Interferon beta 1a(The University of Southampton)

For Print（184KB） March 2, 2023 Biogen Japan Ltd. Eisai Co., Ltd. Biogen Japan Ltd. (Headquarters: Tokyo, President and Representative Director: Takatsugu Den, “Biogen Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) 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. Biogen Japan Ltd. MEDIA CONTACT: Public Relations & CSR Department MOB: +81-(0)70-1501-4315 TEL: +81-(0)3-3275-1745 Eisai Co., Ltd. MEDIA CONTACT: Public Relations Department TEL: +81-(0)3-3817-5120 [Notes to editors] 1. About Multiple Sclerosis Treatments TECFIDERA, TYSABRI and AVONEX TECFIDERA (dimethyl fumarate) is an orally-administered medicine for the treatment of relapsing forms of multiple sclerosis, including relapse-remitting multiple sclerosis, the most common type of multiple sclerosis. TECFIDERA was approved in Japan for the prevention of relapse and for delaying the accumulation of physical disability in multiple sclerosis in December 2016, and was launched in February 2017. First approved in 2013 in the United States, TECFIDERA has been approved in over 54 countries. TECFIDERA is widely used in the United States and countries in Europe as a first-line treatment, and the number of patients who have been treated with TECFIDERA worldwide to date reached 250,000. TYSABRI (natalizumab, genetic recombinant) is a humanized monoclonal anti-α4 integrin antibody and a disease modifying drug. TYSABRI was approved in Japan for the prevention of relapse and delaying the accumulation of physical disability in multiple sclerosis in March 2014, and was launched in June of the same year. TYSABRI has been approved in over 77 countries worldwide including the United States and countries in Europe, and the number of patients who have been treated with TYSABRI worldwide reached 167,000. AVONEX (interferon beta 1a, genetic recombinant) was approved in Japan for relapse prevention of multiple sclerosis in July 2006, and was launched in November of the same year. In December 2013 a pen formulation was approved and subsequently launched in June 2014. 2. About Biogen Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world. The company routinely posts information that may be important to investors on its website at https://www.biogen.com/. Follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube. Biogen Japan is a subsidiary of Biogen in the U.S. Biogen Japan, as the Japanese affiliate of one of the oldest independent biotechnology companies, started its operation in Japan in 2000. To learn more about Biogen Japan, please visit https://www.biogen.co.jp/. 3. About Eisai Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), with working on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter @Eisai_SDGs 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 Biogen Japan’s promotional activities in Japan with respect to MS products; the anticipated benefits and potential of Biogen’s termination of the co-promotion; collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs; 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 studies may not be indicative of full results or results from later stage or larger scale clinical studies 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 transition of co-promotion to Biogen Japan; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Fewer participants treated with SNG001 compared to placebo progressed to hospitalisation (1/110 vs 7/110, P=0.07) SNG001 was well-tolerated with a favourable safety pro with previous studies High level of adherence to SNG001 treatment at-home was observed, with 90% of patients completing all doses of the once-daily regimen SOUTHAMPTON, England--(BUSINESS WIRE)-- Synairgen plc (LSE: SNG), the respiratory company developing SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta to treat or prevent severe viral lung infections, today announces topline data for participants treated with SNG001 in the US National Institutes of Health (NIH)/ AIDS Clinical Trials Group (ACTG)-led ACTIV-2 Phase 2 adaptive platform trial for COVID-19. Between February and August 2021, 221 symptomatic, non-hospitalised adult participants with COVID-19 were enrolled in the Phase 2 SNG001 evaluation and randomised between active drug (N=110 treated) and placebo (N=110 treated1), across 25 US sites. There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology. Fewer participants required hospitalisation following treatment with SNG001 (N=1/110, [1%]) compared to placebo (N=7/110, [6%]), an 86% relative risk reduction, that was not statistically significant (P=0.07; two-sided Fisher’s exact test). There were no deaths in either arm. There were 13 participants with treatment-emergent Grade 3 or higher Adverse Events (AE) with four on SNG001 [3.6%] and nine on placebo [8.2%]. Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2 trial in October 2021. Later, in March 2022, the NIH decided to halt all participant recruitment in the trial due to the significant shift in the nature of the pandemic which would necessitate a substantial modification of the study design which was not feasible in a multiple treatment-arm platform trial of this size. Richard Marsden, CEO of Synairgen, commented: “The data from the ACTIV-2 trial in the US showing a non-significant but encouraging 86% relative risk reduction in hospitalisation following treatment with SNG001 in home-based patients are very interesting when considered in the context of therapeutic options for the management of non-hospitalised patients during a pandemic. “These results are really encouraging and build upon the strong body of non-clinical and clinical evidence, which includes Synairgen’s home-based trial (SG016) in high-risk patients,2 supporting SNG001’s potential as a broad-spectrum antiviral for a wide range of severe lung infections including COVID-19. We will now begin to evaluate the full data set and factor these findings into our development plans.” William Fischer, M.D., University of North Carolina (UNC), a lead investigator of SNG001 said: “These results, including a decrease in hospitalisations and adverse events among participants who received SNG001, are promising and warrant further investigation in a larger Phase 3 clinical trial. SNG001 is the first nebulized inhaled therapeutic to demonstrate promising results and, if confirmed in larger studies, could represent a potential treatment option for people who have COVID-19 but are not hospitalised.” Participants self-administered SNG001 or placebo via a nebuliser at home to complete 14 daily doses, with the first dose taken either at the study site or at home, with instructions provided by study staff and through an instructional video available online on how to take the study medication. There was a high level of adherence to the once-daily treatment in patients taking SNG001, with 90% of patients receiving full treatment. The ability to self-administer is important in the context of a pandemic when the ability of infected patients to travel to a clinic may be very challenging. The primary goals of the trial were to evaluate safety, to see if the investigational therapeutic could reduce the duration of symptoms through study day 28, and to see if the investigational therapeutic could increase the proportion of patients with undetectable virus in nasopharyngeal swabs at specific time points. Synairgen continues to actively pursue and refine multiple clinical approaches including company- and investigator-sponsored studies and possibly platform studies (as and when appropriate), to confirm the most expeditious clinical development path for SNG001 in patients hospitalised due to a severe viral lung infection including SARS-CoV-2, influenza, RSV, adenovirus, parainfluenza and rhinoviruses. This announcement reports on the reduction in hospitalisations, a key endpoint for determining efficacy of antivirals for COVID-19. Full results, including other key endpoints, will be presented and/or published by the NIH in due course. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. Notes for Editors About Synairgen Synairgen is a UK-based respiratory company focused on drug discovery, development and commercialisation. The Company’s primary focus is developing SNG001 (inhaled interferon beta) for the treatment of severe viral lung infections, including COVID-19, as potentially the first host-targeted, broad-spectrum antiviral treatment delivered directly into the lungs. SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). Founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see . About SNG001 SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta) for inhalation that is delivered directly into the lungs using a mesh nebuliser, which the Company is developing as a potential host-directed antiviral treatment for patients hospitalised with severe viral lung infections, including COVID-19. SNG001 has broad potential applicability for patients hospitalised with respiratory symptoms due to viral infections such as SARS-CoV-2, influenza, RSV, adenovirus, parainfluenza and rhinoviruses. Viruses have been shown to suppress the production of IFN-beta, a naturally occurring protein that orchestrates the body's antiviral defences, with the aim of evading host immune responses. By administering IFN-beta into the lungs, the aim is to correct this deficiency, potentially switching back on the lungs' antiviral pathways to clear the virus. SNG001 has been shown to demonstrate potent in vitro antiviral activity against a broad range of viruses at concentrations that are achievable following inhaled delivery of SNG001 including RSV, rhinovirus, various influenza strains including H5N1, MERS-CoV and SARS-CoV-2 including Alpha, Beta, Gamma, Delta and Omicron variants of concern. About ACTIV-2 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was a public-private partnership to develop a coordinated research strategy to accelerate the development of the most promising COVID-19 treatments and vaccines (Protocol ACTIV-2/A5401; "Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt out COVID)"). ACTIV-2 is an adaptive Phase 2/3 trial testing agents in non-hospitalised adults experiencing mild to moderate COVID-19 sponsored by NIAID, part of the National Institutes of Health, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG). 1 One participant randomized to placebo did not receive study intervention and was excluded from all analyses. The treated population therefore included 220 participants (110 SNG001, 110 placebo). 2 Synairgen conducted a trial of SNG001 in high-risk, home-based COVID-19 patients (SG016) in which fewer patients treated with SNG001 were hospitalised (0/56) compared to placebo (2/58). In total across SG016 and ACTIV-2, 1/165 SNG001-treated home-based COVID-19 patients have been hospitalised.