(IN BRIEF) Roche and Alnylam have entered into a partnership to jointly develop and commercialize zilebesiran, an investigational RNAi therapeutic for the treatment of hypertension. Hypertension affects a significant number of adults worldwide and is a major risk factor for death and disability. The positive Phase 1 data suggests that zilebesiran could be a promising treatment option for patients with hypertension at high cardiovascular risk. The collaboration aims to leverage Alnylam’s expertise in RNAi therapeutics and Roche’s global commercial reach to make a significant impact on severe cardiovascular diseases.
(PRESS RELEASE) BASEL, 25-Jul-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a new partnership with Alnylam to develop and commercialise zilebesiran, an investigational RNAi therapeutic currently in Phase 2 for the treatment of hypertension. Hypertension affects more than 1.2 billion adults worldwide and is the main, independent, preventable risk factor for death and disability, with approximately 80% of the adults with hypertension worldwide not being able to effectively manage their blood pressure.1
Based on the positive Phase 1 data2, zilebesiran could be a best-in-disease treatment and provide transformational benefit, especially for patients with hypertension at high cardiovascular risk. It also has the potential of improved adherence and compliance to treatment due to the possible biannual subcutaneous dosing regime. In addition, zilebesiran could provide patient benefit in additional cardiovascular indications with high unmet medical need.
“We are excited to work together with Alnylam and leverage our strong R&D capabilities, our leadership in cardiovascular diagnostics and our global commercial footprint to further develop and provide this promising therapy with best-in-disease potential to patients,” said Teresa Graham, CEO Roche Pharma. “Throughout our history, we have redefined the standard of care across various disease areas. Together with a strong partner like Alnylam, we are looking forward to making a significant impact for patients living with hypertension at high cardiovascular risk and potentially other cardiovascular indications.”
“We are thrilled to announce this collaboration, as it combines Alnylam’s proven track record in RNAi therapeutics with Roche’s global commercial reach, commitment to innovation and desire to transform the landscape for patients with severe cardiovascular diseases,” said Yvonne Greenstreet MBChB, Chief Executive Officer of Alnylam. “With this collaboration, we now can develop zilebesiran in a more robust way, allowing us to have cardiovascular outcomes data in hand at launch to ensure results relevant not only for health authorities but also for access and clinical practice in order to ultimately reach as many patients as possible.”
In a Phase 1 study, zilebesiran compared to placebo, was associated with dose-dependent reductions in serum angiotensinogen (AGT), achieving tonic blood pressure control with consistent and durable blood pressure reduction throughout a 24-hour period, sustained up to six months after single doses of ≥200 mg. Zilebesiran also demonstrated an acceptable safety profile supporting continued clinical development. The safety and efficacy of zilebesiran are being investigated in Alnylam’s KARDIA Phase 2 clinical program either as a monotherapy (KARDIA-1) or in combination with one of three standard-of-care antihypertensive medications (KARDIA-2).2
Terms of the agreement
This partnership will allow both partners to pursue a joint development plan and commercialization approach to unlock the full value of zilebesiran. As a part of this agreement, Alnylam and Roche will co-commercialize zilebesiran in the U.S. and share cost and profits equally. Outside the U.S. Roche obtains exclusive commercialisation rights. Alnylam will lead a joint clinical development plan for the first indication with Roche’s participation, which includes a cardiovascular outcomes trial prior to submission of zilebesiran for regulatory approval, with all development costs shared by Alnylam and by Roche. Roche may lead development for additional indications in the future.
Under the terms of the agreement, Alnylam will receive an upfront payment of $310m and is eligible to receive development, regulatory and commercial milestones including substantial near-term milestones, together with equal profit and loss share in the US and royalties ex-US.
About zilebesiran
Zilebesiran is an investigational, subcutaneously administered RNAi therapeutic targeting angiotensinogen (AGT) in Phase 2 development for the treatment of hypertension in high unmet need populations. AGT is the most upstream precursor in the Renin-Angiotensin-Aldosterone System (RAAS), a cascade which has a demonstrated role in blood pressure (BP) regulation and its inhibition has well-established anti-hypertensive effects. Zilebesiran inhibits the synthesis of AGT in the liver, potentially leading to durable reductions in AGT protein and ultimately, in the vasoconstrictor angiotensin (Ang) II. Zilebesiran utilises Alnylam’s Enhanced Stabilization Chemistry Plus (ESC+) GalNAc-conjugate technology, which enables subcutaneous dosing with increased selectivity and a wide therapeutic index. The safety and efficacy of zilebesiran have not been established or evaluated by the FDA, EMA or any other health authority.
