Roche is hitching its wagon to Alnylam’s midstage hypertension med, zilebesiran, and coughing up $310 million in upfront cash for the journey.
The new partnership gives the Swiss pharma full ex-U.S. rights to the drug and co-U.S. rights alongside Alnylam, in exchange for the $310 million plus up to $2.8 billion in potential milestone payments. The two companies will co-commercialize and split profits of the drug in the U.S., according to Monday's announcement.
Alnylam will lead the joint development of the asset through its first indication, currently listed as hypertension, with both companies splitting costs. Roche will have the opportunity to spearhead the development for any future indications.
Alnylam CEO Yvonne Greenstreet said that the partnership allows Alnylam to “develop zilebesiran in a more robust way,” specifically by having cardiovascular outcomes data available at the time of a potential launch.
The treatment is currently in two phase 2 trials, including a placebo-controlled study testing zilebesiran in patients with mild to moderate hypertension. Recruitment for that trial—which was aiming to enroll almost 400 participants—wrapped up in February. Patients will receive either zilebesiran or placebo for the first six months of the trial before placebo patients are randomized to one of four potential treatment doses. Alnylam planned to report interim data from the trial midway through the year but has yet to do so.
Another larger phase 2 study is testing zilebesiran as an add-on therapy to Pfizer’s Norvasc, Daiichi Sankyo’s Benicar and indapamide. Recruitment is still ongoing in that trial with more than 600 patients expected to be enrolled.
Zilebesiran offered a glimmer of promise in its phase 1 results, showing a dose-dependent reduction in a particular gene associated with hypertension and blood pressure control that persisted for up to six months at dose levels of at least 200 mg. The primary endpoint of the monotherapy phase 2 trial is the change from baseline in 24-hour blood pressure at the three-month mark following treatment.
The deal serves as a significant entry for Roche in the metabolic space, where it has few contenders. The company’s current pipeline lists RG6359, a treatment for Pompe disease, as the only clinical-stage metabolic asset.
Editor's note: This story was updated to include the amount of potential milestone payments.