. The conferences focused on execution against Enablon’s Industry 4.0 Connected Enterprise vision, announcing new platform innovati