About hypertension
Hypertension, or high blood pressure, is the leading cause of cardiovascular disease worldwide, and a major risk for premature mortality.3 Early effects of hypertension can include subtle target organ damage such as left-ventricular hypertrophy and cognitive dysfunction.4 Over time, uncontrolled hypertension can lead to cardiovascular disease including stroke (ischaemic and haemorrhagic), coronary artery disease, heart failure, peripheral artery disease, chronic kidney disease and end-stage renal disease, dementia, and Alzheimer’s disease.5,6,7
Despite well-established management strategies such as lifestyle modifications and several classes of available antihypertensive treatments, fewer than 20% of people with hypertension are able to effectively manage their blood pressure.8,9
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] https://www.who.int/news-room/fact-sheets/detail/hypertension
[2] https://www.nejm.org/doi/full/10.1056/NEJMoa2208391?query=featured_home
[3] Mills, K. et al. Nature Reviews Nephrology. 2020;16:223-237.
[4] Mennuni, S. et al. Nature Journal of Human Hypertension. 2014;28:74-79.
[5] Oparil, S. et al. Nature Reviews Disease Primers. 2018;18014.
[6] Nazarzadeh, M. et al. JAMA Cardiology. 2019;4(8):788-795.
[7] Thorin. E. Hypertension. 2015;65:36-38.
[8] Burnier, M. ad Egan, B. Circulation Research. 2019;124:1124-1140.
[9] Hypertension. World Health Organization.
Media Contact:
Phone: +41 61 688 8888
e-mail: media.relations@roche.com
SOURCE: ROCHE
MORE ON ROCHE, ETC.:
- Digi Communications N.V. announces the release of Q3 2024 financial results
- Digi Communications NV announces Investors Call for the presentation of the Q3 2024 Financial Results
- Pilot and Electriq Global announce collaboration to explore deployment of proprietary hydrogen transport, storage and power generation technology
- Digi Communications N.V. announces the conclusion of a Memorandum of Understanding by its subsidiary in Romania
- Digi Communications N.V. announces that the Company’s Portuguese subsidiary finalised the transaction with LORCA JVCO Limited
- Digi Communications N.V. announces that the Portuguese Competition Authority has granted clearance for the share purchase agreement concluded by the Company’s subsidiary in Portugal
- OMRON Healthcare introduceert nieuwe bloeddrukmeters met AI-aangedreven AFib-detectietechnologie; lancering in Europa september 2024
- OMRON Healthcare dévoile de nouveaux tensiomètres dotés d’une technologie de détection de la fibrillation auriculaire alimentée par l’IA, lancés en Europe en septembre 2024
- OMRON Healthcare presenta i nuovi misuratori della pressione sanguigna con tecnologia di rilevamento della fibrillazione atriale (AFib) basata sull’IA, in arrivo in Europa a settembre 2024
- OMRON Healthcare presenta los nuevos tensiómetros con tecnología de detección de fibrilación auricular (FA) e inteligencia artificial (IA), que se lanzarán en Europa en septiembre de 2024
- Alegerile din Moldova din 2024: O Bătălie pentru Democrație Împotriva Dezinformării
- Northcrest Developments launches design competition to reimagine 2-km former airport Runway into a vibrant pedestrianized corridor, shaping a new era of placemaking on an international scale
- The Road to Sustainable Electric Motors for EVs: IDTechEx Analyzes Key Factors
- Infrared Technology Breakthroughs Paving the Way for a US$500 Million Market, Says IDTechEx Report
- MegaFair Revolutionizes the iGaming Industry with Skill-Based Games
- European Commission Evaluates Poland’s Media Adherence to the Right to be Forgotten
- Global Race for Autonomous Trucks: Europe a Critical Region Transport Transformation
- Digi Communications N.V. confirms the full redemption of €450,000,000 Senior Secured Notes
- AT&T Obtiene Sentencia Contra Grupo Salinas Telecom, Propiedad de Ricardo Salinas, Sus Abogados se Retiran Mientras Él Mueve Activos Fuera de EE.UU. para Evitar Pagar la Sentencia
- Global Outlook for the Challenging Autonomous Bus and Roboshuttle Markets
- Evolving Brain-Computer Interface Market More Than Just Elon Musk’s Neuralink, Reports IDTechEx
