AstraZeneca has secured the last piece to a global puzzle of licensing agreements with Ionis Pharmaceuticals for the rare heart disease drug eplontersen.
The partners have now extended a global licensing deal for the transthyretin amyloidosis (ATTR) therapy to Latin America, which means another $20 million for Ionis, according to a Friday release. The deal has now reached $3.6 billion in potential milestone payments to come, up from $3.5 billion previously agreed.
AstraZeneca already had rights to commercialize eplontersen in all other countries except the U.S., where it will co-develop the drug with Ionis. The latest deal will now allow the U.K. Big Pharma to circle the globe once the therapy is approved.
Eplontersen was found to stall disease progression in patients with ATTR during a phase 3 trial which read out in April. The therapy is being developed to treat all types of ATTR and would go up against Alnylam’s Amvuttra and Onpattro.
AstraZeneca has put billions on the line to co-develop and commercialize the med with Ionis. The original licensing package, signed in 2021, included $200 million upfront, $485 million in additional conditional payments and up to $2.9 billion in sales-related milestone payments. The companies are working together on development and commercialization efforts in the U.S.
The therapy has already been filed with the FDA for ATTR polyneuropathy, a form of the condition that affects the peripheral nerves. The U.S. regulator has set an action date of December 22 for the application and granted eplontersen orphan drug designation. AstraZeneca and Ionis plan to seek regulatory approval in the EU and other countries later this year.
Meanwhile, the phase 3 CARDIO-TTRansform study for ATTR cardiomyopathy rolls on. This form of the disease leads to progressive heart failure.