Just days after Alnylam Pharmaceuticals showed that a single injection of zilebesiran can control blood pressure for up to six months, the biotech has joined forces with Roche to usher the mid-stage medication through its clinical trials into clinical use.
Zilebesiran is an investigational RNA interference therapeutic agent that inhibits hepatic angiotensinogen synthesis, which plays a key role in hypertension development.
- Perhaps more notably, zilebesiran’s ability to control blood pressure over long periods could address the daily medication adherence challenges that often undermine hypertension care.
Roche seems to agree about the value that a long-lasting hypertensive might generate, committing to pay $310M upfront followed by milestone-based payments worth up to $2.8B for Alnylam… And that’s not including Alnylam’s share of post-commercialization sales.
The alliance combines Alnylam’s RNAi therapeutics expertise with Roche’s massive funding and extensive track record with drug development and commercialization. More specifically:
- Alnylam will lead the joint clinical development for zilebesiran’s hypertension indication, splitting development costs with Roche 40% / 60%
- Roche will lead future clinical development for other indications
- Alnylam and Roche will co-commercialize zilebesiran in the U.S., where the companies will split an equal share of profits
- Roche will exclusively commercialize zilebesiran outside the U.S., giving Alnylam low double digit royalties on net foreign sales
In the near term, Alnylam and Roche will primarily focus on clinical development, including one Phase 2 trial evaluating zilebesiran as a monotherapy and another Phase 2 combining zilebesiran with existing BP meds (including Pfizer’s Norvasc).
We’ll have to wait to see whether zilebesiran will become the long-lasting antihypertensive that many in cardiology have been waiting for. But there are reasons to be optimistic, given Alnylam’s track record with previous RNAi drugs (5 FDA-approved drugs since 2018, including a cholesterol med that’s now Novartis’ Leqvio) and Roche’s R&D and global commercialization horsepower.