- Latin Trails Wraps Up a Successful 3rd Quarter with Prestigious LATA Sustainability Award and Expands Conservation Initiatives ↗️
- Astor Asset Management 3 Ltd leitet Untersuchung für potenzielle Sammelklage gegen Ricardo Benjamín Salinas Pliego von Grupo ELEKTRA wegen Marktmanipulation und Wertpapierbetrug ein
- Digi Communications N.V. announces that the Company’s Romanian subsidiary exercised its right to redeem the Senior Secured Notes due in 2025 in principal amount of €450,000,000
- Astor Asset Management 3 Ltd Inicia Investigación de Demanda Colectiva Contra Ricardo Benjamín Salinas Pliego de Grupo ELEKTRA por Manipulación de Acciones y Fraude en Valores
- Astor Asset Management 3 Ltd Initiating Class Action Lawsuit Inquiry Against Ricardo Benjamín Salinas Pliego of Grupo ELEKTRA for Stock Manipulation & Securities Fraud
- Digi Communications N.V. announced that its Spanish subsidiary, Digi Spain Telecom S.L.U., has completed the first stage of selling a Fibre-to-the-Home (FTTH) network in 12 Spanish provinces
- Natural Cotton Color lancia la collezione "Calunga" a Milano
- Astor Asset Management 3 Ltd: Salinas Pliego Incumple Préstamo de $110 Millones USD y Viola Regulaciones Mexicanas
- Astor Asset Management 3 Ltd: Salinas Pliego Verstößt gegen Darlehensvertrag über 110 Mio. USD und Mexikanische Wertpapiergesetze
- ChargeEuropa zamyka rundę finansowania, której przewodził fundusz Shift4Good tym samym dokonując historycznej francuskiej inwestycji w polski sektor elektromobilności
- Strengthening EU Protections: Robert Szustkowski calls for safeguarding EU citizens’ rights to dignity
- Digi Communications NV announces the release of H1 2024 Financial Results
- Digi Communications N.V. announces that conditional stock options were granted to a director of the Company’s Romanian Subsidiary
- Digi Communications N.V. announces Investors Call for the presentation of the H1 2024 Financial Results
- Digi Communications N.V. announces the conclusion of a share purchase agreement by its subsidiary in Portugal
- Digi Communications N.V. Announces Rating Assigned by Fitch Ratings to Digi Communications N.V.
- Digi Communications N.V. announces significant agreements concluded by the Company’s subsidiaries in Spain
- SGW Global Appoints Telcomdis as the Official European Distributor for Motorola Nursery and Motorola Sound Products
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2023 financial year
- Digi Communications N.V. announces the exercise of conditional share options by the executive directors of the Company, for the year 2023, as approved by the Company’s Ordinary General Shareholders’ Meetings from 18th May 2021 and 28th December 2022
- Digi Communications N.V. announces the granting of conditional stock options to Executive Directors of the Company based on the general shareholders’ meeting approval from 25 June 2024
- Digi Communications N.V. announces the OGMS resolutions and the availability of the approved 2023 Annual Report
- Czech Composer Tatiana Mikova Presents Her String Quartet ‘In Modo Lidico’ at Carnegie Hall
- SWIFTT: A Copernicus-based forest management tool to map, mitigate, and prevent the main threats to EU forests
- WickedBet Unveils Exciting Euro 2024 Promotion with Boosted Odds
- Museum of Unrest: a new space for activism, art and design
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by companies within Digi Group
- Digi Communications N.V. announces the agreements concluded by Digi Romania (formerly named RCS & RDS S.A.), the Romanian subsidiary of the Company
- Green Light for Henri Hotel, Restaurants and Shops in the “Alter Fischereihafen” (Old Fishing Port) in Cuxhaven, opening Summer 2026
- Digi Communications N.V. reports consolidated revenues and other income of EUR 447 million, adjusted EBITDA (excluding IFRS 16) of EUR 140 million for Q1 2024
- Digi Communications announces the conclusion of Facilities Agreements by companies from Digi Group
- Digi Communications N.V. Announces the convocation of the Company’s general shareholders meeting for 25 June 2024 for the approval of, among others, the 2023 Annual Report
- Digi Communications NV announces Investors Call for the presentation of the Q1 2024 Financial Results
