Alnylam Awarded Innovation Passport in the United Kingdom for Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension

Alnylam Awarded Innovation Passport in the United Kingdom for Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension

- The Innovation Passport is the Entry Point to the Innovative Licensing and Access Pathway, Which Aims to Accelerate the Time to Market and Facilitate Patient Access to Innovative Medicines -

MAIDENHEAD, UK — June 08, 2022 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT), has been awarded an Innovation Passport for the treatment of hypertension by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All Wales Therapeutics and Toxicology Centre (AWTTC).

The Innovation Passport is the entry point to the UK’s Innovative Licensing and Access Pathway (ILAP), which aims to accelerate the time it takes to bring a molecule to market and facilitate patient access to medicine through the development of a target development profile that outlines a unique product-specific roadmap for regulatory and development milestones[i]. Other benefits of ILAP include a 150-day accelerated assessment of the initial Marketing Authorisation Application, rolling review and a continuous benefit-risk assessment.

Simon Fox, Ph.D., Vice President and Program Leader, Zilebesiran Programme at Alnylam said: “Hypertension is a major risk factor for premature mortality and remains the leading cause of cardiovascular disease worldwide[ii]. Despite the availability of oral antihypertensive therapies, many patients remain uncontrolled. We are pleased to see that the MHRA also recognises the need for the development of novel therapeutic approaches for this disease. The Innovation Passport designation underscores the promise of our RNAi therapeutic for the treatment of hypertension, and we are hopeful that by continuing to evaluate the potential of zilebesiran to deliver tonic blood pressure control over 24 hours with an infrequent dosing regimen, we may ultimately be able to fill a critical unmet need in this disease.”

In the UK, an estimated 15 million people have high blood pressure – around 28 percent of adults – and at least half of them are not receiving effective treatmentⁱⁱ. As part of a larger development program to evaluate the efficacy and tolerability of zilebesiran, a Phase 2 study exploring zilebesiran as a concomitant therapy in adults whose blood pressure is not adequately controlled by standard of care antihypertensive medications is ongoing, including at clinical trial sites within the UK.

Brendan Martin, Senior Vice President and Commercial Innovation Lead at Alnylam said: "At Alnylam we want to be as innovative commercially as we are scientifically.  We believe proactive, early dialogue with health technology assessors and commissioners is essential to help the biotech sector flourish and ultimately to ensure patients gain faster access to innovative new treatments which could transform their lives.  We support the UK Life Sciences Strategy and are pleased to see the UK continue to lead the way in introducing pathways, such as the ILAP, that we hope will accelerate uptake of important new medicines."

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[i] Innovative Licensing and Access Pathway. Guidance. Available at: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway. Accessed May 2022.

[ii] British Heart Foundation. UK Factsheet, January 2022. Available at: https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics-uk-factsheet.pdf?la=en&rev=231fa9066a64451e83b107aa63461a37&hash=1CECE96BC260AB985C5BC119F07267E43825D891. Accessed May 2022.