Swiss pharmaceutical giant Roche (SWX: ROG) has signed a deal with US-based RNAi specialist Alnylam (NASDAQ: ALNY), securing rights to co-develop and co-commercialize Alnylam’s zilebesiran, a Phase II stage RNAi therapeutic targeting angiotensinogen (AGT) for the treatment of hypertension.
Financial Terms and Collaboration Details
Under the agreement, Roche will pay Alnylam an upfront fee of USD 310 million, with development and commercial milestones that could bring the total potential deal value to USD 2.8 billion. The collaboration will see Roche and Alnylam co-commercialize the therapy in the United States, sharing profits equally, while Roche will hold full commercial rights in other territories, in return for a low-double-digit royalty on future sales.
Development and Potential Impact of Zilebesiran
Alnylam will lead the development of zilebesiran in its first indication as a treatment for general hypertension, either as a monotherapy or in combination with other anti-hypertensives. The drug candidate offers a once-every-six-months dosing schedule and is considered a potentially transformational “best-in-disease” treatment, particularly for patients with hypertension at high cardiovascular risk. Zilebesiran is currently the subject of two Phase II trials in patients with mild to moderate hypertension.
Clinical Trials and Recruitment Details
KARDIA-1, the first trial, is assessing zilebesiran as a monotherapy, with enrollment of 400 patients already completed. The second trial, KARDIA-2, will assess the molecule in combination with one of three standard-of-care antihypertensive medications – Pfizer’s Norvasc (amlodipine), and Daiichi Sankyo’s Benicar (olmesartan) or Lozol (indapamide). This trial aims to recruit 600 patients, further expanding the clinical evaluation of zilebesiran’s potential in hypertension treatment.-Fineline Info & Tech
