Sosei to Advance Clinical Development in Japan of HTL0018318 in Patients with Dementia with Lewy Bodies (DLB)
Sosei Group Corporation (“Sosei”); TSE Mothers Index:4565) announces that it has agreed with Allergan to an amendment to the 2016 global R&D and commercialisation partnership between Allergan and Sosei’s subsidiary Heptares Therapeutics, in which Allergan gained exclusive rights to Heptares’ broad portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer’s disease (AD).
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171108006751/en/
The amendment sees Sosei gain a licence to develop and commercialise HTL0018318, a novel muscarinic M1 receptor agonist, in Japan as a potential new treatment for patients with dementia with Lewy bodies (DLB). Initially, Sosei will undertake a Phase 2 proof-of-concept monotherapy study, expected to begin in Japan in 2018. Allergan has retained the right to develop HTL0018318 in DLB globally.
DLB is the second most common form of degenerative dementia after AD and relates to dementia associated with the presence of Lewy bodies (abnormal deposits of a protein called alpha-synuclein) in the brain that affect behaviour, cognition and movement. In DLB, loss of presynaptic cholinergic (acetylcholine-producing) neurons is thought to be a key driver of disease symptoms. As in AD, postsynaptic neurons and muscarinic receptors in DLB are preserved, which presents an important opportunity for a selective M1 agonist based approach.
DLB affects up to an estimated 20-30% of all dementia patients. In Japan, this represents approximately 920,000 individuals, and in the US approximately 1.4 million individuals. There are no approved therapies for DLB in the US or Europe, while branded donepezil (Aricept®, Eisai) is conditionally approved in Japan.
Commenting on the announcement, Peter Bains, CEO at Sosei, said: “This is a very exciting development in our partnership with Allergan. It provides Sosei with a major go-to-market opportunity for our lead program, which is consistent with our growth strategy. Sosei has developed an extensive understanding of the DLB opportunity in Japan, and alongside our clinical development capabilities and track record of successful product development in Japan we believe we can add significant value to the M1 agonist program overall through this activity.”
Notes to Editors
About Muscarinic receptors
Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues. Until now, attempts to develop medicines that target M1 and M4 receptors have been unsuccessful because of side effects caused by the activation of M2 and M3 receptors. Selective M1 or M4 agonists that do not activate M2 or M3 therefore are highly sought after, and expected to address blockbuster markets.
About the Heptares Therapeutics and Allergan Partnership
Heptares Therapeutics and Allergan entered a global R&D and commercialisation partnership in April 2016 under which Allergan licensed exclusive global rights to Heptares’ broad portfolio of novel subtype-selective muscarinic receptor agonists (M1, M4 and dual M1/M4 agonists) in development for the treatment of major neurological disorders, including Alzheimer’s disease.
The companies are advancing a program evaluating a selective M1 agonist (HTL0018318) through clinical studies as a potential treatment for symptomatic cognitive deficits in Alzheimer’s patients; a clinical program to assess the potential of a selective M4 agonist (HTL0016878) to treat certain neurobehavioural symptoms of Alzheimer’s disease; and are developing dual M1/M4 agonists with potential to treat both cognitive and neurobehavioural symptoms through preclinical studies.
In addition, Sosei plans to initiate a Phase 2 clinical study with HTL0018318 in patients with dementia with Lewy bodies in Japan.
Sosei Group Corporation is an international biopharmaceutical company originating from Japan that discovers and develops innovative biopharmaceuticals for the treatment of Alzheimer's disease, schizophrenia, cancer, migraine, addiction, metabolic disease, and other indications. By utilizing its GPCR structure-based drug design platform technology, Sosei has established a product pipeline with first/best in class potential. Through development and commercialization partnerships, Sosei has already delivered two bronchodilators for COPD which generate significant and stable revenue streams that enable further growth. Sosei partners include Novartis, Allergan, AstraZeneca, MedImmune, MorphoSys, Teva, and Pfizer and we are actively looking for new partnerships to enhance the development of our products and help us deliver them to patients worldwide.
For further information about Sosei, please visit http://www.sosei.com/en/.