- Digi Communications intends to propose to shareholders the distribution of dividends for the fiscal year 2023 at the upcoming General Meeting of Shareholders, which shall take place in June 2024
- Digi Communications N.V. announces the availability of the Romanian version of the 2023 Annual Report
- Digi Communications N.V. announces the availability of the 2023 Annual Report
- International Airlines Group adopts Airline Economics by Skailark ↗️
- BevZero Spain Enhances Sustainability Efforts with Installation of Solar Panels at Production Facility
- Digi Communications N.V. announces share transaction made by an Executive Director of the Company with class B shares
- BevZero South Africa Achieves FSSC 22000 Food Safety Certification
- Digi Communications N.V.: Digi Spain Enters Agreement to Sell FTTH Network to International Investors for Up to EUR 750 Million
- Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics
- driveMybox continues its international expansion: Hungary as a new strategic location
- Monesave introduces Socialised budgeting: Meet the app quietly revolutionising how users budget
- Digi Communications NV announces the release of the 2023 Preliminary Financial Results
- Digi Communications NV announces Investors Call for the presentation of the 2023 Preliminary Financial Results
- Lensa, един от най-ценените търговци на оптика в Румъния, пристига в България. Първият шоурум е открит в София
- Criando o futuro: desenvolvimento da AENO no mercado de consumo em Portugal
- Digi Communications N.V. Announces the release of the Financial Calendar for 2024
- Customer Data Platform Industry Attracts New Participants: CDP Institute Report
- eCarsTrade annonce Dirk Van Roost au poste de Directeur Administratif et Financier: une décision stratégique pour la croissance à venir
- BevZero Announces Strategic Partnership with TOMSA Desil to Distribute equipment for sustainability in the wine industry, as well as the development of Next-Gen Dealcoholization technology
- Digi Communications N.V. announces share transaction made by a Non-Executive Director of the Company with class B shares
- Digi Spain Telecom, the subsidiary of Digi Communications NV in Spain, has concluded a spectrum transfer agreement for the purchase of spectrum licenses
- Эксперт по торговле акциями Сергей Левин запускает онлайн-мастер-класс по торговле сырьевыми товарами и хеджированию
- Digi Communications N.V. announces the conclusion by Company’s Portuguese subsidiary of a framework agreement for spectrum usage rights
- North Texas Couple Completes Dream Purchase of Ouray’s Iconic Beaumont Hotel
- Предприниматель и филантроп Михаил Пелег подчеркнул важность саммита ООН по Целям устойчивого развития 2023 года в Нью-Йорке
- Digi Communications NV announces the release of the Q3 2023 Financial Results
- IQ Biozoom Innovates Non-Invasive Self-Testing, Empowering People to Self-Monitor with Laboratory Precision at Home
- BevZero Introduces Energy Saving Tank Insulation System to Europe under name “BevClad”
- Motorvision Group reduces localization costs using AI dubbing thanks to partnering with Dubformer
- Digi Communications NV Announces Investors Call for the Q3 2023 Financial Results
- Jifiti Granted Electronic Money Institution (EMI) License in Europe
- Предприниматель Михаил Пелег выступил в защиту образования и грамотности на мероприятии ЮНЕСКО, посвящённом Международному дню грамотности
- VRG Components Welcomes New Austrian Independent Agent
- Digi Communications N.V. announces that Digi Spain Telecom S.L.U., its subsidiary in Spain, and abrdn plc have completed the first investment within the transaction having as subject matter the financing of the roll out of a Fibre-to-the-Home (“FTTH”) network in Andalusia, Spain
- Продюсер Михаил Пелег, как сообщается, работает над новым сериалом с участием крупной голливудской актрисы
- Double digit growth in global hospitality industry for Q4 2023
- ITC Deploys Traffic Management Solution in Peachtree Corners, Launches into United States Market
- Cyviz onthult nieuwe TEMPEST dynamische controlekamer in Benelux, Nederland
- EU-Funded CommuniCity Launches its Second Open Call
- Astrologia pode dar pistas sobre a separação de Sophie Turner e Joe Jonas
