Ionis Pharmaceuticals (NASDAQ: IONS) and AstraZeneca have announced a collaboration agreement to develop and commercial Ionis’ experimental antisense drug, eplontersen, for transthyretin amyloidosis (ATTR) treatment after expiration of the waiting period as per the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Ionis and AstraZeneca partner to commercialize eplontersen
Eplontersen, which was known as IONIS-TTR-LRx, is used to treat ATTR, a systemic, progressive, and deadly disease, by reducing the production of transthyretin, or TTR protein. It leverages Ionis’ LIgand-Conjugated Antisense (LICA) tech.
As previously announced, the companies will co-develop, develop, and market eplontersen in the United States. Outside of the United States, AstraZeneca has an exclusive license for eplontersen, with the exception of a few Latin American countries. Ionis will get a $200 million upfront payment, around $485 million in approval and development milestones, and sales-related milestone payments of $2.9 billion under the terms of the agreement. In addition, the agreement includes cost-sharing arrangements for territory-specific development, medical, and commercial activities.
Ionis also qualifies for royalties ranging from the low double digits to the mid-twenties percent, depending on the region. Ionis’ Form 8-K, filed with the Securities and Exchange Commission on December 7, 2021, contains more information regarding the deal. As per the agreement terms, Ionis will continue producing and supplying eplontersen for clinical studies.
NDA for eplontersen in hereditary ATTR expected in 2022
Ionis CEO Brett P. Monia said, “We believe that bringing together Ionis’ industry-leading experience in RNA-targeted therapeutics and deep knowledge of the TTR amyloidosis market with AstraZeneca’s global scale and leadership in cardiovascular drug development and commercialization will enable faster and deeper market penetration for the benefit of patients. In addition to being the best strategy to maximize patient and shareholder value for eplontersen, this agreement also represents a key step in bolstering our commercial organization as we prepare to launch multiple products.”
The firms plan to pursue regulatory clearance for eplontersen for hereditary ATTR amyloidosis (hATTR) with polyneuropathy initially, with the possibility of filing a new drug application (NDA) with the US FDA by the end of 2022.
