HQ Team
July 25, 2023: Switzerland’s healthcare company, Roche, signed a pact with US-based Alnylam to jointly develop and commercialize a therapy to treat hypertension in people with high cardiovascular risk.
The therapy, zilebesiran, is based on an experimental RNAi and is currently in phase II trials.
The partners will co-commercialize zilebesiran in the US and share costs and profits equally. Outside the US, Roche obtains exclusive commercialization rights.
Alnylam will lead a joint clinical development plan for the first indication with Roche’s participation, which includes a cardiovascular outcome trial prior to the submission of zilebesiran for regulatory approval.
The development costs will be shared equally, according to a statement from Roche. Roche may lead development for additional indications in the future.
Upfront $310 million payment
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.
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 globally not being able to effectively manage their blood pressure.
Zilebesiran has the potential to improve 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 a high unmet medical need,” according to the statement.
Premature mortality
Hypertension, or high blood pressure, is the leading cause of cardiovascular disease worldwide, and a major risk for premature mortality.
Early effects of hypertension can include subtle target organ damage such as left-ventricular hypertrophy and cognitive dysfunction.
Over time, uncontrolled hypertension can lead to cardiovascular disease, including stroke, coronary artery disease, heart failure, peripheral artery disease, chronic kidney disease and end-stage renal disease, dementia, and Alzheimer’s disease.
