Alnylam enters pact with Roche to develop, commercialize zilebesiran

Alnylam (ALNY) announced it has entered into a strategic agreement with Roche (RHHBY) to develop and commercialize zilebesiran, Alnylam’s investigational RNAi therapeutic for the treatment of hypertension, which is currently in Phase 2 of development. The partnership allows for a bold development plan with the goal of disrupting the hypertension treatment paradigm globally while advancing Alnylam’s P5x25 strategy. Roche provides Alnylam the benefits of an outstanding partner with a global footprint and a proven track record of developing and commercializing novel therapies in complex markets. Roche has a proven history of innovating and commercializing medicines building upon their extensive global footprint which may potentially enable zilebesiran to reach more patients with hypertension, a disease that affects more than 1.2B patients globally. In a Phase 1 study, zilebesiran, compared to placebo, was associated with dose-dependent reductions in serum angiotensinogen, or 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 or in combination with one of three standard-of-care antihypertensive medications. Based on the 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. Zilebesiran 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 additional substantial near-term payments, including development milestone payments over the next few years, as well as regulatory and sales milestones, for a potential deal value of up to $2.8B. In addition, Alnylam is entitled to an equal profit share in the U.S., where Alnylam and Roche will co-commercialize zilebesiran. Roche obtained the exclusive right to commercialize zilebesiran outside the U.S. in exchange for low double digit royalties on net sales of zilebesiran outside of the U.S. Alnylam believes that this partnership will allow the companies to pursue a joint development plan and commercialization approach that has the potential to unlock the full value of zilebesiran. Additionally, 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 40% by Alnylam and 60% by Roche. Roche may lead development for additional indications in the future.