Sosei Group Corporate Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Sosei’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Sosei Group Corporation
Chris Cargill, +44 (0)7912 892 199
Head of Investor Relations and Corporate Communications
Harumi Banse, +81-(0)3-5210-3399
Investor Relations and Corporate Communications (Japan)
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases20.4.2018 13:30 | Tiedote
Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy. Today, April 20, 2018, Biogen and Ionis will host company conference calls and webcasts to discuss the new collaboration. Full webcast details can be found below. Under the terms of the collaboration, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an appr
Versum Materials Celebrates the Grand Opening of Its Research and Development Facility in Hometown, PA19.4.2018 23:37 | Tiedote
Versum Materials, Inc. (NYSE: VSM), a leading materials supplier to the semiconductor industry, announced today the grand opening of its new research and development (R&D) facility at its semiconductor materials manufacturing site in Hometown, Pennsylvania. The ribbon-cutting ceremony took place April 10, 2018. Versum employees, members of the community, local government, customers and strategic partners attended the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419006305/en/ Versum Materials ribbon-cutting ceremony at the company's new R&D facility in Hometown, PA. (Photo: Business Wire) The state-of-the-art R&D laboratory is dedicated to new materials used in the manufacture of semiconductors. Scientists in the facility will synthesize and purify new molecules down to parts per billion impurity levels and below using the latest technologies available in the industry. The researchers can assess the applications f
Pharnext to Showcase PLEOTHERAPY™ R&D Platform at the 8th Annual Global Orphan Drug Conference19.4.2018 18:45 | Tiedote
Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big data genomics and artificial intelligence, today announced that Rodolphe Hajj, Ph.D., the Company’s Chief Pharmacology Officer, will present at the 8th Annual Global Orphan Drug Conference. The presentation will take place as follows: Date & Time: Wednesday April 25th at 4:40 pm EST Title: “Next generation drug repurposing using network pharmacology to develop new therapeutic entities for rare diseases” Venue: Gaylord National Harbor Hotel, Oxon Hill, MD, U.S. Pharnext’s team will also attend the 2018 American Academy of Neurology Annual Meeting as a first-time exhibitor (booth 908). The meeting will take place on April 21-27, 2018 in Los Angeles, CA, U.S. If you are interested in meeting the Pharnext management team during these events, please send an email to email@example.com. About Pharnext Pharne
New Study Investigates the Utility of Masimo SpHb® in Post-operative Red Blood Cell (RBC) Transfusion Best Practices19.4.2018 18:01 | Tiedote
Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the 2018 Annual Meeting of the Network for the Advancement of Patient Blood Management, Haemostatis and Thrombosis (NATA), in which researchers investigated the utility of Masimo noninvasive and continuous hemoglobin (SpHb®) in supporting and enhancing red blood cell (RBC) transfusion best practices as part of post-operative patient blood management (PBM).1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419005949/en/ Masimo Radical-7® with SpHb® and RD rainbow SET™ Sensor (Photo: Business Wire) In the study, Prof. Baricchi and colleagues in the Transfusion Medicine Unit, AUSL-IRCCS of Reggio Emilia and at the Department of Medicine and Surgery at the University of Parma, Italy, sought to evaluate the appropriateness of post-operative RBC transfusion over a three-year period (2013-2015), before and after implementation of a patient blood managem
Synteract Repositions Itself with Centers of Therapeutic Development and Unveils Updated Brand Platform19.4.2018 17:06 | Tiedote
Synteract, an innovative contract research organization (CRO) providing full-service, Phase I-IV services to biopharma companies bringing new medicines to market, has enhanced its focus. The CRO today announced the creation of therapeutic centers of development that include some of the most progressive in the biopharma industry: oncology, especially leading edge immunotherapy studies, neuro-degenerative disorders, pediatrics, and rare and orphan disease. In addition, Synteract revealed its new market positioning with an updated logo, tagline, and website to reinforce its core capabilities. Synteract’s leadership has been proven in these core development areas, over its nearly 30-year history, through its contributions to more than 240 product approvals. Formal establishment of its new centers of development bring more visibility to Synteract’s longstanding, specialized expertise in these complex areas of clinical research. Synteract CEO Steve Powell says, “By aligning operational excel
Nel ASA: Receives Additional Purchase Order from Nikola19.4.2018 17:00 | Tiedote
Nel ASA (Nel, OSE: NEL) has received a USD 5.5 million purchase order from Nikola Motor Company (Nikola), as part of the previously announced hydrogen stations. “We are very proud to announce that we have received an additional order from Nikola related to the electrolyzer and fueling solution for their prototype trucks. The order marks a strengthening of our partnership and is a recognition of the level of competence our team and hydrogen solutions can offer. We look forward to supplying the demo stations, which will lay the groundwork for the world’s largest, most efficient network of low-cost hydrogen production and fueling sites,” says Jon André Løkke, Chief Executive Officer of Nel. On November 15, 2017, Nikola and Nel announced the exclusive partnership and a purchase order for two so-called demo hydrogen refueling stations for Nikola's fleet of prototype hydrogen trucks. The partnership aims at developing low-cost, renewable hydrogen production and fueling sites for the potentia
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme