Zilebesiran is Alnylam’s investigational RNAi therapeutic for the treatment of hypertension, which is currently in Phase 2 of development.
According to both companies, the partnership allows for a ‘bold development plan’ with the goal of disrupting the hypertension treatment paradigm globally.
Roche will provide Alnylam with a global footprint and track record of developing and commercializing novel therapies in complex markets.
In addition, Roche said its global footprint and history of commercializing medicines will enable zilebesiran to reach more patients with hypertension, a disease that affects more than 1.2 billion patients globally.
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.
Zilebesiran also demonstrated an acceptable safety profile supporting continued clinical development.
Based on this positive Phase 1 data, zilebesiran could potentially be a best-in-disease treatment and provide transformational benefit, especially for patients with hypertension at high cardiovascular risk.
It also has the potential to improve adherence to treatment due to its possible biannual subcutaneous dosing regimen. In addition, zilebesiran may be effective in additional potential cardiovascular indications with high unmet need.
Under the terms of the agreement, Alnylam will receive an upfront cash payment of $310 million and is eligible to receive development, regulatory and sales milestones, including substantial near-term payments, for a potential deal value of up to $2.8 billion.
Alnylam and Roche will co-commercialize zilebesiran in the U.S. However, Roche obtains exclusive right to commercialize the treatment outside of America.
Yvonne Greenstreet, CEO of Alnylam, said: “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.”
“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.”
Teresa Graham, CEO of Roche Pharma, added: “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.”
“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.”