- La astrología puede señalar las razones de la separación de Sophie Turner y Joe Jonas
- Empowering Europe against infectious diseases: innovative framework to tackle climate-driven health risks
- Montachem International Enters Compostable Materials Market with Seaweed Resins Company Loliware
- Digi Communications N.V. announces that its Belgian affiliated companies are moving ahead with their operations
- Digi Communications N.V. announces the exercise of conditional share options by an executive director of the Company, for the year 2022, as approved by the Company’s Ordinary General Shareholders’ Meeting from 18 May 2021
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2022 financial year
- Digi Communications N.V. announces the availability of the 2022 Annual Report
- Digi Communications N.V. announces the general shareholders’ meeting resolutions from 18 August 2023 approving amongst others, the 2022 Annual Accounts
- Русские эмигранты усиливают призывы «Я хочу, чтобы вы жили» через искусство
- BevZero Introduces State-of-the-Art Mobile Flash Pasteurization Unit to Enhance Non-Alcoholic Beverage Stability at South Africa Facility
- Russian Emigrés Amplify Pleas of “I Want You to Live” through Art
- Digi Communications NV announces the release of H1 2023 Financial Results
- Digi Communications NV Announces Investors Call for the H1 2023 Financial Results
- Digi Communications N.V. announces the convocation of the Company’s general shareholders meeting for 18 August 2023 for the approval of, among others, the 2022 Annual Report
- “Art Is Our Weapon”: Artists in Exile Deploy Their Talents in Support of Peace, Justice for Ukraine
- Digi Communications N.V. announces the availability of the 2022 Annual Financial Report
- “AmsEindShuttle” nuevo servicio de transporte que conecta el aeropuerto de Eindhoven y Ámsterdam
- Un nuovo servizio navetta “AmsEindShuttle” collega l’aeroporto di Eindhoven ad Amsterdam
- Digi Communications N.V. announces the conclusion of an amendment agreement to the Facility Agreement dated 26 July 2021, by the Company’s Spanish subsidiary
- Digi Communications N.V. announces an amendment of the Company’s 2023 financial calendar
- iGulu F1: Brewing Evolution Unleashed
- Почему интерактивная «Карта мира» собрала ключевые антивоенные сообщества россиян по всему миру и становится для них важнейшим инструментом
- Hajj Minister meets EU ambassadors to Saudi Arabia
- Online Organizing Platform “Map of Peace” Emerges as Key Tool for Diaspora Activists
- Digi Communications N.V. announces that conditional stock options were granted to executive directors of the Company based on the general shareholders’ meeting approval from 18 May 2021
- Digi Communications N.V. announces the release of the Q1 2023 financial results
- AMBROSIA – A MULTIPLEXED PLASMO-PHOTONIC BIOSENSING PLATFORM FOR RAPID AND INTELLIGENT SEPSIS DIAGNOSIS AT THE POINT-OF-CARE
- Digi Communications NV announces Investors Call for the Q1 2023 Financial Results presentation
- Digi Communications N.V. announces the amendment of the Company’s 2023 financial calendar
- Digi Communications N.V. announces the conclusion of two Facilities Agreements by the Company’s Romanian subsidiary
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by the Company’s Romanian subsidiary
- Patients as Partners Europe Returns to London and Announces Agenda Highlights
- GRETE PROJECT RESULTS PRESENTED TO TEXTILE INDUSTRY STAKEHOLDERS AT INTERNATIONAL CELLULOSE FIBRES CONFERENCE
- Digi Communications N.V. announces Digi Spain Telecom S.L.U., its subsidiary in Spain, entered into an investment agreement with abrdn to finance the roll out of a Fibre-to-the-Home (FTTH) network in Andalusia, Spain
- XSpline SPA / University of Linz (Austria): the first patient has been enrolled in the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment (CRT-DRIVE)
- Franklin Junction Expands Host Kitchen® Network To Europe with Digital Food Hall Pioneer Casper
- Unihertz a dévoilé un nouveau smartphone distinctif, Luna, au MWC 2023 de Barcelone
- Unihertz Brachte ein Neues, Markantes Smartphone, Luna, auf dem MWC 2023 in Barcelona
- Editor's pick archive....